Institutional Animal Care and Use Committees (IACUCs) and Institutional Review Boards (IRBs) review research proposals to ensure that research involving animals or human subjects is conducted ethically and that the rights and welfare of research subjects are protected. Foundational to that work is ensuring researchers comply with applicable federal, local, and state regulations as well as institutional policies.
Research noncompliance occurs when researchers (intentionally or unintentionally) fail to comply with established regulations, policies, and/or committee-approved research protocols. Noncompliance can occur in various ways; for example, a researcher may be in noncompliance for any of the following reasons:
- Failure to maintain study records for the appropriate length of time
- Failure to appropriately document study-related activities (such as obtaining appropriate signatures on consent documents or surgical records)
- Implementation of amendments prior to obtaining committee approval
- Conduct of study procedures in a manner that is inconsistent with the committee-approved research protocol
- Continued research activity after study expiration
- Conduct of study procedures by unapproved study personnel or inadequately trained study personnel
- Conduct of research with study populations outside of those outlined in the inclusion criteria of the committee-approved research protocol
- Failure to appropriately report adverse events or protocol deviations to the committee
While this is by no means an exhaustive list, it demonstrates that noncompliance comes in many forms. It is study-specific and not always identified by committees in the same manner. Some instances of noncompliance may be discovered through post-approval monitoring activities, while others come to the committees via whistleblowers, or reports submitted by the researchers themselves. Whatever the case, committees must decide what happens after noncompliance has been identified.
All instances of noncompliance do not raise the same level of concern for research compliance committees. Different forms of noncompliance may have varying levels of impact. Some instances of noncompliance may not necessarily increase risk for research subjects while others may greatly increase the risks associated with the research.
For example, the committee may view noncompliance by a researcher who uses two more than the approved number of subjects quite differently from noncompliance by a researcher who performs a high-risk procedure without the appropriate training and qualifications. For this reason, compliance committees often evaluate noncompliance on a case-to-case basis to determine the next steps after noncompliance has been determined.
After a finding of noncompliance, compliance committees have a variety of choices for addressing findings. The committee may decide to give a written warning about what has occurred, require that study team members are retrained, and/or request that the researcher submit a protocol amendment or report for the committee to review. Compliance committees also have the option of suspending research. These actions focus on the noncompliant researcher and study team. However, there are situations where noncompliance has broader impacts.
A finding of noncompliance may cause compliance committees to evaluate their own policies and procedures to determine whether further clarifications are needed, or even if additional policies should be developed. This doesn’t only occur after multiple researchers have had the same issue of noncompliance; sometimes a single incident is enough to cause the compliance committees to make policy changes. While the goal is to prevent future instances of noncompliance, the result could be tighter restrictions (more rules) for all researchers, including those who have a track record of compliance.
There are also times when compliance committees do not communicate an official policy change to researchers, yet begin to conduct more stringent review of protocols based on their experience with noncompliance. Researchers who previously submitted protocols and weren’t questioned by the compliance committee about certain aspects may now find that the compliance committee is requesting a lot more information. While it is understandable that the committees increase focus on aspects that were problematic during a previous instance of noncompliance, it may be difficult for researchers to understand a sudden shift in requirements for approval when compliance committees have not communicated to researchers about a procedural change.
An additional possibility after a finding of noncompliance is that the noncompliant researcher obtains a “bad name” with the compliance committee. Compliance committees may be on high alert and scrutinize all additional submissions from the researcher differently than submissions from others doing similar work. While some extra scrutiny may be warranted, this can eventually become problematic. If the compliance committee is unable to evaluate future work without referring to noncompliance that occurred in the past, research progress could be hindered. This is especially true for researchers who have learned from their mistakes and work hard to remain in compliance.
Findings of noncompliance can be overwhelming for both researchers and compliance committees. There are changes that take place after noncompliance that impact compliance committees and administrators as well as Principal Investigators and study teams. While many decisions made by compliance committees after a finding of noncompliance are intended to address the individual(s) found to be noncompliant, there is a possibility that many others will be impacted. Compliance committees must consider whether their actions after a finding of noncompliance match the risk associated with the noncompliance and the likelihood of reoccurrence. Compliance committees should also consider whether policy changes are necessary and whether or not the review of future research will be impacted in a way that is warranted.
The 2022 PRIM&R Annual Conference (PRIMR22) will bring the entire research community together and serve as a forum for discussing common themes that span the research enterprise, including post-approval monitoring and addressing noncompliance. Attendees will have the opportunity to network and address challenges facing research programs, their administrators, and leaders.
PRIMR22 will take place online December 12-15, with in-depth workshops on December 6 and December 9.
Iris L. Jenkins, PhD, currently serves as the Associate Director of Research Compliance/Human Research Protection Office (HRPO) at the University of Massachusetts Amherst. In this role she oversees the daily operations of the IRB staff, serves as a member of the IRB, provides guidance to researchers and relevant campus entities on matters of human subjects regulatory compliance, and conducts education and outreach activities. Dr. Jenkins has over ten years of research compliance experience having served previously as a Program Coordinator for the Institutional Animal Care and Use Committee, as a Research Compliance Specialist working with both the Institutional Animal Care and Use and Institutional Biosafety Committees, and as an IRB Analyst with the primary responsibility of reviewing human subjects protocols.
Dr. Jenkins earned a BA in Biological Sciences from Mount Holyoke College and an MS in Plant Pathology from the University of Arizona. She gained experience as a human subjects researcher while earning her PhD from the University of Massachusetts Amherst in Neuroscience & Behavior. Her graduate research focused on the development of visuospatial reasoning in human infants and toddlers. Her research experience continues to influence her work as an administrator. She is enthusiastic about helping researchers accomplish their goals while remaining in compliance with applicable regulations and policies
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