Consent and other legalities

1. Consent and other legalities MedLawconsult XX Conference Seattle 2005

2. Sketching the discussion What are biobanks … Residual tissue … What legal issues … Are ethical issues as well Consent ‘Ownership’ privacy Feed-back of results Import- export, exchange Against a background

3. Background, balance of values ‘self determination’ / autonomy Protection from ‘harm’ Privacy protection Expectations of patients Better prospects for future patients Solidarity ‘freedom’ of research Protection of harm Divide research realm and economical world

4. Background2, other issues • Tissue (data) = economic value • Patents, IPR • Commercial interest of researchers • Economic interest for governments • Protecting research infrastructure > barriers exchange of tissue • Erosion of public trust • Public / commercial culture, the culture of ‘feelings’ instead of ratio • Those who feel wronged • Uneasy reaction by political elite • Policy making on incidents • Promises of a risk-free society • Research easy target (even though nothing went wrong) • Double bind because of economic value XX Conference Seattle 2005

5. Background 3, ‘emperics’ Host of international documents UNESCO Human genetic data Council of Europe OECD WMA, ‘Helsinki’ Race to the top What do patients want Some kind of involvement Expect something in return, feed-back …

6. What are biobanks a collection of tissue which can be used for research so with data connected …

7. Types of Population Prospective Tissue taken out for research gwa, large and see whether you find any correlations Disease driven Retrospective Using residual tissue Hypothesis driven

8. For consent, what type of tissue Coded anonymous tissue Double coding Sufficiently secure, researcher will not retrieve identity

9. Types of consent Specific for each protocol Standard of clinical trials France, our CCMO Multi choice consent Especially whether or not feed-back Commercial use etc. Council of Europe, Germany Broad consent UK Opt out Denmark, Netherlands , Belgium

10. A cry for harmonisation ? European Directive ? Very naïve Usually does not really harmonise Data protection Directive Makes things more complicated Clinical trials Directive

11. Clinical trials directive discussion Not directly relevant However, now commonly recognised that it has adverse effects for academic clinical research Me: q.e.d. for ‘harmonisation’ Various solutions suggested More explanation More support for academic Researchers Trimming down the Directive A whole new Directive or even Regulation encompassing all biomedical research, also epidemiological etc., so also biobanking

12. No harmonisation at all ? Yes, bottom up: Quality PET’s Basic ethics Governance Not about consent The rule of recognition suffices for that

13. Rule of recognition (Tubafrost) If tissue may used for research at the country where it comes from according to the consent regulations of that country, it can also be used for that research in another country even if that other counry has different consent rules. Home country control principle

14. Feed back, Yes ? Growing tendency in literature Participants seem to expect this Because of gwa and non hypothesis driven research distinction between incidental findings and research results have become blurred However, no obligation in recommendations etc. yet UNESCO, right to know ‘your’ genetic data Unless: individual case, acute, life threatening

15. Good reasons for no individual feed-back Statistical methods, too crude for personal prediction; Coding makes it practically impossible Sheer number makes it practically unfeasible Time factor, comes too late Clinical meaning often still very unclear; Applies to all with this risk factor, if useful in clinical practice should be applied to all … Biobanking is not screening Researchers are usually not the treating doctors Etc.

16. However Something must be done about: Patient expectations Ideas of ownership, Benefit sharing Worries about privacy as DNA is seen more and more as inherently identifiable

17. Must avoid to be seen like this….

18. Good Research Governance - achieving a fair and transparent balance between the interests at stake PUBLIC BENEFIT - bottom up Not only researchers, also with interested patients Management of expectations… Against often paternalistic tendencies of ethicists and regulators

19. Harm from observational research, like biobanking ? Data public good, if managed properly, strict privacy protection no individual harm feasible

20. Now, some of those good research governance principles Transparency about projects and who is who Patient orientated website Involvement patient groups Involvement other stakeholders All policies written out : Policy of how are projects approved, how is scarce tissue used for projects etc. Privacy protection IPR issues, balance researcher, inventor, contributors to tissue bank, etc. Data-sharing Dissemination results of research Whether or not individual feed-back In short: how project will benefit the public good