Search Results: clinical
OAR Outlines Overarching AIDS Research Priorities; Studies of Behavior and Social Conditions with Multiple Negative Outcomes Deemed Low Priority
At the September 1 meeting of the National Institutes of Health (NIH) Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils, Acting Associate Director for AIDS Research and Acting Director for the Office of AIDS Research (OAR) Robert Eisinger provided the Council with an update on OAR’s activities, including the recent release of NIH’s high-priority areas of HIV/AIDS research and accompanying guidelines for determining funding for this research (see related story). Eisinger highlighted NIH director Francis Collins’ August 12 statement extolling the ”extraordinary progress that has been made in HIV/AIDS research over the past 34 years, transforming what…
HHS Releases Proposed Updates to the Common Rule
The Department of Health and Human Services has released its proposal to update the regulations that govern research involving human subjects (the Common Rule). The long-awaited Notice of Proposed Rulemaking (NPRM) explains the proposed changes and poses a number of questions for which the department is seeking public comment, to be submitted within 90 days of the NPRM’s publication. The Office of Human Research Protections (OHRP) plans to hold several webinars in the coming weeks to explain the changes as well as an in-person town hall meeting in Washington, DC in October. The Common Rule has not been updated since…
NIH Plans for Redirection of National Children’s Study Funds
National Institutes of Health (NIH) Principal Deputy Director Lawrence Tabak provided an update on the “redirection” of National Children’s Study (NCS) appropriated funding at the September 1 meeting of the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Council of Councils. Despite the NIH’s discontinuation of the NCS, in FY 2015, Congress provided $165 million for the study with direction to the agency to continue to support the mission and goals of the study, along with flexibility on how to carry this task out. Tabak announced that the awards associated with this funding will be made in September. As…
William T. Riley Appointed NIH OBSSR Director
On July 30, National Institute of Health (NIH) director Francis Collins announced the appointment of William “Bill” T. Riley, PhD, as the next Director of the Office of Behavioral and Social Sciences Research (OBSSR). Riley has served as Acting Director of the OBSSR since May, 2014. Riley has been with NIH since 2005, serving as Deputy Director of the Division of AIDS and Health & Behavior Research at the National Institute of Mental Health (NIMH). He joined the National Heart, Lung, and Blood Institute as Program Director of the Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences in 2009….
NIH Releases Alzheimer’s Disease Bypass Budget Proposal for FY 2017
On July 27, National Institutes of Health (NIH) director Francis Collins released the first Professional Judgement Budget, also known as the Bypass Budget, for Alzheimer’s disease (AD) and related dementias, Bypass Budget Proposal for Fiscal Year 2017—Reaching for a Cure: Alzheimer’s Disease and Related Dementias Research at NIH. The bypass budget was mandated by Congress in the National Alzheimer’s Project Act enacted in 2011 (P.L. 111-375). The fiscal year (FY) 2017 bypass budget outlines the “optimal approach NIH would take in an ideal world unconstrained by fiscal limitations.” It concludes that NIH could “significantly accelerate progress against Alzheimer’s disease with…
NIH Seeks Input on Congressionally-Mandated Agency-Wide Strategic Plan
The National Institutes of Health (NIH) recently issued a time-sensitive Request for Information (RFI) (NOT-OD-15-118) inviting comments and suggestions on the framework for its congressionally-mandated NIH-wide Strategic Plan. NIH is requesting feedback by August 16, 2015. The agency also plans to host webinars in early to mid-August to gather additional input. NIH Deputy Director Larry Tabak presented the agency’s first iteration of its draft plan at the June 11 meeting of the NIH Advisory Committee to the Director (ACD) (see Update, July 14, 2015). At the July 20 meeting of the ACD, Tabak presented a revised draft framework incorporating the…
NIH Seeks Comments on Proposed Alternative to National Children’s Study
The National Institutes of Health (NIH) is inviting comments on its proposed plan for the Environmental influences on Child Health Outcomes (ECHO) program and has issued a time-sensitive Request for Information (RFI). Background The ECHO program responds to the NIH’s decision to discontinue the National Children’s Study (NCS) in December 2014, per the recommendations of a working group of the Advisory Committee to the Director (ACD) of NIH (See Update, December 19, 2014). NIH emphasizes that in keeping with the spirit of the NCS, ECHO aims to address the critical goal of understanding the impact of environmental influences on children’s…
Congressionally-Mandated Strategic Plan, FY 2016 Budget Discussed by NIH Advisory Committee to the Director
The June 11-12 National Institutes of Health (NIH) Advisory Committee to the Director (ACD) meeting included the discussion of a number of important issues for the agency, including its fiscal year (FY) 2016 budget and its efforts to develop a five-year strategic plan by December 2015.
