In Nichomachean Ethics, Aristotle discusses “means” and “ends.” Ends are those virtues we wish for, whether they be happiness or health. Means are the roads or actions by which we reach those ends, including watching the sunset to feel happy or exercising regularly to stay healthy. Aristotle notes different types of actions we take to accomplish our ends, two of which are deliberation and choice. We deliberate about which actions will best move us towards our desired end. Among the available actions, we then make a choice, picking an ideal course of action through careful “reason and thought.” These two actions are necessary in making an ethical decision.
For example, one’s end may be improved health. This individual deliberates between several options: running every morning, reducing sugar in daily meals, or eliminating meat from her diet. From these options, she chooses to reduce the amount of sugar in her daily meals because she dislikes running and enjoys eating meat. Once a choice is made after deliberation, the individual has committed a voluntary action, an action within her will that moves her towards her end.
Now let us consider actions over which an individual does not have total control. Aristotle might say that if an action does not originate within the individual, it is an involuntary or forced action. Aristotle points out that sailors who jettison materials because of a storm (an event outside of their control) were forced to action that they would not have otherwise committed. These types of actions are considered involuntary, and not within one’s total control.
Voluntary Participation and Informed Consent
The concept of choice, as defined by Aristotle, informs how the Institutional Review Board’s (IRB) conceptualizes the process of obtaining informed consent. Within a human subjects research context, informed consent is the process by which a research participant, after having received and understood all research-related information, voluntarily indicates their willingness to participate in a research study (e.g., Informed Consent Form Template). In this case, informed consent is based on both deliberation and choice; the participant has the necessary information and time to compare the risks and benefits of participating in the study and then make a choice whether to participate. The IRB protects each participant's choice to participate, and in doing so, protects the participant. If an individual is not fully informed of the scope of the project, or they are forced to participate for reasons outside of themselves, the IRB will see this as a violation of the participant's rights.
An example of this may occur when researchers work with illiterate participants. Traditional consent procedures make use of written consent and signatures; however, if an individual is unable to read and comprehend the scope of the research study, their decision is not fully informed. In circumstances like these, the IRB recommends the use of a verbal consent script (e.g., Verbal Informed Consent Template), with regular checks to ensure participant understanding.
Informed Consent is a Process
Oftentimes, researchers visualize informed consent as a form distributed at the start of a research study. However, informed consent is a process, not just a form. In order to ensure that a participant’s actions are voluntary throughout the duration of the study, researchers must allow participants to terminate their participation at any point during the study without penalty, even after signing the consent form. Researchers can also ask if a participant would like to continue between study activities, or if they observe that the individual is experiencing fatigue or discomfort. If there is compensation for participating in the study, it is also important for the researchers to clearly explain what will happen to the compensation if the participant terminates the study early. Clear and open communication will allow the participant to deliberate and make an informed choice at every step of the study.
Weighing the Influence of Compensation on Choice
There are times when the benefits or compensation provided to participants in constrained contexts may influence their choice to participate or may be perceived as forcing them to participate. For example, participants with no or extremely limited access to healthcare may participate in clinical medical trials that they find risky and undesirable, with the hopes of accessing otherwise unobtainable medication and a large monetary compensation. In this circumstance, even though the participant is fully informed of the risks associated with their participation, the choice is not entirely voluntary as they are acting within the constraints of their current situation. The IRB would recommend the researcher refrain from undue influence or messages that elevate the status of their study or overinflate the benefits of participating. The IRB may also encourage the researcher to provide non-research related options for healthcare or services such as free clinics, telehealth, or other options not directly tied to study participation. IRB reviewers pay close attention to benefits or compensation and will weigh both the risks and benefits to ensure the participant is not unfairly influenced to participate in a study.
The IRB is responsible for ensuring the protection of participants’ rights in human subjects research. Informed consent in research requires that the researcher clearly define the extent of research and allow participants the necessary time to make an informed decision about whether to participate in a research study. Maintaining this process throughout the study will help protect participant’s rights and ensure each participant is able to deliberate options and make an informed choice.