including informed consent - hbm4eu...including informed consent deliverable report d 7.4 wp 7 -...

HORIZON2020 Programme Contract No. 733032 HBM4EU

1st material for communication to participants, including informed consent

Deliverable Report

D 7.4 WP 7 - Survey design and fieldwork preparation

Deadline: January 2018 Upload by Coordinator: 19.06.2018

Entity Name of person

responsible Short name of

institution Received

[Date]

Coordinator Marike Kolossa-Gehring UBA 13/06/2018

Grant Signatory Stelios Yiannopoulos MOH-CY (Partner No. 6)

13/06/2018

Pillar Leader Argelia Castaño Calvo ISCIII 13/06/2018

Work Package Leader Ulrike Fiddike UBA 04/01/2018

(v0.1 on 12/12/2017

v0.2 on 22/12/2017

v1.0 on 04/01/2018

v2.0 on 19/04/2018

v3.0 on 11/06/2018)

Task leader Andromachi Katsonouri MOH-CY

Responsible author Andromachi Katsonouri

MOH-CY

E-mail [email protected]

Short name of institution

Phone +357-22805015

Co-authors Dora Partassides, Daphne Kleopa, Elena Anastasi, Catherine Ganzleben, Derya Ay, Ovnair Sepai, Lorraine Stewart, Tiina Santonen, Simo Porras

Ref. Ares(2018)3230894 - 19/06/2018

D 7.4 - 1st material for communication to participants, including informed consent Security: Public WP 7 - Survey design and fieldwork preparation Version: 3.0 Authors: Andromachi Katsonouri Page: 2

Table of contents

Table of contents ............................................................................................................................ 2

1 Authors and Acknowledgements .............................................................................................. 4

2 Introduction .............................................................................................................................. 5

3 General considerations for effective communication with participants in HBM4EU biomonitoring surveys .............................................................................................................. 6

4 Materials for participants in HBM4EU surveys ......................................................................... 8

4.1 Materials to support recruitment ........................................................................................ 8

4.1.1 The invitation letter .................................................................................................... 9

4.1.2 The information leaflet ............................................................................................... 9

4.1.3 The chemical factsheets .......................................................................................... 10

4.1.4 The reply cards ........................................................................................................ 10

4.1.5 The reminder letter .................................................................................................. 10

4.1.6 The letter of thanks to ineligible persons .................................................................. 10

4.2 Materials to support the fieldwork.................................................................................... 10

4.2.1 The appointment letter ............................................................................................. 10

4.2.2 The pre-visit letter and instructions .......................................................................... 11

4.2.3 The withdrawal form ................................................................................................ 11

4.2.4 Certificate of informed consent ................................................................................ 11

4.3 Materials to support the reporting of personal results to participants ............................... 11

4.3.1 The thank you letter and report of personal results .................................................. 11

4.3.2 The chemical factsheets .......................................................................................... 11

5 Guidelines for the development of key communication products for survey participants ........ 12

5.1 Invitation letter ................................................................................................................ 12

5.1.1 Make it personal ...................................................................................................... 12

5.1.2 Use motivational quotes and clear calls for action .................................................... 12

5.1.3 Use simple language to explain the importance of study & participation .................. 12

5.1.4 Emphasise the credibility of the study ...................................................................... 13

5.1.5 Explain clearly what you are asking from participants .............................................. 13

5.1.6 Confidentiality and right to opt out ............................................................................ 13

5.2 Information leaflet ........................................................................................................... 13

5.2.1 Description of the study. .......................................................................................... 13

5.2.2 Credibility and value of the study. ............................................................................ 14

5.2.3 Participation ............................................................................................................. 14

5.2.4 Legal and ethical aspects ........................................................................................ 15

5.2.5 Operational Procedures and/or Logistics. ................................................................ 18


5.2.6 Communication and structure aspects ..................................................................... 19

5.3 Certificate of informed consent ....................................................................................... 20

5.3.1 Informed consent framework.................................................................................... 20

5.3.2 Identifiers of the study and the researcher taking the consent and the consenting participant ................................................................................................................ 20

5.3.3 Information and Understanding ................................................................................ 20

5.3.4 Volunteerism and opting out .................................................................................... 20

5.3.5 Collection of personal data ...................................................................................... 21

5.3.6 Transfer of samples and data .................................................................................. 21

5.3.7 Right to know ........................................................................................................... 21

5.3.8 Risks and benefits ................................................................................................... 22

6 Tailored materials for the HBM4EU occupational survey: Exposure of workers to hexavalent chromium and other hazardous chemicals ........................................................... 23

7 Bibliography ........................................................................................................................... 24

8 Appendixes: Written communication products for HBM4EU survey participants .................... 27

Appendix 1: Invitation letter .................................................................................................... 28

Appendix 2: Information leaflet, including info on study, role of participants, chemicals ......... 31

Appendix 3: Reply cards ........................................................................................................ 39

Appendix 4: Reminder letter ................................................................................................... 44

Appendix 5: Thank you letter ................................................................................................. 47

Appendix 6: Fact sheets on chemicals ................................................................................... 50

Appendix 7: Appointment letter .............................................................................................. 54

Appendix 8: Pre-visit (reminder) letter .................................................................................... 58

Appendix 9: Informed consent ............................................................................................... 62

Appendix 10: Withdrawal form ............................................................................................... 67

Appendix 11 & 12: Thank you letter / Report of personal results ............................................ 70

Appendix 13: Leaflet with information for workers .................................................................. 75

Appendix 14: Consent form for participating workers ............................................................. 79

Appendix 15: Fact sheet "Working safely with chromium" ...................................................... 82

Appendix 16: Leaflet with information for employers .............................................................. 85

Appendix 17: Consent form for employers ............................................................................. 89


1 Authors and Acknowledgements

Lead author: Andromachi Katsonouri, Ministry of Health, Republic of Cyprus (MOH-CY)

Document history:

Version Submission Authors and Acknowledgements

1.0 04/01/2018 Lead author: Andromachi Katsonouri, Ministry of Health, Republic of Cyprus (MOH-CY)

Other Contributors :

Task 7.5 MOH-CY Dora Partassides, Daphne Kleopa, Elena Anastasi

EEA Catherine Ganzleben, Derya Ay

DH Ovnair Sepai, Lorraine Stewart

WP7 leader UBA Ulrike Fiddicke

WP8

(for the hexavalent chromium occupational survey)

FIOH Tiina Santonen, Simo Porras

NHCPs The national hub contact points (NHCP) of Belgium, Croatia, Cyprus, Denmark, France, Israel, Latvia, Portugal, Slovenia, Spain, and Switzerland provided information on national practices related to communication with participants. The NHCP of Finland & coordinator of the European Health Examination Survey (EHES) provided valuable input based on the EHES.

2.0 19/04/2018 A revised document was prepared based on feedback from reviewers and the WP7 Leader

Authors:

Task 7.5 MOH-CY Andromachi Katsonouri (Lead Author), Giagkos Lavranos, Dora Partassides

Reviewers:

European Commission

Sofie Norager, Peter Korytar, Mariann Karcza

HBM4EU MB Members of the Management Board

Task 1.5 Berit Faber, Lisbeth E. Knudsen, Hanna Tolonen

3.0 11/06/2018 A revised document was prepared based on feedback from reviewers, the WP7 Leader and the MOH-CY task 7.5 team

Author:

Task 7.5 MOH-CY Andromachi Katsonouri

Reviewers:

Ethics Board Berit Faber, Lisbeth E. Knudsen, Hanna Tolonen, Ovnair Sepai, Paul Scheepers

This document has been created for the HBM4EU project. HBM4EU has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733032.


2 Introduction Survey participants are a crucial category of HBM4EU stakeholders, since the success of the project ultimately depends on their willingness to volunteer their time, biological samples and personal information. For this reason, an essential aspect of the preparations for the implementation of HBM4EU surveys involves the development of communication materials for the participants around the following strategic aims:

1. Build trust by ensuring transparency and openness towards the study participants

2. Communicate effectively with survey participants to ensure their understanding of the broader project objectives and their own role in HBM4EU research

3. Enhance recruitment and informed consent of participants, including people with disability, low educational background and minors

4. Improve the awareness of participants on the relevant environmental health issues

5. Promoting behavioural changes to reduce chemical exposure and improve health and well-being

6. Report individual results wherever desirable and/or required and to the extent possible their interpretation, taking into consideration the scientific uncertainties

7. Raise awareness of the role of HBM4EU activities in protecting human health from chemicals

This deliverable describes the first set of written materials developed for survey participants in HBM4EU surveys. It includes:

(a) an overview of key concepts, which must be kept in mind during the development of materials for survey participants

(b) a description of the different types of materials, which may be used in HBM4EU surveys

(c) guidelines for the development and adaptation of key materials

(d) templates of materials for general population surveys. These may be adapted according to the study plan of each specific HBM4EU survey

(e) tailored materials for the first occupational HBM4EU survey, which will investigate the exposure of workers to hexavalent chromium and other hazardous chemicals


3 General considerations for effective communicatio n with participants in HBM4EU biomonitoring surveys

The development of communication materials for participants in HBM4EU surveys must carefully consider the needs of their end-users and the study plan of each survey. The following considerations are important:

► Trust : Communication must be based on trust and transparency. This is best achieved through honest and effective bidirectional communication between the research team and the participants, which adds value for both parties. The credibility of the survey funders and organisers is a key element for building trust. Trust can also be enhanced through genuine efforts to address the needs and concerns of the participants and through the involvement of trusted members of local communities in national communication actions.

► Message : Must be specific to the intended audience, clear, free of jargon and unnecessary technical details, short and to the point and appropriate for audience age / maturity / educational background. The implications of the project for them must be very clearly presented and where appropriate, simple recommendations must be provided. The use of graphical illustrations and easy to read fonts and colours is recommended.

► Burden for participants : The written materials must clearly: convey the time participants will need to invest; the samples and information they need to provide; address their concerns (e.g. safety, privacy, busy schedules, knowing their personal body burden) and present their rights.

► Value for participants : Value creation involves: value to society through the participants’ contribution to the advancement of scientific knowledge and policy for the protection of human health; personal value through receiving their personal/overall results if so desired and/or required and their significance and (if applicable) any other tangible incentives

► Uncertainties : Risk communication must take into consideration the uncertainties and gaps in our knowledge. This is especially relevant for the communication of the results to the survey participants.

► Confidentiality and respect : The written materials and all communication actions must emphasise that participation is voluntary and that the participant can opt out at any time; that the confidentiality of personal results will be guaranteed; and the privacy of participants will be respected.

► Co-creation : Broad and extensive scientific literature, as well as the DEMOCOPHES experience show that the best output is achieved through the engagement of participants as co-creators in participatory research. Community involvement is an effective way to enhance recruit rates and engage participants (e.g. school-based recruitment coupled to awareness raising and educational actions).


► Communication channels : These must be appropriate for the audience and chosen to minimise the burden while maximising the benefit for the participants. Possible channels are:

− Face to face: Based on the experience of partner countries and the published scientific literature, this is the most effective communication channel, but also the most resource-demanding.

− Written Communication (e.g. the focus of this task), usually through post or in combination with face-to-face meetings: Written products must be tailored for the intended audience and the study plan of the survey.

− Internet: The internet can be a powerful way to reach potential participants and to communicate with actual participants, but requires careful planning, more specialised skills and is more resource-intensive.

► Flexibility : The written materials must be adapted by each national study leader to best serve their national situation. This may be necessary due to possible cultural, legal and practical differences among the countries running HBM4EU surveys.

The preparation of the HBM4EU communication materials in this deliverable took into consideration the following:

− the “Legal and ethics policy document” developed by HBM4EU WP1

− the new European General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679)

− the advice of the Cypriot Commissioner for personal data protection obtained in a face to face meeting

− the lessons learned from COPHES / DEMOCOPHES, national biomonitoring studies and other relevant participatory studies such as the European Health Examination Survey (EHES).


4 Materials for participants in HBM4EU surveys As summarised in Table 1, the written material needed to support communication with participants in HBM surveys can be categorised as follows: (a) material to support recruitment, (b) material to support sampling and (c) material to support the dissemination of the results to participants and (d) materials to support awareness raising and promotion of precautionary behavioural changes.

Table 1. Materials for supporting communication wit h participants in HBM4EU population surveys

Need Written communication product

Support recruitment 1. Invitation letter

2. Information leaflet, including info on study, role of participants, chemicals (may differ per age group and study)

3. Reply cards

4. Reminder letter

5. Thank you letter (for persons interested to join the study, but are ineligible)

6. Fact sheets on chemicals

Support sampling 7. Appointment letter

8. Pre-visit letter

9. Certificate of informed consent

10. Withdrawal form

Disseminate results to participants

11. Thank you letter

12. Report of personal results

Raise awareness & promote precautionary behavioural changes


14. Layman presentation of the collective results (not under the responsibility of task 7.5)

A number of HBM4EU surveys of the general population will take place during the lifetime of the project. At the time of writing, the details of the different surveys are not known. For this reason, the goal of this deliverable was to create templates of writen communication materials for participants in HBM4EU surveys. These templates may be used for the development of products tailored the needs and requirements of the different surveys. The templates are presented in the Appendix. The Appendix also includes tailored materials, developed to support the first occupational HBM4EU (exposure of workers to hexavalent chromium, see §6).

