An IRB review of a clinical trial comprises the following items:
1. Application, amendment, termination, or resumption after suspension of a clinical trial,
2. Regular progress reports,
3. Deviation reports,
4. Serious adverse effect reports,
5. Clinical investigation report,
6. Disclosure of conflicts of interest from investigation site team, and
7. Other key items related to the clinical trial.
The IRB shall audit ongoing clinical trial at least once per year.

Attention shall be directed to the following items in the IRB’s review of the clinical investigation plan:
1. The design and execution of clinical trials must comply with the principles of risk minimization to minimize harm to subjects and ensure that risks and benefits are balanced.
2. Conduction and content of clinical trial comply with scientific principles;
3. Inclusion and exclusion criteria and recruitment methods;
4. Medical care, damage or loss compensation, and other remedy provide to the subjects;
5. Protection of the subjects’ privacy;
6. The content of the informed consent form and the process of obtaining inform consent;
7. The protection of vulnerable populations; and
8. Necessary management measures protecting the safety of the subjects.

Following the review described in Article 37, a decision shall be made in a written form and shall include the following items:
1. Name of the clinical investigation plan;
2. Version number and development date of the clinical investigation plan, informed consent form, case report form, and other clinical trial-related information;
3. The clinical trial institution, investigator, and sponsor;
4. Review results and rationales; and
5. The date upon which the review decision was made.

The IRB shall have at least five members, including law experts and other persons of disinterested community members; more than 2/5 shall not be affiliated with the clinical trial institution; and members of either gender shall not comprise less than 1/3 of the total number of members.

IRB members shall recuse himself/herself in any of the following situations:
1. Being the investigator, coinvestigator, or sponsor of the clinical trial under review;
2. Being, currently or in the past, the spouse, any relative within the fourth degree of relationship or relative by marriage of third degree of relationship of the investigator;
3. Having an employment relationship with the sponsor; and
4. Other situations deemed necessary by the IRB for the avoidance of conflicts of interest.

IRB members who have not participated in IRB reviews and discussions shall not participate in decision-making.

Without valid reasons, IRB members and other individuals who have participated in reviews shall not disclose any confidential they have obtained from performing their duties.

The list of members of IRB and the meeting minutes shall be published.

When conducting the review or inspection referred to in Article 37, the IRB may demand that the investigator or sponsor improve the clinical trial within a given period of time and may suspend or terminate the trial upon identification of any of the following situations:
1. Changing the content of the clinical trial without obtaining approval from the IRB or the central competent authority, as stipulated by applicable regulations;
2. Obvious evidence that the subjects’ rights or safety have been affected;
3. Obvious abnormal frequency or irregular degree of severity of adverse effects;
4. Evidence verifying that the clinical trial is no longer necessary; and
5. The occurrence of other situations that affect evaluations of the trial’s risks and benefits.

After completion of the clinical trial, the IRB shall conduct an investigation and notify to the clinical trial institution and the central competent authority upon identification of any of the following situations:
1. Violations of laws or regulations or noncompliance with the clinical investigation plan,
2. Severe late onset adverse events, and
3. Severe effect on subjects’ rights.

The IRB shall preserve the clinical investigation plan, meeting minutes, inspection records, and other related documents for at least 3 years after clinical trial completion.

The IRB shall not obstruct, evade, impede, or refuse inspections conducted by the central competent authority.