1. Social value and other ethical issues in research on SARS and STIs Jim Lavery, Ph.D. Centre for Global Health Research St. Michael’s Hospital, University of Toronto CDC STI Conf. Philadelphia, PA Feb 25, 2004

3. Overview SARS and STI research agenda SARS and STI research agenda Shared challenges for research ethics Shared challenges for research ethics Social value of research as critical link between SARS and STI research Social value of research as critical link between SARS and STI research

4. Global SARS Outbreak 2003 Tested public health capacity and preparedness in countries around the world Tested public health capacity and preparedness in countries around the world Reinforced the global nature of infectious disease and complex requirements of cooperation and governance Reinforced the global nature of infectious disease and complex requirements of cooperation and governance Illuminated various gaps in current knowledge Illuminated various gaps in current knowledge

5. SARS Research Agenda Biomedical research (clinical, epi, diagnostic, therapeutic and vaccine) Biomedical research (clinical, epi, diagnostic, therapeutic and vaccine) Social and behavioural research Social and behavioural research HSR, policy, governance, ethics HSR, policy, governance, ethics Reflects clear appreciation of social and public significance Reflects clear appreciation of social and public significance

6. SARS Research Agenda Research intimately linked to evaluation and improvement of public health practice Research intimately linked to evaluation and improvement of public health practice

7. Ethical Issues The ethics of quarantine The ethics of quarantine Privacy and confidentiality of personal information and public need to know Privacy and confidentiality of personal information and public need to know HCW duty to care HCW duty to care Collateral damage (other unmet needs) Collateral damage (other unmet needs) Risk assessment & communication* Risk assessment & communication* Governance & global issues Governance & global issues

8. How does this research agenda compare to the agenda for STIs?

9. STI (PCRS) Research Agenda what works and at what cost? what works and at what cost? defining and evaluating new process and outcome measures, including behaviour change defining and evaluating new process and outcome measures, including behaviour change exploring new strategies to improve the uptake and effectiveness of partner notification. exploring new strategies to improve the uptake and effectiveness of partner notification. (Fenton & Peterman AIDS 1997)

10. STI Research Agenda Research intimately linked to evaluation and improvement of public health practice Research intimately linked to evaluation and improvement of public health practice

11. Ethical Issues Privacy & confidentiality Privacy & confidentiality Informed consent Informed consent Effects on relationships Effects on relationships Medical safety of sex partners Medical safety of sex partners Risk assessment Risk assessment Risk communication and preparation Risk communication and preparation

12. ETHICAL ISSUES SARSSTIs Quarantine / restriction of movement and interaction with others ++++ HCW duty to care +++++ Informed consent +++ Governance & global issues +++++ Privacy & confidentiality ++++++ Collateral damage (effects on relationships & safety of others) ++++++ Risk (assessment, communication and presentation ++++++

13. ETHICAL ISSUES SARSSTIs Quarantine / infringements of civil liberties ++++ HCW duty to care +++++ Informed consent +++ Governance & global issues +++++ Privacy & confidentiality ++++++ Collateral damage (effects on relationships & safety of others) ++++++ Risk (assessment, communication and presentation) ++++++

14. Research Ethics Focus Assume unresolved ethical issues in biomedical, S&B research related to SARS and STIs Assume unresolved ethical issues in biomedical, S&B research related to SARS and STIs Focus on a broader challenge for research ethics Focus on a broader challenge for research ethics

15. Research Ethics What research to do and why? What research to do and why? Social value Social value Respect for subjects & communities Respect for subjects & communities Collaborative partnership* Collaborative partnership* How to do the required research? How to do the required research? Scientific validity Independent review Fair subject selection Favourable R/B assessment Informed consent Emanuel EJ, et al. What makes research ethical? JAMA 2000

16. Social Value in SARS & STI Research What constitutes social value in SARS & STI research? What constitutes social value in SARS & STI research? In general, research should help to resolve uncertainty related to justification of the relevant public health practices / intervention(s). In general, research should help to resolve uncertainty related to justification of the relevant public health practices / intervention(s). High demands of collaborative partnership and respect for subjects and communities High demands of collaborative partnership and respect for subjects and communities

17. Uncertainty and the justification of public heath interventions

18. Public Health Ethics (Upshur REG. Principles for the justification of public health intervention. Canadian Journal of Public Health 2002; 93(2): 101-103) Precautionary principle** Precautionary principle** Least restrictive means principle Least restrictive means principle Harm principle Harm principle Reciprocity principle Reciprocity principle Transparency principle Transparency principle

19. Pubic Health Ethics Precautionary principle and least restrictive means Precautionary principle and least restrictive means Application requires management of uncertainty Application requires management of uncertainty Both require evidence for fair application Both require evidence for fair application

20. SARS & STI Research Agenda NOT simply scientific agenda, but also of critical importance to the fair exercise of PH authority to restrict civil liberties NOT simply scientific agenda, but also of critical importance to the fair exercise of PH authority to restrict civil liberties Social value of research lies in the ability of the evidence to contribute to this public goal Social value of research lies in the ability of the evidence to contribute to this public goal

21. Conclusions SARS and STI research share many practical and ethical challenges SARS and STI research share many practical and ethical challenges Public health research ethics is emerging as an important area in bioethics Public health research ethics is emerging as an important area in bioethics SARS and STIs offer a valuable opportunity to think critically about the social value of public health research and its ethical justifications SARS and STIs offer a valuable opportunity to think critically about the social value of public health research and its ethical justifications

22. For More Information laveryj@smh.toronto.on.ca