informed consent form - ariseinitiative.org · informed consent form annalisa landi fondazione per...

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 824021

Informed Consent form

Annalisa Landi

Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

ETHICAL & REGULATORY CONTEXT


“Participation by individuals capable of giving

informed consent as subjects in medical research

must be voluntary.

Although it may be appropriate to consult family

members or community leaders, no individual

capable of giving informed consent may be

enrolled in a research study unless he or she

freely agrees.”

One of the three fundamental ethical principles for using any human

subjects for research is the Respect for persons:

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. THE BELMONT REPORT - Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979

protecting the autonomy of all people and

treating them with courtesy and respect and

allowing for informed consent. Researchers

must be truthful and conduct no deception…

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• GUIDELINE 9: INDIVIDUALS CAPABLE OF GIVING INFORMED CONSENT

• GUIDELINE 10: MODIFICATIONS AND WAIVERS OF INFORMED CONSENT

• GUIDELINE 11: COLLECTION, STORAGE AND USE OF BIOLOGICAL MATERIALS AND

RELATED DATA

• GUIDELINE 12: COLLECTION, STORAGE AND USE OF DATA IN HEALTH RELATED RESEARCH

• GUIDELINE 16: RESEARCH INVOLVING ADULTS INCAPABLE OF GIVING

INFORMED CONSENT

• GUIDELINE 17: RESEARCH INVOLVING CHILDREN AND ADOLESCENTS

• APPENDIX 2: OBTAINING INFORMED CONSENT: ESSENTIAL INFORMATION FOR

PROSPECTIVE RESEARCH PARTICIPANTS


‘Informed consent’ means a subject's free

and voluntary expression of his or her

willingness to participate in a particular

clinical trial, after having been informed of

all aspects of the clinical trial that are

relevant to the subject's decision to

participate or, in case of minors and of

incapacitated subjects, an authorisation or

agreement from their legally designated

representative to include them in the clinical

trial

Reg (EU) n. 536/2014* definition

‘Consent’ of the data subject means any

freely given, specific, informed and

unambiguous indication of the data

subject's wishes by which he or she, by a

statement or by a clear affirmative action,

signifies agreement to the processing of

personal data relating to him or her

Reg (EU) 2016/679 (GDPR) definition

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*It was adopted and entered into force in 2014, but the timing of its application depends on confirmation of full functionality of Clinical Trial Information System through an independent audit, estimated at the end of 2020.


The anticipated benefits justify the foreseeable

risks and inconveniences

The subjects, or his or her legally designated

representative, have been informed

The subjects, or his or her legally

designated representative,

have given informed consent

The rights of the subjects to

physical and mental integrity, to privacy and to the protection of the data concerning

them are safeguarded

Little pain, discomfort, fear and any other foreseeable risk for

the subjects and both the risk threshold and the degree of distress specifically defined in the protocol and

constantly monitored

The medical care provided to the subjects is the

responsibility of an appropriately qualified medical

doctor

The subject or his or her legally designated

representative provided with the

contact details of an entity where further information can be

received

No undue influence,

including that of a financial nature,

is exerted on subjects to

participate in the clinical trial

CLINICAL TRIAL REGULATION PROVISIONS ON CONSENT

New clinical trial Regulation-Reg (EU) n. 536/2014

Prior to the beginning of the trial, the investigator should have the favourable opinion of the Ethics Committee on the written informed consent form and any other written

information to be provided to subjects!

A clinical trial may be conducted only where all of these conditions

are met!

CLINICAL TRIAL REGULATION PROVISIONS ON CONSENT

Informed consent:

❖ in emergency situations

❖ in paediatric trials

❖ for incapacitated subjects

❖ in ‘cluster trials’

❖ for pregnant or breastfeeding women

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DETAILS on the content are in CHAPTER V of

the Clinical Trial Regulation -Protection of Subjects and

Informed Consent

“The informed consent foreseen under the Clinical Trial Regulation must not be confused with the notion of

consent as a legal ground for the processing of personal data under the GDPR.

