When is it necessary to request a statement from Kela s Research Ethics Committee?

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1 Kela s Research Ethics Committee and the preliminary ethical review of research dealing with human sciences The task of the Research Ethics Committee is to conduct, upon request, an ethical review of research projects in the human sciences and to issue statements on human-related register, survey and interview studies that rely on personally identifiable data available from Kela. The Research Ethics Committee will not conduct a review of research projects that fall within the scope of the Medical Research Act (488/1999 Laki lääketieteellisestä tutkimuksesta). The Committee can also deal with any particular ethical issues that arise during the research process. The preliminary ethical review will never shift the responsibility of the researcher for his/her own research and its conclusions to the Research Ethics Committee. The researcher shall carefully read the ethical principles in the humanities and social and behavioural sciences as issued by the Finnish Advisory Board on Research Integrity (TENK) (link). A researcher must independently assess the need for a preliminary ethics review of the research and request, if necessary, a statement from the Ethics Committee. The researcher can also request a statement from the Ethics Committee when so required by a research financier or co-operative partner, or the plan is for the results of the research to be published in a scientific journal that requires a preliminary ethical review. If the research project includes multiple sub-projects, the researcher shall request a preliminary ethical review separately for each subproject. Research in the human sciences must always be submitted for a preliminary ethical review prior to the initiation of the research if: 1. The study intervenes in the physical integrity of subjects. 2. The study deviates from the principle of informed consent (ethical review is, however, not required if the research is based on public or published data, registries or documents or archived material). 3. The study, which is not conducted as part of the normal activities of a school or an early childhood education and care unit, involves children under the age of 15 without obtaining a separate parental consent or providing parents or guardians with information that enables them to forbid the child from taking part in the study. 4. The study exposes research subjects to exceptionally strong stimuli and the evaluation of possible harm requires special expertise (for example, studies containing violence or pornography). 5. The study may cause long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life. 6. The study can signify a security risk to subjects (for example studies concerning domestic violence). When is it necessary to request a statement from Kela s Research Ethics Committee? A statement on research is requested from Kela s Research Ethics Committee, for instance, in the following cases: Kela is providing individually identifiable data for research purposes. A sample population for a questionnaire survey is being retrieved from Kela s registers and the research involves the gathering of sensitive information. Kela s register data is being combined with data retrieved from other sources, such as questionnaire or interview material. A statement from Kela s Research Ethics Committee is generally not necessary in the following cases: The study utilises unidentifiable register data and a statement is not required for any other reason. The research project has been reviewed by another ethical body and no other party requires a separate review by Kela s Research Ethics Committee. The project is a development project that does not involve any scientific research nor is an ethical review required for any other reason. 1(4)

2 The matter concerns a final project or thesis for a qualification or degree and a statement is not required for any special reason, for instance, by Kela as a provider of data. Required documents for the statement request The request for a statement shall be submitted as a single PDF file containing the required appended documents, in numbered order: 1. Cover letter o Grounds for the request (why the review is being requested, e.g., required by a funding agency) o Information about any earlier ethical reviews o List of documents included in the request for a statement o Contact information for the person responsible for the research as well as the date and signature. 2. Summary of the research plan o A summary of an English-language research plan in Finnish or Swedish. 3. Research plan o Sample research plan outline that can be utilised as applicable: Name of the research (Title) Authors and date of research plan I. Background information and motivation for the research questions Earlier research results on the topic Possible theoretical framework The unknown - grounds for your own study Information about whether the study is part of a larger project II. Research objectives Key research problem Specific research questions Possible hypotheses III. Material and methods Description of research material Acquisition and composition of material Statistical (or other) analysis of material IV. Research ethical and legal perspectives Ethical and legal issues related to the topic, methods and material Issues concerning responsible conduct of research Research permits and application process V. Research timetable and funding Implementation plan including an estimated timetable and the duration of the different phases Possible funding plan VI. Description of the research team Organisation involved in the research Key merits of researchers in terms of the project Work division (incl. principal investigator for the study) Possible research co-operation 2(4)