A description of the different materials follows below.

4.1 Materials to support recruitment Prospective participants will receive an invitation letter to join the HBM4EU survey. The letter will be accompanied by an information leaflet about the study and what participation involves and factsheets on the chemicals which will be investigated. It is suggested that a copy of the certificate of informed consent (which participants must complete and sign before they can officially join the study) is also provided, to give them the opportunity to review it before they decide if they want to join the study.


People interested to join the study can use a reply card to express their interest. People not wishing to participate, but willing to answer (anonymously) a few questions designed to assess participation bias, may use a different type of a reply card.

Those who expressed an interest to participate in the survey but don’t fulfil the inclusion criteria of the study, should be informed by receiving a letter of thanks with an appropriate explanation.

The content of each of these materials is described below. All materials are writen in plain language, appropriate for the intended audience.

4.1.1 The invitation letter

The invitation letter should include the following:

• Organiser’s specific details

• Aim of the study

• How the invitees were chosen

• What taking part involves

• Confidentiality

• Funders of the study

Guidelines related to the development of the invitation letter can be found in the “Invitation letter guidelines”

4.1.2 The information leaflet

The information leaflet supplements the invitation letter. It must describe the study aims and what participation involves in simple language. The following list covers the main topics and questions answered on the template information leaflet:

• About HBM4EU and its importance for public health

• Who funds the study

• Why the study is being done and who approved it

• Why am I asked to take part?

• How will the study be carried out?

• What do I have to do if I agree to take part?

• What happens next?

• How do I prepare for the visit?

• What will happen during our appointment?

• What will happen to my samples, data and results?

• How can I learn about the results of the study?

• How will my privacy be guaranteed?

• Why do you need my written consent?

• How will I benefit if I participate?

• Are there any risks if I join the HBM4EU study?

• Are there any costs to me?

• What if I have any concerns or complaints while I’m taking part in the study?

• How can I quit the study?

• Who do I contact if I’m unsure about anything or would like further information about the study?

Guidelines for the development of this leaflet can be found in § 5.2.


4.1.3 The chemical factsheets

It is suggested that factsheets about the chemicals to be investigated, are provided to participants both during recruitment and when reporting the results of the study. They can be enclosed together with the information letter in order to give a brief description about the chemicals being examined by the HBM4EU study and with the report of personal results to remind participants on the sources of exposure and how to prevent getting exposed.

The factsheets should describe what these chemicals are, where they are found, how people may become exposed to them, how Human Biomonitoring is performed, how they can affect human health and ways to reduce exposure.

4.1.4 The reply cards

Two reply cards have been developed. For easy reference, the one reply card is coloured green and the other is coloured orange.

The green reply card is intended for invitees who wish to participate. It asks participants to complete their contact details, to specify their preference for a day and time they can be contacted and to return it to the contact provided.

The orange card is intended for invitees who do not wish to participate in the study but are willing to answer a few questions aimed to facilitate assessment of potential selection bias. The name and phone of the responder may or may not be asked, depending on the study design. If identifying information is collected, then all data processing must confirm with the requirements of the European General Data Protection Regulation and with ethics standards.

Participants should be instructed to return the reply card of their choice back to the researchers.

4.1.5 The reminder letter

At the time specified by the study plan, invitees who have not yet responded should be reminded to return their reply card to the research team by a specified date. A template reminder letter was developed for this purpose.

4.1.6 The letter of thanks to ineligible persons

Invitees who expressed an interest to participate in the study but did not meet the inclusion criteria or exceeded the recruitment maximum limit should be sent a letter of thanks for taking an interest in the study, with an explanation as to why they can’t participate and how to follow the progress of the project. A template letter was developed for this purpose.

4.2 Materials to support the fieldwork

4.2.1 The appointment letter

Using the information provided with the green reply card, the research team can contact responders who expressed an interest to join the study, to confirm their eligibility and to set a time for the appointment. It is suggested to then send a confirmation letter, with the time and location of their appointment and that the appointment letter is accompanied by two copies of the informed consent form. Participants can be instructed to complete and sign the enclosed consent forms and to have them with them at the time of their appointment. They can retain the one copy for their records and should return the second copy to the research team at the beginning of their appointment.


4.2.2 The pre-visit letter and instructions

This letter can be sent to prepare and remind participants about their appointment’s data and time, and to remind them to have their signed informed consent forms with them at the time of their appointment. The template letter also includes instructions as to what they will have to do before (for example collection of morning urine) and during the appointment.

4.2.3 The withdrawal form

According to ethics guidelines and GDPR1, it must be emphasised that participation is voluntary and can be cancelled at any time if the participant decides to withdraw. In this case, the participants will be asked to confirm their wish by signing a withdrawal form. The withdrawal also covers the right to be forgotten through the removal of the person’s stored data and samples in databases / biobanks, at least up to the extent that this is reasonably possible (i.e. if the matching of coded data/samples to individuals can still be made by the national study leader / custodian of records of each study).

4.2.4 Certificate of informed consent

This is one of the most important materials in participatory studies. The certificate of informed consent (also known as informed consent form) certifies in writing that the person has been accurately and adequately informed about the research and what participation involves and voluntarily consents to participate. Detailed guidelines are presented in § 5.3 for the development of the Certificate of informed consent.

4.3 Materials to support the reporting of personal results to participants

4.3.1 The thank you letter and report of personal r esults

Two template materials have been developed to support the reporting of personal results to survey participants who expressed a wish to receive this feedback or need to do so by legislation:

(a) A thank letter intended to inform participants that the study has been completed and that their personal results are enclosed. It acknowledges their critical contribution to the study and s them for it. It also provides essential information regarding the interpretation of their enclosed personal results and possible call for further action (if applicable). For some chemicals it may not possible to describe what the levels measured in their samples mean for them, whereas for other chemicals there may be no information linking the levels to possible health effects. In these cases, it may only be possible to report the levels found in their samples and to compare them to the collective results.

(b) The report of personal results uses an easy to understand traffic light system to inform participants about the exposure level and compares their values to relevant reference values. It also provides a field for an appropriate recommendation (e.g. actions to take for preventing exposure, what to do if the exposure level is very high).

4.3.2 The chemical factsheets

See section 4.1.3.

1 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (enforcement date: 25 May 2018)


5 Guidelines for the development of key communicati on products for survey participants

5.1 Invitation letter The invitation letter is very important. It creates the first and strongest impression and provides prospective participants with essential information to decide if they will spend further time to consider joining the study. The letter must be carefully structured and should contain only essential, accurate information in a clear and interesting way. It can be thought of as an executive summary of the companion “Information for participants” leaflet.

The following must be kept in mind during its development:

5.1.1 Make it personal <Mr. / Ms. First Name Last Name> <Street Address> <Town/City POSTCODE> Dear < name of addressee]

Comment: Personalise the letter. Address each invitee by his / her name, as this shows respect and may stimulate response.

5.1.2 Use motivational quotes and clear calls for a ction

Let’s create a healthier future together, by reducing exposures to hazardous chemicals.

Please let us know your decision by returning the enclosed reply card.

You can also contact us for any questions or concerns you may have about the study using the provided contact details.

Thank you for your time. We hope to hear from you soon. Without your participation, we cannot succeed in co-creating healthier future for all Europeans.

Comment: Use a motivational quote that you will be using consistently to brand your study. Choose something which communicates that the invitee is important and will be contributing to something singificant. Make them feel included and part of this collective study which will help create a healthier future for all European citizens.

5.1.3 Use simple language to explain the importance of study & participation

We would like to invite you to take part in HBM4EU (Human Biomonitoring for Europe), a study which aims to investigate people’s exposure to hazardous chemicals.

Your participation is vital and will help us measure and limit European citizens’ exposure to potentially hazardous chemicals.

You have been randomly chosen to participate together with [XX] European citizens from [YY] different European countries.

Comment: Explain the aim of the study using simple language and avoid using aims and objectives from the scientific protocol. Use short sentences of no more than 15-20 words. Be aware of your audience and how familiar they are with terminology you use. Also, avoid jargon. Make them understand why they were chosen and why their participation is important.


5.1.4 Emphasise the credibility of the study

In [your country], the study is under the responsibility of [Ministry of (country’s) (Program Owner)].

Sincerely, [Title and Name of the Principal Researcher] [Signature of responsible person]

Comment: State the funders and beneficiaries and the principal researcher of the study as it adds credit and gives value, therefore building trust with participants. Emphasising that the organisers of HBM4EU surveys (funding, implementation) are national governments, the European Commission and an expert network of scientists and that the results will be used to support policy actions for chemical management and public health protection at national and EU level can enhance the response rate.

5.1.5 Explain clearly what you are asking from part icipants

If you do decide to take part, we will be asking you [adjust according to study plan: to visit our Examination Centre at a time and date that suits you / home visits]. There, our research team will collect some bio-samples [specify according to study plan: such as urine, blood and exhaled air], as well as gather some information about [specify according to study plan: your daily lifestyle].

Comment: Explain what the participant needs to do if he chooses to participate in this study in a simple and clear manner. Avoid many details, be as brief as possible and state that further information can be found in the information leaflet.

5.1.6 Confidentiality and right to opt out

Your personal information and samples will be protected by using coding that will make them impossible to trace back to you and you can withdraw from the study any time you wish and without disclosing your reasons, by following the process explained in the relevant section of the study information leaflet.

Comment: Mention that they will remain impossible to trace / match to specific replies or samples, that their privacy will be safeguarded, and that more information regarding this can be found in the information letter. Emphasise they are free to withdraw at any time using the specified process.

5.2 Information leaflet

5.2.1 Description of the study.

[You are invited to take part in a research study. Before you decide whether or not you wish to take part, please read the following information to understand why the research is being done and what it involves. We are happy to answer any questions or concerns you may have. Your participation is voluntary and may opt out at any time.

HBM4EU and its importance to you and to public heal th

We are all exposed to a complex mixture of chemicals on a daily basis. Some chemicals may harm health and for this reason they must be regulated in the environment, consumer products, food and drinking water and certain workplaces. HBM4EU (Human Biomonitoring for Europe) is a European study which will use Human Biomonitoring (measurements of environmental chemicals, their metabolites or reaction products in biological samples collected from people) to understand human exposure to such chemicals and the related health risks.

The results will be used, wherever appropriate, to support policy makers with their decisions regarding the introduction or adaption of relevant laws and interventions for the safe management


of chemicals and the protection of human health in Europe. By engaging with participants like you, HBM4EU will help to raise awareness among the public and promote actions to prevent exposures to potentially harmful chemicals.

HBM4EU is funded by the European Commission and national governments and includes experts from 28 countries and European Union agencies. It started in 2017 and will run until 2021. The study [specify name of the study] is carried out the frame of HBM4EU. In [specify country], it is under the responsibility of [specify Program Owner].

Learn more at [website of the specific study, if available] and https://www.hbm4eu.eu

Comment: Information about the study should be short, to the point and written in simple language. Other relevant information, which is deemed beneficial, should be added to strenghen the importance of the study and its relevance to the invitee (e.g to protect you from exposure to hexavalent chromium, a known carcinogen, by improving safety and control measures in workplaces like yours all over Europe). If invitees feel that they can contribute to a wider social cause and help improve a specific health concern, they may be motivated to read further. Mentioning specific country facts is a strong persuading point.

Importance for public health: as part of persuasion theory (ethos, pathos, logos) you should explain why invitees have been chosen and are being contacted. Mentioning their individual contribution to the study and then continuing with a more collective approach i.e “Importance of study for Public Health” will make it easier to persuade invitees to participate.

5.2.2 Credibility and value of the study.

Why is this study being done and who approved it?

’This research study is taking place to [explain research questions, e.g.]

− … find out if the current safety and control measures used across Europe can protect the public from the exposure to [ harmful chemicals

− … develop new methods to assess the exposure to these chemicals. − … other ]

The study has been approved by the [national Bioethics Committee] and complies with the Data Protection Regulation.

Comment: For each specific HBM4EU survey, this section must be adjusted to describe the research questions. Mentioning funders, beneficiaries and principal researchers of the study adds credit and gives value, therefore building trust with participants and so increasing the response rate. Each country needs to inform their respective Bioethics committees about the study. Mentioning these governmental authorities again increases credibility and value and makes participants more comfortable about giving out their personal information. The telephone numbers of these authorities can be included on the information leaflet. It is also important to mention that invitees have the right to contact an authority independent to the research team in case they have any concerns (see section on legal and ethical aspects).

5.2.3 Participation

Why am I asked to take part?

You have been selected from [ e.g. population registry] to represent [ describe the study population in easy to understand terms ] in [your country]. If recruiting through an intermediary organisation: The [ relevant organisation ] has consented to participate in the study and has agreed to allow the HBM4EU researchers to extend an invitation to you to participate if you decide to do so.


Representativeness and usefulness of the results of the study will depend on people we contact to get involved.

Comment: This section must address the question “Why have you decided to ask me (in particular) to take part in this study?” Keep this simple! Make sure people understand the words you use! Do not assume participants will understand words and terms such as ‘inclusion’, ‘exclusion criteria’ and ‘control’.