Provisions of Chapter V CTR on informed consent, in particular Article 28, respond primarily to core ethical

requirements of research projects involving humans deriving from the Helsinki Declaration.

The obligation to obtain the informed consent of participants in a clinical trial is primarily a measure to

ensure the protection of the right to human dignity and the right to integrity of individuals under Article 1

and 3 of the Charter of Fundamental Rights of the EU; it is not conceived as an instrument for data protection

compliance.”

Besides the consent to the research, participants MUST provide the researcher with the consent to the processing of their personal data…

The lack of consent to data processing may compromise the

participation in the study!

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Interplay between the Clinical Trials Regulation (CTR)

and the General Data Protection Regulation (GDPR)

GDPR PROVISIONS ON CONSENT

Consent remains cornerstone as main legal basis for the processing of personal data!

Request for consent to be presented in a manner which is clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. (Article 7)

The data subject shall have the right to withdraw his or her consent at any time. (Article 7)

For consent to be informed, the data subject should be aware at least of the identity of the controller and the purposes of the processing for which the personal data are intended. (Recital 42)

It requires an affirmative action: silence, inactivity or pre-ticked boxes should not constitute consent!

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✓ TYPE OF DATA PROCESSED

✓ THE PURPOSES/FUTURE PURPOSES OF THE PROCESSING

✓ THE DURATION OF DATA STORAGE OR THE CRITERIA TO DETERMINE IT

✓ ANY TRANSFER OF PERSONAL DATA TO A THIRD COUNTRY AND THE APPROPRIATE SAFEGUARD MEASURES

✓ ANY AUTOMATED DECISION-MAKING (including profiling)

✓ THE RESPONSIBLE FIGURES FOR DATA PROCESSING (the controller, Data Protection Officer “DPO”, the

recipients of the personal data)

✓ THE MAIN RIGHTS OF THE SUBJECT (right to request access or deletion of personal data, the right to request

rectification of personal data, the right to restrict the processing or to object to processing, the right to data

portability, the right to lodge a complaint with a supervisory authority and the right to withdraw consent)

Information to be provided to the data subject when processing personal data

(Articles 13-14)

GDPR PROVISIONS ON CONSENT


The informed consent process is a dynamic and continual process which begins when the recruitment of subjects starts BUT does not end

with the signature of the subject…

INFORMED CONSENT PROCESS

INFORMATION

COMPREHENSION

VOLUNTARY DECISION

COMPREHENSION MONITORED AND

MAINTAINED

AVAILABILITY OF NEW

INFORMATION

RE-CONSENT

INFORMED CONSENT FEATURES

freely given

informed

given for a specific purpose

reasons for processing

clearly stated

explicit and given via a positive act

clear and plain

language

possible and easy to withdraw consent

INFORMED CONSENT FORM

Informed Consent Form

Information sheet

Consent form

A signed and dated copy of the full

Informed Consent Form must be given to

study participants

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To share information about the research with the participant

For signatures if the participant agrees to take part

PART I: INFORMATION SHEET

What will be done with the results?

What will we need to do if you/your child takes part?

What about genetic testing?

What should I do if I want to transfer data and samples?

What will happen if we decide not to take part?

Will my confidentiality be respected?

To whom may I address questions about the research?

Who is organizing this research?

What are the possible benefits and disadvantages of taking part?

Why are you doing this study?Why have I/has my child been

asked to take part?

Have been foreseen secondary uses of data and samples?

What will be done with data and samples after the end of the

research?

Information on the Trial

DrugPurpose

Procedures and

Protocol

Duration

Side Effects

Risks

BenefitsReimbursements

Confidentiality

Study results

Right to Refuse or Withdraw

Subject’s rights

Alternatives to

Participating

Contact informa

tion


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Study titleName of

research centre

Name of Principal

Investigator

Name of Sponsor

Protocol code, version and date

[Information sheet for ____________________]

Introduction part containing information on the research study



Talk to anyone they feel comfortable

talking with about the research

Take time to reflect on whether they

want to participate or not

Ask questions on the research at any

time

Receive more explanations of the words or concepts participants do not

understand

Study participants will be given the possibilities to….

