VCU Human Research Protection Program (HRPP) Blog

The VCU HRPP is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Dr. Ron Evans is an Associate Professor in the Department of Kinesiology and Health Sciences and currently serves as Chair of the VCU IRB Social Behavioral/Biomedical panel.  Dr. Evans has been a faculty member at VCU since 2003 and an IRB member since 2005.  Prior to his current role on the Social Behavioral/Biomedical panel, Dr. Evans served as a panel member, a vice chair, and as the VCU Institutional IRB Chair from 2016-2020.  His research interests include the assessment and further understanding of factors that may influence energy expenditure and physical activity behaviors during weight loss and weight maintenance. In this article, he shares his perspectives on reportable events, such as Unanticipated Problems (UPs) and noncompliance. 

As an IRB Chair, why do you feel it is so important for investigators to promptly submit reports to the IRB for events like Unanticipated Problems (UPs) and noncompliance?

From the IRB Chair perspective, it’s important from a regulatory standpoint.  Per the Code of Federal Regulations, specifically 45 CFR 46.108, there are several functions and operational requirements for IRBs.  These include requirements for everything from sufficient meeting space, to staff support, to the establishment of written policies and procedures.  In addition, 45 CFR 46.108(a)(4) requires IRBs to establish AND follow written procedures for the prompt reporting to the Office of Human Research Protections (OHRP) any unanticipated problems (UPs) involving risk to subjects, any serious or continuing noncompliance, and any suspensions or termination of IRB approval. 

It is important to note that when VCU is submitting a report to OHRP, it is more focused on reporting the institution’s actions in response to the event than the actions of the investigator. Since OHRP most closely assesses the adequacy of the actions taken by the institution to address the issue reported, the goal of our reporting to OHRP is not to specifically draw attention to the investigator, but instead, the goal is to demonstrate to OHRP that our HRPP is working as intended, and has the accountability and transparency structures in place to adequately manage events should they occur.

As a researcher, have you ever had to submit reports for UPs and/or noncompliance on your own research protocols? What went through your head and how were you feeling when you found out about the reportable event? How did your thoughts and feelings change during the process of submitting a prompt report to the IRB?

Unfortunately, yes…I have submitted 3-4 reports to the VCU IRB over the years.  Luckily, these were minor, isolated issues that were not determined to be UPs or serious/continuing non-compliance. But a few of them were determined to constitute general non-compliance and I completely agreed with the determinations since both issues occurred because I (or one of my graduate students) did not follow the approved protocol. Initially, I was most concerned with determining the extent of the issue and how to resolve it, but I was also a little embarrassed to be submitting a report, especially as an IRB panel member. 

But I think it’s important that we realize that administering a research protocol, especially some of the complex protocols that are ongoing at VCU, is often difficult and issues/events that were never expected will occur and will need to be reported. One thing that helped me get through the process was contacting an IRB staff member prior to submitting the report. She helped me think through some options for my corrective action plan and suggested the addition of a few details to clearly describe what happened during the event. 

As an IRB Chair, how would you describe the attitude of the IRB towards reviews of reportable events? What is the goal of the IRB when reviewing reportable events, and what is the end result the IRB wants to achieve?

As a panel, we take reports very seriously. As panel chair, my goal is to ensure that we step through the review of any reported events in a systematic manner:  first considering whether the event was the result of non-compliance on the part of the study team and/or whether the event meets the criteria for an unanticipated problem. Ultimately, the goal of the panel’s review of a reportable event is to determine whether the approved protocol was being followed and if not, did this deviation increase risk to research participants, negatively impact their rights and/or welfare, or impact the scientific integrity of the study. Based on that determination, we can then consider any proposed corrective action plans for the study. 

I also think it is important to note that the reporting process can identify possible issues that may require institution-wide changes to policies and procedures to help minimize the likelihood of this event or a similar event occurring again. Importantly, the IRB does not take a punitive approach towards investigators submitting reports; rather, the goal is to assess actions already taken and recommend additional actions as needed to further address the issue or to prevent recurrence of the same problem.

What advice would you give investigators who are in the position of needing to report UPs or noncompliance to the IRB?

When submitting a report, provide as much detail as possible. I would also encourage investigators to reach out to the IRB staff or an IRB Chair/Vice-Chair for guidance if you are ever unsure as to whether something needs to be reported. It’s important for investigators to understand that submitting a report to the IRB is not the end of the world. However, the reporting process is a required, critical function of the IRB to ensure that the university is in compliance with federal regulations governing human subjects research. It is therefore imperative for investigators to follow reporting requirements, both for the purposes of following regulatory obligations, but most importantly, for the purposes of ensuring the safety and welfare of those individuals who volunteer to be a part of our research. 

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