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.
November 9, 2021
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.
October 22, 2021
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.
September 28, 2021
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.
April 29, 2021
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.
April 28, 2021
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).
April 27, 2021
You likely know that for human-participant research funded wholly or in part by NIH, we automatically issue Certificates of Confidentiality (CoCs) as a term and condition of award. CoCs protect identifiable, sensitive information of people who participate from being disclosed to others not associated with the study. But, for human-participant research funded by an entity other than NIH, did you know that you can reach out to us to request a CoC as well? Read on for more!
January 5, 2021
So you have confirmed that you are doing human subjects’ research after listening to the first podcast in our human subject mini-series. And you have a clear human subjects’ protection and monitoring plan developed for your application after tuning in to the second episode in the series. What should you keep in mind after the award is made? Tune in to this NIH All About Grants podcast episode for tips about important post-award requirements, annual progress reporting, engaging your IRB and NIH when a protocol change is needed, and more.
December 1, 2020
Reminder: Investigators and all key personnel involved in human subjects research are required to receive education in the protection of human subjects. One way to satisfy this requirement is by completing the newly launched Human Research Protection Training offered by the HHS Office for Human Research Protections (OHRP).
November 2, 2020
Conducting research involving human subjects during COVID? Read here for information on requesting an exception to the use of a single IRB.
NIH released a Guide Notice to inform the extramural research community how NIH is implementing the Office for Human Research Protections (OHRP)’s determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
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