Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

In a research study, what factor increases risk to a subject when approached by a figure of authority?

1. Frequency of intervention

2. Length of the study

3. Consenting in the presence of figure of authority

4. Providing financial compensation

The correct answer is: Consenting in the presence of figure of authority

The choice related to consenting in the presence of a figure of authority accurately identifies a key ethical concern in research studies. When subjects are approached by someone in a position of authority, such as a researcher or a physician, there can be an inherent power imbalance that may influence the subject's decision-making process. This can lead to increased pressure on the subject to participate or to agree to procedures, potentially compromising the voluntariness of their consent. Informed consent is a foundational principle in ethical research practices, emphasizing that individuals should make decisions about participation without coercion or undue influence. When subjects are asked to consent in the presence of authority figures, the risk arises that they may feel obligated to comply, which could result in less genuine consent. This aspect is particularly critical in safeguarding the autonomy and rights of research participants. Other factors, such as the frequency of intervention, length of the study, and providing financial compensation, may affect the study but do not inherently increase the ethical risk associated with consent in a way that compromises the integrity of the research process. These factors do not typically affect the exposure to coercion or pressure during the consent process in the same manner that the presence of an authority figure does.