Funding Opportunity Announcements
NIA: Claude D. Pepper Older Americans Independence Centers (P30) (RFA-AG-16-011) NIA: Aging Research to Address Health Disparities (Administrative Supplement) (PA-15-293) NIA: Networks to Develop Priority Areas of Behavioral and Social Research (R24) (RFA-AG-16-008) NIAAA: Screening and Brief Alcohol Interventions in Underage and Young Adult Populations (R21, R01, R03) (PA-15-294), (PA-15-295), (PA-15-296) FIC: International Research Scientist Development Award (IRSDA) (K01) (PAR-15-291) FIC, NHGRI, NIEHS, NIMH: Emerging Global Leader Award (K43)(PAR-15-292) AHRQ: AHRQ Patient-Centered Outcomes Research Clinical Decision Support Learning Network (U18) (RFA-HS-15-003) NICHD: Neurodevelopmental Assessment of Infants and Children in Resource-Limited Settings (R43/R44, R41/R42) (RFA-HD-16-024), (RFA-HD-16-025) NICHD: HIV-infected Adolescents: Transitioning from…
NIH: The Health of Sexual and Gender Minority Populations
The National Institutes of Health (NIH) has issued a funding opportunity announcement (FOA) focused on sexual and gender minority (SGM) populations, including lesbian, gay, bisexual, transgender, and intersex populations. Participating institutes and offices include: Cancer, Alcohol Abuse and Alcoholism, Allergy and Infectious Diseases, Deafness and other Communication Disorders, Dental and Craniofacial, Mental Health, Minority Health and Health Disparities, and the Office of Behavioral and Social Science Research.
NIH: AIDS Research Center/Developmental Research Centers on Mental Health and HIV/AIDS
The Division of AIDS Research (DAR) within the National Institute of Mental Health (NIMH) at the National Institutes of Health (NIH) is seeking applications for Center Core grants to support an HIV/AIDS Research Center (ARC) (PAR-15-197) and applications to support Developmental AIDS Research Centers (D-ARC) (PAR-15-196). ARC supports innovative, interdisciplinary research in the areas of basic research, neuro-AIDS, behavioral and social, integrated biobehavioral, clinical, translational, and implementation science. D-ARC provides infrastructure support that facilitates the development of high impact science in HIV/AIDS and mental health that is relevant to the NIMH mission. NIMH’s intent is to support research that addresses…
PCAST Hears Interim Report on Precision Medicine Initiative
On May 15, the President’s Council of Advisors on Science and Technology (PCAST) received an interim report on the President’s proposed Precision Medicine Initiative (PMI). Opening the meeting, PCAST co-chair and director of the White House Office of Science and Technology Policy (OSTP) John Holdren discussed the ongoing budget process and the challenges associated with the FY 2016 budget. Despite these challenges, Holdren noted, there are a number of exciting initiatives in progress, including the Precision Medicine Initiative.
