Liability Risks in Clinical Research

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Answers to your questions

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. …