How to Audit an Institutional Review Board (IRB)

An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a group of people responsible for reviewing, approving and monitoring clinical studies involving human volunteers. Their main responsibility is to protect the rights, safety and welfare of clinical research volunteers by monitoring the investigator. Clinical Investigators are required to get approval from an IRB prior to starting a clinical trial. Many hospitals and established research centers have onsite IRB’s to oversee research activities. Doctors in private practice generally do not have an IRB. For multi-centered clinical trials and private practicing clinicians, sponsors tend to hire a central IRB. Institutional Review Boards were originally “non-profit” organizations comprised of volunteers from various walks of life. As clinical research evolved, several “for-profit” organizations emerged along with concerns about ethics and the bio-ethic groups. Now that ethics is a money-making enterprise, it is imperative that investigators and sponsors ensure the IRB overseeing the clinical trial is capable of providing such oversight. Read on and find out some of the things one should do to make sure a capable IRB is in charge of their clinical trial.

Instructions

Difficulty: Moderately Easy

Things You’ll Need:

• Basic Good Clinical Practices knowledge
• Good People Skills

1. Request and audit the membership roster and operational guidelines.
   
   IRB’s are required to have a minimum number of members with varying experiences. For example, in the United States, IRB must have a minimum of 5 members (i.e, scientific and non-scientific, ethnic diversity, etc.). Confirm that their practices match their operational guidelines.
2. Assess IRB Members qualifications
   
   Ask for resumes and inquire about members experience in the role they bring to the board. Try to determine who regularly attends meeting. Confirm that the person signing approvals on regulatory documents is listed on the membership roster. Confirm that members voting are not involved with the clinical trial.
3. Review meeting minutes.
   
   This will be easiest if the IRB performed clinical studies applicable to you in the past, otherwise they could claim breach of privacy and refuse the request. In that case, you should ask for a sample of their minutes from other clinical trials with confidential information redacted. Requests these prior to the audit. Your purpose for reviewing the document is to determine if voting practices are compliant with regulations.
4. Inquire about the Clinical Investigator Qualification Process.
   
   How do they decide a Clinical Investigator is qualified to conduct a clinical trial? What actions do they take if subjects file a complaint on the investigator?
5. Ask About the Corrective Action and Reporting Program.
   
   With fraud and research misconduct a fact of clinical research you will want to know how the IRB responds to allegations of unethical behavior or reports of fraud and research misconduct. Do they order an audit of the investigator? Do they report findings to sponsor and/or FDA?
6. Clinical Research Volunteers protection is the responsibility of the ethics committee, sponsor, investigator and FDA. Volunteers or citizens can also help protect research patients by reporting any known misconduct or unethical practice to the sponsor's Quality Assurance department, IRB or the FDA.

Tips & Warnings

• Membership requirements differ from country to country so become familiar with applicable country's ethics committee requirements.