Search Results: clinical

OHRP Issues Guidance on Human Subjects Protections for Coronavirus Actions

The Office of Human Research Protections (OHRP) within the Department of Health and Human Services has issued guidance for institutions and investigators conducting research in response to the COVID-19 pandemic. The guidance covers the following topics: (1) Public Health and Clinical Activities; (2) Excluded Public Health Surveillance Activities; (3) Legally Required Reporting; (4) Research Changes to Eliminate Apparent Immediate Hazards; (5) Proposing and Reviewing Study Changes; and, (6) Whether Suspensions of Research Must be Reported.  The guidance document can be accessed at on OHRP’s website. Back to this issue’s table of contents.

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NIMHD Holds 10th Anniversary Symposium

On March 3, the National Institute of Minority Health and Health Disparities (NIMHD) within the National Institutes of Health (NIH) held the Innovations to Promote Health Equity symposium celebrating the Institute’s 10th anniversary. The symposium, held on the NIH campus in Bethesda, MD, featured comments from NIMHD Director Eliseo Perez-Stable and NIH Director Francis Collins and focused on the latest innovations in health disparities research organized into four topical panels: Division of Intramural Research, Community Health and Population Sciences, Integrative Biological and Behavioral Sciences, and Clinical and Health Services Research. A video recording of the full symposium is available on…

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NIMHD to Celebrate 10th Anniversary with Scientific Symposium

The National Institute on Minority Health and Health Disparities (NIMHD) within the National Institutes of Health (NIH) is hosting a scientific symposium titled Innovations to Promote Health Equity in honor of the institute’s 10th anniversary. The symposium will highlight new discoveries in minority health and health disparities research and will feature four panels focused on the following issue areas: Integrative Biological and Behavioral Sciences Community Health and Population Sciences Clinical and Health Services Research Multidisciplinary Intramural Research at NIMHD The symposium will take place at the NIH campus in Bethesda, Maryland on March 3, 2020 and will be webcast live…

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NIH Seeking Comments on Inclusion Across the Lifespan II Workshop

The National Institutes of Health (NIH) released a Request for Information (RFI) seeking stakeholder input on a planned workshop on Inclusion Across the Lifespan, a policy intended to encourage inclusion of underrepresented participants in clinical studies. The Inclusion Across the Lifespan II Workshop is a follow-up to a 2017 workshop mandated by Congress in the 21st Century Cures Act. Comments will remain open until February 15, 2020. More information can be found in the NIH guide notice. Back to this issue’s table of contents.

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COSSA Washington Update, Volume 38 Issue 16

Featured News NIH Extends Enforcement Delay of Clinical Trials Policy Until September 2021 COSSA in Action August’s Headlines Webchat to Feature Deep Dive on Effectively Advocating from Home AAPSS Answers “Why Social Science? Letters & Statements Congressional News Budget Deal Signed; Congress Leaves for Summer Recess with FY 2020 Outcome Unknown House Subcommittee Holds OSTP Oversight Hearing; Senate Confirms Nominee for Chief Technology Officer Federal Agency & Administration News NIH Establishes Research Network on Opioid Use Disorder in the Criminal Justice System Nomination Opportunities Funding Opportunities Notices & Requests for Comment Open Positions Fellowships & Professional Development Community News &…

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December COSSA Headlines to Feature OBSSR Director

COSSA members are encouraged to sign up for the monthly Headlines webchat on December 13 a 2:00 PM Eastern, in which COSSA staff recap the most important social and behavioral science news from the past month and answer participants’ questions. The December chat will feature a deep dive discussion with Dr. William (Bill) Riley, Director of the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH), who will give an update on new initiatives at OBSSR and discuss the next steps for NIH’s controversial clinical trials policy. Individuals employed by or affiliated with a…

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COSSA Washington Update, Volume 37 Issue 21

Featured News Introducing HEADLINES: A monthly look at what’s new and noteworthy in social science policy COSSA in Action COSSA Encourages Response to NIH Clinical Trials RFI COSSA Seeks Interns for 2019 Disaster Researchers Brandi Gilbert and Nnenia Campbell Answer “Why Social Science?” Letters & Statements Federal Agency & Administration News Census Reissues Request for Input on 2020 Data Products NSF Releases Dear Colleague Letter on Mid-Scale Research Infrastructure Opportunities NIH Seeks Input on BRAIN Initiative Funding Opportunities Notices & Requests for Comment Recent Reports Open Positions Community News & Reports Briefing Highlights Role of Vital Statistics in Protecting Maternal…

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COSSA Washington Update, Volume 37 Issue 17

