instructions for drafting a request for ethical … · instructions for drafting a request for...
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INSTRUCTIONS FOR DRAFTING A REQUEST FOR ETHICAL REVIEW IN THE HUMANITIES AND SOCIAL AND BEHAVIOURAL SCIENCES
The University of Helsinki is committed to the guidelines issued by the Finnish Advisory Board on Research Integrity for the Ethical principles of research in the humanities, the social and behavioural sciences and proposals for ethical review in these fields. According to the above guidelines, an ethical review must be requested for research designs that include the following types of interaction with the research subjects:
1. The study involves an intervention in the physical integrity of subjects.
The ethical guidelines for medical research by the National Committee on Medical Research Ethics can be applied in planning and reviewing studies that involve an intervention in the physical integrity of subjects (see http://www.etene.org/tukija/dokumentit/Muistlco.pdf(in Finnish)). The committee will evaluate anticipated negative effects (risks, harm and their probability) in relation to the intended scientific value of the study. Studies must be conducted in a manner that minimises any negative effects and risks to subjects.
Evaluating physical risks requires expertise and background information based on empirical studies. The ethics committee can, if necessary, request an ethical review from an outside expert if it considers its own expertise inadequate for risk evaluation.
2. The study deviates from the principle of informed consent (an ethical review is not required, however, if the research is based on public or published documents, registries or archived data).
With regard to a study that deviates from the principle of informed consent, the ethics committee will evaluate whether conducting the study is ethically acceptable. Conducting the study is ethically acceptable if the following preconditions are met:
1) the research is justified, and it would not be possible to conduct the research if subjects were informed of the study and their consent asked for,
2) the data collection does not involve risks to participants,
3) if possible, research subjects will be informed afterwards of the nature and purpose of the research,
4) in the collection, processing and reporting of data, adequate attention is paid to the privacy of the research subjects and data protection issues.
3. The subjects are children under the age of 15, and the data are collected without parental consent and without providing the parents or guardians with an opportunity to prevent the child from taking part in the study, and the study is not part of the normal activities of a school or an institution of early childhood education and care.
A study involving children aged under 15 can be conducted without the consent of a parent or other guardian and without informing the parent or guardian if it does not involve risks to the subjects, and the research design is justified by one or more of the following preconditions:
1) The subjects' age and level of development:
The minors who are the intended subjects are able to understand the research topic and what participating in the study requires of them concretely.
2) The research area and method:
The research topic is not sensitive and asking for a parent's or guardian's consent is difficult in practice (for example, studies of youth clubs or school pupils' voluntary clubs, etc.).
3) The viewpoint of the need for information:
The subject matter of the study may prevent the collection of comprehensive data if parents’ consent must be requested for children's participation (for example, domestic violence, social problems, etc.), or the research covers issues which minors may not want their parents to know about (for example, substance use, sexual orientation, etc.).
4. The study exposes research subjects to exceptionally strong stimuli, and evaluating possible harm requires special expertise (for example, studies involving violence or pornography).
5. The study may cause long-term mental harm (trauma, depression, insomnia) beyond the risks encountered in normal life.
6. The study can entail a security risk to the subjects (for example, studies involving domestic violence).
The researcher must describe potential negative effects and risks so that the ethics committee can evaluate whether the study is ethical, weighing possible risks to subjects against the intended scientific value of the study. Studies must be conducted so as to minimise any negative effects and risks to subjects.
The intended scientific value will be weighed against any potential negative effects and the measures taken to reduce negative effects to the subjects during or after the study (physical and mental harm) or to prevent them altogether (data protection). The evaluation must take into consideration the subjects' free will and autonomy, as the subjects themselves are always able to some extent evaluate the risks of participating in a study.
In evaluating experimental studies, the ethical guidelines in the particular field can be applied in a supplementary manner.
A researcher can also request an ethical review if the research subject, funding agency or cooperation partner so wishes or if the results are to be published in a scientific journal which requires ethical review.
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Requests for ethical review, addressed to the University of Helsinki Ethical Review Board in the Humanities and Social and Behavioural Sciences, must be submitted to the board secretary two (2) weeks before the meeting in which the request should be discussed. The requests for statements, with the (necessary?) enclosures, must be sent as one PDF document to the board secretary by email to [email protected]. The following pages contain detailed instructions following the guidelines of the Finnish Advisory Board on Research Integrity for the submission of documents to be enclosed with the request for an ethical review.
REQUEST FOR A STATEMENT/ETHICAL REVIEW
The Ethical Review Board will base its statement on the following required documents:
1. Cover letter (presenting the grounds for requesting a statement and indicating the contact details of the principal investigator)
2. Research proposal and an abstract of it (if the research will be conducted in English, the abstract must be in Finnish or Swedish)
3. Assessment of the ethics of the study by the principal investigator
4. Information letter to the research subjects
If the study deviates from the principle of informed consent, the grounds for conducting such a study must be presented in the assessment of the ethics of the study.
