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

When is an impartial witness necessary during the consent process for an illiterate subject?

1. When the subject prefers to have one

2. To read the consent form to the subject

3. To observe the consent process

4. To sign as a co-signer on the consent form

The correct answer is: To observe the consent process

An impartial witness is necessary during the consent process for an illiterate subject primarily to observe the consent process. This ensures that the subject's decision to participate is made freely and without coercion. The presence of an impartial witness helps to safeguard the integrity of the consent process, as they can verify that appropriate procedures were followed, including confirming that the subject understood the information presented to them. The role of the impartial witness is particularly important in research contexts involving vulnerable populations, including illiterate individuals, as it ensures that ethical standards are upheld. This witness acts as an additional layer of protection, ensuring that the subject's rights and wishes are respected throughout the consent process. In this context, simply having a witness to read the consent form or sign as a co-signer does not fully address the ethical requirements involved. The focus is on the witness's role in observing and confirming that informed consent procedures were properly executed and that the subject's autonomy was preserved. This makes the witness essential in cases where the subject may be more susceptible to misunderstanding or manipulation due to their literacy challenges.