Mid-Atlantic Health Law TOPICS

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Clinical Trials - Follow The Rules

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:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the patient's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the patient;
  3. A description of any benefits to the patient or to others that may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the patient;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the patient will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation is to be paid, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and the patient's rights, and whom to contact in the event of a research-related injury to the patient; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the patient is otherwise entitled, and the patient may discontinue participation at any time without penalty or loss of benefits to which the patient is otherwise entitled.

The regulations also provide that, when appropriate, one or more of the following should also be disclosed to each research subject:

  1. A statement that the particular treatment or procedure may involve risks to the patient (or to the embryo or fetus, if the patient is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the patient's participation may be terminated by the researcher without regard to the patient's consent;
  3. Any additional costs to the patient that may result from participation in the research;
  4. The consequences of a patient's decision to withdraw from the research and procedures for orderly termination of participation by the patient;
  5. A statement that significant new findings developed during the course of the research, which may relate to the patient's willingness to continue participation, will be provided to the patient; and
  6. The approximate number of patients involved in the study.

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.


March 21, 2000




Rosen, Barry F.


Health Care