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NIH Extramural News - December 2017/January 2018

December 2017 / January 2018


Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions

Posted on January 4, 2018 by Mike Lauer

In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial-specific funding opportunity announcements for due dates of January 25, 2018 and beyond. Continue reading 

Two Years (or so) of “Open Mike”

Posted on December 29, 2017 by Mike Lauer

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

Assuring the Integrity of Peer Review

Posted on December 22, 2017 by Mike Lauer

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

The Importance of Timely Grant Closeout

Posted on December 21, 2017 by Mike Lauer

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

When a Country is Open, Do They Have Strong Science Too?

Posted on December 11, 2017 by Mike Lauer

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


Top Stories

Reminder: Changes for January 25, 2018 Application Due Dates

Two major changes impact applications submitted for due dates on or after January 25, 2018. 1) Applicants are required to use FORMS-E. Wondering what this means for late applications or reviewers submitting under the continuous submission policies? See NIH Guide Notice NOT-OD-17-062 to learn more. 2) Applications that include one or more clinical trials must be submitted in response to funding opportunity announcements that allow for clinical trials. See NIH Guide… Continue reading 

New Electronic Submission Requirement for Diversity Supplements

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

Tips for Describing Human Subjects Studies in Multi-project Applications

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

Cold Weather Blues? Think Spring and the 2018 NIH Regional Seminar in Washington, D.C.

Are you an investigator or research administrator new to working with the NIH grants process?  If so, then don’t let the 2018 NIH Regional Seminar on Program Funding and Grants Administration pass you by.  Registration is underway for the spring … Continue reading 


Due Dates on Holidays/Weekends/NIH Office Closures

With winter weather upon us, remember that when a due date falls on a weekend, Federal holiday, or when Washington, D.C.-area Federal offices close (due to severe weather, for example), the application deadline is automatically extended to the next business day. See NIH Guide Notice NOT-OD-17-041 for additional details. If you suspect Federal offices in D.C. are closed due to severe weather you can …. Continue reading 

New Resources

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

You Ask, We Answer

What is “Delayed Onset”?

“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? …. Continue reading

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 …. Continue reading