What Can We Learn from the Early Outcomes from the NIH Director’s New Innovator Awards?

In earlier posts, like this one, we discussed the importance of moving towards “evidence-based funding.”. NIH seeks to apply data-driven strategies to conceptualize, develop, implement, and evaluate policies, such as those that will affect the NIH-supported biomedical research workforce. Today, we’d like to spotlight a recently published analysis of an award program directed to investigators early in their careers – a population that has received much attention at NIH and beyond in recent years. Continue reading

NIH Loan Repayment Program (LRP) Reminder

Applying for an NIH Loan Repayment Program (LRP) award? A reminder that applications along with supporting documentation are due on November 15. The NIH Loan Repayment Programs are a set of Congressionally-mandated programs that are designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. …. Continue reading

New Podcast: “Understanding the Definition of a Clinical Trial and What That Means for You”

A new “All About Grants” podcast is now available! In “Understanding the Definition of a Clinical Trial and What That Means for You” (mp3, transcript), Dr. Mike Lauer, NIH deputy director for extramural research, discusses the changes to clinical trial policies, addresses community questions, and speaks to how these changes will impact applicants and grantees. All About Grants podcast episodes are produced by the NIH Office of Extramural Research, and …. Continue reading

Guidance for Institutions Impacted by Hurricane Maria, and a Reminder of NIH’s Natural Disaster Resources

Due to the exceptional impact of Hurricane Maria, we want to assure grantees that NIH will be doing our part to help you continue your research. Recently, we published an NIH Guide Notice that outlines the application and report submission flexibilities available for Puerto Rico and the U.S. Virgin Islands. We have previously published guidance for those affected by other major hurricanes this year …. Continue reading

New Video Provides Overview of New NIH Policies on Human Subjects Research and Clinical Trials

Do you do research with human participants? If so, you play an important role in NIH initiatives to improve accountability and transparency in the human subject research we fund. This 15 minute video Overview of New NIH Policies on Human Subjects Research and Clinical Trials provides a succinct explanation of the various policy changes and what they mean for you. Continue reading

Clarifying Percent Effort and Support for Career Development (K) Awardees

In response to questions about career development (K) award policies, NIH issued a Guide Notice NOT-OD-17-094, to clarify percent effort requirements for K award principal investigators (PIs), and acceptable sources of research support. We’d like to provide some additional details to put the recent Guide Notice in context with existing K award policies on percent effort. …. Continue reading

Implementing a New Human Subject and Clinical Trial Information Form

We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.

The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms …. Continue reading