If you’re conducting research with human subjects, you might have questions about HHS regulations and NIH policies and how you can prepare proposals and inclusion plans. HHS and NIH experts address many of these questions, along with resources, guidance, and case studies in a 2-part webinar series focused on Human Subjects Research Policies, Clinical Trials, and Inclusion.
Are you working with human subjects in your research and wondering about how HHS regulations and NIH policies apply, how to prepare a research proposal, or how to develop inclusion plans? Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and more at the Human Subjects Research: Policies, Clinical Trials, & Inclusion event on December 6 and 7, 2022.
The Project Outcomes section of the Research Performance Progress Report (RPPR) provides information about the cumulative outcomes or findings of the project. This information is made available to the public through NIH RePORTER, so take that into account when completing this section!
The NIH released new supplemental information for the implementation of the NIH Policy for Data Management and Sharing.
NIH has extended flexibilities for registration and results reporting for studies submitted to basic experimental studies with humans (BESH) funding opportunities. This policy flexibility is now extended through September 24, 2024.
There are limited circumstances when an investigator and institution are permitted to release a participant’s identifiable sensitive information that is protected by a Certificate of Confidentiality. Read on for more.
I Am Conducting a Basic Experimental Study Involving Humans (BESH). Do I Have Flexibilities for Registration and Results Reporting in ClinicalTrials.gov?
It depends. Only BESH studies that were awarded through a BESH-specific funding opportunity are eligible for registration and reporting flexibilities (as noted in NOT-OD-21-088).
NIH-defined phase 3 clinical trials are required to conduct and report analyses by sex or gender, race, and ethnicity for each primary outcome. These analyses, referred to as “valid analyses” are unbiased assessments that on average, yield the correct estimate of the difference in outcomes between two groups of participants.
Working on a Human Subjects Study Record in Our Human Subjects System? ACTION NEEDED: Re-Save the Record Before Submission
Prior to submission of your application or Research Performance Progress Report (RPPR), you should re-save study records in Work in Progress applications even if you are not making changes to the study record. The Save operation updates the underlying data to match that required by the new FORMS-G.
I Am Conducting NIH-funded Research With Humans and Am Obtaining Identifiable Information About the Participants. Is My Research Covered by a Certificate of Confidentiality?
Yes, the research activity that you describe is deemed to be issued a Certificate of Confidentiality (CoC), i.e., your research is covered by a CoC. All NIH-funded research activities in which the investigator collects or uses “covered information” is deemed to be issued a Certificate of Confidentiality.