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.
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).
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. ….
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! ….
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. ….
You Ask, We Answer
Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research. Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies? Find more FAQs and their answers at grants.nih.gov.
Like all NIH application forms, the new PHS Human Subjects and Clinical trials Information form is accessed through the submission method you are using. ASSIST, Workspace and all system-to-system solutions provide a way to access and complete the forms. ….