Opinion (in relation to Independent Ethics Committee)

Opinion of Ethics Committee – is a formal decision or judgment rendered by an ethics committee regarding the ethical aspects of a proposed clinical study based on a thorough review of the study protocol, informed consent documents, and other relevant materials. This opinion is to ensure the protection of the rights, safety, and well-being of the clinical trial participants.

Definitions

ICH E6(R2)

1.42 Opinion (in relation to Independent Ethics Committee):

The judgement and/or the advice provided by an Independent Ethics Committee (IEC) .

Procedure for ethics committee opinion

An ethics committee evaluates whether a proposed clinical study adheres to ethical principles, regulatory requirements, and guidelines for conducting research involving human subjects:

• if the committee determines that the study meets these criteria, it issues its favorable opinion, allowing the trial to proceed;
• conversely, if there are ethical concerns or issues that need addressing, the committee may request modifications to the protocol or additional information before providing its opinion.

See also

Another relevant pages

• Approval of IRB