Individuals must be informed about how they were chosen and where their personal information was taken from (e.g from electoral rolls, social insurance registers, population registers). If recruiting through schools or other settings requiring consent at organisation level, inform that you have requested and were granted permission to recruit participants through the organisation. If not done already, provide assurance that data will be processed in coded format not traceable back to individual source must be provided here.

5.2.4 Legal and ethical aspects

How will I benefit if I participate?

This section must answer the questions:

1. “Will I benefit myself from taking part? How will I benefit?

Some possible benefits include:

• You will receive a medical briefing which is not available during your routine medical examination. Please note that this examination is not a substitute for your regular health care checks.

• You will receive information regarding your exposure to specific chemicals and the associated potential health impact.

• You will receive your personal results [by law any new high incidence of chemical levels should be reported] should you wish to further examine them with your doctor.

• You will be getting up to date knowledge about chemicals which may be dangerous and what their effect on our health is

• [ Describe any other incentives, if applicable]

2. Will others benefit if I take part?”

You and all people like you in [your country] and in Europe will benefit from the collective results of the study, which will be used to [ understand the exposures of people to harmful chemicals and how these can affect the human body / develop harmonised / new methods to measure exposures / develop better chemical management policies across Europe.] [Describe any other incentives, if applicable]

Comment: Motivation of the invitees should be an ongoing process throughout the study’s promotion. In this section, it should be clearly stated what the actual benefit for the invitees will be if they choose to participate: which results will be given to them and how, and what kind of information regarding chemicals they will be receiving through the study. Any incentives partners decide to provide should also be stated here; this depends on each country’s ethical limitations or approvals.

Are there any risks if I join the HBM4EU study?

Some participants may experience minor discomfort during the collection of [blood] samples. All sampling will be conducted by qualified and specially trained health professionals. [If applicable: Study participants will be covered by insurance for any adverse events relevant to their participation, without any charge to them].


Comment: This section must describe any risks associated with taking part. It should be stated that there is minimal risk involved when taking the blood sample, and possibly completely eliminated by having qualified and specially trained nurses taking the blood sample. In addition, if insurance coverage is provided for the duration of the stay in the research center, it should also be stated.

What if I have any concerns or complaints while I’m taking part in the study?

Your wellbeing is our foremost priority and we will take all necessary precautions to ensure your comfort and safety. If you have any concerns during your appointment, please discuss them with our research team or at any time by contacting the study leader [Title, Name, Tel No., Email address]. You have the right to opt out of the study at any time and for any reason (without the need to disclose this). In the unlikely event that you want to file a complaint about the study, you may do so by contacting [Title, Name, Tel No., Email address], who is not formally connected to the study and serves as an independent overseer of its implementation.

Comment: This section may not be required in some national studies. Some national bioethics committees may require the appointment of a trusted person at national level, not formally connected to the study, whom participants can contact if they have concerns or complaints about the study.

How will my privacy be protected?

Your privacy is protected by complying with the requirements of the European General Data Protection Regulation [and specify relevant national legislation, if applicable]. The [specify name of legal entity] is responsible for the protection of your data against loss, unauthorised access /use, modification / disclosure or other misuse. The Data Controller is [specify (name, function, e.g. study coordinator or Director of legal entity)].

All data processing will be done in such a way, that it is no longer possible to attribute your data to you without the use of additional information. Your name will be replaced by a code. Information which identifies you (name, contact details) will be kept separately and under protective measures. All electronic and paper records will be protected from unauthorised access of your private information. Published reports of the study will not contain information that can be traced back to you. Third parties will not have access to your personal results, unless you consent to.

Comment: The new European Regulation for personal data protection applies to all EU countries, effective May of 2018. Any other international or national Data Protection Acts should also be mentioned. In addition, participants should be informed that fieldworkers are also aware of the aforementioned and that they have undergone training regarding the handling of personal data and information. A detailed description on how privacy will be guaranteed could be described here. The Data Protection Authority may have to be informed. It is advised that a written procedure for the protection of personal data is in place at the legal entity carrying out the study and that it is in compliance with the GCPR requirements.

What happens if I say yes, but I change my mind lat er?

You are free to withdraw from the study at any time, without any consequences by [sending an e-mail to / calling specify the name, and email and/or phone number of the responsible person]. We will ask you to confirm your wishes by signing the attached withdrawal form. On this form you can indicate one of the following options:

• “No further contact but my samples and data can be used”.

We will no longer contact you, but have your permission to retain and use information and samples that you have already provided.


• “No further contact and my samples and data cannot be used”.

We will no longer contact you and will destroy your samples and data, unless they have been completely anonymised and we cannot trace them back to you. For the integrity of the study and in the interest of public health, we will retain your coded data in analyses that have already been completed. We will retain your signed consent and withdrawal forms as a record of your wishes and for audit purposes.

You can request a copy of these forms from us using the contact details provided below.

Comment: Participants should know that if they wish, they can withdraw at any time by signing the withdrawal form. However, whether the data derived from a person withdrawing will be discarded or not, may depend on each country’s legislation and it should be communicated to the participants.

Why do you need my written consent?

Your written consent confirms that you volunteer to take part in the study after understanding what is required from you and what your rights are. You have the right to withdraw your participation without any consequence at any point (including any data or samples already provided, if they have not been completely anonymised and so impossible to be traced back to you) and the right to choose if you want to receive your individual results or not. You will also confirm that we can contact you in the future to tell you about your personal results or for historical, statistical or scientific purposes. A copy of the Certificate of Informed Consent, which you will be asked to complete and sign before taking part in the study, is attached to this leaflet and you can keep it for future reference.

Comment: Invitees should know why their written consent is needed. The consent form should include all legal and ethical aspects, and if possible, the possibility of future contact. Most importantly, the consent form should act as a means of ensuring participants understand the scope of the study, the methods used and how the data will be used. This will be guaranteed by participants signing each section of the form. Patient rights (to be forgotten, to receive or not receive personal results subject to limitations due to obligatory report of outlier values or destruction of individual / data matching info after a set time) should be stated and adaptations for special groups (e.g. minors requiring both parent consent, people unable to sign) must be taken into account

Who do I contact if I have any questions or would l ike further information about the study?

You can contact [title, name, function, phone number, email] or visit the websites [website of the specific study] and https://www.hbm4eu.eu].

Comment: It is important that the participants know they are able to speak with someone at any time to ask any questions they may have or express any concerns. This will assist in building trust between the participants, the study and fieldworkers, hence also increasing participation rates.

How can I learn about the results of the study?

When the study is completed [specify according to study plan: in approximately XX weeks/months], you will be informed by [specify name of person, e.g. study coordinator] about your personal results [specify the biomarkers which will be reported to the participant], unless you expressed a wish not to receive them on your certificate of informed consent.

In the event that high levels of chemicals are detected, you will be advised to review your results with your family / personal doctor/ general practitioner.


You will also be informed about the collective results of the study. These will be published as a study report and will be publicly available at [specify correct website, e.g. https://www.hbm4eu.eu or national study website].

Comment: Whether participants will be provided with their personal results depends on each national study. However, where results will be published and what they will be used for should be clearly stated. The ethical standards of some countries may require that participants whose results are over the acceptable limit of chemical exposure are informed and consulted for his/her further actions. In this case, not disclosing such results to the participant in question may be considered Public Health liability/negligence.

What will happen to my samples, data and results?

Your samples and data will be used only according to your informed consent and in a way that protects your privacy according to the European regulation GDPR1 and national requirements. The released results of the study will not identify you in any way.

A code will be assigned to you by [adjust if necessary: the study coordinator], who will then remove all personal identifiable information to protect your privacy and make it impossible to trace your data or samples back to you.

Your coded2 samples will be transferred to specialised laboratories for analysis [specify where the analysis will take place]. Your samples will be examined to measure your exposure to [explain which chemical contaminants will be analysed and why]. Your samples will then be stored at [specify place and length of storage] for possible use in future ethically approved studies of chemical exposure. Coded data collected from you and other participants will be stored and used for research purposes and may be combined with other data from different sources. The sharing of data will be facilitated through dedicated data infrastructures and/or Information systems (such as IPCHEM, which is the European Commission Information platform for Chemical Monitoring3).

The overall results of the study will be provided to national and European authorities to support policy actions related to chemical management for public health protection. They will also be disseminated to other stakeholders, including the general public, scientists and other interested parties.

Comment: You must inform participants how their samples, data and results will be used and must ensure compliance with all European/national legal and ethical requirements.

5.2.5 Operational Procedures and/or Logistics.

Invitees should be fully informed about all operational procedures and logistics (costs and time) the study involves. Costs such as travel expenses should also be stated even if these will be refunded later on.

How will the study be carried out?

The study will take [specify time period] in [your country] and [number] other European countries. It will include a total of [number] participants and [number] of them will come from [your country]. Each participant will provide biological samples and will complete a questionnaire. We will analyse this information to determine your exposure to a variety of potentially harmful environmental chemicals.

2 Coded samples and data may be completely anonymized (i.e. samples and data are completely unlinked from the person who provided them) or pseudoanonymized (i.e. the identification and contact information of the person providing them is kept by the study leader, under security and with restricted acccess). It will be decided when the template materials are finalized for the specific needs of each study, if the terms anonymized or pseudoanonymized will have to be differentiated and explained. 3 https://ipchem.jrc.ec.europa.eu


Comment: Describe when and where the study will take place, how many people will be taking part nationally and across Europe, what people can expect to happen by taking part (in general terms), for example, completing a survey and providing biological samples.

What do I have to do if I want to take part?

Comment: This is a very important section must be adjusted for each HBM4EU survey. It must describe (in very simple language) exactly what the participant will be asked to do and must include the estimated time commitment, instructions on how to express interest to participate, how the study appointment will be set (place and date of appointment, samples to be collected and by who, analyses to be performed on each sample, type of personal information to be collected and how (self-completed questionnaire? interview?), any reimbursement for travel expenses, etc.

Are there any costs involved?

Specify if travel and out of pocket expenses can be claimed back and if yes, how.

5.2.6 Communication and structure aspects

5.2.6.1 Linguistics

• Explain any details the participants may not be familiar with. Think of the person reading your information and question yourself while you are writing.

• Test your document with readers or focus groups to ensure it is understandable and reader-friendly.

• Use everyday words, and personalise using “you” or “we” where you can. • Be direct and use the active voice most of the time i.e “We will decide on your application

soon” instead of “A decision on your application will be made soon. • Try to represent the participant as doing action as much as possible. • Avoid unnecessary jargon by using simple words instead of any scientific or technical

terminology i.e carcinogenic. • Define unfamiliar abbreviations and acronyms but try to keep these to a minimum. • Avoid Latin and French expressions and try to use full words. Try not use e.g., i.e and etc.

You can use ‘in lieu’ or ‘inter alia’ to avoid confusion. • Remove unnecessary words and phrases. Avoid using nouns made from verbs, use

concrete actions i.e use “consider” instead of consideration.

5.2.6.2 Design and structure

• Keep the text manageable. Use plain literacy and avoid too many sentences for each section. Have an average of 15-20 words in each sentence.

• It is acceptable to use well-punctuated sentences with shorter, snappier ones for variety. • Break up dense text using sub-headings, question and answer formats and bulleted lists.

This will help the reader to find their way through the document but also identify sections that they may be more interested in.

• Use any colour and images appropriately, making sure they are easy on the eye and have a clear purpose.

• If using tables or figures make sure they genuinely help explain the text. • Use space to help your text stand out (1.5 line spacing, justified text). • Use clear readable font (Arial, Verdana or Tahoma and aim for 12 point as standard). No

more than three distinct fonts in a document is advised. • Emphasise text carefully by keeping capital letters to a minimum and avoid SHOUTING AT

YOUR READER! Avoid using italics or underlining; it makes text harder to read.


5.3 Certificate of informed consent

5.3.1 Informed consent framework

As with all participatory research, ethical and privacy requirements are extremely important for HBM4EU surveys. It is important for all researchers involved in the study to be aware of the legal and ethical obligations that they have towards the study participants. They should understand why informed consent is needed at all stages of the study including data collection, processing or analysis, storage or bio banking, publication of results. Fieldworkers and recruiters of the study should know the issues and the framework in the informed consent material and why these are important. The process of informing prospective participants and receiving their written informed consent, must be possible to document. The study design should allow a minimum of 24 hours for the invitees to consider the invitation before they consent to participate. It must be noted that ethics requirements may differ from one country to another. It is the responsibility of each study leader to ensure that the national ethics requirements are obeyed.

The certificate of informed consent generally contains the following fields:

5.3.2 Identifiers of the study and the researcher t aking the consent and the consenting participant

The consent form should include the title / general description of the study, the name / contact information of the researcher taking the consent.

5.3.3 Information and Understanding

I was given the “Information for Participants” leaflet, which explains the following related to the research study:

• the purpose of the study and how it will be carried out • what my participation involves • my rights (to withdraw, to be forgotten and remove any data/samples provided, to choose

whether I wish to be informed of my personal results) • my commitments.

I had the opportunity and time (at least 24 hours) to consider and comprehend the information in the “Information for Participants” leaflet.

