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 IN PATIENT RECRUITMENT

Liability for what?

Against whom?

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

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

HOW ARE CONFLICTS HANDLED?

Disclosure

Avoidance

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