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➢ Introduction part


ARISE TEMPLATE

➢ Introduction part

Description of the study/ research and the reason of the invitation to participate in the research

➢ Why are you doing this study?➢ Why have I/has my child been

asked to take part?

Details on the project

Details on the disease

Study rationale

Study purposes


➢ Description of the research study

Description of the study/ research and the reason of the invitation to participate in the research

Why are we doing this study?

Details on the project

Details on the disease

Study rationale

Study purposes

Future purposes



Example: Sickle Cell Disease (SCD) is an autosomal recessive disorder of haemoglobin S (HbS) gene. […] This study is included in a research project developed by a multi-disciplinary workforce of paediatricians, haematologists, laboratory scientists and other health workers in order to foster sharing of best practice in newborn screening, diagnosis and treatment of SCD

leading to improvement in overall disease outcome. <PLEASE INCLUDE STUDY PURPOSES/FUTURE PURPOSES (if any)>We are asking your child to participate in this study because affected by SCD.

<PLEASE ADD OTHER INCLUSION CRITERIA>.

➢ Description of the research study

What are the possible benefits and disadvantages of taking part?

Description of the risk and benefit of taking part in the research

Example: Currently, there is no direct benefit for you. However, your participation will allow us to gain knowledge about SCD and other haemoglobinopathies.

There is no risk for your health. <PLEASE INCLUDE OTHER DETAILS ON THE BENEFITS AND RISKS, if any>.

An ad-hoc insurance must be agreed if needed


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➢ Risks & Benefits

Description of the procedures that will be undertaken

Example: Your participation consists of allowing us to use your data and blood samples. <PLEASE INCLUDE DETAILS ON

DATA AND SAMPLE TYPES AND, IF A PROSPECTIVE COLLECTION IS FORESEEN, THE STUDY PROCEDURES FOR THE COLLECTION> The data and samples will be pseudonymised

under a unique study number and sent to specialized laboratories in … <PLEASE INCLUDE DETAILS ON DATA AND

SAMPLE TRANSFER>. There, we will perform <PLEASE INCLUDE DETAILS ON THE ANALYSIS TO BE PERFORMED>.

➢ What will we need to do if you/your child takes part?

Type of analysis

Sample collection

Data collection

Genetic tests

Secondary use of data

and samples


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➢ Study procedures

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Purposes of the storage

Accessibility conditions of samples and related data

Location and duration of retention

Responsible persons for keeping samples and results

Procedure for handling any stored identifiable samples

Possible transfer of samples and related data

Plans to handle data and samples after the storage period



Sample collection

➢ What about genetic testing?

The consent for genetic testing MUST be different from the consent obtained

for the main research!


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Genetic testing

Use of sample

Genetic tests

Storage of samples

De-identification of samples

Use of data associated with

samples

Being re-contacted for

further research

Receiving information

on the results of the study

Authorisation to….

Description of possible further uses of data and samples

➢ What will be done with data and samples after the end of the research?

➢ Have been foreseen secondary uses of data and samples?

Consent for further purposes should be obtained in the original

consent…

or

Subjects should be re-contacted for being involved in other

studies…



Secondary use

“It is often not possible to fully identify the purpose of personal data processing for scientific research

purposes at the time of data collection. Therefore, data subjects should be allowed to give their

consent to certain areas of scientific research when in keeping with recognised ethical standards for

scientific research […].”

GDPR - RECITAL 32

GDPR - RECITAL 33

Further processing for (…) scientific (…) research purposes (…) shall, in accordance with Article 89(1), not be considered to be incompatible with the

initial purposes!




Secondary use

“Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them”

“If the controller has conflated several purposes for processing and has not attempted to seek separate consent for each purpose, there is a lack of freedom….”