I had the opportunity to ask questions and I received satisfactory answers.

Comment: Participants must be adequately informed about the study and must be given a consideration period of no less than 24 hours to decide if they wish or not to participate. All the information given to participants about the study should be communicated in simple linguistic style and in a manner that is easy to understand. It is important to avoid jargon and scientific or technical words that participants might not be able to understand. Participants should be able to ask questions and receive satisfactory answers.

5.3.4 Volunteerism and opting out

I understand that my participation in the research, as defined in the “Information for Participants” leaflet, is voluntary and that I am free to withdraw at any time (without giving any reason and without my medical care or legal rights being affected), by following the procedure explained in the “Information for Participants” leaflet.

I understand that if I choose to withdraw from the study, data related to me and collected prior to my withdrawal will continue to be used solely for the purpose of allowing the research to be completed. These data will be “coded” (my name will be replaced by a code) to protect my identity.


Comment: It must be emphasised that participation is voluntary and is not being influenced by coercion, manipulation or pressure. Also, participants should be aware that they have the right to withdraw from the study at any time.

5.3.5 Collection of personal data

I consent that the [name of organisation, represented by … (name and function of the data/sample controller)] will have the exclusive access to my identifying personal information and will encode my data and samples according to the currently available safeguards, in such a way that other users of my data cannot trace back to me.

I consent to [ the long-term / duration] storage and use of my coded samples [ (type)] and coded personal data collected in this study for research related to public health and environmental health purposes, even in the event of my death or my becoming incapacitated.

Comment: If the national study is planning to store bio-samples for future purposes then it should be stated on the consent form. Duration of long-term storage should also be stated. The exact samples and where they will be stored should also be stated in the information letter. It is preferred to use the word “long-term storage” rather than “biobank” as it might be intimidating for some.

It should be guaranteed that the protection of their personal data and bio-samples will in no case be disclosed to any third party. Also, assurance that bio-samples or personal information provided will not be tested or used for any other purpose other than for the purpose listed (i.e. alcohol and drug usage). Each country has to specify for what scientific, historical or statistical purposes the samples may be used in the future.

5.3.6 Transfer of samples and data

I consent that my coded samples and/or data can be transferred to specialised laboratories, biobanks, databases, data infrastructures, research establishments, administrative authorities and institutions in the European Union and associated countries or used for public announcements and reports within the scope of the research.

Comment: The procedures that will be followed to keep participants’ information and bio-samples secure and confidential will be described in the information leaflet. Specific national and European legislation or regulations on Data Protection and Privacy should also be provided in the information leaflet. In some countries there may be legal limitations regarding storage.

5.3.7 Right to know

I consent that the [name of organisation, represented by … (specify the name and full contact details of responsible person)] may contact me in the future for public and environment health-related research purposes and/or to inform me about my personal results, if I choose to receive them.

I understand that I have the right to receive my personal results as stated in the “Information for Participants” leaflet and I indicate my preference as follows (please mark one option only):

• I wish to receive my personal results • I wish to receive my personal results only if they exceed the health-based guidance values

used in the study (wherever applicable) • I do not wish to receive my personal results.

Comment: Participants have the right to choose if they wish to receive their results or not. The study plan should pay careful attention on how to deal with incidents of high exposures.


5.3.8 Risks and benefits

I understand that I will not benefit financially from taking part in this study.

Comment: It should be clearly stated that participants will not benefit financially; other incentives given will be stated in the information letter. Risks and benefits are also stated in the information letter.


6 Tailored materials for the HBM4EU occupational su rvey: Exposure of workers to hexavalent chromium and othe r hazardous chemicals

A number of tailored materials have been developed to support the first occupational survey of HBM4EU, which will investigate the exposure of workers to hexavalent chromium and other hazardous chemicals. The materials, which were developed in close collaboration with the organisers of the study, are summarised in the following table and are presented in the Appendix.

Table 2. Tailored materials to support the HBM4EU occupational survey for the exposure of workers to hexavalent chromium and other hazardous chemicals

Need Written communication product

Materials for workers

1. Leaflet with information for workers

2. Consent form for participating workers

3. Factsheet “Working safely with chromium”

Materials for employers

1. Leaflet with information for employers

2. Consent form for employers


7 Bibliography

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8 Appendixes: Written communication products for HB M4EU survey participants

Template materials for HBM4EU general population su rveys

1. Invitation letter

2. Information leaflet, including info on study, role of participants, chemicals

3. Reply cards

4. Reminder letter

5. Thank you letter (for persons interested to join the study, but are ineligible)


7. Appointment letter

8. Pre-visit letter

9. Certificate of informed consent

10. Withdrawal form

11. Thank you letter

12. Report of personal results

Tailored materials for the HBM4EU occupational surv ey: Exposure of workers to hexavalent chromium and other hazardous chemicals

13. Leaflet with information for workers

14. Consent form for participating workers

15. Factsheet “Working safely with chromium”

16. Leaflet with information for employers

17. Consent form for employers

This project has received funding from the European Union’s

Horizon 2020 research and innovation programme under grant

agreement No 733032.

Info: Email: [email protected]

Appendix 1

Invitation Letter

for inviting people to participate in HBM4EU population surveys

InvL_AD_v0.5 / 11.06.2018

HBM4EU TASK 7.5 TEMPLATE

INVITATION LETTER for inviting people to participate in HBM4EU population surveys

INSTRUCTIONS ON HOW TO USE THIS TEMPLATE

This is a template, which can be used to develop a letter for inviting people to participate in HBM4EU surveys. You may

introduce changes, as required by the study design and national requirements. To use this template, change the red text

with appropriate wording and delete all brackets / instructions in italicized blue text.

Encoding of task 7.5 templates

The templates prepared by task 7.5 are given an acronym, shown in the footer, which denotes the type, version, year of

last revision and follows the key:

TYPE: InvL = Invitation Letter

TARGER AUDIENCE: AD = Adults

VERSION: Vxx = Version No.

DATE OF LAST REVISION: DD-MM-YY

GOVERNMENT / INSTITUTE LOGO

InvL_AD_v0.5 / 11.06.2018

Institute Name

Institute Address

Email: Responsible person

Tel.: of responsible person

FAX: of responsible person

Prospect code: XXX

Date XX Month 20XX

Mr. / Ms. First Name Last Name

Street Address

Town/City POSTCODE

Invitation to join the human biomonitoring study HBM4EU

[Include a personalized introductory message to make the information relevant to your audience, to

get their attention and interest to read on. Be accurate and not overpromising]

Let’s create a healthier future together, by preventing exposures to harmful chemicals /

Let’s improve our health by preventing exposures to harmful chemicals ]

Dear Mr. / Ms. [Last Name],

We would like to invite you to take part in HBM4EU (Human Biomonitoring for Europe), a study which

aims to investigate people’s exposure to [environmental chemicals]. In [your country], the [Ministry of

(country’s) (Program Owner)] is responsible for leading this study.

Your participation is vital and will help to control people’s chemical exposure nationally and across

Europe through laws and interventions. By engaging with participants like you, HBM4EU will help to

raise awareness among the public and promote actions to prevent exposures to harmful chemicals.

You have been randomly selected to participate, together with [XX] European citizens from [YY]

different European countries. Representativeness and usefulness of the results of the study will depend

on people we contact to get involved. It will take [XX] of your time to provide [samples] and complete

a questionnaire. Your participation is voluntary and you can opt out at any time.

Your personal information and samples will be coded and anonymized to protect your privacy. You can

find out more about the study by reading the enclosed leaflet or the webpage XXX.

Please complete and return the appropriate enclosed reply card by [insert date] to confirm/refuse

participation.

Please do not hesitate to contact us should you have any concerns or wish to discuss further.

Thank you for your time. Without your participation, we cannot succeed in creating a healthier future

for everyone in Europe.

Yours sincerely,

[Title and Name of the Principal Researcher]

[Signature of responsible person]





Appendix 2

Information leaflet, including info on study, role of participants, chemicals

InfoL-AD V0.5 / 06.06.18


INFORMATION LEAFLET

for participants in HBM4EU population surveys


This is a template, which can be used to develop a tailored information leaflet for participants in HBM4EU surveys. You

may introduce changes, as required by the study design and national requirements. To use this template, change the

red text with appropriate wording and delete all brackets / instructions in italicized blue text.


The templates prepared by task 7.5 are given an acronym, shown in the footer, which denotes the type, version, year

of last revision and follows the key:

TYPE: InfoL = Information Leaflet for participants




InfoL-AD V0.5 / 06.06.18

Information for Participants

[title of study, e.g. HBM4EU biomonitoring study on

exposure to [specify name of pollutant(s)]

[A personalized introductory message follows, which aims to make the information relevant to your

audience in order to get their attention and interest to read on, while being accurate and not

overpromising

Let’s create a healthier future together, by preventing exposures to harmful chemicals /

Let’s improve our health by preventing exposures to harmful chemicals ]

Information for study participants

You are invited to take part in a research study. Before you decide whether or not you wish to take

part, please read the following information to understand why the research is being done and what it

involves. We are happy to answer any questions or concerns you may have. Your participation is

voluntary and you may opt out at any time without disclosing your reasons.

HBM4EU and its importance to you and to public health

We are all exposed to a complex mixture of chemicals on a daily basis. Some chemicals may harm

health and for this reason they must be regulated in the environment, consumer products, food and

drinking water and in certain workplaces. HBM4EU (“Human Biomonitoring for Europe”) is a European

Joint Program, which aims to understand human exposure to such chemicals and the related health

risk by using human biomonitoring (measurements of environmental chemicals or their reaction

products in biological samples collected from people).

The results will be used, wherever appropriate, to support policy makers with their decisions regarding

the introduction or adaption of relevant laws and interventions for the safe management of chemicals

and the protection of human health in Europe. By engaging with participants like you, HBM4EU will

help to raise awareness among the public and promote actions to prevent exposures to potentially

harmful chemicals.

HBM4EU is funded by the European Commission and national governments and includes experts from

28 countries and European Union agencies. It started in 2017 and will run until 2021. The study [specify

name of the study] is carried out the frame of HBM4EU. In [specify country], it is under the

responsibility of [specify Program Owner].

Learn more at [website of the specific study, if available] and https://www.hbm4eu.eu/

Why is this study being done and who approved it?

The study has been approved by [specify national Bioethics Committee] and complies with the

European general data protection requirements1.

1 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ L 119, 4.5.2016, p. 1–88 (General Data Protection Regulation, “GDPR”)


InfoL-AD V0.5 / 06.06.18

It is taking place to: [explain research questions. Some examples are given below.

• find out if the current safety and control measures used across Europe can protect the public from

the exposure to chemicals of concern.

• develop new methods to assess the exposure to these chemicals.

• investigate potential associations between exposure to these agents and adverse health events

• identify good practices and propose relevant health intervention or prevention policies

• … other]

Why am I asked to take part?

You have been selected randomly [specify how the selection took place, for example: through a

population registry] to represent [describe the study population in easy to understand terms (what

makes a person eligible to participate in the research)] in [specify country].

By agreeing to take part, you can help to ensure that people like you are properly represented in the

survey results. This is important for making the study more reliable and useful.

If recruiting through an intermediary organization (e.g. school, Ministry of Education, workplace): The

[specify the intermediary organization] has consented to participate in the study and has agreed to

allow us to extend an invitation to you to participate.

How will the study be carried out?

The study will take place [specify time period] in [specify your country] and [if applicable specify the

number other European countries]. It will include a total of [specify total number of] participants and

[specify number of national participants] of them will come from [specify your country]. Each

participant will provide biological samples ( [specify type] ) and will complete a questionnaire about

himself/herself and possible sources of exposure. We will analyze this information to assess your

exposure to [chemicals of concern. Specify which chemicals will be investigated].

What do I have to do if I agree to take part?

If you agree to participate, please complete and return the enclosed green reply card (“I want to

participate”) within [specify number] days from its receipt.

Adjust the following text according to your study plan. The suggested option is to ask those who do not

wish to participate in the study to answer a short non-responder questionnaire anonymously by using

an ANONYMOUS orange reply card, which includes a non-responder questionnaire (i.e. no GDPR

requirements). You may use a different approach, if you find it more appropriate.

The following text supports the suggested option, using an anonymous “orange reply card”:

If you do not want to participate, you can help us improve future studies by returning the orange reply

card within [specify number] days from its receipt. By answering a few optional questions completely

anonymously, you can help us to understand how the people who choose not to take part in the study

compare to the people who want to take part. Please return the orange card [specify how and to who].

You may consider using online versions of the reply cards for convenience.

What happens after you receive my reply card?

[Adapt the text below according to the needs of your study plan]

1. On receiving your green “yes” card, we will confirm if you are eligible to participate in the study.

This study will include volunteers that must meet the following requirements: [specify eligibility

criteria] and we can only include participants that fulfill them, up to a maximum of [specify

number] individuals.

2. If you do not fulfill the eligibility requirements or the maximum participation limit of this study

has been reached by the time when we received your green card, you will receive a letter about

InfoL-AD V0.5 / 06.06.18

it. You may also be asked whether you wish to be contacted by your national study coordinator

for participation in future HBM4EU studies.

