A client enrolled in a clinical study says, "I want to stop participating, but I am afraid the team will be upset." Which action should the nurse take?
1Ask the client to continue until the principal investigator can approve the request
2Affirm the right to withdraw without penalty and notify the research coordinator✓ Correct answer
3Explain that study compensation must be returned before withdrawal is discussed
4Tell the client to ask family members whether leaving the study is appropriate
Explanation
Research participation is voluntary, and a participant may discontinue without penalty or loss of entitled benefits. The nurse should support the client's choice and promptly communicate it through the study process.
Quick answer Support the client's voluntary withdrawal and notify the research team through the established process.
Why this is correct Valid informed consent continues throughout a study rather than ending at enrollment. The participant may change the decision, and concern about disappointing staff must not become pressure to remain or a threat to ordinary entitled care.
Easy analogy or mental picture Research consent is like an open door the participant may choose to leave through. The analogy emphasizes voluntariness but does not erase safety follow-up that may be offered after study treatment stops.
Memory hook Research consent stays voluntary from enrollment through withdrawal.
NCLEX decision rule When a participant wants to leave a study, protect voluntariness, clarify that withdrawal does not carry improper penalty, and notify the research team. Do not require investigator permission, repayment, or family authorization.
Why the other choices are wrong Investigator approval is not required for the participant's decision. Compensation terms cannot be used as coercion, and a capable adult does not need family permission to withdraw.
References
[1]
NCSBN: 2026 NCLEX-RN Test PlanNational Council of State Boards of Nursing
[2]
45 CFR 46.116: General Requirements for Informed ConsentU.S. Electronic Code of Federal Regulations