Director's Voice

Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans. The research that NIH funds doesn’t always fall neatly into a single category. Basic research involving humans that seeks to understand the fundamental aspects of phenomena also may meet the NIH-definition of a clinical trial. We refer to these studies as BESH—Basic Experimental Studies involving Humans (see our previous blog). Since this type of research meets the NIH definition of a clinical trial, these trials must register and report summary results information for transparency and other purposes outlined in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov. This blog was co-authored by Drs. Michael Lauer, Deputy Director for Extramural Research, and Carrie Wolinetz, Associate Director for Science Policy.

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Research Spotlights Findings from Recently Published Research

Making long-term memories requires teamwork

Memory is fundamental to human behavior and when impaired, as seen in diseases associated with aging such as Alzheimer’s, can severely impact a person’s daily life and quality of life. Recent research supported by the NIH BRAIN Initiative, NINDS, the American Heart Association, the Della Martin Foundation, and the Burroughs Wellcome Fund sheds light on how long-term memories are made.
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Treating PTSD leads to a decrease in the incidence of type 2 diabetes in veterans

In a recent publication, researchers supported by the NHLBI and the Harry S. Truman Memorial Veterans' Hospital conducted a retrospective cohort study in veterans with posttraumatic stress disorder (PTSD) to determine if PTSD symptom improvement is associated with changes in type 2 diabetes (T2D) risk.
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Your networks influence your social perceptions

Recent research supported by NICHD, Complex Systems Society’s Bridge Fund and GESIS, and the Army Research Office, investigated social perception bias and how a person’s peer networks influence these biases. Social perception bias is an individual’s tendency to assume that others think the same as they do, and to underestimate the size and influence of a minority group.
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In the Know Events and Announcements

Dr. Felicia Hill-Briggs "Advancing BSSR to Address National Priorities for Health Care and Population Health Improvement" Webinar

On Tuesday, September 24, 2019, at 2 p.m. ET, Felicia Hill-Briggs, Ph.D., ABPP, Professor of Medicine and Core Faculty of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University School of Medicine, will present "Advancing BSSR to Address National Priorities for Health Care and Population Health Improvement." The recording of this webinar will be available with closed captioning on OBSSR’s website approximately one month after the event. If you have questions about the webinar or require reasonable accommodations, please contact Erica Moore at 301-594-4392 or erica.moore2@nih.gov, and/or the Federal Relay at 1-800-877-8339.
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NIH Behavioral and Social Sciences Research Festival Save the Date: December 6, 2019

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. Location: NIH Campus, Natcher Conference Center (Bldg. 45).
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OBSSR Methodology Seminar: Text Mining for Behavioral and Social Sciences Research

OBSSR hosted a one-day seminar on August 9, 2019, on principles and techniques of text mining for behavioral and social research. The seminar also showcased innovative health research examples. The age of Big Data has ushered in a wave of high-volume digital information and much of it is text based. Text mining is a form of data mining that involves collecting and analyzing large volumes of textual data to reveal patterns and relationships. Techniques for mining can be used to extract key concepts, spot trends, summarize content from documents and gain semantic understanding, and index and search text for use in predictive analytics. Text mining has become an important research process with many different commercial and academic applications, and it is becoming more widely applied in social science studies. The seminar was video recorded and the archive is available on the NIH Videocast website.
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OBSSR Welcomes New Public Health Analyst Alyssa Dolge, M.P.H.

OBSSR is pleased to welcome Alyssa Grauman Dolge to the office and DPCPSI. Alyssa is a Public Health Analyst who will support OBSSR leadership by coordinating, evaluating, and providing strategic planning for budget, contracts, and operations. She will also contribute to ongoing and new scientific, evaluation, and program coordination initiatives across the office. Prior to joining OBSSR, Alyssa spent over a decade in NCI’s Division of Cancer Control and Population Sciences where she managed numerous activities throughout the years, including budget, contracts, operations, communications, and large scientific initiatives. Alyssa received her B.S. and M.P.H. from the University of Michigan and is an avid Wolverine fan.

