10 Years of Helping Small Businesses Make an Impact

In the rapidly evolving world of modern medicine, it is important that the transition of basic scientific discoveries into new medical treatments takes place with both precision and speed.

NIH’s Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs – which I’ve discussed a few times on the blog before – are a key part of NIH’s translational research portfolio. …. Continue reading

Fiscal Policies for 2015

Happy 2015! Just a quick blog to let you know that last week, NIH announced policies for fiscal operations for fiscal year (FY) 2015, implementing the 2015 Consolidated Appropriations Act signed by President Obama on December 16, 2014. NIH has a budget of $30.31 billion, an increase of approximately $240 million over the FY 2014 final budget allocations of $30.07 billion. We also announced the stipend levels for Ruth L. Kirschstein National Research Service Awards (NRSA), and salary limits …. Continue reading

2014 By the Numbers

Application and award summary data for fiscal year 2014 are now available in the NIH Data Book. These data are of particular interest for all of us this year, considering the historic low of the success rate last year, and the reduction of NIH’s budget in fiscal year 2013, due to sequestration. For this reason, in the table below, we include both FY2013 and FY 2012 data for comparison purposes. …. Continue reading

Transport of Research Material Containing Infectious Agents or Other Biological Hazards

We’ve received some questions about shipment and receipt of biological samples, particularly in the context of the ongoing Ebola outbreak in West Africa; for example, whether grantees can accept biological materials from Africa, and whether NIH has in place any requirements for transporting such research materials. In light of these incoming questions, I think this is a good time to remind you that a number of regulations are in place to ensure …. Continue reading

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