3. If your participation is confirmed, we will contact you to agree on a suitable date for your

appointment with our research team at [adapt according to your study plan, e.g. OPTION A:

our Examination Centre, [specify location / street address] and your travel costs will be covered

by us / OPTION B: your home].

4. You will be asked to confirm your willingness to participate in the study by completing and

signing the enclosed consent form in duplicate. You will keep one copy for your records and we

will keep the other for our records. You can ask any questions you wish and you can take the

time you need to clarify any concerns prior to signing.

5. Prior to the appointment, you will receive a reminder (pre-visit) letter/sms/phone call [ with

notice of any preparations required before the appointment. Specify the required preparations,

e.g. provide morning urine ]. You can indicate your preferred way to receive this reminder on

your reply card.

How do I prepare for the visit?

No special preparation is necessary. [If any preparation is required, specify it here (e.g. able to provide

morning urine), since it may affect the person’s final decision whether or not to participate in the study].

What will happen during our appointment?

[Adapt the text as appropriate for your study, e.g. Option A: On arrival at the Examination Centre a

member of our team will be available to answer any questions you may have / Option B: A member of

our research team will visit you at home]. You will have time to ask any questions you may have and

receive answers.

If you have not already completed and signed a consent form prior to the appointment, you must do

so at this point.

The researcher will take your [specify type biological samples].

We will ask you to complete a questionnaire to collect information about you, your living conditions,

food intake, your workplace and your possible contact with chemicals.

The visit will last no longer than [specify number] minutes. Include if applicable, e.g. if the appointment

takes place in an examination center: You will be given a fixed payment to cover your travel expenses.


[The Principal Investigator of the study must ensure compliance with all European/national legal and

ethical requirements. Adapt the template as necessary].

Your samples and data will be used only according to your informed consent and in a way that

protects your privacy according to the European regulation GDPR1 and national requirements. The

released results of the study will not identify you in any way.

A code will be assigned to you by [adjust if necessary the study coordinator], who will then remove all

personal identifiable information to protect your privacy and make it impossible to trace your data or

samples back to you.

Your coded samples will be transferred to specialized laboratories for analysis [specify where the

analysis will take place]. Your samples will be examined to measure your exposure to [explain which

chemical contaminants will be analyzed and why]. Your samples will then be stored at [specify place

and length of storage] for possible use in future ethically approved studies of chemical exposure. Coded

data collected from you and other participants will be stored and used for research purposes and may

be combined with other data from different sources. The sharing of data will be facilitated through

InfoL-AD V0.5 / 06.06.18

dedicated data infrastructures and/or Information systems (such as IPCHEM, which is the European

Commission Information platform for Chemical Monitoring2).

The overall results of the study will be provided to national and European authorities to support policy

actions related to chemical management for public health protection. They will also be disseminated

to other stakeholders, including the general public, scientists and other interested parties.

How can I learn about the results of the study?

When the study is completed [specify according to study plan: in approximately XX weeks/months],

you will be informed by [specify name of person, e.g. study coordinator] about your personal results

[specify the biomarkers which will be reported to the participant], unless you expressed a wish not to

receive them on your certificate of informed consent.

In the event that high levels of chemicals are detected, you will be advised to review your results with

your family / personal doctor/ general practitioner.

You will also be informed about the collective results of the study. These will be published as a study

report and will be publicly available at [specify correct website, e.g. https://www.hbm4eu.eu/ or

national study website].

How will my privacy be protected?

[It is advised that a written procedure for the protection of personal data is in place at the legal entity

carrying out the study and that it is in compliance with the GCPR requirements].

Your privacy is protected by complying with the requirements of the European General Data Protection

Regulation [and specify relevant national legislation, if applicable]. The [specify name of legal entity] is

responsible for the protection of your data against loss, unauthorized access /use, modification /

disclosure or other misuse. The Data Controller is [specify (name, function, e.g. study coordinator or

Director of legal entity)].

All data processing will be done in such a way, that it is no longer possible to attribute your data to you

without the use of additional information. Your name will be replaced by a code. Information which

identifies you (name, contact details) will be kept separately and under protective measures. All

electronic and paper records will be protected from unauthorized access of your private information.

Published reports of the study will not contain information that can be traced back to you. Third parties

will not have access to your personal results, unless you consent to.


Your written consent confirms that you volunteer to take part in the study after understanding what is

required from you and what your rights are. You have the right to withdraw your participation without

any consequence at any point (including any data or samples already provided, if they have not been

completely anonymized and so impossible to be traced back to you) and the right to choose if you want

to receive your individual results or not. You will also confirm that we can contact you in the future to

tell you about your personal results or for historical, statistical or scientific purposes. A copy of the

Certificate of Informed Consent, which you will be asked to complete and sign before taking part in the

study, is attached to this leaflet and you can keep it for future reference.


• You will have the opportunity to receive a [adapt to the specific situation of your study

specialized medical briefing], which is not typically available during your routine medical

2 https://ipchem.jrc.ec.europa.eu

InfoL-AD V0.5 / 06.06.18

assessment. However, please note that this examination is only complementary to and not a

substitute for your regular health care checks.

• You will receive information regarding your exposure to specific chemicals and, wherever

applicable, the associated potential health impact.

• You will have the right to receive your personal results (if you wish) [by law any new high

incidence of chemical levels should be reported], which you may subsequently further examine

with your doctor.

• You will learn about selected chemicals, their possible effect on health and ways to avoid

exposure

• [Describe any other incentives, if applicable]

• You and all citizens in [specify country] and in Europe will benefit from the collective results of

the study, which will be used to [adapt as appropriate, e.g. understand the exposures of people

to harmful chemicals and how these can affect the human body / develop harmonized or new

methods to measure exposures / develop better chemical management policies across Europe].


Some participants may experience minor discomfort during the collection of [blood] samples. All

sampling will be conducted by qualified and specially trained health professionals. [If applicable: Study

participants will be covered by insurance for any adverse events relevant to their participation, without

any charge to them].

Are there any costs to me?

No, the study will be conducted at no cost to you. Participation is voluntary, without reimbursement.

[If applicable: Travel and out of pocket expenses can be claimed back through [specify reimbursement

procedure].

What if I have any concerns or complaints while I’m taking part in the study?

Your wellbeing is our foremost priority and we will take all necessary precautions to ensure your

comfort and safety. If you have any concerns during your appointment, please discuss them with our

research team or at any time by contacting the study leader [Title, Name, Tel No., Email address]. You

have the right to opt out of the study at any time and for any reason (without the need to disclose this).

In the unlikely event that you want to file a complaint about the study, you may do so by contacting

[Title, Name, Tel No., Email address], who is not formally connected to the study and serves as an

independent overseer of its implementation.

What happens if I say yes, but I change my mind later?

You are free to withdraw from the study at any time, without any consequences by [sending an e-mail

to / calling specify the name, and email and/or phone number of the responsible person]. We will ask

you to confirm your wishes by signing the attached withdrawal form. On this form you can indicate one

of the following options:

• “No further contact but my samples and data can be used”.

We will no longer contact you, but have your permission to retain and use information and

samples that you have already provided.

• “No further contact and my samples and data cannot be used”.

We will no longer contact you and will destroy your samples and data, unless they have been

completely anonymized and we cannot trace them back to you. For the integrity of the study

and in the interest of public health, we will retain your coded data in analyses that have already

been completed. We will retain your signed consent and withdrawal forms as a record of your

wishes and for audit purposes.

InfoL-AD V0.5 / 06.06.18

You can request a copy of these forms from us using the contact details provided below.

Who do I contact if I have any questions or would like further information about the study?

You can contact [title, name, function, phone number, email] or visit the websites [website of the

specific study] and https://www.hbm4eu.eu/].

Thank you for your time and consideration!





Appendix 3

Reply cards


GREEN REPLY CARD

“YES, I want to participate”

RCY_AD_v 0.2 / 30.05.18

INSTRUCTIONS ON HOW TO USE THIS TEMPLATE:

This template is a reply card from volunteers wanting to participate in a HBM4EU survey. Before using,

remove all instructions (shown in blue italicized text) and adjust the text and formatting to suit your study.

You may consider providing this form online, so that it can easily be returned using a smart phone.


The templates prepared by task 7.5 are given an acronym, shown in the footer, which denotes the type,

version, year of last revision and follows the key:

TYPE: RCY = Reply card (Yes)




HBM4EU study [Specify name of study]

Green Reply Card: “Yes, I want to participate”

Thank you for taking time to consider the information for

participants and for your interest to participate in the HBM4EU study

[Specify name and acronym/code of the study]

Please complete the following information to help us check whether

you fulfill the study’s eligibility criteria for participation and to

indicate how you prefer to be contacted for organizing an

appointment with our research team.

Your information will be held confidential and used only for the

purpose of determining your eligibility and organizing an

appointment.

First

Name:……………………………………Surname……………………………………….

Address:…………………………………….……………………………………………..…

Phone number:………………………………………

Email: …………………………………………….…….

[Specify the Eligibility criteria of the particular HBM4EU study.

Some Possible criteria:

Age

Sex

Years of residence in area…]

I prefer to be contacted in the following way (please mark/fill all

that apply):

� By phone

The most suitable day and time you can reach me is:

Day

Time availability Most preferable

day and time

(Please indicate

with “√”)

FROM

HH:MM

TO

HH:MM

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

� By email

� By post

Please return this reply card to [specify person and contact info]

by [specify how to return the form to the HBM4EU team].

RCY_AD v 0.2 / 30.05.18


ORANGE REPLY CARD

“I don’t want to participate”


This template is a reply card from people not wanting to participate in HBM4EU surveys, but willing to answer a short

questionnaire aiming to assess potential biases in participation. The template contains an indicative non-responder’s

questionnaire, which should be adjusted to best suit your study. Before using, remove all instructions (shown in blue

italicized text) and adjust the red text, the formatting and the questions. You may consider providing the non-

responders questionnaire online, so that it can easily be returned using a smart phone, while enabling easy processing.




TYPE: RCN = Replay card (No)




RCN_AD_V0.6 / 30.05.18

Orange Reply Card

NO, I do not want to participate in the HBM4EU study

I don’t mind answering a few questions anonymously

INSTRUCTIONS

Thank you for taking time to consider the information for participants in this HBM4EU study.

Please help us understand how the people who choose not to take part in the study compare

to the people who want to take part, by answering the following questions. Your anonymous

answers will be used strictly for this and audit purposes and to improve future studies.

Mark all that apply. If you feel uncomfortable answering a particular question, you may skip it. [Give instructions on how the participant will return the card to you. Return the form

by….]

1. Gender [if appropriate for the study] :

Male Female

2. My age is: [give appropriate ranges for the particular HBM4EU study]

3. My current status is:

employed

unemployed [Optional to use or erase: Please specify:

retired looking for work unable to work

studying family care / housekeeping other ]

4. My highest level of education is:

elementary high school undergraduate graduate / professional

5. I smoke I don’t smoke

6. I’m in good health I have health problems

7. I do not wish to participate in this study because (Please check all that apply)

I don’t have time I am not interested in the subject

I don’t like what I would need to do I don’t see a value for me

I don’t see a value for society I don’t like / trust the study organizers

other (please specify)…………………………………………………………………………………………………..

RCN_AD_V0.6 / 30.05.18





Appendix 4

Reminder letter

RemL_v0.4_11.06.2018


REMINDER LETTER

for reminding invited people to express their interest in participating in

HBM4EU studies


This is a template, which can be used to develop a letter to remind people to express their interest in participating in

HBM4EU surveys. You may introduce changes, as required by the study design and national requirements. To use this

template, change the red text with appropriate wording and delete all brackets / instructions.




TYPE: RemL = Reminder Letter





[Institute Name]

[Institute Address]

Email: [Responsible person]

Tel.: [of responsible person]

FAX: [of responsible person]

[Mr. / Ms. First Name Last Name, Title]

[Company Name]

[Street Address]

[Town/City POSTCODE]

Date [Day Month, 20XX]

Prospect Code [xxx]

Reminder about your invitation to participate in the HBM4EU study [specify]

Dear [Addressee]

Last [specify time], you received an invitation to participate in the HBM4EU research study. The

information you can provide by participating will be used to support policies for protection public

health from exposures to harmful chemical pollutants. You can also learn about your personal exposure

to chemical pollutants and ways to reduce it.

We hope that despite your very busy schedule, you have had sufficient time to consider the invitation

to participate in the HBM4EU study.

Should you choose to participate then complete and return the green reply card entitled “I want to

participate”.

If you are not interested in participating in this study, then please complete and return the orange reply

card entitled “I do not want to participate”.

We look forward to receiving your response by [specify date ].

If you have any further questions, please contact us using the details provided above or visit our

website: https://www.hbm4eu.eu/the-project/

Yours sincerely,

[Name Country’s Leader].





Appendix 5

Thank you letter (for persons interested to join the study, but are ineligible)

ThaL_AD_v0.4 / 11.06.2018


Letter of thanks for thanking people who expressed interest in participating in HBM4EU studies,

but cannot be accepted


This is a template, which can be used to develop a letter for thanking people who expressed an interest in participating

in HBM4EU surveys but are ineligible or the upper limit of participants has been reached. You may introduce changes,

as required by the study design and national requirements. To use this template, change the red text with appropriate

wording and delete all brackets / instructions.




