Seeking Comments on Draft NIH Policy for Data Management and Sharing

Over the years, NIH has released policies to encourage data sharing. Our first data sharing policy in 2003 was limited to awards requesting more than $500,000 in direct costs in any year. Subsequent data sharing policies focused predominantly on genomic data sharing (Genome-Wide Association Studies Policy; Genomic Data Sharing Policy). There are clear and well-accepted advantages of data sharing including increasing sample size, facilitating reproducibility analyses, and increasing the impact of the taxpayer’s investment in data collection to advance science. These advantages are not limited to large grants or to genomic studies; they are applicable to data sharing of nearly all of the research that the NIH supports. Therefore, after considering initial input from the scientific community, the NIH this week released its Draft NIH Policy for Data Management and Sharing that is intended to encourage data sharing of all NIH-supported research.

Social and Behavioral Sciences Key to Research Funded by the NIH HEAL Initiative to Tackle the National Opioid Crisis

The National Institutes of Health has awarded $945 million in total fiscal year 2019 funding for grants, contracts, and cooperative agreements across 41 states through the Helping to End Addiction Long-term Initiative or NIH HEAL Initiative. The NIH-wide research effort aims to improve treatments for chronic pain, curb the rates of opioid use disorder (OUD) and overdose and achieve long-term recovery from opioid addiction.

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.

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.

eSource: Introductory Social and Behavioral Science Training Materials

eSource is a collection of online chapters that provide an introduction to selected behavioral and social science research approaches, including theory development and testing, survey methods, measurement, and study design.  eSource was developed for OBSSR around 2010 by the New England Research Institute (NERI) with contributions from topic experts.  These chapters have not been updated to reflect advances in the past decade, and the exercises are not interactive in PDF format, but OBSSR continues to make these chapters available online for those who wish to use them as supplemen