Under GCP, which is a key obligation when enrolling participants?

Under GCP, which is a key obligation when enrolling participants?

• A. Obtaining informed consent must be voluntary and ongoing.
• B. Enrollment can proceed without consent if the study benefits society.
• C. Consent is only needed for initially enrolling.
• D. Consent expires after one year.

Answer: (A)

In Good Clinical Practice, the core obligation when enrolling participants is that informed consent must be voluntary and ongoing. This ties to respecting each person’s autonomy: no one should be enrolled without freely agreeing after being given clear information about what the study involves, including risks, benefits, procedures, and rights. Importantly, consent isn’t a single handshake at the start; it’s an ongoing process throughout the trial. If new information arises or study procedures change, participants should be informed and asked to reaffirm their willingness to continue. Participants also have the right to withdraw at any time without penalty. This is why options that suggest enrollment without consent, consent only at first enrollment, or consent that expires after a set time do not fit. They undermine respect for participants’ autonomy and fail to capture the ongoing nature of consent in clinical research.

In Good Clinical Practice, the core obligation when enrolling participants is that informed consent must be voluntary and ongoing. This ties to respecting each person’s autonomy: no one should be enrolled without freely agreeing after being given clear information about what the study involves, including risks, benefits, procedures, and rights. Importantly, consent isn’t a single handshake at the start; it’s an ongoing process throughout the trial. If new information arises or study procedures change, participants should be informed and asked to reaffirm their willingness to continue. Participants also have the right to withdraw at any time without penalty.

This is why options that suggest enrollment without consent, consent only at first enrollment, or consent that expires after a set time do not fit. They undermine respect for participants’ autonomy and fail to capture the ongoing nature of consent in clinical research.