TYPE: ThaL = Thank you Letter





ThaL_AD_v0.4 / 11.06.2018

[Name of responsible person]

Institute Name

Institute Address




Date [XX Month 20YY]


[Company Name]

[Street Address]


Prospect code: [xxxxx]

Thank you for expressing an interest in the HBM4EU study!

Dear [Addressee],

Thank you for your interest to participate in the HBM4EU survey [specify]. Because of volunteers like

you, we can look forward to creating a healthier future in [your country / Europe]. This survey aims to

investigate the exposure of a specific segment the population in [your country] and other countries

to [specify chemical pollutants]. To ensure the usefulness of the results of this survey, the people

who participate must meet the following profile:

[Specify criteria]

Unfortunately, on this occasion you did not meet the inclusion criteria due to [xxx], [xxxx]. We hope

this does not deter you from agreeing to participate in future studies.

Thank you again for choosing to make a difference through volunteering to participate. You can still

be a part of our community, by following the progress of HBM4EU and learning how it is helping to

protect people from harmful exposures to chemical pollutants. You can do so by visiting our

webpage, https://www.hbm4eu.eu/, which will be regularly updated.

Yours sincerely,

[Study leader]





Appendix 6

Fact sheets on chemicals

FaSh_AD_v0.2 / 11.06.2018


Fact Sheets about the chemicals, which will be investigated in HBM4EU studies


This is a template, which can be used to develop fact sheets on chemicals of concern.

[Factsheets aim to provide study participants with targeted and concise information on the investigate chemicals. The

template must be appropriately formatted (e.g. layout, fonts, visual aids, colours) to create effective final materials.

Hardcopies of the factsheets are intended to be given to prospective participants when they are invited to join the study

and when they are informed about their personal results. The factsheets should be made available on the HBM4EU

website in the languages of the countries implementing the study.




TYPE: FaSh = Fact Sheet





FaSh_AD_v0.2 / 11.06.2018

Keep yourself safe

from exposure to [name of the investigated chemical]

Becoming exposed to [name of chemical] may affect health. This leaflet tells you what [name of

chemical] is, where it occurs, how you may become exposed, how it may harm you and what

precautions you should take to protect your health. It also tells you about human biomonitoring of

[name of chemical] and its usefulness.

What is [name of chemical]?

Describe the chemical very briefly (e.g. natural occurrence, basic physical properties).

Where is [name of chemical] found?

Describe briefly the processes and products where the chemical may be found.

How can [name of chemical] enter your body?

Describe sources of exposure (e.g. eating contaminated food, skin contact with

materials containing the chemical).

How can [name of chemical] harm you?

As with all chemical exposures, the risk related to [name of chemical] exposure depends on your

personal traits and habits, how much of the chemical you were exposed to, how you were exposed,

how long and how often the exposure occurred, and whether other chemicals were present.

[Adjust as appropriate for the investigated chemical]

Single exposures to [name of chemical] may cause:

• [describe health effects]

Repeated or prolonged exposure to [name of chemical] may cause:

• [describe health effects]

Human Biomonitoring of [name of chemical]

[ Specify type of human samples, e.g. blood, urine, hair] can be used to measure people’s exposure to

[name of chemical]. This is called human biomonitoring. [Specify information which can be obtained

from specific matrices, e.g Hair analysis is an appropriate method to determine a person’s history of

mercury exposure through the consumption of fish].

Finding a detectable amount of [name of the chemical] in a person doesn’t imply that it will cause an

adverse health effect. Biomonitoring studies provide physicians and public health officials with

reference values to tell if people have been exposed to higher levels of [name of the chemical] than

are found in the general population. Biomonitoring data can also help scientists plan and conduct

research on exposure and health effects.


FaSh_AD_v0.2 / 11.06.2018

What must you do to prevent exposure to [name of chemical]?

• [Describe, in bullet form, risk management options, which the reader can apply].

How can you get more information?

[This section is optional. It may be adopted at national level, as deemed appropriate, to refer to

appropriate national sources of extra information, an official national body or competent authority. It

may also refer to the HBM4EU website, for layman presentation of extra information on the chemical

and the relevant project results].





Appendix 7

Appointment letter

ApptL_v0.4 / 11.06.2018

Task 7.5 Template

Appointment / pre-visit letter

For confirming a participant’s appointment and providing instructions


This is a template, which can be used to develop a letter to participants in HBM4EU surveys, for confirming the time/place

of their appointment and for instructing them on any preparations needed prior to the appointment. You may introduce

changes, as required by the study design and national requirements. To use this template, change the red text with

appropriate wording and delete all brackets / instructions.




TYPE: ApptL = Appointment Letter





ApptL_v0.4 / 11.06.2018

[Institute Name]

[Institute Address]

Email: [Responsible person]

Tel.: [of responsible person]

FAX: [of responsible person]


Prospect code: [XXX]

Participant code:[xxxxx]

[Mr. / Ms. / Title First Name Last Name]

[Street Address]


HBM4EU human biomonitoring study [specify]

Thank you for choosing to help create a healthier future in [Europe/your country]

Confirmation of date and time of appointment visit and pre-visit instructions

Dear [Mr. / Ms. / Title Last Name],

Thank you for agreeing to participate in the HBM4EU study.

We wish to confirm the details of your appointment with your [HBM4EU researcher, specify name of

person, if known (title, name)]. [If a home visit is involved: HBM4EU researchers always have

identification with them that they will show you when they arrive at your home].

When: [specify date and time]

Address: [Option 1: Study center: specify address of the study centre. Please also see enclosed map for

directions / Option 2: Home visit: your home]

It is necessary that you keep your appointment, as above. If you aren’t able to keep your appointment,

please call us promptly to reschedule. Our contact information is [Name: XXX, Phone No.: XXXX, Email:

XXXX].

Adjust according to the study plan: At the time of your appointment you will be asked to provide your

signed certificate of informed consent. This serves to verify that you were adequately informed about

the study and willing to participate. Please make sure to have read carefully the “Information for

participants” leaflet and the “certificate of informed consent”. You can also find these materials online

at [specify link].

If you have any questions, please contact us and we will be happy to answer them. You will also be able

to ask any further questions about the study and your involvement during your appointment and

before we proceed with sampling and interviewing you.


ApptL_v0.4 / 11.06.2018

[If applicable (i.e. collecting morning urine) or adjust accordingly: You will be asked to provide a sample

of morning urine on the day of your appointment. To facilitate this, nearer the date of your

appointment we will send to you urine containers and explanations on what you will need to do.]

Thank you again for choosing to make a different through volunteering to participate. Because of

volunteers like you, we can look forward to creating a healthier future in [your country / Europe] by

reducing the exposures of people to harmful chemicals.

Yours sincerely,

[Name of Study Leader]





Appendix 8

Pre-visit letter

PreVL_AD_v0.4 / 11.06.2018

Task 7.5 Template

Reminder Letter For reminding participants about keeping their appointment


This is a template, which can be used to develop a letter for reminding participants in HBM4EU studies about keeping

their appointment with the fieldworker. You may introduce changes, as required by the study design and national

requirements. To use this template, change the red text with appropriate wording and delete all brackets / instructions.




TYPE: ThaL = Thank you Letter





PreVL_AD_v0.4 / 11.06.2018

[Name of responsible person]

Institute Name

Institute Address





[Company Name]

[Street Address]



Prospect code: [XXX]

Participant Code [xxxx]

Reminder about your HBM4EU study appointment and pre-visit instructions

Dear [Addressee],

We would like to remind you that your appointment [at the Examination Centre located at [address] /

your home / other venue] is on the [Date] at [Time].

Please consider the following information, in preparation for your appointment:

You are welcome to ask any questions you may have by contacting us at the contact information above

or by discussing them with our team member on the day of your appointment.

Consent form:

[Make sure to give clear instructions to participants about when they will complete the consent form

and how to return it to the research team, in order to avoid confusion across the different study

materials. Adjust the following (and other materials) according to study plan:

We can proceed with your appointment only after having your written consent to participate in the

study. Give clear instructions on when the participant must complete the form and how to return it,

e.g.

Please bring the two copies of the consent forms with you during the visit. Make sure you have read

them carefully and entered your initials at the end of each clause and signed the form. You will retain

the one copy for your records and we will retain the second copy for our records. Without the signed

consent form the interview cannot proceed so please complete them prior to arrival for your

appointment.


PreVL_AD_v0.4 / 11.06.2018

Adjust according to the study plan: Collection of morning urine on the day of your appointment:

We have enclosed [urine] container(s) and an instruction leaflet on how to provide the [urine] samples.

Please fill in the enclosed container(s) with your first urine sample on the morning of the day of your

appointment. You will give your sample to our research team during your appointment.

We remind you that you can find detailed information on what will happen during and after your

appointment in the “Information for participants” leaflet we provided you with. You may also find this

information online at [specify exact link].

Thank you for taking part in the HBM4EU study.

Yours sincerely,

[Name Country’s Leader].





Appendix 9

Informed consent

CIF_AD V0.4 / 06.06.18


CERTIFICATE OF INFORMED CONSENT FOR PEOPLE LEGALLY ABLE TO PROVIDE CONSENT


This is a template, which can be used to develop a tailored certificate of informed consent for participants in HBM4EU

surveys, who are legally eligible to provide their informed consent. According to GDPR1, this applies to ages over 16.

To use this template, change the red text with appropriate wording and delete all instructions and brackets in italicized

blue text. You may introduce further changes, as required by the study design and national requirements, while

ensuring compliance with GDPR.

________

1GDPR is regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection

of natural persons with regard to the processing of personal data and on the free movement of such data, and

repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4.5.2016, p. 1-88.




TYPE: CIC = Certificate of Informed Consent




CIF_AD V0.4 / 06.06.2018

CERTIFICATE OF INFORMED CONSENT

Study description

Title

Researcher identifier

Name Telephone

Department Email

Institution

Address

Participant Statement of Informed Consent

I, the undersigned, hereby confirm the following: Initials

1. I was given the “Information for Participants” leaflet, which explains the following

related to the research study:

- the purpose of the study and how it will be carried out

- what my participation involves

- my rights (to withdraw, to be forgotten and remove any data/samples

provided, to choose whether I wish to be informed of my personal results)

- my commitments.

2. I had the opportunity and time (at least 24 hours) to consider and comprehend the

information in the “Information for Participants” leaflet.

3. I had the opportunity to ask questions and I received satisfactory answers.

4. I understand that my participation in the research, as defined in the “Information

for Participants” leaflet, is voluntary and that I am free to withdraw at any time

(without giving any reason and without my medical care or legal rights being

affected), by following the procedure explained in the “Information for Participants”

leaflet.


CIF_AD V0.4 / 06.06.2018

5. I understand that if I choose to withdraw from the study, data related to me and

collected prior to my withdrawal will continue to be used solely for the purpose of

allowing the research to be completed. These data will be “coded” (my name will be

replaced by a code) to protect my identity.

6. I consent that the [ Specify name of organization, represented by …………. (specify

the name and function of the data/sample controller) ] will have the exclusive access

to my identifying personal information and will encode my data and samples

according to the currently available safeguards, in such a way that other users of my

data cannot trace back to me.

7. I consent to [Specify: the long-term OR specify duration] storage and use of my

coded samples [specify (type)] and coded personal data collected in this study for

research related to public health and environmental health purposes, even in the

event of my death or my becoming incapacitated.

8. I consent that my coded samples and/or data can be transferred to specialized

laboratories, biobanks, databases, data infrastructures, research establishments,

administrative authorities and institutions in the European Union and associated

countries or used for public announcements and reports within the scope of the

research.

9. I consent that the [ Specify name of organization, represented by …………. (specify

the name and full contact details of responsible person ] may contact me in the

future for public and environment health-related research purposes and/or to

inform me about my personal results, if I choose to receive them.

10. I understand that I have the right to receive my personal results as stated in the

“Information for Participants” leaflet and I indicate my preference as follows (please

mark one option only):

� I wish to receive my personal results

� I wish to receive my personal results only if they exceed the health-based

guidance values used in the study (wherever applicable)

� I do not wish to receive my personal results.

11. I understand that I will not benefit financially from taking part in this study.

My signature below indicates my consent to take part in the study.

_________________________ ________________________ _______________ ___________

Name of Participant Signature of Participant Location Date

If the participant consents to participate in the study but is not able to provide signature, the following

must be completed:

CIF_AD V0.4 / 06.06.2018

I witnessed the accurate reading of the “Information for Participants” leaflet and the “Certificate of

Informed Consent” to the participant.

I witnessed that the participant had time (at least 24 hours) to consider the information and the

opportunity to ask questions.

I confirm that the participant was not coerced into giving consent, and that his/her consent was

given freely and voluntarily and without any objection raised.

Thumb print of the participant

_________________________ ________________________ ______________ ___________

Name of witness Signature of witness Location Date

Statement by the researcher / person taking consent

I made sure, to the best of my ability, that the participant understands that the following will be

done:

[describe the specifics of the study, which relate to the participant:

1. <<……………….>>

2. <<……………….>>

3. <<…………………>>

4. <<………………..>> ]

I confirm that the participant was given time (at least 24 hours) to consider the information, had

the opportunity to ask questions about the study and that all the questions asked have been

answered truthfully and to the best of my ability.

