NIH
21st Century Cures Act Discussion Draft Released
House Energy and Commerce Committee Chairman Fred Upton (R-MI) released a discussion draft of the 21st Century Cures Act on January 27. The draft bill is the culmination of a year of hearings and roundtable discussions held by the Committee. Its release was accompanied by a section-by-section discussion of the document and a one-pager highlighting the legislative ideas. The Committee has repeatedly stated that the draft is a “starting point in the legislative process to spur discussion.” Accordingly, they are seeking public feedback on the proposals. The Committee also cautioned that the “inclusion of a policy in the draft should…
Accelerating Biomedical Research Act Introduced in House and Senate
On January 26, Rosa DeLauro (D-CT), Brian Higgins (D-NY), and Peter King (R-NY) reintroduced the bipartisan Accelerating Biomedical Research Act (H.R. 531).The bill “would allow Congress to restore the purchasing power of the National Institutes of Health (NIH)’s funding to what it would have been if it had kept up with inflation since 2003.” It would create a new Budget Control Act cap adjustment for the agency. Any funding provided in excess of $29.4 billion would trigger a budget cap increase to accommodate the additional funding provided. The measure would allow appropriators to increase NIH funding by ten percent for the…
Medical Innovation Act Introduced in House and Senate
On January 29, Senators Elizabeth Warren (D-MA), Ben Cardin (D-MD.), Sherrod Brown (D-OH), and Tammy Baldwin (D-WI) introduced the Medical Innovation Act (S.320), which is designed to increase “funding for critical medical research.” A companion bill, H.R. 744, was introduced in the House by Representatives Chris Van Hollen (D-MD), Jan Schakowsky (D-IL), Peter Welch (D-VT), and Kathy Castor (D-FL). According to the press release, the measure would require large pharmaceutical companies that break the law and settle with the federal government to reinvest a small percentage of their profits into the National Institutes of Health (NIH) and the Food and…
American Cures Act Introduced in Senate
On January 28, Senator Dick Durbin (D-IL) reintroduced the American Cures Act (S. 289). The bill would support research at the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense Health Program, and the Veterans Medical and Prosthetics Research Program. The measure is designed to set a steady growth rate in federal appropriations for biomedical research conducted at these agencies. Annually, the bill would increase funding for each agency and program at a rate of GDP-indexed inflation plus five percent. The “steady, long-term investment” provided by the legislation, if enacted, “would allow the agencies…
Senators Release Innovation for Healthier Americans Report, Request Feedback
On January 29, Senators Lamar Alexander (R-TN), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and Richard Burr (R-NC), released Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development. The report addresses challenges to getting safe treatments, devices, and cures to patients more quickly and effectively, looking specifically at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
NIH: Four Opportunities in the Science of Behavior Change
Human behavior accounts for approximately 40 percent of the risk associated with preventable premature deaths in the U.S. Researchers are beginning to make progress in understanding some of the basic mechanisms that account for less-than-optimal initiation and maintenance of behavior change. The National Institutes of Health (NIH) via its Common Fund supports a Science of Behavior Change (SOBC) program initiative that “seeks to promote basic research on the initiation, personalization and maintenance of behavior change” (see Update, February 10, 2014). By integrating work across disciplines, the agency believes that this effort will lead to an improved understanding of the underlying…
NIH: BD2K Biomedical Science Training Coordination Center
The National Institutes of Health (NIH) is seeking applications for a coordination center designed to narrow the gap between the availability of biomedical big data and the ability of biomedical scientists to utilize such data accurately, effectively, and efficiently. The funding opportunity announcement, NIH Big Data to Knowledge (BD2K) Biomedical Science Training Coordination Center (RFA-ES-15-004), responds to increasingly large, diverse, and complex biomedical datasets. These datasets tax conventional methods for sharing, managing, and analyzing data. Researchers’ abilities to capitalize on biomedical big data science-based approaches are limited by poor data accessibility and interoperability, the lack of appropriate tools, and insufficient…
NIH: BD2K MOOC on Data Management for Biomedical Big Data
The National Institutes of Health (NIH) is seeking applications designed to develop an open, online educational course that complements and/or enhances the training of a workforce to meet the nation’s biomedical, behavioral, and clinical research needs. The funding opportunity announcement (FOA), NIH Big Data to Knowledge (BD2K) Initiative Research Education: Massive Open Online Course (MOOC) on Data Management (RFA-LM-15-001), focuses on curriculum or methods development.
NIH Discontinues the National Children’s Study
The National Institutes of Health (NIH) has decided to discontinue the National Children’s Study (NCS). At the December 12 meeting of the NIH Advisory Committee to the Director (ACD), a working group charged by NIH director Francis Collins to evaluate whether the NCS “as currently outlined is feasible, especially in light of increasing and significant budget constraints,” concluded that the NCS as currently designed is not. The working group further recommended “that the NIH champion and support new study designs, informed by advances in technology and basic and applied research, that could make the original goals of the NCS more…
SMRB Accepts Working Group Report on Pre-college Engagement in Biomedical Science
On December 15, the National Institutes of Health (NIH) Scientific Management Review Board (SMRB) unanimously approved the Report of the SMRB Working Group on Pre-college Engagement in Biomedical Science. Chaired by Clyde Yancy, Northwestern University, the working group was charged by NIH director Francis Collins “to recommend ways to optimize NIH’s pre-college programs and initiatives that both align with the NIH mission and ensure a continued pipeline of biomedical science students and professionals.” The group released preliminary findings at its October meeting (see Update, October 28, 2014).
