1. P ATIENTS AT THE C ENTER : R ECRUITMENT INTO N ON - T HERAPEUTIC C LINICAL T RIALS Bartha Maria Knoppers, Director Denise Avard, Research Director Lee Black, Academic Associate Centre of Genomics and Policy McGill University

2. O UTLINE 1. Recruiting patients into non-therapeutic clinical trials 2. Liability 3. Conflicts of interest 4. Informed consent 5. Concluding remarks

3. R ESEARCH VERSUS C LINICAL C ARE Clinical care: Primary duty is to patient Research: Still have responsibilities to participants, but integrity and goals of research are competing considerations

4. R ECRUITING PATIENTS Necessity of medical research Necessity to recruit patients? Healthy versus sick participants

5. R EASON TO P ARTICIPATE ? Clinical trials using healthy participants Clinical trials using patients from a particular disease population Some of these trials could potentially benefit patients

6. R EASONS W HEN NO B ENEFIT ? Altruism Therapeutic Misconception Physician’s or researcher’s actions? False hope?

7. A ND P OTENTIAL R ISKS TO P ARTICIPANTS ? Q-CROC 1: Liver biopsy required as part of protocol Higher than minimal risk from biopsy Informational risks?

8. C AN P HYSICIANS R ECRUIT T HEIR O WN P ATIENTS ? Simple answer: YES BUT…. Liability? Conflicts of interest? Properly informed consent to participation?

9. L IABILITY IN P ATIENT R ECRUITMENT Liability for what? Against whom?

10. L IABILITY What do you tell your patient about a research study? Who obtains consent from the patient? How much does the treating physician know? Important factor: Is the physician merely recruiting, or does he or she have some other interest in the research?

11. C ONFLICTS OF I NTEREST

12. Here, conflicts in the recruitment of patients/participants Can come from many different places Might not be very obvious Not all conflicts can or should be mitigated

13. F INANCIAL C ONFLICTS OF I NTEREST Most obvious: Payment to researcher by industry Payments to cover legitimate costs of research not viewed negatively Payments to recruit patients into study Some physicians/researchers are paid a per-patient rate for recruitment

14. O THER C ONFLICTS OF I NTEREST Not as obvious, but still considered conflicts Researcher recruiting own patient into study Non-financial de minimis incentives to recruit patients

15. H OW ARE C ONFLICTS H ANDLED ? Disclosure Avoidance

16. I NFORMED C ONSENT Ethical and legal basis for obtaining informed consent of research participants prior to participation Who obtains consent and what is disclosed are important factors

17. INFORMED CONSENT STANDARDS Legal standards vary by jurisdiction, but basically the same Clinicians: standards for research higher than for clinical care In research need to be truly informed

18. I NFORMED C ONSENT : W HO I NFORMS ? Physician, researcher, nurse, coordinator? Different health professionals can take different parts of the process Who is in best the best position to obtain a fully informed and valid consent?

19. C ONSENT BY P HYSICIAN Physician already has a preexisting relationship with the patient Does the physician fully understand the research? Will the physician influence the patient’s decision? Is there a conflict of interest?

20. C ONSENT BY R ESEARCHER Researchers generally have the best knowledge of the study Researcher might also serve as patient’s physician Conflicts of interest?

21. C ONSENT BY N URSE OR C OORDINATOR Often these individuals are involved with the research study Physicians often refer patients to nurses and coordinators for additional information on the research When obtaining consent is part of their duties, time availability can be beneficial Can appear to be a more impartial party than the physician or researcher

22. I NFORMED C ONSENT All those obtaining consent must ensure all relevant information is provided REB approval Patient questions Appropriate person should obtain the consent Depends on size of study and available staffing Preferable to have someone other than physician or researcher Physician and research can and should still be involved in providing information to patient

23. T HE B IG Q UESTION : S HOULD P HYSICIANS R ECRUIT P ATIENTS ? No ethical or legal reasons not to Some limitations on level of involvement

24. C ONCLUDING T HOUGHTS We cannot force physicians to recruit, or patients to participate Physicians should be encouraged to raise potential research participation with patients Concerns of liability should not be a barrier: most concerns can be easily addressed

25. R ECIPROCITY “Such research can be granted ethical endorsement under the principle of reciprocity, which encompasses the idea that accepting benefit from past medical research, inherent in the utilisation of medical services, carries some expectation of a willingness to participate in research for the common good” Bioethics Advisory Committee, Personal Information in Biomedical Research, Singapore, 2007