Report on Research Compliance 20, no. 4. April 2023
◆ During its first meeting of the year, scheduled for March 22-23, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will review a Government Accountability Office (GAO) report that faulted both the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) for spotty oversight of institutional review boards (IRBs). The 11-member committee, which currently has three vacancies, will hear from a “panel of expert speakers addressing the topic of defining stakeholders and evaluating” the quality and effectiveness of human research protection programs and IRBs, according to the agenda described in a March 2 Federal Register notice.
SACHRP will also discuss draft FDA guidance, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs.” The meeting will be held via webcast. Links to watch the webcast will be posted on SACHRP’s meeting webpage. (3/16/23)
◆ Researchers who study genomics and genetics should “tailor their use of population descriptors based on the type and purpose of their study, and explain why and how those descriptors were selected in their work,” concludes a report by the National Academies of Sciences, Engineering, and Medicine (NASEM), Using Population Descriptors in Genetics and Genomics Research: A New Framework for an Evolving Field.
“If appropriate, researchers should consider using multiple descriptors for each study participant to improve clarity,” according to a March 14 news release about the report. “The report offers a decision tree to help researchers choose whether race, ethnicity or indigeneity, geography, genetic ancestry, or genetic similarity are most appropriate for their work. Genetic similarity will be the preferred population descriptor in most cases, though in some instances, other population descriptors may be considered appropriate. In the case of studies investigating the effects of racism on health, for example, racial labels may be appropriate.” NIH Acting Director Larry Tabak and two other NIH officials offered praise for the report, saying it “will inform NIH’s ongoing efforts to safeguard scientific integrity in genomics and promote the responsible design of research studies so that all populations benefit from scientific advances.” (3/16/23)
◆ The HHS Office of Research Integrity (ORI) is funding accepting applications for research projects that will address transparency in the reporting of research; effective communication between researchers to avoid and resolve authorship and/or collaboration disputes; handling allegations of research misconduct; and “interventions to address issues related to research culture and climate (e.g., overly-competitive environments, toxic workplaces, bullying, harassment, etc.) that can negatively impact the integrity, conduct, quality, and reliability of research,” the agency announced March 3. Funded research should result in the creation of “innovative approaches/tools/resources based on the results of this research” and “demonstrate the impact and/or effectiveness of these approaches/tools/resources.” The agency “anticipates funding three to six awards of between $75,000 and $150,000 in total costs (direct plus indirect) per year, for a project period not to exceed two years (two 12-month project periods and budget periods).” The deadline for applications is May 10.
In addition, ORI set a deadline of May 17 to accept applications to fund conferences “designed to provide a forum for discussion and produce tangible outcomes related to at least one of the following themes: 1) fostering an environment that promotes research integrity and the responsible conduct of research; 2) prevention of research misconduct; 3) effective handling of research misconduct allegations; 4) training in the responsible conduct of research; or 5) other topics linked to research integrity and compliance” with the federal misconduct statute. “ORI anticipates funding two to four one-year awards of between $25,000 and $50,000 in total costs (direct plus indirect).” ORI will hold separate technical assistance webinars for applicants on March 23. (3/9/23)
◆ Although it was finalized in January, NIH announced on March 6 the agency had posted the National Science Advisory Board for Biosecurity (NSABB) report, Proposed Biosecurity Oversight Framework for the Future of Science. “The NSABB was charged to review and evaluate [U.S. government] policies on Potential Pandemic Pathogen Care and Oversight (PC3O) and Dual Use Research of Concern (DURC),” acting NIH Director Larry Tabak said. “This report contains the findings and recommendations of two NSABB Working Groups, which were endorsed by the NSABB with minor modifications to the report and are aimed at ensuring U.S. biosecurity efforts are positioned to keep pace with an evolving scientific enterprise.”
The panel made 12 findings and offered 12 related recommendations, some of them with multiple parts. Among its findings is that while there is overlap, significant differences between the various oversight frameworks need to be harmonized. NSABB also called for broadening the definition of pandemic-related research subject to greater oversight, increased transparency in HHS review committee deliberations and that review of research at international institutions that receive U.S. support be “coupled to processes equivalent to requirements that govern domestic research.” Funding applications should state when “research is reasonably anticipated to produce any of the seven experimental effects, and if the proposed research may involve research of concern, as described in this report. Such research would need to be identified as having undergone appropriate institutional review,” which the report outlined. “I would like to thank the NSABB members for their thoughtful and careful consideration and analyses of these important policy issues, as well as members of the scientific community and the public who have provided their comments,” said Tabak, adding that the government “will announce the next steps in the review process” after various federal agencies review the NSABB report. (3/9/23)
◆ Acknowledging that the agency receives a dozen authorship dispute complaints a year, Mike Lauer, NIH deputy director for extramural research, recently offered “informal advice for researchers and institutions to consider.” NIH officials “generally do not handle authorship disputes as possible research misconduct violations,” nor does ORI the HHS Office of Research Integrity. “Rather, authorship disputes among research collaborators must be addressed internally at their institution and/or lab,” he wrote on his Open Mike blog, Lauer offered a host of recommendations to address such disputes, including using a publications committee to establish authorship in advance and to manage “issues that come up due to changing circumstances once a project is under way (e.g., one of the project members drops out).” Labs could “write and disseminate their own authorship policies and procedures. You could consider also including these in a lab manual,” Lauer added. “Most journals already require that the corresponding author attest that the other authors are in agreement with the entire content of the paper. A manuscript should only be submitted if everybody agrees. Institutions could set up policies and procedures to assure that all researchers understand and abide by this requirement.” He said, “being proactive can help mitigate the risk of possible authorship disputes” and noted that “how we manage these conflicts and frustrations in a civil professional way…is key for maintaining safe and respectful workplaces, conducive to high quality research.” (3/2/23)
◆ After reviewing $4.3 million in expenses claimed by Incorporated Research Institutions for Seismology (IRIS) for the period Nov. 1, 2018, to Oct. 31, 2021, auditors for the National Science Foundation (NSF) Office of Inspector General (OIG) found just $470 in unallowable costs—expended for bartenders. According to its website, IRIS is a consortium of more than 125 universities that helps facilitate, acquire, manage, and distribute seismological data. As described in a Feb. 7 report, the “bartender service expenses [were] incurred to provide a cash bar for participants attending an NSF-sponsored workshop” in October 2019. “As costs associated with alcoholic beverages are not allowable per federal regulations” and per NSF policies, “the costs incurred to provide the cash bar are unallowable,” auditors said.
The bartender costs were among 50 transactions totaling $4,297,934 out of a universe of 11 awards for $56.6 million that were part of the audit. In its response, IRIS officials said the questioned costs were for two “banquet bartenders” who served both alcoholic and nonalcoholic beverages as a part of a dinner during a three-day, 300-person meeting. Meeting participants paid for alcohol themselves, and “no alcohol beverage costs were charged to the federal award supporting this workshop.” The organization said it “accepts the auditor’s opinion that the bartender fees could be associated with the cash bar and agrees to reimburse NSF or remove these costs from the award charges. Due to stricter guidelines since issued by NSF, similar workshops in the future will no longer include a cash bar or permit the serving of alcohol at such sponsored events.” Auditors also found that “IRIS did not treat fringe benefits consistent with” negotiated indirect cost rates, which they called a “compliance exception” not associated with any questioned costs. (3/2/23)
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