CITI Training Practice Exam

Which guidelines allow only subjects who can consent for themselves to enroll in non-therapeutic research studies?

1. FDA

2. ICH

3. Both FDA and ICH

4. Neither FDA nor ICH

The correct answer is: ICH

Non-therapeutic research studies refer to those that do not involve the administration of treatment or medication to participants. Such studies may include surveys, questionnaires, observational studies, or other activities that do not involve a medical intervention. In the context of research ethics, it is important to only enroll participants who are capable of giving their informed consent. In this case, the correct answer is B ICH. The ICH (International Conference on Harmonisation) guidelines state that only individuals who are capable of giving informed consent can be included in non-therapeutic research studies. Both FDA and ICH may have guidelines for research studies, but for this specific situation, the ICH guidelines are more relevant as they specifically address the enrollment of participants who can consent for themselves. Therefore, options A, C, and D are incorrect. The FDA (Food and Drug Administration) may also have guidelines on research