Search Results: clinical

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.

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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…

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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).

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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…

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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…

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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.

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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…

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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…

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COSSA Washington Update, Volume 33 Issue 22

Featured News SAVE THE DATE: COSSA Annual Meeting & Advocacy Day COSSA in Action Scientific Community Expresses Support for NIH and Its Peer Review Process COSSA and Partners Urge Support for International and Foreign Language Education for FY 2015 Congressional News FY 2015 Funding Bills Approaching December 11 Deadline Federal Agency & Administration News Deadline Extended for Applications to SBE Leadership Posts NIH to Use Single IRB to Speed the Initiation of Clinical Research, Seeks Comments NIH Seeks Comments on Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information OMB Finalizes New Statistical Policy Directive Reminder: Comments on Proposed…

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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.”

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NIH: 2015 NIH Director’s Early Independence Awards

The National Institutes of Health (NIH) Common Fund recently released its FY 2015 NIH Director’s Early Independence Awards (EIA) funding opportunity announcement (RFA-RM-14-004). The NIH Common Fund supports cross-cutting programs that are expected to have exceptionally high impact. These initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The EIA initiative is designed to allow exceptional junior scientists to accelerate their transition to an independent research career by “skipping” the traditional postdoctoral training. Candidates must be within one year…

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NIMH Creates New Unit to Support Its Research Domain Criteria Initiative

On October 31, the National Institute of Mental Health (NIMH) announced the creation of a new unit designed to reframe mental health research by facilitating communication among scientists, clinicians, and the public. The new unit was established to support the development of the institute’s Research Domain Criteria (RDoC) initiative. According to NIMH, RDoC “attempts to bring the power of modern research approaches in genetics, neuroscience, and behavioral problems of mental illness, studied independently from the classification systems by which patients are currently grouped.” The aim is to accelerate the pace of research that translates basic science into clinical settings “by…

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OHRP Solicits Comments on Draft Guidance on Risk Disclosure in Research Evaluating Standards of Care

The Office of Human Research Protections (OHRP) has issued draft guidance on “Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”  As more and more comparative effectiveness research is conducted to evaluate different treatments commonly used by medical practitioners (“standards of care”), the guidance is an attempt to assist researchers in determining how to disclose potential risks of the different treatments they are studying.

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NIH Makes Awards to Enhance Diversity of the Scientific Workforce

On October 22, the National Institutes of Health (NIH) announced the awarding nearly $31 million in FY 2014 to enhance diversity in the biomedical research workforce. The awards are part of a five-year program and will “support more than 50 awardees and partnering institutions in establishing a national consortium to develop, implement, and evaluate approaches to encourage individuals to start and stay in biomedical research careers.” Twelve of the awards will be supported by the NIH Common Fund and all of the NIH 27 institutes and centers and will be part of three initiatives that form the Enhancing the Diversity…

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NSF: RAPID Proposals Sought to Address Ebola Crisis

The National Science Foundation has issued a Dear Colleague Letter requesting research proposals “to conduct non-medical, non-clinical care research that can be used immediately to better understand how to model and understand the spread of Ebola, educate about prophylactic behaviors, and encourage the development of products, processes, and learning that can address this global challenge.” NSF’s Rapid Response Research (RAPID) funding mechanism will be used to fund the proposals. Back to this issue’s table of contents.

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NIGMS Advisory Council Approves New Grant Mechanism, Discusses Reproducibility

At the September meeting of the National Institute of General Medical Sciences (NIGMS) Advisory Council, director Jon Lorsch provided an update on a number of issues, including the National Institutes of Health’s (NIH) data reproducibility efforts, the NIGMS strategic planning process, and an overview of the impacts of the previous NIH budget-doubling period “on the biomedical research ecosystem.” In addition, the Council approved the Institute’s concept clearance to create the new Maximizing Investigators’ Research Award (MIRA), clearing the way for NIGMS to proceed. Reproducibility Lorsch noted that reproducibility is not a single issue but an issue of reproducibility of data,…

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AHRQ Solicits Scientific Information on Health Information Exchange

The Agency for Healthcare Research and Quality (AHRQ) Effective Healthcare Program is soliciting submissions of scientific information to inform its review of Health Information Exchange, which AHRQ defines as the “electronic sharing of clinical information among users such as health care providers, patients, administrators or policy makers across the boundaries of health care institutions, health data repositories, States and others.” The agency is particularly interested in scientific information related to the effectiveness, harms, prevalence, facilitators and barriers, and sustainability of Health Information Exchange. More information is available in the Federal Register notice. Submissions must be received by September 29, 2014….

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NIH Seeks Applications for Training Modules Designed to Enhance Data Reproducibility

Responding to several studies that have shown that a substantial amount of basic and preclinical research results cannot be reproduced by other laboratories under the conditions described in publications, the National Institutes of Health (NIH) is seeking applications for creative educational activities that have a primary focus of developing courses for skills development, specifically training modules for graduate students, postdoctoral fellows, and beginning investigators designed to enhance data reproducibility.

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COSSA Washington Update, Volume 33 Issue 15

In this issue… Featured Article Analysis of FY 2015 Senate Labor-HHS Bill Congressional Activities & News Uncertain Outlook for Completion of FY 2015 Spending Bills America COMPETES Reauthorization Bill Introduced in Senate Senate Appropriations Proposes Small Increase for NEH Federal Agency & Administration Activities & News White House Issues Annual S&T Guidance for FY 2016 Budget White House Seeks Input on Strategy for American Innovation NIH Seeks Next Director of the Office of Behavioral and Social Sciences Research NIH Seeks Next Position Director of the National Institute on Minority Health and Health Disparities The CTSA Program at NIH: The NCATS…

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The CTSA Program at NIH: The NCATS Advisory Council Working Group Response to the IOM Report

Earlier this summer, the National Center for Advancing Translational Sciences (NCATS) Working Group on the IOM (Institute of Medicine) released its report, The CTSA [Clinical and Translational Science Awards] Program at NIH. The report is the Working Group’s response to the recommendations in an IOM report regarding the National Institutes of Health’s (NIH) CTSA Program. The response included the Working Group’s acknowledgement that the CTSA program is key to the goal of “accelerating the process of transforming discovery into application and to increase the rate of adoption.” The CTSA program supports a national consortium of medical research institutes working together…

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