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

Is participant consent required for CRAs to review data from subjects who have withdrawn from a study?

1. Yes

2. No

3. Depends on the type of study

4. Only with IRB permission

The correct answer is: No

In clinical research, participant consent refers to the agreement given by subjects to allow their data to be used in a study. When a participant withdraws from a study, they are essentially indicating that they no longer wish for their data to be included in the research activities moving forward. When it comes to the review of data from subjects who have withdrawn, consent is not typically required for the data that has already been collected prior to the withdrawal. Regulations often permit the use of previously collected data for analysis, provided that this was made clear to participants during the consent process. Such stipulations are part of ensuring that researchers can analyze the gathered data while respecting the participants' autonomy in choosing to withdraw. If the study involves further engagement post-withdrawal or the collection of new data, then consent may be necessary. However, in the context of reviewing already collected data from subjects who have taken the step to withdraw, there is generally no requirement for obtaining further consent. This understanding is grounded in the principles of ethical research, which aim to balance the rights of individual participants with the need for scientific inquiry using available data.