Arja Kuula, Development Manager , Finnish Social Science Data Archive

1. Arja Kuula, Development Manager, Finnish Social Science Data Archive Ethics review and data archiving IASSIST conference 2009 Thursday May 28, Tampere, Finland

2. Finland: normative framework for ethical evaluation • Act on Medical Research (488/1999) • Medical research: ”research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of disease in general” • Research using only register data or e.g. psychological or sport studies excluded from the scope of application.

3. Finland: normative framework for ethical evaluation • Research in humanities, social and behavioral sciences has been left outside the legislation • No legal requirement for ethics evaluation • General responsibility to protect personal integrity and private life • In November 2007, the National Advisory Board on Research Ethics appointed a working group to look into the need for ethics review in the humanities and social sciences.

4. Working group 1.11.2007-31.12.2008 • To evaluate the need for ethics review in the humanities, behavioral and social sciences • Chair: Arja Kuula,Finnish Social Science Data Archive • Vice Chair: Outi Konttinen, National Advisory Board on Health Care Ethics (ETENE)/Sub-Committee on Medical Research Ethics • Secretary: Liisa Nieminen, National Advisory Board on Research Ethics • Members: Katie Eriksson, Kaijus Ervasti, Heta Gylling, Kari Hämäläinen, Christer Kuvaja, Klaus Mäkelä, Vuokko Niiranen, Ritva Nupponen, Ulla-Maija Peltonen, Matti Savolainen

5. Mandate of the working group • To ascertain the need for ethics review • To put forward the necessary proposals concerning documents required for ethics review (frame of reference and guidelines) • To put forward the necessary proposals concerning implementation of ethics review (timetable, organisation, funding, and anticipated effects on the academic community) • Transparency of work: http://www.tenk.fi/hymy/hymy_eng/ (letter of appointment, mandate, seminar programmes and presentations, minutes of meetings, written publications)

6. The need for an ethics review system in Finland • Researchers themselves need the evaluation for the moral basis of their study • Research subjects need protection • International publications, foreign sponsors, or foreign research partners require the review • Competence and capacity of medical ethics committees are not adequate

7. Proposals • The system for ethical review will not be based on legislation, but universities and research institutes will be invited to join the organization on a voluntary basis and to adhere to the principles and arrangements laid down by the Advisory Board. • The goal is that the committees have a regional mandate so that all researchers can submit their project plans to a committee irrespective of where they work. • A proposal to take measures to amend legislation so that the rights guaranteed to children in the Constitution of Finland and in the UN Convention on the Rights of the Child to influence matters pertaining to themselves to a degree corresponding to their level of development.

8. Researchers must submit their research plan to ethical review if a study contains any of the following features: 1. The study involves intervening with the subjects' physical integrity. 2. The study deviates from the principle of informed consent 3. The subjects are children under the age of 15 and the study is not part of the normal activities of a school or an institution of early childhood education and care and the data are collected without parental consent and without providing the parents or guardians the opportunity to prevent the child from taking part in the study.

9. Researchers must submit their research plan to ethical review if a study contains any of the following features: 4. The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise. 5. The study may cause long-term mental harm (trauma, depression, sleeplessness) beyond similar risks encountered in normal life. 6. The study can pose a security risk to subjects. A researcher can also request an ethical review if the research subject, the funding agency or a cooperation partner so requires or if the results are to be published in a scientific journal which requires ethical review. The reason for requesting an ethical review must always be specified.

10. Ethical principles related to data archiving and re-use • If the study deviates from the principle of informed consent it should be evaluated • BUT ethical review is not required if the research is based on public documents, registries or archived data. • Research ethics principles concerning the protection of privacy aim to find a balance between confidentiality and the openness of science • Research in the humanities and social and behavioral sciences is not always repeatable, but the scientific community should have the possibility if necessary to verify research findings from the data analysed in a study. • Openness is a key defining characteristic of science and also a precondition for testing the validity of scientific information, critically evaluating information and advancing science. • Data which is carefully archived for secondary research reduce the need to collect undue research data containing identifiers. • Archiving data reduces the pressure to research small population groups. • It is especially important to archive research data which are significant from a cultural, a historical or a secondary research viewpoint.

11. Privacy and confidentiality • Data containing identifying information can be collected and used when it is appropriate from a research viewpoint. • With the consent of the subject data with identifying information can also be stored for secondary research. • It is important to respect the autonomy and own judgment of the research subjects. In social research, participants are usually fully competent to assess the risks involved without outside expertise. • The protection of subjects' privacy should be ensured by setting strict conditions for the secondary use of data.

12. Privacy and confidentiality • The limits of the sensitivity and privacy of the matters that are dealt with in studies depend primarily on the research subjects. • By giving consent the subjects have demonstrated their willingness to participate in a study while being aware of the study's scope and methods. • If the subjects participate in a study by writing about their experiences or filling in a questionnaire, they regulate their own participation by avoiding matters and questions that they consider damaging, harmful or too intrusive.

13. Autonomy and own judgment of research subjects • (1) Jenny Graham, Ini Grewal and Jane Lewis: Ethics in Social Research: the views of research participants. 2007 NatCen. (50 in-depth interviews with adults who had recently participated in research) • Interviewees strategies for withholding information: Choosing ‘non of the above´ answer option; Giving misinformation; Holding back details and information; Giving only a general outline, no details; Showing discomfort • (2) Research participants that data archive has contacted (Contacting research participants concerning the archiving of four qualitative datasets) • 169 were contacted, only four of those did not accept the archiving • Main reason to give the consent to archiving: wish to advance science (=the original reason to participate in research) • Open access to research data for other researchers taken as matter-of-course • In social research people can affect the research process much more than in medical research

14. Ethical review • The review process should put special emphasis on adequate data management. • Information given to research participants, data security, plans to remove or protect identifiers, data archiving plan • Specific consent with regard to the use of data in only one project without an archiving plan may be justified only on the grounds that data cannot be anonymized and the archiving of data with identifiers for secondary research would in all likelihood be detrimental to subjects.

15. Conclusion • Proposals (the report) circulated to universities and research institutes for comments and was mainly approved • The ministry of education decides on the organization and the timetable of the proposed evaluation system • If the proposed system will be enforced, it should not contradict data archiving and re-use in any way

16. Further information • http://www.tenk.fi/hymy/ENG/index.htm (proposals and ethical principles are published in English in June 2009) • Klaus Mäkelä & Kerstin Stenius: A new Finnish proposal for ethical review in the humanities and social sciences. Paper presented at the Third Working Meeting of the International Study of Ethical Codes and Ethical Control in the Social Sciences, London, Great Britain, April 1-2, 2009. Available: http://nat.stakes.fi/SV/arkivet/2009/stenius.htm