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
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
You’ve heard about it and may even know someone who attended, but is it right for you? With the next NIH Regional Seminar on Program Funding and Grants Administration coming to Washington DC May 2-4, let us help you decide. Or check out our YouTube video to get thoughts from previous attendees. If you are an investigator or research administrator new to working with the NIH grants process, don’t let the 2018 NIH Regional Seminar in Washington, D.C. pass you by. Registration is underway now and seminars typically sell out! Learn about the NIH grants process and polices directly from ~ 70 NIH & HHS program, grants management, review and policy staff. …. Continue reading
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
Two major changes impact applications submitted for due dates on or after January 25, 2018.
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.
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
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
Having Challenges Tracking Down Students and Postdocs at the Time of the RPPR? Here is a Tip to Make It Easier…
Establishing a process where you have students and postdocs establish an eRA Commons account at the time they start working on an NIH grant award can save you a lot of time and energy trying to track down people who may no longer be at your institution at the time of your Research Performance Progress Report (RPPR) submission. You may even want to have them create an ORCID ID as well! …. Continue reading
Sometimes when you are trying something for the first time, it can appear to be somewhat confusing, intimidating, and possibly overwhelming. eRA is continuously developing new resources for our applicants and grantees to eliminate that perception. Recently eRA has focused on ways to help people new to navigating eRA Commons for the NIH grant application, award, and reporting processes. Because these processes require attention to detail and patience, it can often be overwhelming for those who have never done it before. …. Continue reading