Tune in to the ACD Meeting Today and Friday

I’m at the December Advisory Council to the Director (ACD) meeting today and tomorrow. Several updates and reports from ACD working groups are on the agenda.

Today, we’ll discuss the whirlwind of activities that NIH and HHS have been involved in related to the 2014 Ebola crisis, and we’ll hear updates on peer review evaluation and workforce diversity efforts. I’ll also be co-presenting with Dr. Sherry Mills, director of the Office of Extramural Programs within OER, and co-chair of the ACD’s Physician-Scientist Workforce working group. …. Continue reading

Following Up on the Biosketch Implementation

We certainly heard a lot of input on the blog on the issue of the new biosketch format. I really appreciate the dialog. Even when the input is critical it is so important to hear what you think. Remember that the blog is just one of many points of input when we make policy decisions, however. In this case NIH …. Continue reading

Streamlining IRB Review of Multi-Site Clinical Research Studies

For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. …. Continue reading

Learn More About Collaborating with NIH’s Clinical Center

In 2012, NIH created a unique opportunity for extramural researchers to collaborate with our intramural scientists and use the exceptional resources of the NIH Clinical Center. I want to remind you of the third round of this program, called “Opportunities for Collaborative Research at the NIH Clinical Center”, in time for the upcoming pre-application date on December 10. …. Continue reading

Implementing the Modified NIH Biosketch Format

Many people have been asking about the new NIH biosketch. As you may recall, in May 2014, NIH announced that we were piloting changes to the biosketch section of grant application forms. This modified format allows researchers to describe how their background and expertise relates to their proposed project. We will require this new format for most grant applications submitted for fiscal year 2016 funding, as described in a guide notice published today. This sounds like a long way off but remember that the first applications for FY 2016 funding begin with due dates of January 25, 2015. The new format is now available in the “additional format pages” section of the SF424 applications page. …. Continue reading

A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants can make informed decisions about potential trial participation and know how their participation may have helped others. …. Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. …. Importantly, today NIH also announced a proposal to apply these same proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that every NIH-funded clinical trial be registered …. Continue reading

Better Research Trainee Data through Streamlined Reporting Processes

Training of the next generation of biomedical scientists is a core responsibility of NIH and its partner grantee institutions.The NIH Advisory Council to the Director‘s Biomedical Research Workforce Working Group recommended that NIH should “develop a simple and comprehensive tracking system for trainees” as part of the broader challenge of gathering better biomedical workforce data. Unambiguous identification of NIH trainees was an absolutely critical first step in establishing the ability to examine contributing factors that lead to various post-training careers. Accordingly we started collecting information in this way by requiring that all post-doctorates and all graduate and undergraduate students listed in a grantee’s progress report have an eRA Commons ID (as of 2009 and 2013, respectively). The next important step is developing a system to automate the capture of trainee data that has long been provided by extramural institutions in their training grant applications. …. Continue reading

Retention Rates for First-Time R01 Awardees

We have seen increased interest in the biomedical workforce by Congress and especially by our community. From our end we’ve in particular observed heightened attention to how the dynamics of the workforce impact researchers in the early stages of their careers. So the topic definitely deserves our continued attention and I thought in light of this it’d be a good time to share some of NIH’s analyses on one specific aspect of this that my office has been closely examining. …. Continue reading

New NIH Awards to Enhance Diversity in the Scientific Workforce

Today marks an important step forward for NIH’s support of a diverse scientific workforce. NIH has announced the awardees of unique, targeted programs for developing new approaches to engage researchers from underrepresented backgrounds and for preparing them to thrive in scientific careers. …. Continue reading

A Pause in Funding Certain Types of Gain-of-Function Research

The White House announced today that U.S. government agencies will institute a pause in the funding of new “gain-of-function” research on influenza, SARS, and MERS viruses that could increase the pathogenicity or transmissibility to mammals …. During this funding pause, the government will carry out a deliberative process to assess the risks and benefits of such studies and will develop a new Federal policy regarding the funding of this research. …. Continue reading