3 Financial interests of the researchers VII. Significance of research Novelty value of the study Significance in terms of society, health, etc. VIII. Data management plan Plan for the acquisition, handling, storage and further access or archiving of the data IX. Publication plan X. Sources XI. Appendices 4. Assessment by the researcher about the potential ethical issues associated with the research o The assessment shall be based on the ethical principles of human sciences (respecting the autonomy of research subjects, avoiding harm and ensuring privacy and data protection) o If necessary, the ethical guidelines for the relevant discipline are also applicable. 5. Information leaflet for research subjects (if necessary, this also serves as the consent document) o Contact information for the principal researcher and related research organisation o Funding agency for the research o Other members of the research team o Source of contact information of research subjects o Topic, purpose, objective and significance of research o Implementation method for the research List any procedures that the research subjects will be required to undergo and how much time participation in the research will take. The research subjects must also be informed about any possible benefits or disadvantages of research participation. o How and for what purposes is the information intended to be used The research subjects shall be informed and their consent requested, if the information to be acquired will be combined with data from another source, such as official register information. Research participants shall be given specific information about the registers used in the research. Research participants shall also be informed about and provide consent for the possible later use of the material. o Rights of research subjects Research subjects shall be informed that participation is voluntary and that they can withdraw from participation at any time without the need to state their reason and without consequences. The information leaflet shall explain what will happen to the data that has already been acquired, if an individual decides to withdraw from participation. The research subjects shall be informed about the possibility to request additional information concerning the research and the contact information for the person from whom to request it. o Secure storage and handling of research material o Information about further access, archiving and destruction of research material o If the information leaflet also serves as the consent form: the date, the signatures and name clarifications of the research subject and researcher, and the research subject s date of birth and address or personal ID number 6. Research subjects consent form (if it is separate from the information leaflet) o A consent form is required in addition to the information leaflet, if the research data will be analysed in an identifiable manner or the data acquired from the research subject will be combined with information from another source, such as official register information. o Consent for the handling of sensitive information shall primarily be given in writing 3(4)

4 o The consent form shall correspond to the information leaflet: Title of the study for which the consent is being requested The research subject has been given sufficient information about the study Statement that participation in the research is voluntary Specific information about the research material being combined with information from another source. The consent form shall contain a way (such as ticking a box) for the research subject to indicate consent specifically for the combination of data. Information about the voluntary nature of participation in the research, the possibility to withdraw from participation at any point without the need to state one s reason and without consequences. Information about what will happen to the data that has already been acquired, if an individual decides to withdraw from participation. the date, the signatures and name clarifications of the research subject and researcher, and the research subject s date of birth and address or personal ID number 7. Other material given to the research subjects o e.g., questionnaire forms, interview framework, journals, tests, etc. 8. Scientific research data file o The relevant form to be completed is available from the website of the Data Protection Ombudsman 9. Statements concerning previous preliminary ethical reviews General instructions When creating an information leaflet, consent document and questionnaire form, it is a good idea to make note, among other things, of the following aspects: o Clear and understandable wording without any difficult field-specific scientific jargon o Use of language that is polite and respectful towards the target group o Use of a linguistic style that can be easily understood by the target group o Family and gender-neutral language o Information about whether the research subject will be asked any questions of a sensitive nature o Research subjects shall not be asked any questions that are unnecessary or irrelevant in terms of the research o If there are several target groups within the research, a separate consent form shall be drawn up for each target group o Model phrases that should be used in the information leaflet and consent document can be found, for example, Data management guidelines for research. Submission of the request for a statement The statement request and necessary appendices shall be sent as a single PDF file via no later than two weeks before the meeting of the Committee to the Committee secretary at kela.tutkimuseettinen.tmk(at)kela.fi. The Committee can only process written statement requests that arrive prior to the stated deadline. The statement request, study design, project plan and appendices should be carefully considered and finalised. 4(4)

5 A request for a statement that is submitted prematurely often leads to supplementary processes that may unnecessarily delay the start-up of the project. 5(4)