NHGRI's SBRB Seminar Series with Dr. Molly Bray on October 7

The National Human Genome Research Institute (NHGRI) invites you to the October Social and Behavioral Research Branch (SBRB) Seminar Series featuring guest presenter, Dr. Molly Bray, University of Texas, Austin. Dr Bray will present “A Multi-Omic View of Exercise Response” on October 7, 10–11 a.m. in building 50, Room 1227/1233.
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NCCOR Launches New Measures Registry Learning Modules

This month, during National Childhood Obesity Awareness Month, the National Collaborative on Childhood Obesity Research (NCCOR) launched a new tool: NCCOR’s Measures Registry Learning Modules. NCCOR’s goal in introducing these Learning Modules is to provide a useful resource for those in the field. The Modules highlight key concepts from the four domain-specific Measures Registry User Guides in four 15-minute videos, making it easier to understand measurement issues in the four major domains of the Measures Registry: individual diet, food environment, individual physical activity, and physical activity environment. They also help walk users through use of the Measures Registry—a searchable database of diet and physical activity measures relevant to childhood obesity research. These trusted tools will save time and ultimately accelerate progress in childhood obesity research.
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Funding Announcements NIH Funding Opportunities and Notices

The NIH Office of the Director has released two Funding Opportunities Announcements (FOAs) that invite applications from entities/institutions to participate in the Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) as a Clinical Site and/or as the Data Coordination and Operations Center (DCOC). Applicants are limited to institutions from the 24-Institutional Development Award (IDeA)-eligible States/Jurisdictions. The ISPCTN will conduct multicenter clinical trials research, assuring the participation of children living in rural or underserved communities located in IDeA states, and build pediatric research capacity for IDeA states to support the conduct of clinical trials of relevance to rural or underserved children in IDeA states.

The program anticipates funding at least 15 site awards and 1 Data Coordination and Operations Center, each with an expected five-year project period.

For full details, please see both FOAs listed below. Additionally, both FOAs will be accompanied by an informational webinar in the coming weeks so that potential applicants can learn more and ask questions.

• RFA-OD-19-025
  Data Coordinating and Operations Center for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (U24 Clinical Trial Required - Infrastructure)
• RFA-OD-19-026 
  Clinical Sites for the ECHO IDeA States Pediatric Clinical Trials Network - 2 (UG1 Clinical Trial Required)

Letter of Intent for both of these Applications are due November 12, 2019, by 5 p.m. ET. Applications for both opportunities are due by December 2, 2019, by 5 p.m. ET.

The Rat Opioid Genome Project: Clinical Trials Not Allowed (U01-Clinical Trial Not Allowed)

The purpose of the Rat Opioid Genome Project (ROGP) is twofold. The first goal is to identify genetic, genomic, and molecular (epi)genetic variants that underlie phenotypes associated with vulnerability to distinct stages along the opioid use disorder (OUD) trajectory (e.g. initial/acute use, escalation of use, acquisition of tolerance, dependence, uncontrolled use, abstinence and relapse or recovery). The second is to identify genetic, genomic, and molecular (epi)genetic variants underlying phenotypes of conditions associated with OUD (e.g. respiratory depression, hyperalgesia, constipation, urinary retention, etc.). We expect this to facilitate the discovery of targets for intervention and guide the development of individualized therapeutics to treat these different aspects of OUD.

RFA-DA-20-010

Letter of Intent due by October 18, 2019. Application due by November 19, 2019, by 5 p.m. ET.

The scientific research contact is Amy Lossie, 301-827-6092, or lossieac@mail.nih.gov.

Protocol Template for Behavioral and Social Sciences Research

Resource for Communicating the Science, Methods, and Operations of a Clinical Trial

This Protocol Template for Behavioral and Social Sciences Research is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. The template can also be a useful tool for those trials funded by NIH Institutes or Centers that do not require stand-alone clinical protocols. Using the template to anticipate decision points and potential challenges before a study launches can help avoid delays down the road. Use of the protocol template is encouraged but not required.
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Social and Behavioral Research eLearning Course

Good Clinical Practice in Social and Behavioral Research

Complete the free NIH Good Clinical Practice (GCP) Training through the Society of Behavioral Medicine. In September 2016, the NIH issued a Policy on Good Clinical Practice Training for NIH awardees involved in NIH-funded clinical trials. The principles of GCP help assure the safety, integrity, and quality of clinical trials. Certificates will be given upon completion of the training.
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