Paragraph 7.2 - Scientific research

“When research purposes cannot be fully specified, a controller must seek other ways to ensure the essence of the consent requirements are served best, for example, to allow data subjects to consent for a research purpose in more general terms and for specific stages of a research project that are already known to take place at the outset. As the research advances, consent for subsequent steps in the project can be obtained before that next stage begins. Yet, such a consent should still be in line with the applicable ethical standards for scientific research…”



Secondary use

Description of the measures to be adopted to safeguard the confidentiality of

participants

➢ Will my confidentiality be respected?



➢ Subjects’ confidentiality & data protection

ARISE TEMPLATE

Compliance with the European General Data Protection Regulation (GDPR) Reg. (EU) 2016/679 and

with applicable national/local laws

Data subject’s rights

Transfer of data and samples

Responsible figures for data processing

De-identification measures (e.g. pseudonymisation,

anonymisation)

Data storage (i.e. period and location)

Access to data



DATA MINIMISATION

PRINCIPLE

“Personal data”: any information relating to an identified or

identifiable natural person (‘data subject’); an identifiable natural

person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a

name, an identification number, location data, an online identifier or to

one or more factors specific to the physical, physiological, genetic,

mental, economic, cultural or social identity of that natural person

“Processing”: any operation or set of operations which is performed on

personal data […] such as collection, recording, organisation, structuring,

storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission,

dissemination or otherwise making available, alignment or

combination, restriction, erasure or destruction

“Pseudonymisation”: the processing of personal data in such a manner

that the personal data can no longer be attributed to a specific data

subject without the use of additional information […]

“Genetic data”: personal data relating to the inherited or acquired genetic characteristics of a natural

person which give unique information about the physiology or the health of that natural person [..]

“Biometric data”: personal data [...] which allow or confirm the unique

identification of that natural person (e.g. facial images or dactyloscopic

data)

The GDPR does not concern the processing of anonymous

information!




Compliance with the European General Data Protection Regulation (GDPR) Reg. (EU) 2016/679

Please check the other applicable national/local

laws!!


What will happen if we decide not to take part?

Voluntary Participation!Please indicate clearly that the decision to participate is entirely voluntary. If they

decline to participate, they will continue with their normal care.

Description of what will happen if participants decide not to take part in the study

Example: It is up to you as to whether or not taking part in this study. If you agree to participate, you will sign an informed consent form. If you decline to participate, you will continue with the normal care. Your decision will not have any influence in the management of the disease. Your decision to participate is entirely voluntary.

The study will be conducted on the basis of fair compensation in the case of damage, on the rights and safeguards dictated by law, on the right to refuse or to

withdraw from the study at any time without giving a reason for the decision. Your confidentiality will be maintained at all times.

No further data besides that essential for the study will be collected.

Right to refuse or to withdraw from the study at any time without giving a reason for the decision!





Besides the rights to withdraw consent at any time, since the coming into force of the GDPR, the subject should be informed of the following rights:

❖ Right to request access to personal data

❖ Right to request deletion of personal data

❖ Right to request rectification of personal data

❖ Right to restrict the processing or to object to processing

❖ Right to data portability

❖ Right to lodge a complaint with a supervisory authority





Ad-hoc DATA SHARING/MATERIAL TRANSFER AGREEMENTS should be set up to ensure that the transfer is performed in compliance with all applicable laws

➢ What should I do if I want to transfer data and samples?

Please consider that for transferring anonymised data the GDPR does not apply!

The transfer is allowed only if the consent has been obtained from the study

participants!




Transfer of data and/or samples

“Any transfer of personal data which are undergoing processing or are intended for processing after transfer to a third country or to an international organisation shall take place only if.…”(Article 44)

➢ ADEQUACY DECISION (Article 45) - adequate level of protection assessed by the Commission the transfer does not require any specific

authorisation!

Periodic review of the decision.. at least every four years!

