Tag Archives: human subjects

All About Grants Podcast: Human Subjects’ Research Post-Award

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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.
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New Human Research Protection Training Available!

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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 →

Exceptions to Use of a Single IRB During the COVID-19 Public Health Emergency

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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 →

“All About Grants” Podcast – Human Subjects’ Protection and Monitoring Plans

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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 →

A Walk-Through of the PHS Human Subjects & Clinical Trials Information Form

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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 →

New Certificates of Confidentiality System for Non-NIH Funded Research

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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 →

Reminder of NIH Requirement to Adhere to the Revised Common Rule and Use a Single IRB for Multi-Site Studies

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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 →