Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust in the research enterprise. Responsible Conduct of Research (RCR) principles are broad, and provide scientists and scholars from every discipline with a guiding framework of professional responsibilities. Many IRB professionals and members may not realize that “protection of human subjects” is one of the core RCR topics. Gaining knowledge about RCR and research integrity can help IRB and HRPP personnel enhance and promote ethical research.
On October 25, PRIM&R hosted a webinar to provide an overview of RCR and explain its importance and relevance to the human subjects research community. The panel included Fariba Houman, PhD, CIP, research compliance officer at Boston Children’s Hospital, and Julie F. Simpson, PhD, director of research integrity services at the University of New Hampshire.
After the webinar, the presenters responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand.
Do you have specific examples of RCR training guides or objectives for IRBs?
If IRB members are researchers, they may already get this training within an institution/organization. For non-researchers, a more general overview of standards may be sufficient. PRIM&R webinars on RCR and a guest lecture on how to recognize possible research misconduct—given by a research integrity officer (RIO) or a research compliance officer—may be sufficient to raise awareness. You can ask the RIO to describe a few cases of misconduct in human research to make it relevant for your IRB members.
It is important for IRB chairs to become comfortable parsing whether a specific noncompliance may fit the definition of fabrication or falsification and whether the RIO should be consulted.
Many institutions subscribe to the Collaborative Institutional Training Initiative (CITI) RCR course, so IRB members at such institutions should be able to access that resource. The Office of Research Integrity hosts a variety of institutional resources on their RCR Resources webpage, and the Online Ethics Center for Engineering and Science (OEC) houses a searchable collection of resources (v) which can be used by institutions. Some large research institutions, such as the University of Pittsburgh, have RCR guidelines which can be used as a training guide. Columbia University has a Research and Data Integrity (ReaDI) program, which is applicable to researchers at any institution, and thus can be used by IRBs broadly.
How do FDA and OHRP jurisdictions intersect with that of the Office of Research Integrity (ORI)?
There is a helpful presentation by Laura Odwazny and Jo An Rochez describing the specific and overlapping jurisdictions between OHRP and ORI.
The Office of Inspector General report recommended posting whistleblower protections information for complainants that bring allegations directly to OHRP. This is now posted on the OHRP website.
FDA published a notice of proposed rulemaking in 2010 that has since been abandoned. If the rule had been enacted, it would have required institutions to promptly report any person who has engaged in falsification of data in human research, non-clinical lab studies, and preclinical studies in animals to the FDA. This was deemed necessary as there is a large gap between the scope of research subject to FDA oversight and the scope of research covered by federal funding agencies.
SACHRP issued a report in 2012 pointing out the problems this separate rule would create and asked for harmonization.
Do you have specific suggestions or recommendations for IRBs to maintain adequate review/oversight for potential research integrity issues (e.g., conflict of interest) after implementation of the 2018 requirements of the Common Rule, especially since some studies will not have continuing review by the IRB?
Applications for continuing reviews can help IRBs to monitor accrual, spot issues, and verify adherence to the protocol and other institutional requirements. With the revised Common Rule not requiring a continuing review for all protocols, the IRB may need to rely on amendments only or specifically ask investigators a question on changes to their conflict of interest (COI) disclosure information since the last IRB review.
COI disclosure monitoring could be on the checklist during routine QA audits. Be aware that auditing may be more difficult and time-intensive when you are not the IRB of record or if you serve as one for other sites. The single IRB (sIRB) mandate makes communication about research integrity issues more challenging. Research misconduct proceedings must be confidential to protect the respondent and complainants, so it's worth consulting with your research integrity officer before communicating with an external sIRB.
We are unfamiliar with the term “DRPs.” Do your RIOs write letters of concern specific to DRPs? Are DRPs one and the same as noncompliance?
Detrimental Research Practices (DRPs) is the term used in the 2017 National Academies report, Fostering Integrity in Research. They use it instead of “Questionable Research Practices (QRPs)”, which has been widely used in the RCR literature to date. The authors state:
Many of the actions the 1992 panel identified as questionable research practices (often labeled QRPs) have gained less institutional consensus, and consequently there is less agreement on policies and incentives to address them. However, this panel has identified some of these practices as not questionable at all but as clear violations of the fundamental tenets of research (p. 73).
This change in nomenclature is to signal the authors’ view of the seriousness of some of these practices (not just questionable, but detrimental to research integrity). As they note, some practices considered DRPs in the United States constitute misconduct in other countries that have a broader definition of misconduct.
The authors list examples of DRPs on page 74. Some, such as failing to retain data, could be considered noncompliance, for example, if an institution has a policy on data retention. Most, however, do not constitute noncompliance, but rather violate research integrity, and should be identified and not tolerated. Chapter 5 in the report contains a discussion of DRPs and how they can be discouraged.
Generally, RIOs only get involved in cases of where there is an allegation of misconduct according to an institution’s misconduct policy. That said, if the misconduct policy has a broader mandate that includes “other serious deviations” that do not constitute misconduct according to the federal regulations, a RIO may be involved.
Does the Department of Defense (DoD) have an RCR requirement?
We have found the following directives about certain DoD research integrity requirements (addressing primarily research misconduct and human subjects protections). They are:
- Department of Defense Instruction 3210.7 (5/14/2004): Research Integrity and Misconduct
- Department of Defense Instruction 3216.02 (11/8/2011): Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
But neither is a broad RCR training requirement for DoD grants (along the lines of NSF, NIH, or USDA). We did, however, find an RCR training requirement for the Department of the Navy, Bureau of Medicine and Surgery (BUMED) (Enclosure 4 Part 7).
- BUMED Instruction 6500.3A (6/17/2016): Research Integrity, Responsible Conduct of Research Education, and Research Misconduct
This RCR training requirement is not a research grant recipient requirement (like, for example, NSF’s) but is broadly applicable, including, but not limited to, all Navy Medicine educational institutions, programs, and activities, employees, contractors, consultants, and individuals involved in Navy Medicine research activities. Its scope covers all Navy Medicine research programs.
We also spoke with Mr. Howard Stone, JD, LLM, CIP, director of the Army Human Research Protections Office. He stated:
DODI 3216.02 does require that as part of their administrative review of DoD-supported research that DoD Components evaluate non-DoD institutions' human research protections education and training policies to ensure that their personnel will be qualified to perform the DoD-supported research, the rigor of which evaluation is calibrated to the complexities and risks of the research. As stated below, DoD Components may have different procedures for conducting such an evaluation, and non-DoD institutions and DoD-supported researchers should reach out to the respective DoD Component HRPOs to see how their human research protections training will be evaluated. Generally, completion of a CITI-type training program and providing related documentation (e.g., training completion certificate) to the HRPO will suffice.
PRIM&R thanks Dr. Houman and Dr. Simpson for sharing their expertise.
The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to firstname.lastname@example.org.