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.
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.
Enhanced checks on non-compliance with clinical trial registration and reporting came into effect in eRA’s Human Subjects System on October 1 that could delay your RPPR submission if you are late on either front.
The revised Common Rule identifies certain public health surveillance activities as being excluded from applicability of the Common Rule. Although we anticipate that the determination of NIH-funded research qualifying as a public health surveillance activity will be extremely rare, NIH will have a process for requesting use of this exclusion.