More and more doctors are supplementing their income by soliciting their patients to participate in clinical trials sponsored by pharmaceutical companies. Doctors doing so need to remember that the law requires them to protect their patients' rights in this regard by, among other things, obtaining their patients' informed consent, and by obtaining the approval of the applicable Institutional Review Board (IRB) if the clinical trial involves hospital patients.
In fact, federal regulators have recently warned researchers that they should expect increased governmental scrutiny in regard to the protection of patient-volunteers. This warning comes on the heals of the shutdown by the Food and Drug Administration (FDA) of all gene therapy trials at the University of Pennsylvania after the death of an eighteen year old volunteer.
A. Informed Consent
No researcher may involve human subjects in research unless the researcher has obtained the informed consent of the subject or the subject's legally authorized representative. FDA regulations explicitly require that such consent must be in writing, dated and signed.
Informed consent assures that prospective human subjects will understand the nature of the research, and can knowledgeably and voluntarily decide whether or not to participate. Informed consent protects both parties -- the subject, whose autonomy is respected, and the researcher, who otherwise faces legal hazards.
Before soliciting a patient to participate in a clinical trial, a doctor should be sure that the consent form complies with the basic elements set forth in FDA regulations. The consent form should include:
The regulations also provide that, when appropriate, one or more of the following should also be disclosed to each research subject:
The information in the consent form should be written in language that is understandable to the patient or the patient's representative. In addition, the informed consent may not contain any exculpatory language, for example, subjects may not be asked to waive (or appear to waive) any of their legal rights, nor may they be asked to release the investigator, sponsor or institution (or its agents) from liability for negligence.
B. Institutional Review Boards In addition, when the clinical trial involves a hospital patient, that hospital's IRB also needs to approve the trial. An IRB is a board, committee, or other group formally designated by an institution to review biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications to secure, or disapprove research.
C. Bottom Line Doctors should protect their patients and themselves. They should be sure to ask the right questions when approached to solicit subjects for a clinical trial. Does the informed consent form contain all of the elements discussed above? Further, if hospital patients are involved, has the on-site IRB approved the clinical trial? An ounce of prevention is worth a pound of cure. Otherwise, instead of supplementing their incomes, doctors may find that they have subjected themselves to liability and their patients to harm.