Redefining HRPP Stakeholders in an Institution's IRB Training Program

By Tasha Mohseni

Tasha Mohseni is a Compliance Coordinator from Arizona State University who is passionate about IRB education programs. Specifically, Tasha is interested in optimizing educational outreach strategies as well as measuring learning effectiveness from an IRB’s education program.

As the year 2024 is coming to a close, I’ve done a great deal of reflection regarding IRB effectiveness given SACHRP’s Recommendation on GAO-23-104721, INSTITUTIONAL REVIEW BOARDS: Actions Needed to Improve Federal Oversight and Examine Effectiveness, that was approved in October 2023. Specifically, SACHRP stated, “A high-quality IRB could be described as one in which well-trained, well-supported IRB members with appropriate expertise carefully deliberate on the ethics and regulatory compliance of proposed and ongoing research in ways that promote participant protection and understanding, while also supporting and partnering with researchers to facilitate ethical, compliant research without imposing overly burdensome or inefficient requirements and reviews." Though IRB member and staff education is a surrogate endpoint and not a true measure of effectiveness, this made me wonder if SACHRP truly considered all potential HRPP stakeholders within an institution’s IRB training program.

When I think of an IRB’s training program, I don’t solely think about IRB members and staff training needs. Sure, as SACHRP indicates, it is helpful to have more IRB members and staff to have certifications such as the CIP, CIM, CCRP or equivalent. But what about…the institution’s investigators? What resources do they need to ensure they are conducting ethical and sound human subjects research? It surprised me that SACHRP didn’t state that training investigators could also potentially serve as a surrogate endpoint. In fact, educating investigators is just as crucial (if not, even more crucial than IRBs) – as they directly interface with participants every day.  Investigators should be able to think critically about their study design and ensure optimal protection of participants’ welfare. We, as in IRBs, need to move away from this so-called audit culture into more of a collaborative culture (where educational outreach and teaching moments are welcomed).

I love whenever I am reviewing a study and an investigator asks a question that may seems obvious to me why something is required, it may not be obvious to the investigator. I remember an investigator asking me once, “Do I really need to include a statement that participants are 18 or older in the consent form when the participants are mid-career professionals?” I remember my initial impression was that maybe this investigator was in a rush and thought maybe I was nitpicking. I remember feeling overwhelmed with all the back and forth I had a natural inclination of wanting any thoughts or reminders of this study out of my head. But then, I took a deep breath, paused, and placed myself in the investigator’s shoes. I thought to myself, “Okay…I can cite whatever regulation I want to show WHY from a regulatory standpoint why the statement is required because to provide consent, the participant must be an adult, and as an institution we like to see that in there because with consent comes voluntariness and all that good stuff…but this doesn’t feel like it’s the problem.” The problem is how we communicate and educate these investigators. If we could show investigators WHY something is important versus telling investigators to meet regulatory requirements, I feel this would drive the point home further.

How do we solve this problem? With education! How can we educate our researchers at our institutions?

1. Ensure you are targeting your intended audience when performing IRB training outreach. Are we solely targeting the principal investigators on IRB submissions when performing outreach? Are we including student researchers? Outreach strategies are pivotal in maximizing attendance in your IRB outreach sessions. You will also want to tailor your presentation based on the audience you are targeting. Are these first-time study submitters? Are there specific areas of research that you commonly see with this audience (e.g., online survey research, AI)?

2. Create a handout detailing recommendations for a specific area in human subjects research. Handouts are a great way to explain intricate processes. You want to ensure that you have a great balance between graphics and text. You can ensure your handouts are inclusive for all learners by reviewing these top accessibility tips.

3. Record training videos related to the institution’s IRB for researchers. Does your institution receive emails about a specific process in your electronic IRB submission system? What about on a specific topic area in human subjects research? If you answered “yes” to either of these questions, I encourage you to boost researcher’s efficiency with your institution’s IRB processes by creating training videos (and handouts to supplement).

How does your institution define HRPP stakeholders for your IRB training program? Please comment below and share your knowledge with your Ampersand community!