Search Results for: "clinical trials"

Why Attend the Spring 2018 NIH Regional Seminar in Washington, DC

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. ….

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.

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).

Reminder: Changes for January 25, 2018 Application Due Dates

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…

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 seminar in Washington, D.C. (May 2-4).  With only seminar planned for 2018, you won’t want … Continue reading “Cold Weather Blues? Think Spring and the 2018 NIH Regional Seminar in Washington, D.C.”

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.

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. ….

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. ….

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 ….