This is the fourth of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Gretchen Parker, PhD, RAC, CIP, Pearl’s IRB Co-Chair, Senior Advisor, was interviewed for this piece.

If you have any regulatory, quality, or clinical development questions for Pearl Pathways’ advisors, forward them to us and we will provide answers in future posts.

1. Please briefly explain your role at Pearl and a bit about your background.

I am Pearl’s Chair of Institutional Review Boards (IRB), handling the day-to-day IRB activities. I hold a Ph.D. in Molecular Endocrinology and Biochemistry and earned my Post-Doctoral Fellowship in Biochemistry and Molecular Biology. I have over 15 years’ experience in the field of regulatory and human subject protection.

2. Can you provide a brief explanation of the role of IRBs in the regulatory process?

Prior to the involvement of IRBs in the regulatory process, drug researchers had only to prove that drugs were safe – not effective – prior to approval. If the drug was tested in humans, there was no oversight to ensure the participants’ safety. Now, that’s a key part of the IRB’s role. We ensure participants are treated ethically, are providing informed consent, and that their safety is prioritized in research.

3. How can a research firm determine if and when an IRB review is needed?

Reviews are not required for all research, but if you want to publish your work, an IRB review is essential. My advice is, if you think you don’t need a review, do it anyway – and get into the process early. Let the IRB decide if you need a review to avoid any unwanted surprises.

4. Who serves on an IRB?

On our IRB, we have scientific professionals and non-scientific participants that often reflect the patient or participant population being studied. An IRB must have at least 5 members, and at Pearl Pathways, we have 7. Diversity is important, and the board will be made of different genders and other demographics.

It’s important for researchers to consider the makeup of the IRB when thinking about submissions. One mistake many researchers make in preparing their submissions is focusing their information too much on the scientific members of the IRB and not the non-scientific members. The best approach is to think about the IRB as a whole and know that regardless of our expertise or past experience, we don’t know what you’re doing! In other words, all members of the IRB need to understand what research is being done, what the participants’ experience will be, and how data will be used – so submissions need to be written for both the scientific and non-scientific members of the board to be able to review the information and provide their responses. It’s ok to use language that isn’t clinical or scientific so that everyone on the IRB can understand what’s being presented.

5. What sort of information does an IRB require for its review?

A lot! Don’t assume the IRB knows anything related to your research. We want to see not only documentation and records relating to your research, but we also ask submitters to go further. For example, if the drug being tested is FDA approved, include your approval documentation. How were sample sizes determined for your study? What will subjects go through? What barriers to participation (such as transportation) may subjects encounter? We want to know everything about your study, and again, both the scientific and non-scientific members of the IRB need to be able to understand the information.

6. Can you tell us more about how clinical trial recruitment advertising is reviewed by the IRB?

That’s a great question and there are some things to keep in mind when including recruitment advertising in your submission. We review the text and the final content, so I recommend submitting the copy before making the creative. For example, if you’re planning a TikTok video to recruit participants to your trial, don’t make the video before the IRB has reviewed the script for it – the IRB might want to change the script, so you might end up needing to reshoot the video if you’ve already done it.

What we’re looking for is ads that are not misleading. They can’t promise to cure a disease or otherwise mislead participants. If your study will pay participants, that can’t be the leading topic of your advertising. Ads should be clear about the study and what participants can expect. Making sure your text or script is IRB approved before making graphics or videos will save time and money.

7. When preparing their submission, what tips or guidance can you share for the preparation of a strong submission package?

Getting your submission in early is key. In nearly all cases, a few rounds of reviews will be required, so getting in early is important. Be thorough and submit all forms and documentation connected to your work. Build your submission around the idea that the IRB doesn’t know what you’re doing. Don’t leave anything unexplained and make sure anyone – not just medical professionals – can understand what you’re submitting.