5. Consent form to be signed by the research subjects
A consent form is required to supplement the information letter to the research subjects if the analysed research data includes identifying or sensitive information.
6. Other material submitted to the research subjects (interview outline, logs, questionnaires, etc.)
7. Data management plan (plan for the processing, storing and archiving of data)
8. Description of the personal data file (form issued by the Office of the Data Protection Ombudsman) Description of the personal data file is required only if identifiable information of research subjects will be collected in research.
Cover letter
The cover letter, the recommended length of which is 0.5–1 pages, should be addressed to the University of Helsinki Ethical Review Board in the Humanities and Social and Behavioural Sciences.
The cover letter must include the following:
Grounds for the request for a statement
Contact details and signature (with a date) of the principal investigator
If relevant: grounds for not submitting any of the required enclosures to the Ethical Review Board for assessment
The Ethical Review Board follows the principle of openness according to which official documents shall be in the public domain (Act No 621/1999 on the Openness of Government Activities). Consequently, the Ethical Review Board has decided that all documents except research proposals be considered public documents.
ENCLOSURES TO THE COVER LETTER:
1. Grounds for requesting a statement
2. Research proposal and an abstract of it
3. Assessment of the ethics of the study by the principal investigator
4. Information letter to the research subjects
5. Informed consent form to be completed by the research subjects
6. Other material submitted to the research subjects (interview outline, logs, questionnaires, etc.)
7. Data management plan (plan for the processing, storing and archiving of data)
8. Description of the personal data file (form issued by the Office of the Data Protection Ombudsman) Description of the personal data file is required only if identifiable information of research subjects will be collected in research.
1. Grounds for requesting a statement
GROUNDS FOR REQUESTING A STATEMENT
Field of research: ____________________________________________________________________________
Please tick the appropriate box. You may select several options.
( ) The collection of data involves an intervention in the physical integrity of subjects.
( ) Data will be collected without the consent of the subjects.
( ) Research data with identifying or identifiable information will be handled without the consent of the subjects.
( ) The subjects are children under the age of 15, and the data will be collected without parental consent and without providing the parents or guardians with an opportunity to prevent the child from taking part in the study, and the study is not part of the normal activities of a school or institution of early childhood education and care.
( ) The study exposes research subjects to exceptionally strong stimuli, and evaluating possible harm requires special expertise.
( ) The collection of data entails a risk of causing the subjects long-term mental harm beyond the risks encountered in normal life.
( ) The study may entail a security risk to the subjects.
( ) The funding agency or cooperation partner requires an ethical review statement.
( ) The results are to be published in a scientific journal which requires ethical review statements.
( ) The researchers wish to obtain an ethical review statement to help their deliberations.
( ) Other reasons; please specify:
( ) The study involves medical research under section 2 of the Medical Research Act (No 488/1999):
( ) Yes
( ) No
Excerpt from section 2 of the Act:
For the purposes of this Act: 1) medical research means research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general; (794/2010)
2. Research proposal and an abstract of it
The length of the research proposal should not exceed five pages.
The abstract should be 0.5–1 page long.
If the study is conducted in English, the abstract must be submitted in Finnish or Swedish.
Research proposal abstracts are not confidential under the Act on the Openness of Government Activities, and they may be published to promote openness. The abstracts can, however, be drawn up on a general level so as not to disclose the content of the study to third parties.
The research proposal must describe in clear detail all the procedures that the subjects will undergo and justify the appropriateness of such procedures for the implementation and objectives of the research. The research proposal should also indicate the number of the sample of research subjects, with justifications.
3. Assessment of the ethics of the study by the principal investigator
In the assessment of the ethics of the study the principal investigator must discuss the plan for data collection, research methodology, the information provided to the research subjects as well as the plan for processing and storing the data from the perspective of avoiding risk and harm.
The assessment should weigh the potential negative effects or harm to subjects resulting from participation in the study in relation to the intended scientific value of the study. The Ethical Principles of Research in the Humanities and Social and Behavioural Sciences (the autonomy of research subjects, avoiding harm, privacy and data protection) serve as the recommended starting point for the assessment. If necessary, detailed ethical guidelines in the particular research field should also be applied.
If the study does not have the features listed above (1-6) and does not present any risk of causing mental harm beyond the risks encountered in normal life, this should be mentioned in the assessment, with justifications.
If the study includes any of the features listed above (1-6), besides discussing the information submitted to the subjects as well as privacy and data protection issues, the assessment must consider the proposed research methods against the set research questions and the value of the new information that the study is intended to provide.
