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).
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!
0 Comments
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.
0 Comments
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).
5 Comments
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.
1 Comments
Dawn Corbett, NIH’s Inclusion Policy Officer, shares why human subjects’ protection and monitoring plans are important in this next NIH’s All About Grants podcast. We will discuss what should be included in these plans as part of your application, what should be left out, what are risks and what are benefits to study participants, how reviewers assess it all, and so much more.
0 Comments
You have a promising research idea that may involve human participants to carry out the study. Do you know what to do next? Join us for the next NIH’s All About Grants podcast conversation about how you know you are doing human subjects’ research.
2 Comments
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.
0 Comments
For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087.
2 Comments
Certificates of Confidentiality protect identifiable, sensitive research information from disclosure. While Certificates of Confidentiality are issued automatically for NIH-funded research, non-NIH funded research that collects identifiable, sensitive information can request a certificate. NIH has updated its Certificate of Confidentiality request process for non-NIH funded research through a new online system.
0 Comments
0 Comments