NIH: Input Sought on Precision Medicine Cohort
The National Institutes of Health (NIH) is seeking feedback from the scientific community via a Request for Information (RFI): NIH Precision Medicine Cohort (NOT-OD-15-096) to guide it in creating a longitudinal cohort of one million or more Americans who have volunteered to participate in research as part of the President’s proposed Precision Medicine Initiative (PMI) (see Update, April 21, 2015). Specifically, the agency is seeking information on characteristics, purpose, or other overall aspects in the development and implementation of a large U.S. precision medicine cohort. As participants in PMI, individuals will be asked to give consent for extensive characterization of…
COSSA Washington Update, Volume 34 Issue 7
Featured News House COMPETES Bill Targets Social Science Federal Agency & Administration News NIH Appoints Working Group for Precision Medicine Initiative AHRQ 2014 Healthcare Quality and Disparities Report Shows Improved Overall Quality and Access, Lingering Disparities BTS Releases Annual Report Funding Opportunities NIH: Collaborative Innovation Award, Clinical and Translational Science Award Program COSSA Member Spotlight PAA/PRB Briefing Explores the Changing Landscape of Marriage Events Calendar View the archived email.
Nominations Sought for USPSTF Members
The Agency for Healthcare Research and Quality (AHRQ) is inviting nominations for individuals to serve on the U.S. Preventive Services Task Force (USPSTF). The USPSTF is an independent body of experts that makes evidence-based recommendations about the effectiveness of clinical preventive services and health promotion. Qualified nominees will have demonstrated expertise in the following areas: (1) critical evaluation of peer-reviewed research; (2) clinical prevention, health promotion, and primary health care; and (3) implementation of evidence based recommendations in clinical practice. In addition, expertise in the following areas is also desirable: Behavioral medicine Public health Health equity and the reduction of…
NIMH Releases Strategic Plan for Research
The National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH) recently released its Strategic Plan for Research which will guide the Institute’s research priorities over the next five years, from basic science of the brain and behavior, to public health impact. This plan updates the objectives of the 2008 strategic plan. Its aim is to balance the need for long-term investments in basic research with urgent medical health needs.
NIH: Research Education Program Funding Opportunities
The National Institutes of Health (NIH) Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH institutes and centers. Additionally, the program goals include an effort to enhance the biomedical, behavioral, and clinical research workforce; recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral, and clinical sciences; and foster a better understanding of this research and its implications. Several of the institutes recently released funding opportunity announcement seeking applications for activities related to their research domains. NIMH Research Education Mentoring Program for HIV/AIDS Researchers…
Senate HELP Committee Examines “U.S. Leadership in Medical Innovation”
On March 10, the Senate Health, Education, Labor and Pensions (HELP) Committee held its first in a series of anticipated hearings on “U.S. Leadership in Medical Innovation.” Opening the hearing, HELP Committee Chairman Lamar Alexander (R-TN) announced that he and Ranking Member Patty Murray (D-WA) intend to focus on three major actions over the next two years: (1) “fixing” the No Child Left Behind Act; (2) simplifying and reauthorizing the federal government’s supervision of higher education in America; and (3) dealing with the “exciting new era of medicine.” Regarding the latter, Alexander noted that the House is moving on a…
FDA, OHRP Seek Comment on Proposed Guidance on Electronic Consent
The Food and Drug Administration (FDA) has released draft guidance on using electronic media and processes to obtain informed consent in FDA-regulated clinical investigations. The guidance covers how and when electronic informed consent information should be presented, how to ensure subjects’ understanding of the information, how to maintain confidentiality and security, and how to keep appropriate documentation of the consent process. FDA is seeking public comment on the draft guidance by May 8, 2015. Instructions and more information are in in the Federal Register notice. The Office of Human Research Protections (OHRP) is soliciting comments on whether the FDA’s draft…
COSSA Welcomes Fielding Graduate University
COSSA is thrilled to welcome Fielding Graduate University as its newest university member. Located in Santa Barbara, CA, Fielding boasts scholarship and practice in fields such as clinical psychology and media psychology, human and organizational development, and educational leadership and change. COSSA’s full membership list can be viewed here. Back to this issue’s table of contents.