11
May2016

Institutional review boards (IRBs) and research integrity offices (RIOs) play distinct but related roles in research oversight and compliance. It’s critical to understand the differences between each group’s purviews, and the importance of open and effective communication during the review process. On March 17, 2016, PRIM&R hosted a webinar titled Building a Relationship with your Research Integrity Office, presented by Ross Hickey, JD, CIP, CPIA. By the end of this webinar, attendees were able to differentiate between the jurisdiction and responsibilities of the IRB and the RIO when it comes to addressing allegations of research misconduct, understand the different structures in which RIOs, IRBs, and other institutional bodies can be organized, and facilitate effective communication between all parties.

Mr. Hickey began the webinar by defining research misconduct. According to the Office of Research Integrity (ORI), research misconduct is "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." ORI also emphasizes that research misconduct is not caused by honest error or differences of opinion. Mr. Hickey offered the acronym "FFP" to help remember the three key aspects of research misconduct, and expanded on their definitions:

  1. Fabrication is making up data or results and recording or reporting them;
  2. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record; and
  3. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

Research misconduct represents a "significant departure from accepted practices" that has been committed intentionally, knowingly, or recklessly, and that can be "proven by a preponderance of evidence." Many institutions have their own site-specific or expanded definitions of research misconduct.

During the webinar, Mr. Hickey explored the differences between research misconduct and human subjects protections and their corresponding institutional and federal bodies, and detailed common models for organizing research integrity officers and offices. He presented two cases studies, one from the biomedical field and one from social, behavioral, and educational research (SBER), and asked the audience whether they felt the scenarios were examples of research misconduct. He walked through what a research misconduct investigation entails, and then defined the similarities and differences between ORI and the Office of Human Research Protections (OHRP), as well as situations in which the two bodies might interact with one another during research misconduct or a noncompliance event.

During live PRIM&R webinars, attendees have the opportunity to participate in polling questions and to pose questions to the presenter. Mr. Hickey answered several attendee questions during the Q&A session of the webinar.

One audience member asked Mr. Hickey to provide tips for very small institutions when conducting a research misconduct investigation. Mr. Hickey explained that if the allegation is for Public Health Service (PHS)-funded research, the comments section of the ORI regulations states that small institutions may rely on external committees and resources when conducting an investigation. Mr. Hickey encouraged attendees to network and connect with other institutions, and see if there are any regional groups, such as the New England Research Integrity Officer Roundtable, to turn to for support and advice.

Another audience member asked, "Who has the burden of proof to demonstrate research misconduct—the respondent or the institution?" Mr. Hickey explained that it is the institution’s responsibility to prove that research misconduct took place. However, if the individual in question claims it was not misconduct but rather an honest mistake or an unintentional error, then the burden shifts to the individual respondent. They have to prove that the incident was not done intentionally, recklessly, or knowingly.

Another attendee asked whether an individual being prohibited from conducting research due to misconduct would also be prohibited from practicing medicine. Mr. Hickey referred to the federal regulations and explained that the usual corrective action for research misconduct involves suspending the individual from receiving federal funding for research for a certain number of years. Even when this happens, individuals often continue to work in research, they just cannot accept federal funding. Research misconduct would not automatically affect one’s ability to practice medicine; however, if, in the course of the investigation, the board of licensure discovers that the individual violated some other stipulation of their medical license, it could be revoked. That would be a separate process, but it could happen as a result of the misconduct, especially if the incident gained any notoriety or press.

The final question was about the scope of the research integrity officer’s responsibilities. Does the RIO handle allegations of research misconduct for unfunded research, institutionally-funded research, or a creative activity that may not be covered by a federal regulation? The attendee asked whether a research integrity officer would handle, for example, an allegation of plagiarism concerning an article published by a history professor in a peer-reviewed journal. Mr. Hickey referenced a case study discussed in the webinar to explain that according to the federal regulations, this situation would not be considered research misconduct. Institutions might have their own definitions of what constitutes misconduct, but Mr. Hickey felt this example sounded more like academic misconduct, which would involve a separate committee and process. Mr. Hickey believes limiting the definition of research misconduct to the federal definition is a best practice. This is not to overlook other aspects of responsible conduct of research (RCR); rather, it keeps things from becoming too complex, and gives you more flexibility with what mechanisms you employ for different situations.

PRIM&R would like to thank Ross Hickey, JD, CIP,CPIA, for sharing his expertise!

The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you’re interested in purchasing a recording for a group, please email webinars@primr.org.

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