Guest Column | March 8, 2018

Legal & Ethical Considerations For Informed Consent In Clinical Trials

By Helen M. French, RN, BSN

Legal & Ethical Considerations For Informed Consent In Clinical Trials

The purpose of this article is to provide some thoughts as to the role each of us can play in clarifying some issues related to informed consent. These perspectives are based on my experiences as a registered nurse in a career that spanned more than three decades in private hospital settings, a private surgical association, and a university health system.

What Is Informed Consent?

An “informed consent” is the process by which a patient learns about and understands the purpose, benefits, and potential risks of any medical procedures, including clinical research trials, and then agrees to receive the treatment or participate in the trial. You might say informed consent arises both from the ethical principle of basic human rights and from a legal standpoint.

The patient has the freedom to decide what should or should not happen to his or her body, as well as to gather information before undergoing any medical processes. No one has the right to force the patient to act in a particular way. Even a doctor can only act as a helper in the patient’s decision-making process.

Obtaining a consent cannot be achieved using anything called a standard consent form. The level of disclosure has to be on a case-by-case basis and be specific to the proposed procedure or course of treatment. No doctor, hospital, or clinical researcher can certainly avoid legal liability with informed consent. However, the patient is bound by the “consent.” A patient could be “fired” by his or her physician if a treatment outlined in the signed informed consent was not followed.1

The Legal Angle

An “informed consent” signed by the patient, from a legal standpoint, is not the actual consent but evidence that the patient is consenting to a particular procedure at a given time. Legally, no one has the right to touch, let alone treat another person without permission. This would be classified as “battery” — physical assault — and is punishable by law. From this, one might say obtaining consent is necessary for anything other than a routine physical examination.

The only time a consent is not necessary is in the event of an emergency, in which case a doctor may have to operate in the absence of consent to save the life of the patient. It is possible that even with such an intervention, the patient will not survive. Assuming that the doctor is competent and has exercised due care and diligence, the doctor would not be held responsible for a patient's death because the doctor acted in good faith and followed the standard of care in the best interest of the patient.

A patient has to be given the opportunity to ask questions and clarify all doubts. There must not be any kind of pressure. Consent must be voluntary, and a patient should have the freedom to revoke the consent. If consent is given under fear of intimidation, or if it includes misconceptions or misrepresentation of facts, it can be considered invalid.

How can anyone know with any certainty whether consent is valid? Just as with any contract, no matter how meticulously it is drawn up, the only sure way to find out if a contract holds up is when it is validated in a court of law.

In Moore v. Regents of the University of California2, a landmark case in July 1990 in the California Supreme Court, the patient, who signed an informed consent, found out his blood cells were unique in that they produced a protein that stimulated the growth of white blood cells. His cells were used and patented, and Moore eventually discovered that not only his doctor, but also the university, profited from this discovery.

The court found that Moore had no property rights to his discarded cells or to any profits made from them. It did find, however, that the research physician failed to state he would make money from Moore’s cells and that the doctor was obligated to reveal his financial interest in the use of the cells.

The court then looked at the policy behind having Moore's cells considered property. Because exchange of property is a strict liability tort, the court feared that extending property rights to include tissue or organs would have a chilling effect on medical research. Laboratories doing research receive a large volume of medical samples and cannot be expected to know or discover whether somewhere down the line their samples were illegally obtained. Moore could sue only his doctor for the failure to disclose information, and nobody else.

Moore’s case is one of many examples of the potential shortfalls of an informed consent for both parties involved. 

The Ethical Angle

A patient’s perception of the risks or benefits of a medical intervention is unique, variable, and unpredictable. The information provided to a patient should include all material risks. However, the list of risks and side effects cannot be exhaustive to the level of absurdity and impracticality.

For example, very few patients could read the product information leaflet included in any drug packet and understand the information presented. What should be expected is that the doctor should provide information that a sensible or reasonable patient can understand to make a knowledgeable decision about the course of action to be taken in the presence of alternatives. A patient should be given the opportunity to ask questions and clarify all doubts. There must not be any kind of pressure.

Some might ask whether an informed consent is necessary at all, perhaps noting that maintaining a good doctor-patient relationship often works better than the best informed consent.  Is it really worth the paper it is written on if the validity can only be resolved in a court of law?  Does the “informed consent” arise from  legality or ethics?  If from law, that means that ethics plays no part. On the other hand, even if it is legal, it still could become unethical!



About The Author:

Helen M. French, RN, BSN, CNOR Clinician lll, was an operating room nurse from 1974 until 2007. Her professional nursing career spanned private hospital settings, a private surgical association, and a university health system (University of Virginia). During her career, French served as president of her local operating room nursing organization and legislative chairman in her local, state, and national organization. She was also active in the Virginia Nurses Association, sat on an EPA Waste Minimization Task Force, was part of the UVA Hazardous Waste Committee, and founded and coordinated the University of Virginia Medical Equipment Recovery of Clean Inventory (MERCI). She received numerous awards for her professional and volunteer work. Now retired, French volunteers at a VA hospital and is still active in patient advocacy.