Malpractice Consult

By Lee J. Johnson, JD

Answers to your questions

Liability risks in clinical research

Q:I've been asked to serve as a clinical investigator for a new antibiotic for upper respiratory infections. The pharmaceutical company will pay me a fee for each patient enrolled and clinical trial completed in this study. What are the key liability issues? What happens if the antibiotic is found to have some serious adverse effects?

A: Informed consent is the key liability concern for physicians. Did the patient agree to participate in the study with full knowledge of the possibility of side effects or adverse reactions? The patient must be told that he is involved in experimental research, the risks and benefits of participating in the trial, and alternatives to the drug therapy that is being proposed. He must also be told that enrolling in the study means that he may in fact receive a placebo, an established form of therapy, or no treatment at all. You must be certain not only that you have a full and frank discussion with the patient, but that you've adequately documented the talk and the signing of the consent form.

Issues that should be clarified in advance and noted in the consent form are whether and what compensation will be provided if the patient is injured, whether the patient will be paid for participating in the trial or will be responsible for any costs, how the privacy of the patient's medical information will be protected, how much testing will be required, and what records will be kept.

Let's say you've started a study of an unapproved drug. Early in the trial, the FDA approves it for prescription use. You should let the patients know so they could opt out of the study and go on the drug if that's indicated.

Never take on a trial unless you have enough well-trained support staff to counsel patients and document these efforts.

Before you agree to participate, the company should give you an investigator's brochure that will describe the earlier stages of research, any adverse effects that may be expected, a copy of the study protocol, and a sample consent form. If you have questions about the protocol, you can contact the drug company or the Food and Drug Administration directly. The brochure should also name an institutional review board and its affiliation; the board is responsible for ensuring the adequacy of any informed consent documents. If you have concerns, express them to the IRB. You may also consider asking an attorney to review the consent form.

Your potential malpractice liability is an additional concern. The pharmaceutical company may be willing to offer a hold-harmless agreement in the contract. It's certainly worth requesting. But even if the drug manufacturer agrees, that isn't ironclad protection. Your malpractice insurance company may cover you for this type of activity as part of your regular policy, or may be willing to provide additional coverage for a higher premium. Ask your carrier to confirm coverage. Request the confirmation in writing so you'll have a record in case you're later named in a lawsuit.

The author, who can be contacted at 2402 Regent Drive, Mount Kisco, NY 10549, or at lj@bestweb.net, is a health care attorney who specializes in risk management issues. This department answers common professional-liability questions. It isn't intended to provide specific legal advice. If you have a question, please submit it to Malpractice Consult, Medical Economics magazine, 5 Paragon Drive, Montvale, NJ 07645-1742. You may also fax your question to 201-722-2688 or send it via e-mail to memalp@medec.com.

Lee Johnson. Malpractice Consult.

Medical Economics

2002;3:110.