NIH Announces Inclusion Across the Lifespan Policy

Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to ensure that the knowledge gained from NIH-funded research is applicable to all those affected by the conditions under study. Continue reading

Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials

Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men. African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (Howard, 2013). But in many cases, findings from potentially informative stratified analyses may not be widely available. Less than a third of NIH studies required to analyze sex/gender and race/ethnicity have been found to publish sex-stratified results in peer-reviewed journals (Foulkes, 2011). Continue reading

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

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”

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

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

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

Why Project Outcomes Matter in your Interim and Final RPPR

The next time you are filling out your interim or final Research Performance Progress Report (RPPR) for your NIH grant, pay special attention to writing the project Outcomes section (Section I). That’s because any project outcomes submitted on or after Oct. 1, 2017 will be made available to the general public via NIH’s Research Portfolio Online Reporting Tool (RePORTER). Continue reading

Teaming with ORCID to Reduce Burden and Improve Transparency

As you know, our NIH Strategic Plan articulated an objective to “excel as a federal science agency by managing for results,” and to manage by results we must harness the power of data to drive evidence-based policies. Sometimes, however, our world can be complicated by requirements to enter the same types of data over and over again in one system after another. These situations do have an upside: they provide us the opportunity to look for opportunities to simplify. Continue reading