Featured News USDA Announces Plans to Move NIFA and ERS out of DC, Realign ERS with Chief Economist COSSA in Action New from “Why Social Science?”: Misinformation and “Ban-the-Box” Policies Letters & Statements Congressional News State of Play: FY 2019 Appropriations for Social Science Research Senate Committee Considers Droegemeier Confirmation Senate HELP Committee Hears Update on NIH Cures Implementation Federal Agency & Administration News NIH Releases RFI, Delays Enforcement of New Clinical Trials Policy White House Seeks Input on New Government Effectiveness Research Center NSF Launches 2026 Idea Machine White House to Appoint J. Scott Angle to Lead NIFA NSF…

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Common Rule Agencies Release Proposal for 6-Month Delay of Revisions, Optional Implementation of “Burden-Reducing” Provisions; Comments Sought for 30 Days

On April 20, the 17 agencies regulated under the Common Rule, the set of regulations governing human subjects research, released a Notice of Proposed Rulemaking (NPRM) that would delay implementation of revisions to the Common Rule by an additional six months, setting a new compliance date of January 21, 2019. The stated rationale for the delay is to “provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements.” The Obama-era changes had been originally scheduled to go into effect on January 19, 2018 but were delayed by an Interim Final Rule announced in January 2018…

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COSSA Washington Update, Volume 37 Issue 1

Featured News Early Bird Registration Open for 2018 COSSA Science Policy Conference COSSA in Action COSSA Releases 2018 Rankings of College and University Social Science Investment COSSA Board Chair Felice J. Levine Answers “Why Social Science?” Congressional News Congress Returns from Recess Focused on Funding Senators Introduce Bipartisan Bill to Reauthorize International Education Programs Federal Agency & Administration News Delay to Common Rule Implementation Likely NIH Continues to Tweak Policy for Investing in Young Researchers NIH “Clinical Trials” Definition Moving Forward: Researchers Take Notice Trump Appoints James Woodworth to as Commissioner of Education Statistics Recent Reports Open Positions Fellowships &…

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COSSA Washington Update, Volume 36 Issue 21

Featured News COSSA Joins Societies in Requesting Changes to NIH Clinical Trial Policy Congressional News Rand Paul Introduces Bill to “Reform” Federal Research Grant System Labor, Health and Human Services Subcommittee Holds Hearing on Indirect Costs of Research Federal Agency & Administration News William Beach, Former Budget Committee Economist, Nominated as BLS Commissioner GAO to Study Potential Federal Interference in Science NSF’s Statistical Division Seeks Director GAO Report on Firearm Storage Highlights Lack of Federal Funding for Gun Research Publications & Community Events CNSTAT Issues Report on Federal Statistics, Multiple Data Sources, and Privacy Protection NDD United Highlights Impacts of…

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COSSA Washington Update, Volume 36 Issue 20

Featured News COSSA, SAGE Host Why Social Science? Congressional Briefing COSSA in Action COSSA Praises Commission on Evidence-Based Policymaking Report SAGE Answers “Why Social Science?” Congressional News Senate Continues Working as To-Do List and Uncertainty Grows Federal Agency & Administration News HHS May Delay Common Rule Implementation NIH Provides Guidance on New Human Subjects, Clinical Trials Form Publications & Community Events National Academies Releases Interactive Guide on Opioid Epidemic COSSA Member Spotlight COSSA Welcomes the University of Pittsburgh Events Calendar

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COSSA Washington Update, Volume 36 Issue 19

Featured News HOT TOPIC: New NIH “Clinical Trials” Definition to Impact Basic Social and Behavioral Science Research COSSA in Action Tomorrow: Social Science Solutions for Health, Public Safety, Computing, and Other National Priorities Research!America Answers “Why Social Science?” Federal Agency & Administration News GAO Recommends Changes to NSF Indirect Cost Guidance HHS Requests Comments on Draft Strategic Plan NSF Releases Video on Social Science Research’s Importance to Disaster Preparedness NSF Releases Dear Colleague Letters on Research Methodologies for STEM Education and Broadening Participation in Science NSF Extends Application Deadline for Director of Division of Behavioral and Cognitive Sciences Position Publications…

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NIH Announces New Next Generation Researchers Policy

On August 31, the National Institutes of Health (NIH) announced a new policy aimed at increasing the number of early career investigators competing successfully for NIH grants. The Policy Supporting the Next Generation Researchers Initiative implements Section 2021 of the 21st Century Cures Act, enacted in late 2016, which calls for the agency to prioritize investment in the next generation of biomedical researchers. The Next Generation Researchers Policy sets two new definitions of early career investigators: Early Stage Investigators (ESIs) and Early Established Investigators (EEIs). Early Stage Investigators are defined as a “program director/principal investigator who has completed their terminal…

