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.
If One Aim or a Small Part of My Proposed Project in an NIH Grant Application Meets the NIH Definition of a Clinical Trial, Is My Entire Application Considered a Clinical Trial?
Yes. If only one aim or a small part of your project meets the NIH definition of a clinical trial, your entire NIH grant application is considered a clinical trial even if the other aims or parts of the research project are not clinical trials.
Basic Experimental Studies Involving Humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. Looking for more information about what studies fall within the BESH definition and what policies apply? Our latest NIH All About Grants podcast episode will answer these questions and more!
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.
We’ve updated the Walk-through of the PHS Human Subjects & Clinical Trials Information Form video to align with our latest application form update (FORMS-F). In just six minutes, you’ll learn how to use the form and how to complete both delayed onset and full study records.
For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087.
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
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 revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050.
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.