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.
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). Continue reading
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. Continue reading
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. Continue reading
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. Continue reading
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. Continue reading
For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087. Continue reading
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. Continue reading
As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multisite career development (K) and fellowship (F) awards. Continue reading
NIH has updated its human subjects research decision tool to reflect changes effective in the 2018 Revised Common Rule. Answer a few quick questions to find out if your research could be considered human subjects research or if it may be exempt from federal regulations. Continue reading