A Case Study About Informed Consent
Madeleine M. Jester, RN, JD

Abstract

This is a true story about a participant in a clinical trial who suffered a serious medical event while enrolled in the study. It makes a powerful point about how important it is from a risk management perspective to obtain proper informed consent from research subjects.

A Call for Study Subjects

A number of years ago, a pleasant, retired man, Mr. S, received a letter announcing a research study to be conducted in his doctor's office. The letter invited any interested patients to come to a meeting where the details would be explained.

At the meeting, the doctor and his research nurse explained that the purpose of the study was to test an experimental blood pressure drug. Mr. S heard that as part of the study he would discontinue his blood pressure medicine, and would be given placebos or sugar pills as well as active medicine at some time during the study. He also found out about the risks of participating, including the possibility that he could suffer a stroke.

All of the potential study subjects at the meeting received a copy of the informed consent document to read, and the study nurse also gave a presentation on what participation in the study would involve. The potential subjects then had an opportunity to ask questions.

Although he was doing well on his current blood pressure medication, Mr. S, being an altruistic man, decided to take part in the study because he thought it would be a way to help others. He signed the informed consent, after asking a number of questions. His wife, who had come to the meeting with him, supported her husband's participation.

Mr. S was taken off his regular blood pressure medicine as required by the study protocol, and followed every week. He had no problems and felt fine. His blood pressure did go up; not too high, but just enough to show that he did have high blood pressure and could enter the active phase of the study. He started on the new study drug for his blood pressure, and within a week his pressure had come down to a near normal level. The drug was working, and he felt fine.

Two days later, disaster struck. The study coordinator got a call at night from Mr. S's wife saying that he was "acting funny", and that he was having a little trouble talking. It sounded to the nurse as if Mr. S was having a stroke. She told Mrs. S to take her husband to the emergency room right away.

When Mr. S finally arrived at the hospital, he had complete paralysis on his right side. He had suffered a stroke, and a CAT scan showed the blood clot that had done the damage. He never recovered the use of his right side. Before the stroke he had been an avid painter and an excellent pianist; after the stroke his life was changed forever.

No one could say if participating in the study, during which his treatment for high blood pressure was manipulated, had precipitated Mr. S's stroke. On the other hand, no one could say that it had not.

Mr. S brought no action against the investigator or the company that sponsored the research, although he could probably have said that he was influenced to participate in the study because he thought his doctor wanted him to do so. However, he did have the study thoroughly explained in a very careful way, he was made aware of all possible outcomes, and he asked many questions before signing the consent form. His family also had open and frequent communication with study personnel throughout all of these events, and the sponsoring company worked with the family to make sure that his medical expenses were covered. He said himself that he knew exactly what he was getting into, and that he did not blame the doctor for what happened.

This case study makes a powerful point about how important it is from a risk management perspective to obtain informed consent from research subjects in the most careful way, making sure that they have realistic expectations about what a research study really is. As this case study shows, not only can subjects in studies potentially derive no benefit from participating, but they can suffer harm as well.

Although this information has been developed from sources thought to be reliable, the CNA HealthPro Advanced Medical Technology Unit makes no representations as to its correctness or completeness and accepts no liability for any injury or damage that may arise from its use. For specific and complete information, consult an attorney or regulatory affairs professional, or the FDA.

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