Voluntariness falls under both the informed consent and the autonomous actions category in bioethics making it an important factor in a lot of medical practices; specifically, human medical research. Here we define voluntariness according The Nuremberg Code which states that a research subject “should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion” (Beauchamp, 137-138). In general, this is a very lengthy and detailed definition the term, but it brings up some very interesting points about a case we have previously studied, specifically about the voluntariness of consent.

In the case of “Research Involving Alzheimer’s Patients” we are faced with a director of a nursing home for Alzheimer’s patients who is asked to allow her residents to participate in study to test a new drug that promises to reduce the onset of the disease in subjects. After a swift denial of the researcher’s offer, we are asked to evaluate the director’s decision and conclude whether or not this was a violation of the patient’s autonomy. Initially, I noticed that the general consensus amongst our class was that the patients should be able to make their own decision and if a patient lacked the mental capacity to do so, the closest relative who knew him/her best could make the decision on their behalf. After analyzing the definition of voluntariness, though, this decision our class made fell short on the side of allowing a family member to make the call. While these terms could be interpreted differently, allowing another person to make a decision for a less than coherent individual could fall under many of the listed “intervention” elements, opposing the idea of voluntariness in medical research.

Voluntariness is a hard subject to study because no one research subject is the same. “Voluntariness of consent has been more resistant to investigation, leaving policy-makers with little guidance for their efforts to insure that prospective research subjects are able to exercise meaningful choice about whether to participate in research” (Applebaum et.al, 2009). Things such as the case we discusses above are reasons why voluntariness of consent can become incredibly complicated especially when it comes to policy-making. When you have to take a look at mental capacity of a subject and analyze every element given in the formal definition, you find that is it hard to have a concrete idea of what exactly voluntariness is in a particular situation. In the case with the Alzheimer’s patients, I believe that voluntariness was violated in the patients who are of the coherence to make a decision about his/her participation, but I do not think that it was violated in the cases of patients who did not have full mental capacity as that could have crossed the line into force, over-reaching, etc. Essentially, voluntariness has its flaws as an element of informed consent and autonomous action, but it is important to take into account especially when considering human subjects for a research proposal.

Works Cited:

Applebaum, Paul S., Charles W. Lidz, and Robert Klitzman. “Voluntariness of Consent to Research: A Preliminary Empirical Investigation.” IRB: Ethics and Human Research 31.6 (2009). The Hastings Center

Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York, NY: Oxford UP, 2001. Print.

Thomas, John E, et al. “Case 3.1: Research Involving Alzheimer’s Patients.” Well and Good: Case Studies in Biomedical Ethics, Broadview P, 1987.