An IRB-Insider Shares 5 Tips for Trial Success

October 15, 2010
Raffaella Hart

Applied Clinical Trials

As everyone involved in clinical research knows, navigating the IRB is a critical element in achieving a smooth path from trial start-up all the way through completion. Most people usually associate the following words with an IRB: “slow,” “unresponsive,” “nit-picky.”

But it doesn’t have to be this way. In fact, working with, not against, the IRB is key to advancing your research and will ultimately speed your trial up, not slow it down. The important thing to remember is that the IRB actually does want trials to start and finish on time. Every IRB professional I’ve ever worked with is fully committed to advancing scientific progress, and knows that efficient IRB review of clinical trials plays an essential role towards that end.

That said, however, the primary role of an IRB is to ensure trials protect the rights and safety of human subjects, are ethically sound, and meet all regulatory requirements. Delayed trials that are blamed on an “unreasonable” IRB are generally due to unwillingness by one or more parties to work with the IRB to address a legitimate concern about subject protection and/or safety. The following five tips are good to keep in mind in facilitating a more successful IRB relationship—the secret element for keeping study milestones on track.

1. Not every IRB does things the same way. They are all dedicated to subject safety and trial oversight, but each has its own unique process, steps, and meeting schedule. In addition, do not assume that every IRBs documentation and submission guidelines are identical. Knowing how one IRB works does not necessarily translate to success with another one. Understanding the IRBs specific requirements ahead of time, before a submission is made, is essential. Being receptive to, and mindful of, the variability between IRBs will save precious time and prevent aggravation.

2. Communicate ahead of time. Direct communication with the IRB is not necessarily prohibited or frowned upon. Contacting individual IRB members “off the record” is indeed a conflict; however, every IRB has an administrator who is usually willing to provide helpful guidance prior to a submission or IRB meeting. If this is the first time interacting with a particular IRB, take advantage of that administrator to provide insight into its specific processes. Seasoned IRB administrators can also give you a good idea about how the IRB is likely to react to your submission, and can help you adjust as needed or fill in information gaps in order to avoid delays. Why wait for the scheduled IRB meeting to find out about a simple question that could have been addressed previously? The more you and the IRB communicate prior to that meeting, the more likely the IRBs review of your trial will be substantive and will allow your trial to move forward.

3. Submit complete documentation. This is not a new concept, but it cannot be over-emphasized. If you follow steps #1 and #2 above, there is no excuse for incomplete documentation. Knowing what an IRB needs, when they need it, and how it should be submitted seems simple enough, but as an IRB administrator I am continually dismayed how often this concept is ignored. The proposed study may be incredibly worthwhile and medically promising, but unfortunately, this is insufficient grounds for an IRB to grant approval. The protection of human subjects is the top priority, and if there is any doubt this can be ensured, even the most credible study will face delays. My advice to sites, CROs, or sponsors submitting documentation to the IRB is to have a QC system in place to make sure all the requirements are being met. Avoid having just one person responsible for the submissions; have a team meeting to review the documentation criteria and verify that all pertinent information is being provided in the correct format in a timely manner.

4. Foster IRB rapport over the long-term. Getting the trial initiated is only the first step in what will be a long-term relationship with the IRB(s). Over the course of the trial, there will be periodic reviews and assessments of study information and documentation. Protocol deviations and other safety-related issues will be closely monitored. And if the trial involves a “vulnerable” population such as children, pregnant women, or people with impaired decision-making capacity, even closer scrutiny will take place. The IRB can be an important ally in trial oversight, providing invaluable expertise from the perspective of experience with multiple trials. Like any relationship between two parties, the IRB values transparency, honesty, and integrity from the study staff. With FDA requirements and complex protocols extending the duration of trials, consider the IRB as a member of the study team over the long haul.

5. Reputation counts. The reputation of any study site, investigator, and study sponsor is paramount to the momentum of the trial. Like the adage says, you only have one chance to make a good first impression (and certainly many opportunities beyond that to damage it). IRB members are dedicated to their role as trial overseer, and if there is consistently missing or conflicting information from the study staff, this will negatively impact the reputation of the site, investigator, and study coordinator. The IRB has no choice but to inquire about any missing information and seek clarification when information is conflicting, which can lead to delays or increased monitoring by the IRB. If, for example, a site has a history of not reporting protocol deviations, the IRB may require more rigid reporting guidelines for current and future studies. IRBs have long memories, and I personally have seen an IRB decline to work with certain sites because the negative reputation of the site staff was well known. The IRB was not willing to enable sub-standard research. In short, fostering a communicative relationship with the IRB can help keep your trial on track, both in terms of compliance and timelines.

Raffaella Hart is the Director of the Biomedical Research Alliance of New York (BRANY) Institutional Review Board (IRB) www.BRANY.com. She is a Certified IRB Professional (CIP) and has been involved in IRB administration for 10 years. Ms. Hart recently co-authored an article on the history of IRBs, and is a contributing author of the book How to Work In and Within IRBs.