By: Justyn Trott
For a drug to get approved and enter into the market, it has to prove its safety and efficacy in clinical trials. As no individual has a right to breach the fundamental rights of another person in order to achieve his own purpose, an important tool called “informed consent” came into existence. Informed consent is described in ethical codes and regulations for human subject’s research. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language that is easily understood by an individual, so that they can make the voluntary decision on whether or not to participate in the presented research study.
Additionally, it allows the participants to make an informed and voluntary decision to participate in the clinical study. It also describes the obligation of the investigator to inform the subject about personal benefits and risk an individual faces in the study. This is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects.
As described in Spedale v. Constellation Pharm., Inc., researchers at Constellation & Mayo Clinic Arizona are developing a promising new drug, CPI-0610, a type of BET inhibitor, that has the ability to target and elicit anticancer activity towards cancer cells. In order for the drug to hit the market, they need to have successful clinical trials while upholding the clinical trial standards required, including approval from the FDA that the trial is safe and that the trials are consistent with regulatory guidelines. Most importantly before trials can be conducted, there needs to be valid informed consent from participants.
The requirements for obtaining informed consent include: (1) the investigator (or person designated by the investigator) must obtain informed consent; (2) the informed consent must be obtained before procedures are performed and/or before any change in the subject’s current medical therapy is made for the purpose of the clinical trial; (3) the subject (or legally acceptable representative) should not be forced to sign the consent form, participate, or continue to participate in the trial; (4) the subject must personally sign and date the form. The signature of the prospective subject on an informed consent document indicates that the content within the document has been adequately discussed and the subject freely gave the informed consent.
For some individuals, this is not always the case, which is when claims are brought up against institutions and physicians. In Spedale, the participant was not given proper informed consent as the institution failed to specify certain risks that are associated with CPI-0610. Therefore, not supplying enough information so that the individual can make a proper, conclusive decision on whether to continue with the trail. Subsequently, the individual unfortunately received negative results from the trial, resulting in worsening health conditions in the patient. Under Allison v. Brown, the standard of care is breached when there is a failure to disclose material risks associated with a treatment or procedure, or the existence of alternatives if there are any, which can preclude the plaintiff from making an informed decision about whether to undertake a particular procedure or course of treatment.
As it is clear that supplying sufficient information to potential volunteers or subjects is critical, the question lies in how to determine what is sufficient or not. A professional standard was implemented in Canterbury v. Spence, known as “the prudent person test.” According to this test, the information given to an individual must be sufficient to satisfy and fully inform a prudent or reasonable person so that they can decide whether or not they desire treatment. The main objection to the professional standard rule is that it gives too little attention to the patient’s concerns and values. The weakness of the reasonable patient criteria is its emphasis on a generalized notion of what is rational and neglect of patient individuality and variability.
Another standard has been proposed and is currently being used, namely, the subjective substantial disclosure rule. This states that adequate information is information that would be material or important to the decision of the particular patient in a particular circumstance. A key question with this rule is: “Could this information change the decision of this particular person in this particular circumstance?” Such a rule requires a substantial degree of knowledge about the patient, their situation, and what is important to them. With this approach, attention to the patients and their current situations are given, instead of looking at the individual as another number in the trial. In the long run, even though clinical trials play an important role in the medical/technology field, there is a bigger interest in the safety and wellbeing of the participants.
Another weakness of the traditional informed consent procedure is that it is usually viewed as a ‘single’ episode in which the physician provides information, and the patient indicates a choice or consents to the physician’s proposal. Furthermore, informed consent is often given after only a short conversation occurring just before treatment. This rigid focus and context do not adequately address the possibilities of important changes in the information, treatment, and diversification. In the world of clinical trials, there is always the possibility that the trial, treatment, or the information that a person originally consented to changes. Here, a participant is now forced to perform duties that he or she may not have consented to, moreover, they may not even know that they are occurring.
The responsibility of conducting a trial ethically and genuinely lies in the hands of those involved in it. It is obvious from Spedale, that Constellation & Mayo Clinic Arizona face pressures to produce a potential solution to the ongoing battles individuals face with cancer, just as other cancer research facilities face. Unfortunately, this causes problems during the clinical trial phases that take place prior to drugs/medications hitting the market. Everyone must understand their obligations and should not misuse their power for their own benefit. It is also clear that the old notion of informed consent becomes outdated and needs review. The old way cannot fit new situations and the changing needs, knowledge, and growth in the biomedical and genetic research fields. The current ways of informed consent may require a new ethical and legal framework if we want to continue to advance. The rights, safety, and well-being of trial subjects should always prevail over the interest of science and society so that a participant never feels as though they are being deceived in the name of a social cause.
Student Bio: Justyn Trott is currently a second-year law student at Suffolk University Law School, focusing in Intellectual Property Law. He is a staffer on the Journal of High Technology Law. Prior to law school, Justyn received a Bachelor of Science in Biomedical Engineering from the University of Hartford.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHTL or Suffolk University Law School.
