Post on 01-Jan-2016
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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
OUTLINE
1. Recruiting patients into non-therapeutic clinical trials
2. Liability
3. Conflicts of interest
4. Informed consent
5. Concluding remarks
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
RECRUITING PATIENTS
Necessity of medical research
Necessity to recruit patients?
Healthy versus sick participants
REASON TO PARTICIPATE?Clinical trials using healthy
participants
Clinical trials using patients from a particular disease populationSome of these trials could potentially
benefit patients
REASONS WHEN NO BENEFIT?
Altruism
Therapeutic MisconceptionPhysician’s or researcher’s actions?False hope?
AND POTENTIAL RISKS TO PARTICIPANTS? Q-CROC 1: Liver biopsy required as
part of protocol
Higher than minimal risk from biopsy
Informational risks?
CAN PHYSICIANS RECRUIT THEIR OWN PATIENTS?Simple answer: YES
BUT….Liability?Conflicts of interest?Properly informed consent to
participation?
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?
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
FINANCIAL CONFLICTS OF INTEREST Most obvious: Payment to researcher by
industryPayments 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
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
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
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
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?
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?
CONSENT BY RESEARCHER
Researchers generally have the best knowledge of the study
Researcher might also serve as patient’s physician
Conflicts of interest?
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
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
THE BIG QUESTION: SHOULD PHYSICIANS RECRUIT PATIENTS? No ethical or legal reasons not to
Some limitations on level of involvement
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
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