I confirm that the participant was not coerced into giving consent, and that his/her consent was

given freely and voluntarily and without any objection raised.

A copy of this Certificate of Informed Consent was provided to the participant.

_________________________ ________________________ _____________ ___________

Name of researcher /

person taking the consent

Signature of researcher /


Location Date

For internal use only: Participant Code:





Appendix 10

Withdrawal form

WF_V0.6 / 04.06.2018


WITHDRAWAL FORM

for general population studies


This is a template for documenting the wish of a participant to withdraw from an HBM4EU survey. Before using the

template, adjust the red text, format it according to the needs of your study and remove all instructions (shown in blue

italicized text).




TYPE: WF = Withdrawal form




WF_V0.6 / 04.06.2018

HBM4EU Study [Specify survey name and code]

Participant Withdrawal Form

Dear Participant,

you can withdraw from the HBM4EU study at any time and without disclosing your reasons, by completing and

signing this form. [If applicable (for studies involving children / young people): This includes the possibility to withdraw

data and samples collected in the past from a child, after consent of a parent / guardian, who has subsequently grown

and may now express his/her own assent or dissent]. The form can be completed by you or by someone who is able

to act on your behalf. Your signed consent and withdrawal forms will be kept by [specify organization name] as a

record of your wishes. The options available to you for withdrawal are shown. Please indicate your preference by

marking the appropriate box and adding your initials.

I wish to withdraw from the HBM4EU study and request: Initials

� NO FURTHER CONTACT BUT MY CODED1 SAMPLES AND INFORMATION CAN BE USED

I will no longer be contacted but give my permission to [Specify name of HBM4EU partner

organization carrying out the study] to retain and use information and samples already provided by

me.

� NO FURTHER CONTACT AND MY SAMPLES AND INFORMATION CANNOT BE USED

I will no longer be contacted by [Specify organization name] and the information and samples I

already provided cannot be used for further analyses. My samples will be destroyed, but I understand

that it may not be possible to trace all distributed samples remnants. I understand that it is not possible

to remove coded data originating from me from analyses that have already been completed.

[Specify organization name] will only hold my information for audit purposes.

1 The term “coded” means that my name has been replaced by a code, in order to protect my personal data.

On behalf of the participant withdrawing from the HBM4EU study:

___________________ ______________________________ _____________________________________

Location and date Name of participant Signature of participant or

Name and signature of designated representative

On behalf of [Specify name of HBM4EU partner organization carrying out the study]:

___________________ _____________________________ _________________________________

Location and date Name of HBM4EU staff Signature of HBM4EU staff

For internal use only:

Participant Code





Appendixes 11 & 12

Thank you letter

Report of personal results

ResLR_v0.5 / 11.06.2018

Task 7.5 Templates

Communication of personal results (a) Letter and (b) Report of personal results with recommendations


Below you will find templates of a letter and a report for informing participants about their personal results.

A personalized letter and report must be prepared for each participant.

The report uses the ‘traffic light system’ for describing the results. You may wish to adapt the template to suit your

country.

You must change the text in brackets according to the specifics of your country and/or for the individual participant.

The templates show all possible options. You MUST adapt the template for EVERY individual participant, depending on

his or her personal results.




TYPE: ResLR = Letter and Report of Personal Results




[Name of responsible person

Study centre contact details

Address

Telephone number

Email Address]

[Participate Code

Participant Name

Participant Address]

[Date]

HBM4EU study [“name and code of study”]

Personal results

Dear [Mrs/Mr ….],

Thank you for your participation in the HBM4EU research study [“name and code of study”]. Your input

has made a significant contribution to our efforts to improve [public health/workers’ health] in [your

country] and in Europe. The study took place in [number] countries from [XX1/YY1 to XX2/YY2

(month/year, referring to period of survey implementation] and it involved a total of [number] people.

You were one of the [number] of [nationality] who participated by providing samples and information.

The study has been completed and we are pleased to enclose a copy of your results.

We analyzed your [type of samples] in specialized laboratories to [determine the level of each

investigated chemical / find out how much of each investigated chemical they contained].

In reviewing and interpreting your results please remember that in general:

• these results are only a snapshot of your exposure at the time the sample was taken

• a high level can occur due to a temporary (short-term) exposure to a chemical

• a high level can be reduced if you take actions to prevent your exposure to the chemical

• high level(s) do not necessarily mean you will experience adverse health effect(s).

Your personal results are enclosed in this correspondence. For each chemical, an explanation is

provided to help you interpret your results. Fact sheets are also provided for these chemicals, which

include recommendations for minimising exposure.


If any of your levels are high, it is advised that you read and follow the recommendations provided.

[You may wish to further adapt this section according to the scientific knowledge / known health values

/ uncertainties associated with each chemical under investigation and personal results of the

participant.]

Should you wish to discuss any part of your results report, please do not hesitate to contact us. We

will be happy to discuss your results and provide advice.

Yours sincerely,

[signature of responsible person]

[name of responsible person]


Report of personal results

[Name and code of HBM4EU survey]

Name [Participant Name]

Address XX Street Name, Postal Code, City

Date of report DD/MM/YY

Investigation Your Result Reference Values for this chemical*

[chemical name] [numeric value] [unit] Above [YY] unit High risk

[XX] – [YY] unit Moderate risk

Below [XX] unit Desirable

*[Specify source of reference values]

Recommendation Use applicable option and erase the rest.

Case 1: No action needed. Information about minimising/eliminating

exposure is contained in the enclosed fact-sheet.

Case 2: We recommend reduction of your exposure to the extent possible.

Information about minimising/eliminating exposure is contained in the

enclosed fact-sheet.

Case 3: Your results are high. Please call us to discuss possible actions.

[Adopt according to your national study design, e.g.: We recommend you

visit your doctor. A letter for your doctor is enclosed].

................................................

[signature]

[responsible person’s name]

Move the arrow

to the

applicable box

The arrow compares your result with

the given reference values





Appendix 13

Leaflet with information for workers


HBM4EU Occupational biomonitoring study on hexavalent chromium

and other harmful chemicals

Information for Participating Workers

You are invited to take part in a research study. Please read the following information to

understand why the research is being done and what it involves. We are happy to answer any

questions or concerns you may have.

About HBM4EU

People are exposed to a complex mixture of chemicals throughout their daily lives. These

chemicals can be found in the environment, consumer products, food and drinking water and at

workplaces.

Human biomonitoring involves collecting samples from people, e.g. blood, hair, saliva or urine,

and measuring the levels of indicators of chemicals that are of interest. HBM4EU (Human

Biomonitoring for Europe) is a European study, which aims to harmonize and use human

biomonitoring to understand people’s exposure to such chemicals and the related health risks, in

order to improve chemical risk management. At workplaces, human biomonitoring can inform us

on the need to reduce exposure. HBM4EU is funded by the European Commission and national

governments. It includes experts from 28 countries and European Union agencies and will run

from 2017 to 2021. Learn more at https://www.hbm4eu.eu/.

About this study

We want to check if the current safety and control measures used at the workplaces across

Europe can protect from the exposure to hexavalent chromium (Cr(VI)) and other harmful

chemicals. In addition, we want to study new methods to assess the exposure to these chemicals.

The study has been approved by the [national Bioethics Committee] and complies with the Data

Protection Regulation.

Why did you choose me?

We are inviting workers whose duties involve possible exposure to hexavalent chromium (Cr(VI))

(welding, plating and surface treatment activities) and workers without such duties, for

comparison. You were chosen because you work in a workplace in which you may be exposed to

hexavalent chromium (Cr(VI), or we consider you as a suitable control person since your work

tasks do not include such exposures. Your employer has consented to participate in the study and

has agreed to you participating if you decide to do so.

What do I have to do if I agree to take part?

You don’t have to change your usual routine since the study will take place during normal working

hours. If you decide to participate, you will confirm your agreement by completing and signing the

enclosed consent form.

We will then find a suitable time to perform the study. You will meet the researchers during the

work week for the collection of samples.

If your duties involve stainless steel welding or chromate plating or surface treatment, you will

be asked to provide:

• Exhaled breath samples, by breathing normally into a sterile disposable tube for about 15

minutes, at both the beginning and end of your working week

• Urine samples before the work shift at the beginning of your working week and after the

work shift at the end of your working week. We will provide you with a collection bottle

which you can give to the researcher.

• Two small samples of blood (16 ml) will be collected from the vein in your arm. These will be

collected post-shift preferably in the end of the work week or at least after one or two days

of work.

• You will also need to fill a questionnaire which includes questions on your work tasks,

personal protection and lifestyle aspects which may affect the results of the chemical

analyses.

From some (not all) participants, we may also wish to collect personal air samples, which are

collected by wearing a specific air sampling device on your work clothes, while you carry out your

normal work tasks during one single work day. Wipe samples from your hands might also be

collected in order to measure hand contamination.

Optionally and only if you consent to, we may take photographs or video to document your work

area and practices. We will blur these materials to protect your identity and your company. You

can still participate in the study without being present in photographs or video recordings.

If your duties don’t involve chrome plating, surface treatment or stainless steel welding, you will

be asked to provide the following:

• A sample of the urine you pass first thing in the morning before meeting with the

researcher. We will provide you with a collection bottle which you can give to the

researcher.

• An exhaled breath sample, by breathing normally into a sterile disposable tube for about 15

minutes.

• Two small samples of blood (16 ml) will be collected from the vein in your arm, at any time

during the working week.

The blood and exhaled breath samples will be collected from you by a trained health professional.


We will replace your name with a code to protect your privacy and will transfer the samples to

specialized laboratories for analysis.

Your samples will be examined to measure your exposure to hexavalent chromium. Depending on

your work tasks they will be also examined for nickel and manganese (if you are working as a

welder), or nickel (if you are performing nickel plating) or for polyfluorinated substances (if you

are working with chrome baths), which may also be significant chemical contaminants in these

work tasks. Urine and blood samples might be additionally analyzed for the early, reversible

cellular effects caused by the chromium in order to study the utility of these tests in the health

surveillance of workers.

Your samples will not be analyzed for alcohol, prescription or illegal drugs.

Anonymized data collected from you and other participants will be stored and used for research

purposes and may be combined with other data from different sources. Your anonymized samples

will be stored at [specify place and length of storage] for use in future ethically approved

biomonitoring studies to study chemical exposure.

Your personal results for urinary chromium will be reported to you [in approximately XX

weeks/months by NNNN], unless you tell us you do not wish to receive them. When the results of

the whole study will be finished, you will receive the summary of the collective results from the all

participating companies.

Your employer will receive the collective results of all the workers, but will not receive individual

results. The collective results from all the participating companies will be published as a study

report which will be openly accessed at https://www.hbm4eu.eu/

How will my privacy be guaranteed?

HBM4EU complies with the European Data Protection Regulation. We guarantee your anonymity

by replacing your name with a code and protecting all electronic and paper records from

unauthorized access. Published reports of the study will not contain information that can trace

back to you or your company. Your employer or other third parties will not have access to your

personal results, unless you consent to.


Your written consent confirms that you volunteer to take part in the study, understand what is

required from you and why. You will also confirm that we can contact you in the future to tell you

about your personal results or for scientific, statistical or historical purposes.


The study will help to develop the safe working practices at your workplace. You will learn about

your personal exposure to chromium and get guidance how to reduce it.


All sampling will be conducted by qualified and specially trained health professionals. There are no

risks, other than possible minor discomfort during sample collection.

Can I quit the study?

We encourage you to discuss with us any concerns you may have, but you are free to withdraw

the study at any time without consequences. We will, however, retain right to use any samples

collected prior to the withdrawal in a confidential manner.

Are there any costs to me?

There are no costs to you. Your participation in the study will take place during your normal

working hours (with the exception of the collection of urine samples first thing in the morning).

You will not face salary deductions for your time commitment to the study.

Who do I contact if I’m unsure about anything or would like further information about the

hexavalent chromium study?

Please contact [Name, Institute of National study Coordinator, Tel: [xxxxxxx], Email [xxxxxxx]





Appendix 14

Consent form for participating workers


WORKER CERTIFICATE OF INFORMED CONSENT

Study description

Title HBM4EU occupational biomonitoring study on chromium and other harmful chemicals

Participant identifier

Name Telephone

Company Email

.................................................

.................................

..................................................

Name of Participant Date Signature of Participant

------------------------------------------------------------------------------------------------------------------------------

Participant Code Initials

1 I have read the companion “Information for Participating Workers” leaflet. I have had the

opportunity to consider the information, ask any questions I wished to and received

satisfactory answers.

2 I understand that my participation is voluntary and that I am free to withdraw at any time

without giving any reason, and without my medical care or legal rights being affected. The

research team will, however, retain right to use any samples collected prior to the

withdrawal in a confidential manner.

3 The [Specify organization] will be able to contact me during working hours to collect my

personal samples and information after I have consented to participate in this study.