4. Information letter to the research subjects
The information supplied to the research subjects must include the following:
1. Name and contact details of the principal investigator
2. Research organisation(s) and source of funding
3. The topic, purpose, objective and significance of the research
4. The method of collecting data or conducting the research (concrete requirements for research subjects, including the time required for participation in the study, etc.; specification of whether the project is a one-off or a follow-up study and what techniques will be used in data collection)
5. The rights of the research subjects: voluntary participation and the right to ask for additional information about the study and to withdraw from the study without sanctions or giving any reasons.
6. The purpose for which data are collected (the purpose of collecting data on the subjects), the degree of identifiability (in what format data will be processed and what kind of data on the subjects will be stored), measures taken to safeguard confidentiality (potential anonymising of the data, technical solutions for data protection) and archiving the data for secondary research.
7. If information obtained from subjects is to be incorporated with information from official registers, the subjects must be given detailed information on the registers to be used in the study.
8. The use of data for further research and form of archiving.
The information submitted to the research subjects must be presented in accordance with their level of development (e.g., in the case of minors), and care must be taken to avoid the use of special vocabulary that may be difficult to interpret.
If the study involves an intervention in the physical integrity of the subjects, the information provided to them should adhere, where applicable, to the guidelines for medical research by the National Committee on Medical Research Ethics: http://www.tukija.fi/c/document_library/get_file?folderId=18753&name=DLFE-680.pdf (in Finnish)
In experimental studies, sufficient information must be provided concerning the design of the experiment. Experimental designs vary considerably from one field to another. The Ethical Review Board will assess the sufficiency of information on a case-by-case basis.
If the study deviates from the principle of informed consent, the grounds for conducting such a study must be presented in the assessment of the ethics of the study.
For examples on informing research subjects, see Data Management Guidelines (Finnish Social Science Data Archive): http://www.fsd.uta.fi/aineistonhallinta/en/informing-research-participants.html#partIV-examples-of-informing-research-participants
5. Informed consent form to be completed by the research subjects
Besides the information letter to the research subjects, a consent form is required if the analysed research data include identifying or sensitive information.
The principal investigator is required to store the original consent forms. If so requested, the researcher may submit to the research subject a photocopy of the signed consent form.
It is recommended that the content of the consent form be consistent with the information letter provided to the subjects, and it should contain information on the following:
o The study for which consent is requested o Whether the subject has been provided with sufficient information about the
specific study and its purpose as well as the method of collecting information o Voluntary participation in the study o Confidentiality and handling of identifying and sensitive data o Storing and archiving of data and their use for further research, if relevant o If the research data are to be incorporated with information from official registers
or with data from other sources, the subjects must be informed of this and their consent must be obtained.
o The subject’s right to withdraw from the study at any point without reporting his or her reasons or facing any sanctions
o How information collected up until the time of withdrawing from the study is to be used
o The subject’s signature, name in block letters and the date must also be given.
For examples on phrases to be used on the informed consent form, see Data Management Guidelines: http://www.fsd.uta.fi/aineistonhallinta/en/informing-research-participants.html#partIV-examples-of-informing-research-participants
6. Other material submitted to the research subjects
Interview outline, logs, questionnaires, etc.
See Best practices for designing forms (Appendix 1)
7. Data management plan (plan for the processing, storing and archiving of data)
See Data Management Guidelines at http://www.fsd.uta.fi/aineistonhallinta/en/index.html
An ethical review examines a study's data management plan and ensures that technical data security solutions have been planned.
The protection of data containing identifiers must be carefully planned. Subjects’ privacy must not be compromised by storing data carelessly or transmitting such data electronically over unsecured connections (e.g., unsecure email).
If necessary, privacy can be protected by anonymising the data and regulating their further use. The purpose of anonymisation is to ensure that reusers of the data cannot immediately identify individual subjects. Identifiers include names, addresses, personal identity codes and student numbers. Moreover, indirect identifiers include workplaces, schools, residences, age, profession, etc.
The data management plan must describe the following: o The storage location of printed material containing identifiers o The stage at which unnecessary data will be destroyed, or alternatively, their
preservation and archiving for secondary research (the scientific community should have the possibility, if necessary, to verify research findings from the data analysed in a study). Openness is key to testing the validity of scientific information, critically evaluating information and advancing science.
o The protection of electronic data containing identifiers (backup copies, user IDs, processing on computers not linked to a network, if necessary) and to what extent identifiers will be deleted or preserved in the data analysed
o Grounds for the participation of each researcher or other member of the research staff in the processing of the data containing identifiers (the research director or the principal investigator is responsible for ensuring that the number of research staff with access to the data is limited)
o A confidentiality agreement, if relevant o Procedures to protect and store identifiers separate from the analysed data for the
purpose of further contacts with the research subjects
8. Description of the personal data file (form issued by the Office of the Data Protection Ombudsman)
Description of the personal data file is required only if identifiable information of research subjects will be collected in research.
