Patients at the Center: Recruitment into Non-Therapeutic Clinical Trials

1. Patients at the Center: Recruitment into Non-Therapeutic Clinical Trials Bartha Maria Knoppers, Director Denise Avard, Research Director Lee Black, Academic Associate Centre of Genomics and Policy McGill University

2. Outline • Recruiting patients into non-therapeutic clinical trials • Liability • Conflicts of interest • Informed consent • Concluding remarks

3. Research versus Clinical Care • Clinical care: Primary duty is to patient • Research: Still have responsibilities to participants, but integrity and goals of research are competing considerations

4. Recruiting patients • Necessity of medical research • Necessity to recruit patients? • Healthy versus sick participants

5. Reason to Participate? • Clinical trials using healthy participants • Clinical trials using patients from a particular disease population • Some of these trials could potentially benefit patients

6. Reasons When NO Benefit? • Altruism • Therapeutic Misconception • Physician’s or researcher’s actions? • False hope?

7. And Potential Risks to Participants? • Q-CROC 1: Liver biopsy required as part of protocol • Higher than minimal risk from biopsy • Informational risks?

8. Can Physicians Recruit Their Own Patients? • Simple answer: YES • BUT…. • Liability? • Conflicts of interest? • Properly informed consent to participation?

9. Liability in Patient Recruitment • Liability for what? • Against whom?

10. Liability • 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. Conflicts of Interest

12. Conflicts of Interest • 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. Financial Conflicts of Interest • 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. Other Conflicts of Interest • Not as obvious, but still considered conflicts • Researcher recruiting own patient into study • Non-financial de minimis incentives to recruit patients

15. How are Conflicts Handled? • Disclosure • Avoidance

16. Informed Consent • 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. Informed Consent: Who Informs? • 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. Consent by Physician • 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. Consent by Researcher • Researchers generally have the best knowledge of the study • Researcher might also serve as patient’s physician • Conflicts of interest?

21. Consent by Nurse or Coordinator • 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. Informed Consent • 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. The Big Question: Should Physicians Recruit Patients? • No ethical or legal reasons not to • Some limitations on level of involvement

24. Concluding Thoughts • 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. Reciprocity “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