October 29, 2020
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.
September 1, 2020
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.
June 2, 2020
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.
March 17, 2020
For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087.
March 3, 2020
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.
February 4, 2020
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.
January 6, 2020
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.
January 25, 2019
On the new Protection of Human Subjects site, you can find useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training, resources, and updated information on the revised human subject regulation (Common Rule).
January 7, 2019
NIH has issued initial guidance on the implementation of the Revised Common Rule NOT-OD-19-050. The effective date for the amended regulation is January 21, 2019. It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule, including those that implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019).
October 10, 2018
As announced in our previous blog post and policy notice, as of September 26, 2018, NIH is no longer able to offer its Protecting Human Research Participants (PHRP) course and does not plan to provide an alternative course. Although similar courses are available elsewhere, such courses are not affiliated with or endorsed by NIH.
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