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Advisory Council on Alzheimer’s Research, Care, and Services Seeks Members

The Department of Health and Human Services (HHS) is seeking seven non-Federal members for the Advisory Council on Alzheimer’s Research, Care, and Services. The 22-member Council consists of 12 non-federal members who fall within six categories: dementia caregivers; health care providers; researchers with dementia-related expertise in basic, translational, clinical, or drug development science; voluntary health association representatives; representatives of state health departments; and dementia patient advocates, including an advocate currently living with the disease. Nominations are due June 16, 2017. For more information, see the announcement. Back to this issue’s table of contents.

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House Appropriations Subcommittee Holds Oversight Hearing on Advances in Biomedical Research

On May 17, the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies (LHHS) held an oversight hearing to discuss the advances in biomedical research by the National Institutes of Health (NIH). NIH Director Francis Collins was accompanied by Institute directors Anthony Fauci (Allergy and Infectious Diseases), Gary Gibbons (Heart, Lung, and Blood), Joshua Gordon (Mental Health), Doug Lowy (Cancer), and Nora Volkow (Drug Abuse). Welcoming the agency before the Subcommittee, Chairman Tom Cole (R-OK) noted that “investment in NIH has been the key driver in making the United States the world leader of biomedical research…

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Funding Opportunity Announcements

AHRQ: National Research Service Award (NRSA) Institutional Research Training Grant (T32) (RFA-HS-17-011)\ NIH Opportunities: NIA: Claude D. Pepper Older Americans Independence Centers (P30) (RFA-AG-18-007) NIA: NIA Academic Leadership Career Award (K07) (PAR-17-287) NIA: NIA MSTEM: Advancing Diversity in Aging Research through Undergraduate Education (R25) (PAR-17-290) NIH: Addressing Suicide Research Gaps: Understanding Mortality Outcomes (R01) (RFA-MH-18-410) [NIMH, NCCIH, NIDA, NIMHD] NCI: U.S. Tobacco Control Policies to Reduce Health Disparities (R01) (PAR-17-217), (R21) (PAR-17-218) NCI: Leveraging Population-based Cancer Registry Data to Study Health Disparities (R21) (PA-17-288), (R01) (PA-17-289) NIAAA: Specialized Alcohol Research Centers (P50) (RFA-AA-18-001) NCCIH: Behavioral Interventions for Prevention of Opioid…

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Preventive Services Task Force Accepting Nominations

The U.S. Preventive Services Task Force (USPSTF) is accepting nominations for new members. The Task Force, which is administered by the Agency for Healthcare Research and Quality (AHRQ), makes evidence-based recommendations about the effectiveness of various clinical preventive services, including screening, counselling, medication. Candidates are particularly sought with expertise in public health, health equity, applying science to health policy, behavioral medicine, and communication of scientific findings to multiple audiences. Nominations are due by June 15, 2017. More information is available in the Federal Register notice. Back to this issue’s table of contents.

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Funding Opportunity Announcements

AHRQ: Developing New Clinical Decision Support to Disseminate and Implement Evidence-Based Research Findings (R18) (PA-17-261) AHRQ: Scaling Established Clinical Decision Support to Facilitate the Dissemination and Implementation of Evidence-Based Research Findings (R18) (PA-17-260) NIFA: Agriculture and Food Research Initiative – Food, Agriculture, Natural Resources and Human Sciences Education and Literacy Initiative (USDA-NIFA-AFRI-006354) NIH opportunities: NIA: Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76) (RFA-AG-18-006) NIA: Coordinating Center for Claude D. Pepper Older Americans Independence Centers (U24) (RFA-AG-18-008) NICHD: Promoting NICHD Areas of Research for HIV/AIDS in Maternal and Child Health (R01) (PA-17-262) NIMH: Initiation of a Mental…

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HHS Secretary Appears Before House Appropriations Subcommittee, Suggests NIH Budget Cuts to Come From “Efficiencies” in Indirect Costs

On March 29, newly appointed Secretary of the U.S. Department of Health and Human Services (HHS) former Rep. Tom Price (R-GA) made his first appearance before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies. Welcoming the Secretary, Subcommittee Chairman Tom Cole (R-OK) began the hearing by pointing out that the proposed cuts in the Budget Blueprint (aka “skinny budget”) released by the Administration on March 16 “are extensive and span the reach of [the] agency.” Cole asked Price how the Department intends to solve “some of the challenges” the budget poses to HHS, including…

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