September 13, 2017

Director's Voice

Clinical Trials Policies: A Rose by Any Other Name. In a blog last October, I described a series of policies recently released by the NIH to improve transparency and our stewardship of clinical trials. In that blog, I noted that the definition of a clinical trial was being interpreted broadly, and that most research with humans that involved a prospective experimental manipulation of an independent variable likely would fall under these policies. With further guidance from the NIH Office of Extramural Research and in recently released case studies, it is clear that the intent of the NIH is to interpret the clinical trials definition broadly to include any NIH-supported study of humans that involves experimental manipulation (described as “prospectively assigned to one or more interventions” in the clinical trials definition).

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NIH Behavioral and Social Sciences Research Festival

SAVE THE DATE: December 8, 2017 — NIH Campus, Natcher Conference Center (Bldg. 45). The Annual NIH Behavioral and Social Sciences Research Festival will be hosted by OBSSR and the NIH Behavioral and Social Sciences Research Coordinating Committee. The purpose of the festival is to highlight recently funded behavioral and social sciences research that the NIH supports; bring together behavioral and social scientists within the NIH extramural and intramural communities to network with each other and share scientific ideas; and explore ways to advance behavioral and social sciences research.

NIH RFI to Solicit Feedback on ECHO-wide Cohort Protocol

The NIH has extended the public comments period for a request for information inviting input on the ECHO-Wide Cohort Data Collection Protocol. The NIH invites advocacy group leaders, physicians, researchers, other members of the scientific community, and the public at large, to provide valuable feedback on this document that will guide data collection for the ECHO Program. Respondents should submit their comments to manjit.hanspal@nih.gov or christina.park@nih.gov by 5 p.m. on Wednesday, September 13, 2017.
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Webinar: How Differences in the Socioeconomic Environment Modifies Genetic Variation in Cognitive Ability

Join the OBSSR Director's Series Webinar on Tuesday, September 26, 2017, at 2 p.m. ET. Eric Turkheimer, Ph.D., will present on "How differences in the socioeconomic environment modifies genetic variation in cognitive ability." It has been known for some time that children raised in impoverished environments do not express genetic differences in cognitive ability to the same extent as children raised in middle class homes, a phenomenon known as the Scarr-Rowe interaction. Dr. Turkheimer will summarize what is known about this phenomenon, focusing on new analyses of some classic twin datasets that have not previously been available. The goal of the new analyses is to emphasize the developmental processes that underlie modification of heritability and other quantitative genetic parameters.
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NSF/SBE Recruiting for a Division Director, Behavioral and Cognitive Sciences

The BCS Division Director, a key member of the SBE Directorate leadership team, provides leadership and direction for the support of research that develops and advances scientific knowledge about the brain, human cognition, language, social behavior, and culture, as well as research on the interactions between human societies and their environments. The Division Director provides overall direction and management to a division that includes a staff of approximately 30 employees and a Fiscal Year 2017 budget of roughly $95 million. The nature of the position calls for an experienced manager with highly-respected expertise in the behavioral and cognitive sciences. The application deadline is September 29, 2017.
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Open Mike: Continuing to Clarify the NIH Definition of a Clinical Trial 

A few weeks ago NIH released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. In addition to providing additional rationale for our conclusions in the case studies, we made a number of changes, to include clarifying: what it means to be “prospectively assigned”; what we consider to be a “health-related biomedical and behavioral outcome”; how to classify “ancillary studies”; in what circumstances we would consider a mechanistic study to be a clinical trial; the use of surveys, questionnaires and user preferences; and more.
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Psychological, Behavioral, and Neurocognitive-Focused Ancillary Studies to the Molecular Transducers of Physical Activity in Humans Consortium

The purpose of this FOA is to support an ancillary study grant application(s) to add psychological, behavioral, and/or neurocognitive assessments to the data collection in adults (> 18 years of age) enrolled at the clinical sites in the Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) supported by the NIH Common Fund. This ancillary study FOA complements the parent MoTrPAC study by supporting research to elucidate the individual level psychological, behavioral, and neurocognitive characteristics that explain variation in individual response and adherence to a program of physical activity. The goal of the research supported by this FOA is to characterize individual differences in response to exercise over the course of the MoTrPAC protocol to identify novel treatment targets and inform personalized physical activity intervention approaches in the future. Application Due Date: October 24, 2017, by 5 p.m. local time of applicant organization.
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Genomics at the Frontiers of Social and Behavioral Science Research: Theory, Discovery, and Translation

This special issue of Social Science & Medicine solicits papers focusing on the application of social science theory to advance the study of genomic translation. The National Human Genome Research Institute seeks to publish high impact research that considers the social contextual factors that influence the translation of genomic information through the lens of social science theory. The submission and review process will occur in two stages. First, authors should submit an extended abstract of 800 words by October 15, 2017, along with a cover letter explaining the unique features of the study, review, or commentary and how the contribution fits within the call for papers to GenomicFrontiers.SSM@nih.gov. Authors whose submissions fall within the scope of the special issue will be invited to submit a full manuscript between October 31, 2017 and February 1, 2018, with the goal of publishing the special issue in May 2019.
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