➢ NO ADEQUACY DECISION (Article 46) the transfer is allowed only if appropriate safeguards have been provided by the controller or processor

The data subject has explicitly consented to the proposed transfer, after having been informed of the possible risks of such transfers for the data subject due to the absence of an adequacy decision and appropriate safeguards (Article 49)

DEROGATIONS FOR SPECIFIC

SITUATIONS

✓ Data controller /processor in the EU collecting personal data about a data

subject of any country, anywhere in the world

✓ Data controller/processor based outside the EU collecting personal data

on EU citizens




Transfer of data and/or samples

Information on the sponsor and on the main contact for addressing questions on the research

➢ Who is organizing this research?➢ To whom may I address questions

about the research?

Example:This research is organized by <NAME OF THE SPONSOR>

Any question that arises after reading this document should be addressed to:

Dr. _________________________ (center IP)Hospital ______________________Department of __________________Address_________________________


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Role & responsibilities

Source: Elixir LU. Webinar on Requirements in data protection law and the upcoming General Data Protection Regulation (GDPR). Feb 2018

Additional roles and new

responsibilities




Role & responsibilities

➢ What will be done with the results?➢ What will happen in case of incidental

findings that might be relevant for study participants’ health status?

Description of the how the study results will be made public and if the data subject will be informed on study results. Description on how to deal with incidental findings

Example: The summary of the study results will be made publicly accessible through the web portal https://www.ariseinitiative.org/ <PLEASE ALSO INCLUDE

INFORMATION ON THE PUBBLICATION OF ANONYMISED RAW DATA, IF APPLICABLE>.Aggregated study results may also be communicated to the scientific community

through congresses and scientific papers, maintaining full patient anonymity.You can be informed of the overall study results if you wish, at the end of the project.

Aggregated and anonymous data for the dissemination activities

Overall study results at the end of the project

Consent from study participants if disseminating pseudonymised data


➢ Study results

Plan for the management of incidental findings

PART II: CONSENT FORM

Study titleName of

research centreCode of the

patientName of Sponsor

Protocol code, version and date

ARISE TEMPLATE

❑ have read and understood the information sheet (version ..., date....) provided relating the study

<PLEASE INSERT STUDY TITLE> and have received a copy of this document.

❑ have been able to ask questions which have been answered fully.

❑ understand that my child’s participation is voluntary and I am free to withdraw, without giving any

reason and my child’s care will not be affected in any way.

❑ have had enough time to fully consider my child’s participation in the study.

❑ want to be informed of the overall study results at the end of the project.

❑ give permission to be informed of incidental findings that might be relevant for my child’s health status.


PART I – CONSENT TO THE RESEARCH:

❑ understand that my child’s clinical information may be reviewed by properly authorized individuals as part of the study and that such information will be treated as strictly confidential.

❑ am aware of the type of data and samples that will be collected.

❑ give permission for using of the samples and data for the study purposes stated in the information sheet.

❑ am aware that the persons stated in the information sheet will have the authority to access my child’s study data and medical records.

❑ agree that anonymised study data will be communicated or published in specialized reports.

❑ give permission for storage of the study data and samples until <please include the storage period>.

❑ am aware of the identity of the data controller and of the data protection officer.

❑ am aware of the transfer of data.

❑ am aware that I have the right to request access to and rectification or erasure of my child’s personal data or restriction of processing concerning personal data or to object to processing as well as the right to data portability.

❑ am aware that if I/my child withdraw from the study, samples will be destroyed and data already collected will be anonymised andmay be processed by authorised researchers.



PART I – CONSENT TO THE THE DATA PROCESSING:

As detailed in the information sheet

Genetic purposes

Further purposes

Study purposes

When you give your consent, you will asked if you gave permission for using samples and data for…

Please consider that you should obtain consent to

further use existing data/samples or to recontact

participants for obtaining new consent for other researches!




ARISE TEMPLATE



I/we authorise the participation of my/our child in this research study

Print Name of Parent(s)/Legally designated representative(s)__________________Signature___________________Date ___________________________

Day/month/year

If only one parent is signing this document, please confirm

☐ I confirm that the other parent does not oppose to the participation of our child in this study, or

☐ I am the only legally designated representative.