4 I consent that the [Specify organization] has the right transfer my sample(s) and/or

personal data, in coded form to protect my identity, to specialized laboratories to analyze

the chemicals and markers specified in the “Information for Participating Workers”

leaflet.

5 I consent that the [Specify organization] has the right to store my sample(s) and personal

data in a biobank for [no of years] for future ethically approved biomonitoring studies.

I understand that the [Specify organization] may contact me in the future regarding the

use of my stored sample(s) and personal data. My contact details may be stored

exclusively for this purpose and will not be disclosed to any third party.

6 I consent to the use of cameras by the [Specify organization] as follows:

� I do not wish to be photographed during the research visit

� I give permission for photography, under the condition that the photographs will be

blurred to protect my identity in any published reports.

7 I understand that I will not benefit financially by taking part in this study.

8 I understand that I will receive information on my personal results for urinary chromium. I

will receive this information from [Specify for each country].

In addition, when the whole study is completed, I will receive the summary of the final

collective results of the study. I want to receive this by email/by post to the following

address:

_____________________________________________________________

Statement by the researcher/person taking consent

I confirm that the participant was given an opportunity to ask questions about the study, and all

the questions asked by the participant have been answered correctly and to the best of my ability.

I confirm that the individual has not been coerced into giving consent, and the consent has been

given freely and voluntarily.

.......................................................

..................................... ...................................................

Name of Researcher /


Date Signature of Researcher /






Appendix 15

Factsheet “Working safely with chromium”


Working safely with chromium

Working with some forms of chromium (Cr) may affect health. This leaflet tells you about the possible

health effects, the preventative measures your employer must apply and the precautions you should

take to protect your health.

What is chromium (Cr)?

Cr is a relatively common chemical element. It is found naturally in rocks, soil, plants, animals and

volcanic dust and gases. Cr compounds form a large and varied group of chemicals. They can be solid,

liquid or gas and have no taste and no odor. The most significant forms of Cr are metallic chromium

(Cr(0)), trivalent chromium (Cr(III)) and hexavalent chromium (Cr(VI)). Under some conditions, Cr forms

can change from one to another.

• Cr metal is steely-grey and shiny. It has high corrosion resistance and hardness and is used

mostly in the production of stainless steel and chrome plating. Cr metal is not harmful to human

health.

• Cr(III) occurs naturally in living organisms. It is an essential nutrient in trace amounts. It is found

in some industrial processes and has a low toxicity.

• Cr(VI) is very toxic. It is classified as a carcinogen, which means that it can cause cancer.

In which industrial processes and products can Cr(VI) be found?

• Production and use of stainless steel and other chromium alloys (and during the welding and

cutting of these).

• Electroplating.

• Production of dyes, paints, inks, pottery and plastics using Cr pigments.

• Leather tanning.

• Wood treatment.

• Chromate-containing primers and other surface coatings.

• Smelting of ferrochromium ore.

• Impurities in portland cement, etc.

How can Cr(VI) get into your body?

• By inhaling airborne Cr(VI) in contaminated dust, fumes or mist.

• Skin contact through handling solutions, coatings or cements containing Cr(VI).

• Swallowing it, through handling food contaminated with dust on your hands.

How can Cr(VI) harm you?

As with all chemical exposures, the risk related to Cr(VI) exposure depends on your personal traits and

habits, how much of the chemical you were exposed to, how you were exposed, how long and how

often the exposure occurred, and whether other chemicals were present.

Single exposures to Cr(VI) compounds may cause:

• Irritation and inflammation of the nose and upper respiratory tract.

• Irritation, burns or ulcers of the skin, if your exposure is through the skin.

• Eye damage from splashes.

Repeated or prolonged exposure to Cr(VI) compounds may cause:

• Cancer of the lung.

• Damage to the nose, including ulcers and holes in tissue flap separating the nostrils.

• Inflammation of the lungs.

• Allergic reactions in the skin (dermatitis) and respiratory tract (e.g. wheezing).

• Kidney damage.

• Potential effects on reproduction (e.g. male fertility, fetal development).

What must employers do to protect their workers?

[Personalize this section according to national law and limits.

Possible EU Legal frame:

1. Directive 2004/37/EC “European Directive for carcinogens or mutagens at work”. Currently under

revision.

2. Directive 89/391/EC

3. Chemical Agents Directive

MS may have stricter national laws.

The national Cr(VI) occupational limits must be defined.]

The [refer to EU/national] law requires employers to:

• Assess the risks to your health and the precautions needed for your protection

• Prevent you from getting exposed to Cr(VI), or where this cannot reasonably be done,

adequately control your exposure

• Reduce your exposure to airborne Cr and its compounds so far as reasonably practicable, and in

any case to below the following workplace exposure limits:

o for Cr (VI) compounds, XX milligrams per cubic metre (mg.m3) of air, averaged over an 8-

hour period

o for other chromium compounds, XX mg.m3 averaged over an 8-hour period

• Maintain all fume and dust controls in efficient working order

• Provide fit testing of any tight-fitting respirators

• Find out how much Cr you are exposed to, normally through a monitoring programme, and tell

you the results

• Arrange any health checks that are necessary

• Inform, instruct and train all employees who may be exposed to chromium

What must you do, if you work with processes involving Cr(VI)?

• Use the extraction equipment or other control measures correctly,

• Use the protective clothing and equipment provided.

• Always use the washing facilities provided, which should be adequate and suitable for your

needs.

• If you have to wear a respirator make sure:

o it fits properly

o if it is a tight-fitting mask, that you have been fit tested and are clean shaven

o it is clean and in good working order

o the filter is changed regularly

o stored in a clean/dry place, preferably a locker.

• Report defects in enclosures, extraction equipment or other control measures to your

employers.

• Don’t eat, drink or smoke in work areas where chromium may be present.

How can you get more information? [Adopt at national level, as you find appropriate. May refer to the

national competent authority for occupational health and safety or other appropriate official body].





Appendix 16

Leaflet with information for employers


HBM4EU occupational biomonitoring study on chromium


Information for Participating Companies

Introduction

We would like to invite your company to take part in HBM4EU (Human Biomonitoring for Europe),

a pan-European study which aims to investigate workers’ exposure to hazardous chemicals in the

workplace.

HMB4EU is a European project running from 2017 to 2021 and including experts from 28

European countries and European Union agencies. It is funded by the European Commission’s

Horizon 2020 Program and by our national governments. Further details can be found at

https://www.hbm4eu.eu/about-hbm4eu/.

We are reaching out to companies authorized to use hexavalent chromium Cr(VI) under the EU

REACH Regulation and affected by the proposition to limit workers’ exposure to Cr(VI) and other

chemicals under the EU Directive on carcinogens or mutagens at work (Directive 2004/37/EC).

Your participation can further benefit your company’s risk assessment & management and

corporate responsibility practices. Our role is completely funded and participation into the project

does not result in any out-of-pocket costs for your company.

About the study

The aim of this study is to evaluate the exposure to carcinogenic hexavalent chromium (Cr(VI)) at

the European workplaces and to evaluate if the current safety and control measures are able to

protect workers from harmful exposure. Secondly, we are testing the utility of new, more specific

methods to assess the worker’s exposure to hexavalent chromium from the human samples.

These methods will avoid the confounding effect caused by the exposure to less harmful trivalent

chromium.

We will also evaluate the exposure to nickel, manganese, and perfluoroalkylated substances if

exposure to such chemicals is anticipated in your company. Biological monitoring in urine, blood

and breathing samples will be the main method in the assessment of exposure, but industrial

hygienic sample (air and hand wipe) measurements might be also carried out.

From each participating company, we will need up to a total of 15 workers, as follows:

(a) up to 10 workers whose duties involve welding or surface treatment activities

(however, if the company has e.g. multiple sites or multiple processes falling under the

scope of the study, also higher number of participating workers is possible), and

(b) up to 5 workers who do not have such duties, to be used as a comparison group.

What does my company have to do if we agree to take part?

Once your company agrees to participate, the next steps are:

1. Following your signed consent, our Research Team will contact you to arrange a

suitable time for our team members to visit your premises and speak to you and your

workers about our study. An information leaflet will be given to your workers. Workers

will then have to agree to participate by signing their own consent forms.

2. Our research team will visit your company on an agreed date to take biological and

hygienic samples from participating workers and to ask them a few questions about

their background and working routines, and to collect information on the relevant

processes and work activities.

3. If we have your permission, we may take photographs of relevant processes and work

activities, which will be amended such that workers or the company cannot be

identified. This material may be also used for demonstration purposes in the

information session in which results of the study are presented in your company.

4. Samples and information will be taken from your workers during working hours.

5. The duration of sampling and information collection will depend on the category of the

participant, i.e. exposed versus unexposed. For chromium exposed worker’s it will take

two times 15 minutes to give a breath sample and about 10-15 minutes to fill the

questionnaire. Time will be needed also for two blood samplings and urine samples.

For unexposed workers each sample is given only once.

6. Once samples are gathered, information regarding your company and workers’ names

will be coded and anonymity will be guaranteed.

7. Samples and information gathered from your workers will then go for analysis.

What are the benefits for the companies participating to the study?

This Pan-European study will help you to comply with your possible obligations under EU chemical

legislation (REACH) and/or your obligations under the EU Directive on carcinogens or mutagens at

work (Directive 2004/37/EC), which will set an EU-wide binding limit value (BOELV) for the

exposure to hexavalent chromium exposure at work.

By participating, your company will:

• Receive an electronic copy of the report with the collective results of the study published

on the website of the HBM4EU project. The report will not contain any information

identifying your company or your workers.

• Receive your company-specific hygienic report electronically. The report will include

recommendations for the surveillance and monitoring procedures of your workers.

• You can also choose to receive an electronic report of the collective urinary chromium

biomonitoring results of your workers, but will not receive individual results. Your workers

will receive their personal chromium exposure results.

• Your workers will gain awareness regarding the safety measures that they need to follow

when carrying out activities involving exposure to hexavalent chromium

Does our company have to take part?

No, it is entirely up to you to decide whether or not to take part. If you do decide to take part, you

will be asked to sign a consent form.

However, even if you sign the consent form you are still free to withdraw at any time and without

giving reason and we will not approach any member of your staff to participate in the study.

However, we will retain right to use any samples collected prior to the withdrawal in a confidential

manner.

Are there any risks if my company joins HBM4EU?

There are no risks involved if your company joins HBM4EU, and your company’s name will not be

disclosed no matter what the results regarding chemical exposure.

How will my company’s privacy be guaranteed?

• Participants are anonymous as their names are replaced with a code, and therefore cannot

be traced as working for your company.

• Any information that may lead to the identification of a worker or your company will not

be stated in any published reports i.e. country or company name.

• Computer security will be used to block any unauthorised access and all paper records will

be securely stored.

• Information or samples provided to researchers will not include your company’s

registration numbers.

• Any results reported by this study will not contain information that may identify your

company or staff. Only anonymous results of research conducted by the research team will

be published and made available on the study’s website: https://www.hbm4eu.eu/

Are there any costs involved?

There are no costs involved except brief working time of your staff members allocated for this

study.

Who has reviewed the study?

The study is reviewed by the Bioethics committees and the Data protection commissioners of

[Country]

Who do I contact if I would like more information about the hexavalent chromium study?

You can always reach out to [Name Surname of Research Coordinator of the Country]

Tel: [xxxxxxx] Email: [xxxxxxxx]





Appendix 17

Consent form for employers


EMPLOYER CERTIFICATE OF INFORMED CONSENT

Study description

Title: HBM4EU occupational biomonitoring study on chromium


Code:

Researcher identifier

Name: Telephone:

Institution: Email:

Company information

Name:

Street Address: Telephone:

Country: Email:

Company contact person

Name: Telephone:

Position: Email:

Company Code Initials

1 I have read the companion “Information for participating companies” leaflet. I have

had the opportunity to consider the information, ask any questions regarding it and

have received satisfactory answers.

2 I understand that my company’s participation is voluntary and we are free to

withdraw at any time without giving any reason, and without my company’s legal

rights being affected. The HBM4EU research team will retain the right to use any

samples collected from the workers prior to the withdrawal in a confidential manner.

3 I understand that my company will not benefit financially from taking part in this

study.

4 I consent that the HBM4EU research team will enter my company’s premises to

collect biological and industrial hygienic samples and exposure related information

from workers who have agreed to participate in this study by signing their own

consent form.

5 I confirm that my workers’ salary will not be affected due to their participation in this

study, which will take place during working hours.

6 I consent to the use of cameras by the HBM4EU research team as follows:

� I do not give permission for any photography during the research visit

� I give permission for photography to document work areas and practices, under

the condition that the photographs will be blurred to protect the identity of my

company and my workers in any published reports.

7 I understand that my company has the right to receive the collective chromium

biomonitoring results of our workers via the nominated company contact, but will

not receive individual results. I indicate my company’s preference as follows:

� My company wishes to receive the collective biomonitoring results of our

workers

........................................................

.............................. ......................................................

Name and position of company

representative Date

Signature of Company

Representative

� My company does not to wish to receive the collective biomonitoring results of

our workers

My company will also receive electronic copies of our company specific industrial

hygienic report and the overall findings of this research study.

including informed consent - hbm4eu...including informed consent deliverable report d 7.4 wp 7 -...

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