IRB Meetings — Beyond The Regulations

December 15, 2016 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

Have you ever wanted to know what goes on at a convened Institutional Review Board (IRB) meeting? What does the board talk about, how is each clinical research study evaluated, and what kinds of questions will the board raise before approving a study?

These were all questions I had when I joined a local IRB at a large institution.

The experience I had serving as a voting board member and discussing clinical research on the other side of the process has provided me with a valuable perspective.

I hope that sharing some of the things I have learned along with providing some general information about IRB regulations will shed some light on the IRB’s process of review.

Image courtesy of Master isolated images at FreeDigitalPhotos.net	As regulatory professionals, IRB review is a checkbox on our list for a well‑designed drug development program, but what does it mean to have that box checked? IRB review is a dynamic process, and the board members devote a lot of time reviewing and discussing each research protocol. Below are some of the answers I found to the general questions I had about IRB review.

This is a short summary of the general requirements per the FDA regulations. For more information, see the full regulation (21 Code of Federal Regulation [CFR] Part 56).

An IRB is required to have at least five members of varying backgrounds:

• Qualified to review the scope of the clinical research
• Diverse in background and profession
• Gender diversity

At least one non-scientist and one non-affiliated member are required, and IRBs are encouraged to also have expertise on vulnerable populations and outside consultants as necessary, depending on the research being reviewed by the board.

For many boards, the non-scientist members are made up of community leaders, former or current research participants, and special groups representatives (for example, patient advocates).

An IRB is responsible for:

• Reviewing and approving, requiring modifications, or disapproving all covered research
• Ensuring that written informed consent forms are appropriate for the study and in compliance with regulations (see the full regulation [21 CFR Part 50])
• Requiring documentation of the informed consent process (or documentation of waiving informed consent in accordance with regulations)
• Notifying Investigators in writing of decisions
• Conducting continuing review of research no less than once a year

Each IRB must also follow individual institutional polices and processes. Consequently, each board member is constantly balancing the needs of the institution, the requirements of the regulations, and the importance of the research, while at the same time focusing on the board’s primary mission: protection of human research subjects. This was something I had never thought about before, but the IRB really serves as a voice for the university, the community, and the patients who visit the university hospital and clinics where the research is conducted.

Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net

As such, each decision can have an impact that goes well beyond a specific research protocol or clinical research program.

There are three important elements for an IRB’s decision process:

1. Beneficence—Risk/benefit analysis, experimental design, and qualifications of the Principal Investigator
2. Justice—Subject selection, inclusion/exclusion requirements, subject recruitment
3. Respect for persons—Informed consent, surrogate consent, and assent, privacy and confidentiality, protection of subjects (especially vulnerable populations)

While the board I sat on would sometimes get lost in a discussion of specific study details (“Where exactly does that get injected?”), the chair was always on hand to bring the talk back to the these main points in order to reach a decision.

One of the most interesting things I learned was the importance of informed consent and how much time gets devoted to discussing the whole process — which goes beyond just the informed consent form.

In the eyes of the IRB, informed consent is not a single event or just a form to be signed but is an educational process that takes place between the Investigator and the prospective subject. How potential research subjects are recruited is usually an important topic of discussion for a particular protocol.

Each institution has its own requirements for the layout and the specific information they want to see in an informed consent form. The board will spend a large chunk of time reading, reviewing, discussing, and editing the informed consent form.

In my experience, consent form edits were, by far, the main comments sent back to Investigators for modification before approval of a protocol. For example, “Did you know that your study only recruits male subjects and your consent form has a whole paragraph describing pregnancy prevention for female subjects?”

As mentioned above, the risks versus the potential benefits of participation are also key to the IRB’s discussion of a clinical research protocol:

Does the good outweigh the bad? What is the potential benefit to a subject or to the community at large? Are the risks well known and is there an adequate plan to minimize them? Is the research design sound?
	Image courtesy of Stuart Miles at FreeDigitalPhotos.net

A well-designed clinical research protocol will answer the IRB’s questions, leaving more room in the discussion for implementation, rather than questioning the purpose or potential benefit of the research.

Once the board has approved the protocol and the research begins, the relationship with the IRB continues and has to be maintained.

• The IRB provides continuing review of each protocol as appropriate to the degree of risk and not less than once per year.
• This is set for each new protocol and can be changed or updated once a protocol has been approved.
• Each IRB will follow their own institutional polices for the continuing review process, but must provide a substantive and meaningful review, per the regulations.

Some of the things the IRB will discuss for continuing review of a protocol include: Subject accrual Any specific data monitoring committee or safety committee meeting notes Changes in the protocol (especially if they add or change the risks or benefits)
	Image courtesy of Stuart Miles at FreeDigitalPhotos.net

Have any further questions?

IMPACT has experienced regulatory affairs professionals ready to assist you. If you would like to discuss your specific needs, please contact us or give IMPACT a call today at (919) 899-9248.

Category: Regulatory Affairs
Keywords: IRB, review, FDA regulation, informed consent

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