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.
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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.
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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.
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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.
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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.
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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.
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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.
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NIH awardees must report individual-level study participant data on: 1) Sex/Gender, 2) Race, 3) Ethnicity, and 4) Age at Enrollment in annual progress reports. This individual-level data must be de-identified and submitted using the required .csv template file.
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Working on a study that might meet both the definition of basic research and the NIH definition of a clinical trial? Check out our new webpage on Basic Experimental Studies involving Humans (BESH).
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