Patients Deserve Informed Consent in Medical Research

Shawn Lenahan suffered from non-Hodgkin's lymphoma and was treated in 1998 at a hospital, where it was misdiagnosed. As a result, he received improper chemotherapy to the point where his disease progressed unchecked.

He then went to the University of Chicago Hospitals, where it was recommended that he be treated with a high-dose chemotherapy/stem-cell transplant regimen called Protocol 8558. Some of the patient's cells would be collected before the start of the chemotherapy/stem-cell regimen, and an experimental technique would be used on particular cells to stimulate them to produce an immune reaction to cancer cells. These cells would then be brown in a lab and injected back into the patient’s body in the hope that it would fight any remaining cancer cells and help restore the patient's immune system at the end of the chemotherapy/stem-cell procedure. During the course of this treatment, he died.

His special administrator brought a 21-count complaint on numerous theories of liability, including the failure to provide adequate informed consent to participate in the program. The plaintiff alleged that the university and the hospital conspired to conduct this project knowing that "human subjects would be recruited using a consent form that concealed their expectation that 95 percent of the participants would die." Lenahan v. The University of Chicago, et al., Ill.App.3d. , 808 N.E.2d 1078 (1^st Dist. 2004).

The plaintiff alleged that the university and the hospital were signatories to a policy stating that "they each bear an independent institutional responsibility to obtain informed consent from all human subjects in the clinical trial." In failing to disclose all of the risks and alternatives to treatment, plaintiff pleaded that the defendants deviated from their policy and federal regulations, and Lenahan would not have participated had he been adequately informed.

On appeal, the court found that the hospital and university had adopted policies and governmental procedures regarding the propriety of the consent forms. Therefore, these defendants may be held liable for claims arising from the lack of informed consent, and the plaintiff had set forth adequate facts for the question to be put to the trier of fact to determine.

The court raised the case of Kus v. Sherman Hospital, 268 Ill.App.3d 771, 644 N.E.2d 1214 (2d Dist. 1995)., wherein a patient who was implanted with intraocular lenses had not been informed that the lens was experimental and that it was being evaluated for safety and effectiveness. There, too, the court found that although physicians generally have the duty to obtain informed consent from their patients, the hospital here also could be liable because it had established an Institutional Review Board (IRB) to assure that a "legally effective" informed consent was obtained.

An IRB is a committee whose primary purpose is to protect the rights and welfare of the people involved in biomedical research studies. 21 C.F.R. sect. 56.102(g)(2002); 45 C.F.R. sect. 46.102(g)(2001). One of the ways it does so is through reviewing the protocol as well as the informed-consent documents.

This country prides itself on its leadership role in biomedical research, as well it should. The Human Genome Project is just one example of the capabilities as well as the challenges facing medical researchers in the years to come. But medical research certainly has come a long way from the documented atrocities in this country in the 1950s when prisoners, state hospital inmates and mentally disabled children were tested in risky medical experiments without any regulatory oversight and often with tragic results.

Today, such clinical research is governed by federal regulations that are promulgated by the Department of Health and Human Services and the Food and Drug Administration.

Still, Lenahan is not alone. A number of cases across the country have been documented in connection with treatment received in clinical trials, including that of a health research volunteer who died in a Johns Hopkins School of Medicine asthma experiment. Robert Steinbrook, "Protecting Research Subjects: The Crisis at Johns Hopkins," 346 N. Eng. J. Med. 716, 720 (2002).

Certainly physicians are at the front lines in advising patients of risks, armed with the knowledge of the patient's medical history and of the impact the medical procedure could have on the patient. It is clear, however, that hospitals, clinics and others should be held liable when they participate in drafting consent forms and ensuring compliance with federal regulations.

A patient who agrees to participate in experimental medical projects should not become a human guinea pig without the ability to make an informed decision as to the potential consequences. People may not want to be involved; it is their choice, as it is their bodies. If the institution or the physician cannot find adequate participants, then perhaps that is a testament more to the risky procedures involved than to the potential liability involving lack of informed consent.

Some people certainly may have medical problems such that they potential benefit outweighs the risks, even if deadly. But the patient needs to be fully informed in order to make an intelligent decision.

Disclosure is necessary for instilling trust in the doctor/patient relationship as well as in the civil justice system. Hiding critical information merely to attract participants is not the answer. Any institution or medical professional who does so should be held responsible for such unethical conduct.

Over the years, patients have been conditioned to physicians' paternalism. That is now augmented with an attitude of patient self-determination and autonomy. Tort law is responding to these social and political changes.