DESCRIPTION OF THE SCIENTIFIC RESEARCH DATA FILE
Personal Data Act (523/1999) Section 10
Date of drafting: ______________________
NB.! The form has been modified for the purposes of scientific research and is therefore more informative than an ordinary data file description. Guidelines for filling in the form are attached. If necessary, use a separate attachment for answering. The controller must make the data file description generally available.
1a. Research Data file controller (person / organisation carrying out research) - an organisation / a private researcher for the use of whom the data file is set up and who is entitled to determine the use of the file (in case of joint research projects, all parties and their responsibilities and duties must be explained also from the viewpoint of personal data processing)
Name and contact information (address, telephone...)
1b. Person responsible for research or corresponding group
1c. Persons involved in the research - all researchers or other persons who have a right to access the file during research
2. Person responsible for and/or contact person on research data file issues
Name and contact information (address, telephone...)
3. Object of research / one-off research project,
purpose of research - the name of the research data file / research has to specify the purpose of the data file created during the research
title: -------------------------------------------------------
-------------------------------------------------------
follow-up research,
title: --------------------------------------------------------
-------------------------------------------------------- duration:
4. Contents of the data file - distinguishing data (such as name, personal identity code, date of birth)
- research information
5. Composition of research data - from whom, what data and on what grounds
6. Research is carried out
nationally
within EU/EEA territory
outside EU/EEA territory
7. The principles of data file
protection
- the method of protection during different phases of processing
- the data file collected during research includes both manual and
data is confidential
Manual data:
digitally stored data (logical data file)
Information recorded in digital data systems:
user account
password
registration of use
access control
Distinguishing data are removed in the analysis phase
Data are analysed by means of distinguishing data because
(state the grounds for storing distinguishing data):
8. Research data file; destroying or transferring to archive
The research data file will be destroyed
The research data file will be transferred to an archive without distinguishing data
with distinguishing data
Location:
OFFICE OF THE DATA PROTECTION OMBUDSMAN MODEL FORM 23 Aug 2004
Tel: +358 10 36 66700
Tel: +358 10 36 16670 (information service 9 a.m. to 3 p.m.) Fax: +358 10 36 66735
www.tietosuoja.fi
[Unofficial translation]
APPENDIX 1 Best practices for designing forms When designing informed consent forms and questionnaires, a number of aspects should be taken into consideration prior to requesting an ethical review, as such aspects may have an impact on the research subjects’ understanding of the study and their attitude towards it. Below is a compilation of aspects that often emerge during ethical reviews.
- Clarity and intelligibility: In the information letter to the subjects and in the consent form, researchers should use language that is intelligible to the target group. For example, in a study involving children, care should be taken to describe the research in a manner that takes into account the child’s phase of development. Similarly, information letters and consent forms designed for laypersons should not contain field-specific terminology that non-professionals cannot be expected to understand.
- Language: Information letters and consent forms should be in the subjects’ native language or in a language that they understand fluently. Within the resources of the study, it might be necessary to consider the translation of questionnaires to ensure the participation of linguistics minorities in the study. For example, it is recommended that in national surveys based on random samples the questionnaire be translated into Swedish. Care should also be taken to ensure that the language used in the forms is polished.
- Gender- and status-neutral language: Depending on the research topic and target group, researchers should consider whether their choice of words excludes any group of respondents. For example, when studying the diversity of families, it might be necessary to include other alternatives for the background variables of “male”, “female” / “father”, “mother”, such as “other” / “other parent or adult carer”.
- Sensitive questions: The cover letter should be carefully formulated to ensure that the recipient is well informed about and prepared for the researcher’s sensitive questions. Also, attention should be paid to the content of the background variables and questions on the form, the options provided for potential responses and the accuracy of measurements. For example, is the collection of details on some sensitive matter really necessary?
- Collection of unnecessary data: Questionnaires and consent forms should not contain questions asked merely to be on the safe side. The questions should be relevant and to the point
- Data protection: Forms must be designed so that the respondents need not worry about the
misuse of the information they submit. For example, identification markers printed on the form may raise suspicion. When asking for background data, it is advisable to mention that such data are collected for statistical purposes.
- Respect for others: When drafting information letters and forms, use polite, respectful language.
Depending on the target group, the manner of addressing the recipients may well serve as a sign of respect for them.
Further information in Finnish about designing forms: Harinen, Päivi. 2009. Tarkastelussa taustamuuttujat. Yhteiskuntapolitiikka 74:3, 338–340. MOTV. Kyselylomakkeen laatiminen. http://www.fsd.uta.fi/menetelmaopetus/kyselylomake/laatiminen.html