Certification for IRB Professionals (CIP) Practice Exam

In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent?

1. A study involving a desirable or neutral characteristic assessed by the research team.

2. A study in which subjects were assigned to activities based on an undesirable or unflattering physical characteristic assessed by members of the research team.

3. A study that does not involve human subjects at all.

4. A study where informed consent was verbally given without documentation.

The correct answer is: A study in which subjects were assigned to activities based on an undesirable or unflattering physical characteristic assessed by members of the research team.

In the context of obtaining informed consent, the appropriateness of providing subjects with information about missing elements hinges on the nature of the study and the characteristics being examined. In a study where subjects are assigned to activities based on an undesirable or unflattering physical characteristic, revealing certain aspects of consent could potentially harm the subjects' self-esteem or privacy. This consideration aligns with ethical principles aimed at protecting vulnerable populations and maintaining confidentiality. Such studies may involve sensitive information that could lead to stigmatization if disclosed, thus making it crucial to limit the information shared with participants. On the other hand, in studies involving desirable or neutral characteristics, or where no human subjects are involved, sharing information about missing elements of consent is generally less harmful or, in some cases, irrelevant. In studies where consent was verbally given without documentation, although it may still be important to inform participants about their rights and the study's scope, it does not carry the same potential for negative impact as in option B. Therefore, the potential risks associated with disclosing missing elements of consent in studies related to undesirable characteristics justify the choice made.