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.

2019 Matilda White Riley Honors Event Highlights Innovative Behavioral and Social Sciences Research

On June 6, 2019, the Office of Behavioral and Social Sciences Research (OBSSR) hosted the 12th NIH Matilda White Riley Behavioral and Social Sciences Honors. Each year, this honors event commemorates the contributions of Dr. Matilda White Riley (PDF, 684 KB), who advanced health-related behavioral and social sciences research at the NIH and served many of the functions of the OBSSR before the Office was created nearly 25 years ago.

High-Risk, High-Reward Research of the Behavioral and Social Sciences

The National Institutes of Health Health High-Risk, High-Reward program (HRHR) is a Common Fund effort created to accelerate the pace of biomedical, behavioral, and social science discoveries by supporting exceptionally creative scientists conducting highly innovative research. The program seeks to identify scientists with high-impact ideas that may be risky or at a stage too early to fare well in the traditional peer review process. The program encourages creative, outside-the-box thinkers to pursue exciting and innovative ideas in any area of biomedical, behavioral, or social sciences research within the NIH mission. The High-Risk, High-Reward program is open to all areas of research relevant to the NIH mission, but to date, applications from behavioral and social sciences research (BSSR) investigators have made up only a small fraction of the applicant pool. To support a more diverse scientific portfolio, the NIH Office of Strategic Coordination and the Office of Behavioral and Social Sciences Research (OBSSR) is encouraging BSSR investigators to consider applying to one of these initiatives.

Clinical Trials Protocol Template for the Behavioral and Social Sciences

The Clinical Trials Protocol Template for the Behavioral and Social Sciences is a resource for communicating the science, methods, and operations of a clinical trial. This template is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. Use of the protocol template is encouraged but not required.

Accomplishments of the Behavioral and Social Sciences—Let’s Generate a Comprehensive List

For a number of years, the OBSSR has made available a fact sheet (PDF, 1,071 KB) that lists some key accomplishments of health-related behavioral and social sciences research. That fact sheet, developed in 2013, is becoming dated and is a short list of only a few key accomplishments resulting from behavioral and social sciences research. The NIH behavioral and social sciences staff could generate an updated list, but we can generate a much more extensive and diverse list of accomplishments if we enlist the help of the larger behavioral and social sciences research community. Plus, your crowdsourcing input can also be used to help us identify the accomplishments that should be highlighted.

The Protocol Template for Behavioral and Social Sciences Research Involving Humans: A New Community Resource!

A few months ago, back in August 2018, we authored a blog letting the community know that we were working on a new resource for behavioral and social science researchers to prepare research protocols for human studies measuring a behavioral or social outcome or testing a behavioral or social science-based intervention. We are now happy to report back that the template has been finalized and is ready for researchers to utilize. Even better news is that the template has been fully integrated into the NIH’s Clinical e-Protocol Writing Tool!

Implementation Science Underpins the HHS Initiative on Ending the HIV Epidemic

In the State of the Union Address, the President announced the Department of Health and Human Services’ (HHS) initiative on Ending the HIV Epidemic. The goals are bold, to reduce new infections by 75 percent in 5 years and by 90 percent in 10 years, but are possible due to advances in two areas of research supported by the NIH. First, extensive research on HIV has produced an armamentarium of testing strategies and treatments that have extended the lives and quality of life of people infected with HIV and provided effective prevention strategies. Second, for over a decade, NIH has supported implementation science research for a range of medical conditions and treatments, including HIV.