Last year, as I reflected on finishing my first full year as NIH Deputy Director for Extramural Research, I noted five themes that reflected most of the content of this blog: applicant behavior, activity, and outcomes; peer review; basic science; biomedical research workforce and training; and scientific rigor, transparency, and research impact. Looking back on 2017, which was certainly a busy and active year, many of these themes continue to be at the forefront, though one in particular, the make-up and future of the biomedical research workforce, has been the center of much debate. …. Continue reading
Eight months ago, CSR Director Dr. Richard Nakamura and I posted a blog on “A Reminder of Your Roles as Applicants and Reviewers in Maintaining the Confidentiality of Peer Review.” We asked you to imagine a scenario: you are a reviewer for an upcoming panel meeting, and shortly before the meeting an investigator associated with an application communicates with you, asking for a favorable review in exchange for an academic favor. We asked what you would do – accept the offer, ignore it, or report it?
We used the blog as an opportunity to remind all of us how important it is that we all do our utmost to assure the integrity of peer review. …. Continue reading
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. Continue reading
As no scientist is an island, the overall scientific enterprise grows stronger when people work together. But, an interesting question emerges from this concept for us to explore: how can we quantify the effect of collaboration on productivity and impact on science? Continue reading
Recent policy changes requiring clinical trial applications to be submitted to FOAs that specifically allow clinical trials, first announced in fall of 2016, impact how all NIH applicants choose a FOA, whether you are submitting a clinical trial or not. Continue reading
The PHS Human Subjects and Clinical Trials Information form is new to all of us and will take some time to get used to this new approach to collecting human subjects information. If your Program Project or Center multi-project application involves human subjects research, here are a few things to keep in mind. …. Continue reading
The funds provided in response to Diversity Supplement requests are used to improve the diversity of the biomedical research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research. Currently, NIH does not require that diversity supplements be submitted electronically, which poses a challenge to NIH staff when trying to identify and track diversity supplement awardees and their subsequent research careers. Effective January 25, 2018, all single and multi-project diversity supplement requests MUST be submitted electronically …. Continue reading
As we approach the implementation date for NIH’s Policy on the Use of a Single Institutional Review Board (Single IRB) for Multi-Site Research, we would like to remind you of the resources available for understanding this policy.
The policy affects multi-site studies involving non-exempt human subjects research funded by NIH, and applies to grant applications with due dates on or after January 25, 2018 and R&D contracts in response to solicitations issued on or after January 25, 2018.
We encourage you to familiarize yourself with the single IRB plan, considerations in the selection of the sIRB, costs, exceptions to the policy, and where you should include this information as part of your grant application or contract proposal.
Visit the following resources to learn more: …. Continue reading
If you are new to working with the NIH grants application and awards process….you need to read on! With only one NIH Regional Seminar on Program Funding and Grants Administration scheduled for 2018, you will not want to miss out on this unique opportunity in Washington, DC, from May 2-4, 2018. …. Continue reading
On December 31, 2017 Grants.gov will no longer allow applicants to download an entire application form package as a single PDF for offline data entry and later submission. For the 80% of NIH applicants that used ASSIST or institutional system-to-system solutions in FY2017, this change will have little impact. Die-hard downloadable forms users, however, need to switch to another submission option quickly. …. Continue reading
Two New “All About Grants” Podcasts: 2018 Appendix Policy Changes, and Why We Encourage You to Submit Your Application Early
NIH’s Office of Extramural Research brings you two new “All About Grants” podcasts to ring in the new year. In “Why it’s so Important to Submit Applications Early”, Dr. Cathie Cooper, director of the Division of Receipt and Referral in the NIH’s Center for Scientific Review, talks about the importance of submitting application early due to changes in NIH’s policies and application forms for 2018…. Continue reading
Our new Preparing Your Application Using ASSIST page provides step-by-step guidance for navigating the submission process using ASSIST, NIH’s online submission system for the preparation, submission and tracking of grant applications to NIH. …. Continue reading
You Ask, We Answer
Which Funding Opportunity Announcement (FOA) Should I Use if My Human Subject Research Study is Delayed Onset?
The type of FOA you will need depends on whether you anticipate that your delayed onset human subject study will meet the definition of a clinical trial.
If it will, you will need to choose a funding opportunity that explicitly allows clinical trials (it will be designated ‘Clinical Trial Optional’ or ‘Clinical Trial Required’). Be sure to check the ‘Anticipated Clinical Trial’ box when completing your Delayed Onset Study record within the application.
If no clinical trial is involved, you will need to choose a funding opportunity designated as ‘Clinical Trial Optional’ or ‘Clinical Trial Not Allowed.’
When completing your application, follow the SF 424’s Delayed Onset Study instructions …. Continue reading
“Delayed Onset” generally means that human subjects research is anticipated within the period of award but definite plans for this involvement cannot be described in the application. It does not apply to a study that can be described but will not start immediately.
Have other questions about clinical trials? Visit …. Continue reading