Home Ethical Issues Informed Consent Enrolling Patients

Who should conduct informed consent discussions with potential donors?

Informed consent discussions should be free of coercion. Therefore, the timing, setting, and agents for informed consent processes should be carefully selected. Research nurses trained in informed consent procedures and not involved in the clinical care of patients are the common and appropriate group for obtaining donor consent.

There are conflicts of interest for clinicians who are directly connected with the research. If they have a professional or financial stake in how the research protocol will turn out, this may cloud their objectivity in determining their patients' best interest. At the very least, it may give rise to the perception that the goal of quality patient care has been displaced by research goals or personal gain.

One international ethics document, the Declaration of Helsinki from the World Medical Association states this point clearly: "When obtaining informed consent for the research project, the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress." The Declaration recommends in such cases that consent be discussed by a third party who is not engaged in the research or in treating the patient.

For some repositories, clinicians (pathologists), act as principal investigators in collection protocols and work with research nurses to enroll donors. The clinicians typically are not end-users of the tissue collected from their donors and have no stake in whether or not a particular person consents or refuses to consent. They may have a financial conflict of interest if they, rather than their institution, receive payment for each donor enrolled or sample obtained.