Should I Report the Sex or Gender of Study Participants to NIH?

December 16, 2021

NIH uses sex/gender to indicate that either sex or gender may be reported for inclusion enrollment purposes. The NIH encourages investigators to design their data collection instruments in a way that allows the participants to self-identify their sex or gender in a way that is meaningful within the study’s context. Participants always have the option not to identify with either sex/gender category. If both sex and gender identity are collected, investigators may choose which one to report based on the scientific question(s) that are the focus of the study.

New and Updated Resources Available to Help Design Rigorous Clinical Trials

June 9, 2021

We have embarked on a series of initiatives at NIH in recent years to enhance the quality, efficiency, accountability, and transparency of our supported clinical research. While we are all making great progress, our concerns about clinical trials that are overly complex, have small sample sizes, or rely on surrogate end points that lack clinical relevance remain. One resource to help address these concerns is the NIH Research Methods Resources website that NIH’s Office of Disease Prevention (ODP) launched in 2017. Since the site was recently revamped, we wanted to spotlight the new available tools and resources that can help you better plan the design, conduct, and analysis of rigorous NIH-defined clinical trials.

Celebrating 20 Years of ClinicalTrials.gov and Looking to the Future

January 7, 2020

NIH’s National Library of Medicine has launched an effort to modernize ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. Creating a roadmap for modernization requires feedback from a wide array of stakeholders on how to continue serving, balancing, and prioritizing their varied information needs. As ClinicalTrials.gov celebrates its 20th anniversary on February 29, 2020, we’re asking for your input on how it can best continue to serve your needs for many more years to come.

Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans

July 24, 2019

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 However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov. The NIH has determined that more time is needed to address these challenges. Today, NIH published a Guide Notice (NOT-OD-19-126) announcing the extension of delayed enforcement of registering and results reporting of BESH on ClinicalTrials.gov through September 24, 2021.

The Protocol Template for Behavioral and Social Sciences Research Involving Humans Is Here

April 1, 2019

A new Behavioral and Social Sciences Research Template is now available to guide investigators through the systematic development of a comprehensive clinical protocol. The new template, based on the previously released Phase 2 & 3 Clinical Trial Template, is fully integrated into the NIH’s Clinical e-Protocol Writing Tool, and can be used by 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. This template may be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol.