In addition to members who collectively have the qualifications and experience to review and evaluate...

The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.

This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.

"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective."

Objectives:

Maintain impartiality in ethical review.

Ensure diverse representation within the IRB/IEC.