Arja%20Kuula,%20Development%20Manager,%20Finnish%20Social%20Science%20Data%20Archive

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Arja Kuula, Development Manager, Finnish Social
Science Data Archive

• Ethics review and data archiving
• IASSIST conference 2009
• Thursday May 28, Tampere, Finland

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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.

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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.

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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

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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)

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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

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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/st
  enius.htm