Accelerating Clinical Research by Streamlining Multi-site Review of Human Subjects Research

June 21, 2016

Research involving human participants is key to improving public health and advancing medicine. Oversight of such research by institutional review boards (IRBs) both protects research participants and promotes ethical science. IRB review and approval is a critical step in initiating the start of a research project and for multi-site studies, NIH is taking an important step to help streamline the process. Today, NIH is issuing the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (sIRB Policy) ….

How Many Researchers are Seeking SBIR/STTR Funding?

June 14, 2016

We were pleased to see the interest in our recent blog on the unique number of investigators applying for and receiving NIH research project grants (RPGs). Some of you (through the blog page or through other media) have asked about whether we have similar data for our Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program. We have generated analogous figures for SBIR and STTR grants, and today’s post shares this investigation of the question, “How many unique researchers are seeking SBIR/STTR funding?” ….

How Many Researchers?

May 31, 2016

Last year, Kimble et al. published the findings of a workshop held at the University of Wisconsin on proposed strategies to rescue biomedical research in the US. The workshop organizers brought to together a number of stakeholders, who concluded that the research community faces two chief problems: “Too many researchers vying for too few dollars; too many postdocs competing for too few faculty positions.” These conclusions raises at least two questions: How many scientists, or more specifically how many principal investigators, does NIH fund? And how many scientists (more specifically aspiring principal investigators) want to receive NIH funding? Today I’d like to discuss two ways to examine these questions, by looking at the number of principal investigators awarded funding, not just on a yearly basis, but also in a way that captures a broader view of NIH-supported scientists over a window of time. ….

Grant Renewal Success Rates: Then and Now

May 26, 2016

In one of my earlier blog posts, I described an analysis looking at whether attempts at renewal are successful. We looked at data from fiscal years 2013-2015, and found that renewal applications have higher success rates than new applications, and that this pattern is true for both new and experienced investigators. In response to your comments and queries, we wanted to follow up on the analysis with some historical data that looks are whether success rates of competing renewals decreased disproportionately compared to new grant applications’ success rates. ….

How New US Overtime Provisions Will Affect Postdoctoral Researchers

May 18, 2016

The Fair Labor Standards Act (FLSA) is the law that contains overtime pay provisions for employees across the United States, entitling all US workers to overtime pay unless they are exempted because they are paid on fixed, preset salaries; are engaged in executive, administrative, or professional duties; and are paid at least $23,660 per year. Today, a historic change to this act has occurred – under the new rule, the overtime pay threshold will be increased to $47,476, effective December 1, 2016. ….

Honoring Recipients of the Presidential Early Career Awards for Scientists and Engineers

May 6, 2016

This week I had the pleasure of meeting the newest recipients of the Presidential Early Career Awards for Scientists and Engineers. These awards, also known as PECASE, are the highest honor given by the federal government to outstanding scientists and engineers in the early stages of their independent research careers. NIH is proud to support twenty PECASE recipients this year ….

Citations Per Dollar as a Measure of Productivity

April 28, 2016

NIH grants reflect research investments that we hope will lead to advancement of fundamental knowledge and/or application of that knowledge to efforts to improve health and well-being. In February, we published a blog on the publication impact of NIH funded research. We were gratified to hear your many thoughtful comments and questions. Some of you suggested that we should not only focus on output (e.g. highly cited papers), but also on cost – or as one of you mentioned “citations per dollar.” Indeed, my colleagues and I have previously taken a preliminary look at this question in the world of cardiovascular research. Today I’d like to share our exploration of citations per dollar using a sample of R01 grants across NIH’s research portfolio. What we found has an interesting policy implication for maximizing NIH’s return on investment in research. ….

Building a Better Biomarker Glossary

April 18, 2016

Precise and clear communication across biological and clinical research disciplines supports efficient translation of results from basic research into applied therapeutics and interventions. Both the NIH and FDA are keenly interested in working together to help the biological and clinical research communities speak a common language, so that research results can be clearly understood by both groups. This is especially true in considering the vocabulary used to describe measures of health, disease, or physiological processes…..

Innovating to Make it Easier for You to Find the NIH Grants Information You Need

April 4, 2016

More isn’t always better, especially when it comes to wading through information on NIH grant policies and processes. We talk about burden frequently, usually in reference to policies and processes that add burden to our grantee community. But there is another source of burden: having to spend time digging through resources to find critical information you need to apply for or manage your grant award. For the past year my staff have been strategizing how to improve upon the way we deliver information, with the goal of reducing the time it takes you to find the information you need. To do this, they embarked on a comprehensive, data-driven approach to understand ….

NIH and FDA Seek Feedback on Clinical Trial Protocol Template

March 31, 2016

I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. The template provides a standard format, and corresponding instructions and sample text, for…