Informed consent for reusing data: Is it possible? Does it matter?

1. Informed consent for reusing data: Is it possible? Does it matter? Ethics and Archives Seminar Series University of Essex 19 September 2008 Libby Bishop University of Leeds and University of Essex

2. What is informed consent? Purpose of the research What is involved in participation Voluntary nature of participation Benefits and risks Mechanism of withdrawal Usage of data – for primary research and sharing Strategies to ensure confidentiality of data (anonymisation, access….) Funding, contact details, complaint procedure, questions

3. IC in social science research • Historical – Nuremberg, Geneva Convention, Declaration of Human Rights • Informed consent-key to preventing medical abuse • Expanding (inappropriately?) to any social research on people • Critique of paternalism (“doctor knows best”) • “Regulatory drift” • Managerialist curtailment of researcher autonomy • Assumes a de-socialised, rational individual • Institutional CYA (no easy alternatives for RECs) • “Ethical hypochondria”

4. Why archives need researchers to get IC Sensitive personal data can only be processed for research purposes if one of several conditions is met: explicit consent (ideally in writing) has been obtained (Data Protection Act)

5. Is IC possible for data reuse? By strict definition (knowing purpose of research)--no But there are other solutions Recontact General consent Consent does not have to be specific But if these fail…

6. Why do we care about IC again? Philosophical foundations Consent is a waiver of rights An action that would otherwise breach rights or cause harm is made permissible (Manson) Reasons lack of IC might be ok No rights breached, no harm or risk Minimal risk but counterbalancing ethical duties also in effect

7. Ethics for archives is bigger than IC No different than balancing duty of confidentiality to participants and duty to disclose to research community

8. Data Sharing Review – 2008 “As a general rule, it seems right that personal information obtained consensually for a specified purpose should not then be used for an incompatible purpose that goes outside the terms of the original consent…For this reason, the second Data Protection Principle, which prohibits reuse of information in any manner that is incompatible with the original purpose, stands as a significant safeguard. It is important to note, however, that ‘incompatible with’ is not the same as ‘different from’” (5.17). “Consent clauses should be written in a way that provides for reasonable additional uses of information, while giving patients and others sufficiently specific explanations and safeguards to prevent inappropriate uses or sharing of information about them” (5.20). http://www.justice.gov.uk/reviews/datasharing-intro.htm

9. Arguments for archiving and sharing data • Securely store and protect data • Not burdening over-researched, vulnerable groups • Project voices of participants • Provide greater research transparency • Enable fullest ethical use of rich data In each, ethical duties to participants, peers and public may be present

10. Confidential research data can be used and shared • By combining one or more of these strategies: • Obtain informed consent • Protect identity (one option is anonymisation) • Restrict access (e.g. by group, use, time)

11. IC impossible for some research Covert research Research on illegal activities Evaluation research Observer effects Some critical research

12. What are the ethical implications for what does NOT get into the archive? Entire research projects that do not have IC Data types for which consent is more difficult (audio, video)