NIH: Cancer Institute Releases Series of Funding Announcements
The National Cancer Institute (NCI) recently released a series of funding opportunity announcements (FOAs) designed to enhance the diversity of the NCI-funded cancer research workforce. The awards support individuals from groups that have been shown to be underrepresented in the biomedical, behavioral, social, and clinical sciences. The Institute notes that a major obstacle to developing a stronger national health disparities cancer research effort has been the lack of significant strategic training programs for students and scientists. It further notes, “Greater involvement of students and scientists from underrepresented backgrounds is integral to a successful national cancer research effort involving more underserved…
Scientific Community Expresses Support for NIH and Its Peer Review Process
On December 2, the Coalition to Promote Research (CPR) sent letters to Congress expressing its “continued and strong support for the competitive peer review process used by the National Institutes of Health (NIH).” The letter, signed by 128 diverse organizations, noted that the scientific community is “extremely concerned about the recent criticism of the NIH’s funding decisions and the accompanying mischaracterization of NIH-supported research in the media and by some in Congress. The ongoing targeting of specific grants produces a chilling effect across the entire scientific community. These attacks inhibit the very scientific progress the critics claim to support. Our…
NIH to Use Single IRB to Speed the Initiation of Clinical Research, Seeks Comments
On December 3, the National Institutes of Health (NIH) issued a draft policy to promote the use of single institutional review boards (IRB) in multi-site clinical research studies. The draft policy proposes that all NIH-funded multi-site studies carried out in the U.S. utilize a single IRB regardless of the funding mechanism. Hence, the agency is seeking public comments on the draft policy through a 60 day comment period closing January 29, 2015. According to the release announcing the draft policy, exceptions would be allowed if local IRB review is necessary to meet the needs of special populations or where it…
NIH Seeks Comments on Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
The National Institutes of Health (NIH) is seeking comments on its draft policy “to promote broad and responsible dissemination of information on clinical trials funded by the NIH” through registration and submission of summary results information to ClinicalTrials.gov. NIH has a number of policies designed to promote the distribution of research results and guide funding recipients in disseminating their results, including the NIH Data Sharing Policy, the NIH Public Access Policy, the NIH Research Tools Policy, and the NIH Genomic Data Sharing Policy. According to the NIH, a recent study found that the results of less than half of NIH-funded…
NIH: Systems Science and Health in Behavioral and Social Sciences
The National Institutes of Health (NIH) has issued a funding opportunity announcement (FOA), Systems Science and Health in the Behavioral and Social Sciences (PAR-15-047), seeking applications that apply system science approaches such as system dynamic modeling, agent-based modeling, social network analysis, discrete event analysis, and Markov modeling to better understand complex and dynamic behavioral and social sciences processes and problems relevant to health.
NIH: Family and Interpersonal Relationships in an Aging Context
The National Institute of Aging (NIA) of the National Institutes of Health (NIH) is seeking applications designed to expand understanding of the role and impact of families and interpersonal relations on health and well-being in midlife and older age.
COSSA & Partners Urge Congress to Complete FY 2015 Omnibus Spending Bill
On November 12, COSSA joined the biomedical and behavioral science community in signing the Ad Hoc Group for Medical Research letter to Congress. The letter, which was signed by 303 organizations, urges Congress to “complete an omnibus spending package [that] includes a Labor-HHS-Education bill that restores funding for the National Institutes of Health (NIH) to at least pre-sequestration levels.” The letter also notes, “An omnibus spending bill with a Labor-HHS appropriation restoring NIH to at least pre-sequester funding levels would mark an important step toward a more sustainable, predictable research environment for patients and their families, as well as for…
NIH: Cancer Prevention, Control, Behavioral Sciences, and Population Sciences Career Development Award
The National Cancer Institute (NCI) recently issued a funding opportunity announcement, Cancer Prevention, Control, Behavioral Sciences, and Population Sciences Career Development Award (PAR-15-033). The award supports the career development of junior investigators with research or health professional doctoral degrees who want to become cancer-focused academic researchers in cancer prevention, cancer control, or the behavioral or population sciences. The award provides salary and mentored research support for a sustained period of “protected time” to junior investigators who are interested in developing academic and research expertise in these health-related fields. NCI will contribute up to $100,000 per year toward the salary of…
Aging and Mental Health Institutes Seek Comments on Draft Strategic Plans
The National Institute on Aging (NIA) and the National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH) are seeking public comment on the development of the Institutes’ strategic plans. The plans will guide the Institutes’ research priorities. National Institute on Aging The NIA recently released a request for information (RFI) seeking guidance on its strategic plan, Aging Well in the 21st Century: Strategic Directions for Research on Aging. The draft plan outlines NIA’s broad strategic directions for the Institute and “provides a point of reference for setting priorities and a framework for systematically analyzing the Institute’s…
IOM Recommends Including Social/Behavioral Determinants in Electronic Health Records
On November 13, the Institute of Medicine (IOM) released Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2, which recommends a “concrete approach to including social and behavioral determinants in the clinical context to increase clinical awareness of the patient’s state, broadly considered, and to connect clinical, public health, and community resources for work in concert.” The report’s recommendations takes into consideration the “substantial empirical evidence of the contribution of social and behavioral factors to functional status and the onset, progression, and effective treatment of disease [that] has accumulated over the past four decades.”