For research studies involving minors…

ARISE TEMPLATE

A researcher or the person going over the informed

consent must sign each consent.…

I declare that I have fully informed above mentioned parent(s)/ legally designated representative about this research study. If during the study new information becomes available that could

influence the consent of the parent(s)/ legally designated representative or can help to provide new treatment or healthcare I will immediately inform them.

Researcher: ______________________ Date: ___ / ___ / ___(Please write in capital letters)

Signature: _______________________


If illiterate but giving oral consent…


ARISE TEMPLATE

QUESTION

❑YES

❑NO

Considering that information related to the clinical trial as well as to the data protection is included in the same sheet, should the consent to data processing be separated from the

consent to the research in the form?

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QUESTION

❑YES

❑NO

Considering that information related to the clinical trial as well as to the data protection is included in the same sheet, should the consent to data processing be separated from the

consent to the research in the form?

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“The informed consent foreseen under the Clinical Trial Regulation must not be confusedwith the notion of consent as a legal ground for the processing of personal data under theGDPR.Provisions of Chapter V CTR on informed consent, in particular Article 28, respondprimarily to core ethical requirements of research projects involving humans derivingfrom the Helsinki Declaration. The obligation to obtain the informed consent ofparticipants in a clinical trial is primarily a measure to ensure the protection of the rightto human dignity and the right to integrity of individuals under Article 1 and 3 of theCharter of Fundamental Rights of the EU; it is not conceived as an instrument for dataprotection compliance.”(European Data Protection Board. Opinion 3/2019 concerning the Questions andAnswers on the interplay between the Clinical Trials Regulation (CTR) and the GeneralData Protection regulation (GDPR) (art. 70.1.b)). January 2019)The rule is to ask a specific consent for the research study and a consent for dataprocessing, while information on data processing could be included in the sameinformation sheet.

USEFUL MATERIAL

✓ARISE template – Informed consent form_study participants

✓ARISE template – Informed consent form_parents/legally designated representatives

✓ARISE template – Data Sharing & Material Transfer Agreement

✓WHO templates

✓European Data Protection Board. Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b)). January 2019

✓Giannuzzi V, Landi A, Bartoloni F, Ceci A (2018) A Review on Impact of General Data Protection Regulation on Clinical Studies and Informed Consent. J Clin Res Bioeth 9: 327. doi:10.4172/2155-9627.1000327

✓https://i-consentproject.eu/i-consent-virtual-workshop-rethinking-informed-consent-emerging-challenges-in-the-digital-era/

✓http://www.hra-decisiontools.org.uk/consent/principles-children.html

https://fgbenzi-my.sharepoint.com/:w:/g/personal/fb_fgbenzi_onmicrosoft_com/ESTiYArPWiJEhGZ7WaOo17YBGimG8uGE9sKkS11X5VDCtQ?e=WtZfaq

https://fgbenzi-my.sharepoint.com/:w:/g/personal/fb_fgbenzi_onmicrosoft_com/EbZ9Z41p93FHsbuIP7p944sB-ovY8M8ppTrZvqNRZCsD8Q?e=0rbVJn

https://fgbenzi-my.sharepoint.com/:w:/g/personal/fb_fgbenzi_onmicrosoft_com/EX3jikyL-GdJj3tL745eQlwBZQLgZJYWjtS1DRaZM283xA?e=HdV4Bl

https://www.who.int/ethics/review-committee/informed_consent/en/

https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_opinionctrq_a_final_en.pdf

https://www.longdom.org/open-access/a-review-on-impact-of-general-data-protection-regulation-on-clinicalstudies-and-informed-consent-2155-9627-1000327.pdf

https://i-consentproject.eu/i-consent-virtual-workshop-rethinking-informed-consent-emerging-challenges-in-the-digital-era/

http://www.hra-decisiontools.org.uk/consent/principles-children.html

Thank you!

Annalisa Landi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus - [email protected]

CONSENT

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I

mailto:[email protected]

This presentation reflects only the author(s)’s view and the EU Research Executive Agency (REA) is not responsible for any use that may be made of the

information it contains.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 824021

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