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July 1, 2017: ASPET Government Affairs and Science Policy Update

July 01, 2017

NIH Director Testifies at Senate Appropriations Committee Hearing: NIH Director Dr. Francis Collins, M.D., Ph.D., testified this week about the proposed FY 2018 budget for the NIH at a Senate Appropriations Committee hearing. Other witnesses included: Dr. Douglas Lowy, M.D., Acting Director of the National Cancer Institute; Dr. Gary Gibbons, M.D., Director of the National Heart, Lung, and Blood Institute; Dr. Anthony Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases; Dr. Richard Hodes, M.D., Director of the National Institute on Aging; Dr. Nora Volkow, M.D., Director of the National Institute on Drug Abuse; and Dr. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health.

While NIH funding cuts in President Trump’s budget proposal was a widely-discussed topic, Senator Patty Murray (D-WA) specifically expressed concern to Dr. Collins about the effects of cutting grant funding for indirect costs from 28% to 10%. The Senator asked Collins what would happen to his intramural research program if funding for indirect costs was reduced to 10%. Collins responded by stating that the issue has attracted a lot of attention in the biomedical research community and that “indirect costs” is an “unfortunate term” because it is difficult to determine what those costs refer to. He also suggested that it would be difficult to imagine how a facility would be managed if funding for such costs were to be reduced.

He further stated about indirect costs: “We are looking at every possible way that we might be able to assist in this conversation by identifying areas in which various administrative burdens that we ask institutions to follow could be reduced, because maybe they’re not as necessary as they are. So, we’re looking at our current regulations, for instance, about conflict of interest, about animal care, about effort reporting. We might in that process be able to identify a way to reduce somewhat the burden, but frankly I don’t think it would add up to an enormous difference in what we’re currently asking our grantee institutions to do, and they are the ones who do the work. We depend on them.” According to Collins, indirect costs such as facilities, utilities, buildings, supply of light and water, operations of administrative services and animal care oversight are necessary to conduct research.

Research Coalition Launches “Advancing Principles of Scientific Stewardship” Petition: The Coalition to Promote Research (CPR) has launched a petition entitled, “Advancing Principles of Scientific Stewardship.” The statement encourages Congress and the Executive Branch to continue supporting: scientific merit review, also known as “peer review”; federally supported research; and scientific integrity and transparency.  To read the full petition and/or sign on, click here.     

NIH Advisory Council Makes Recommendations on Rigor and Reproducibility, Physician-Scientist Training, Workforce Diversity: The Advisory Council to the Director (ACD) at the NIH recently received updates on topics related to the practice and support of biomedical research. During sessions held at the NIH campus in Bethesda, MD on June 8 and 9, NIH leadership briefed the ACD on issues, including recommendations in rigor and reproducibility (R&R), physician-scientists training programs, and supporting workforce diversity.

Michael Lauer, MD, Deputy Director for Extramural Research, summarized policies and recommendations supporting the R&R of NIH funded research, an effort mandated by Section 2039 of the 21st Century Cures Act. He described how input provided by scientific review and program officers through structured interviews during the summer of 2016 informed the framework of NIH strategy to implement R&R policy. Among them were a requirement that grant applications and associated summary statements address R&R and that each grant be quantitatively assessed for measures of R&R by an online-interfaced ratings management system. In the discussion, the ACD addressed questions concerning data stewardship, reagent verification, and validation of animal models in disease.

Lauer also discussed ongoing initiatives of the Physician Scientists Working Group. He presented data demonstrating that fewer physicians receive independent grants and awards, and are doing so at later ages. To address this, the working group proposed increasing the frequency and number of laboratory research opportunities in the Medical Scientists Training Program (MSTP). This initiative is also designed to enroll first and second year medical students who are interested in gaining a meaningful research experience. The modified research-oriented MSTP program is expected to be supported by a dedicated institutional training grant (T32). Additionally, NIH plans to issue new physician-scientists specific granting mechanisms to facilitate their transition to independence at earlier ages.

NIH efforts to support the diversity of trainees and faculty in biomedical research were described by Hannah Valantine, MD, Director of the Office of Scientific Workforce Diversity (SWD). In response to recommendations made by an earlier ACD Working Group on Diversity in Biomedical Research Workforce Report released in 2012, the SWD analyzed demographic trends in NIH support of biomedical researchers with respect to race and assessed the status of the NIH investment in diversity-focused programs at different career stages. Dr. Valantine highlighted how this analysis revealed striking and consistent gaps in support, recruitment and retention for underrepresented minorities (URMs), particularly for African American researchers. To combat these discrepancies, SWD established and supports three flagship programs in an integrated extramural diversity effort. Known as the National Diversity Program Consortium, it consists of the Building Infrastructure leading to Diversity (BUILD) program, The National Research Mentoring Network, and the Coordination and Evaluation Center. This initiative is designed to quantitatively assess the efficacy of diversity and outreach efforts in a systematic way, and to inform a data-driven determination of how future programs should be designed and executed on best practices. Finally, Dr. Valantine laid out the working group on diversity recommendations for 2017, which broadly aim to foster a culture of accountability in institutional processes, to focus on supporting URMs at career transition points, and to deploy proactive interventions supporting unbiased peer review.

Key Trump Administration Nominee Pledges Reduced Regulatory Burden: Professor Neomi Rao, nominated to lead the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB), affirmed her commitment to minimize regulatory burden. At a Senate Homeland Security and Government Affairs Committee (HSGAC) hearing, she supported maintaining the consistency of OIRA’s statutory principles and empirical evaluation of existing or proposed regulations.

OIRA manages the federal rulemaking process through regulatory review and coordination of administrative policy. If confirmed, Rao would be charged with implementing a recent Executive Order charging federal agencies to repeal two existing regulations for every new regulation enacted. Senator Ron Johnson (R-WI) inquired as to how the Executive Order would be implemented. Referring to a 2007 Federal Demonstration Partnership survey which reported that federally-funded research faculty nationwide spend 42 percent of their time on administrative requirements, Johnson also asked what Rao intended to do to reduce regulatory burden on academic research. Rao said that OIRA will follow OMB guidelines and partner with federal agencies to identify and eliminate inefficient, redundant, or overly burdensome rules based on retrospective cost-benefit analyses.

During a similar line of questioning introduced by Senator Rob Portman (R-OH) and Senator Heidi Heitkamp (D-ND), Dr. Rao affirmed her support of the bipartisan Senate Regulatory Accountability Act of 2017 (RAA), a bill that Portman and Heitkamp co-sponsored. She backs RAA provisions mandating that proposed regulations undergo review of efficacy, value, and monetary cost prior to implementation. Rao also agreed that indirect costs, which capture qualitative and non-monetary outcomes, should be considered in cost-benefit assessments. Noting that deregulation necessitates the same level of scrutiny as enacting new rules, she acknowledged the importance of retrospective review as an important aspect of reducing administrative burden.

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