Here are a couple of tips to remain well-informed of current policy between annual Grants Policy Statement updates.
Several months ago, we learned in the press that an NIH-supported investigator was banned from his university campus pending an ongoing investigation into allegations of sexual misconduct. The institution, which was the recipient of the awards in which this investigator was designated as principal investigator (PI), had not informed us of this situation. Once aware, we contacted senior institutional officials to discuss the need to ensure the effective stewardship of the award under these circumstances. We requested that the institution provide us with alternative plans for conducting the research given that this individual would no longer serve as PI and would have no other involvement in the NIH-funded research, and we reminded them (as we recently reminded the community and as reiterated below) that they are responsible for notifying NIH of any change in status that might affect the ability of an individual identified as key personnel to conduct NIH-supported research.
Did you know that grant funds can expire? A recent interview with NIH experts on the topic of “Expiring Appropriations” addresses how you know if you have expiring funds, what to do if you find yourself in this situation, and whether money can be restored. This 10 minute conversation is available as both a video and a podcast.
Does the NIH inclusion policy apply to research using existing datasets or other types of existing resources involving human subjects?
If the study is considered human subjects’ research and meets the NIH definition of clinical research, then it is subject to the NIH inclusion policy.
Remembering back to my days as a PI, I can recall myself saying something like “yea, on my NIH grant…” when discussing my research. This may have been okay over coffee, but it is technically incorrect. We hear this confusion a lot. So, we thought it would be worthwhile to remind you about some of the respective roles of institutions and investigators working on an NIH award.
At any given time, NIH staff are monitoring nearly 50,000 active grant awards. This monitoring happens throughout the grant life cycle, including once the award is over. Just as we strive to award meritorious grants as quickly as we can, it is equally important for us to ensure grant awards are taken off the books in a timely manner. A grant that slips past its closeout due date is costly and time consuming.
We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.
The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms ….
A few weeks ago we released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. We are grateful for your thoughtful and constructive comments and suggestions, many of which we have incorporated into our revised documents and communications. ….
NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies
A few months ago we blogged about our plan to release an updated Certificate of Confidentiality (CoC) policy. Today, we are pleased to announce that we have published the new policy (NOT-OD-17-109), which will go into effect on October 1, 2017. The new policy both enhances the privacy protections of individuals participating in NIH funded research studies and eliminates the need for NIH funded investigators to apply for a CoC. …
Today we posted a policy (NIH Guide Notice NOT-OD-17-101) describing current plans for the Next Generation Researchers Initiative. Since I first blogged about it in June, NIH leadership have reviewed data (see accompanying blog) and deliberated about how best to proceed. Our goal is to increase the number of NIH-funded early-stage investigators and assure, as best we can, that funded early-stage investigators have a reasonable chance to secure stable funding during the earliest stages of their independent research careers. This new policy will supersede previous notices on new and early stage investigators (NOT-OD-08-012, NOT-OD-09-013 and NOT-OD-09-134). ….