NIH Extramural Nexus

Last month I told you about our small business programs, and it got me thinking that many people might not be aware of the many NIH programs that exist beyond the scope of the R01. One such program is the Academic Research Enhancement Award (AREA). These awards create hands-on research opportunities for faculty and students at less research-intensive institutions (less than $6M in research and training funds per year). AREA awards provide up to 3 years of renewable funding, with a maximum of $300,000 in direct costs for the entire project period.

As you can see, the popularity of this program has grown over the past several years. We received the highest number of applications to date last fiscal year.

We have been in touch with AREA-eligible institutions who have helped us hone the program. Starting with the latest review round, we now cluster AREA applications during review so that applications from AREA investigators can be reviewed together. This allows reviewers to focus on the specific goals of the program, which are distinct from the other research grants they were reviewed side-by-side with previously (R01s, R21s and R03s).

We’ve also heard your interest in getting AREA-eligible investigators onto review panels. During this past round, we had greater inclusion of AREA-eligible investigators than ever before, in part due to the Center for Scientific Review’s Early Career Reviewer Program. This program specifically targets investigators from less research-intensive institutions.

Finally, for those of you applying to the AREA program, either for the first time or for a renewal, I urge you to read the program announcement. It was recently updated with new language to emphasize and clarify the goals of the program for both applicants and reviewers. Applicants should pay special attention to the sections about including students in the research and demonstrating that you have experience supervising students. I think one of the great benefits of this program is the exposure students get to research, so be sure to highlight that in your application. Reviewers will be evaluating not only the scientific merit of your application, but also how you plan to address the program goals of exposing students to research and strengthening the research environment of your institution.

Last December (2010), we commissioned a study by the Institute of Medicine (IOM) to assess whether chimpanzees are or will be necessary for biomedical and behavioral research. This week, the IOM issued its findings in its report “Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity.” The primary recommendation of the report is that the use of chimpanzees in research be guided by a set of principles and criteria. The committee proposed three principles to analyze current and potential future research using chimpanzees.

1. That the knowledge gained must be necessary to advance the public’s health;
2. There must be no other research model by which the knowledge could be obtained, and the research cannot be ethically performed human on subjects; and
3. The animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments (i.e., as would occur in their natural environment) or in natural habitats.

Based on its deliberations, the IOM committee concluded that, “while the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary.” The committee also concluded, however, that the following areas may continue to require the use of chimpanzees: some ongoing research on monoclonal antibody therapies, research on comparative genomics, and non-invasive studies of social and behavioral factors that affect the development, prevention, or treatment of disease. The committee was unable to reach consensus on the necessity of the chimpanzee for the development of prophylactic hepatitis C virus vaccine. While the committee encouraged NIH to continue development of non-chimpanzee models and technologies, it acknowledged that new, emerging, or re-emerging diseases may present challenges that may require the use of chimpanzees. 

The NIH Director, Francis Collins, has accepted the recommendations of the report and will put in place a high level committee out of the NIH Council of Councils to provide advice on how to implement the IOM recommendations. We soon will be informing you through the NIH Guide on how applications and awards that propose or include the use of chimpanzees will be handled while implementation of the IOM report is being considered. We will not be issuing any new competing awards that involve chimpanzees during this period.

Thank you to the IOM for its exceptionally thoughtful assessment of this important issue. It was not an easy task, and they should be commended for the depth and seriousness of their conclusions.

Update 12/22: Here is the link to information about NIH research involving chimpanzees.

You probably saw the Guide Notice that we sent out earlier this week about accelerating American Recovery and Reinvestment Act projects that may run beyond September 30, 2013. This September, we received a memo from the Office of Management and Budget Director, Mr. Lew, who underscored the need for all federal agencies to outlay Recovery Act funds as expeditiously as possible in order to have the greatest impact on the economy. Last year, I encouraged you to accelerate Recovery Act projects to the degree possible. And indeed, you have done that well, so much so that there will only be a small fraction of awards to which our notice will apply. So, again, I encourage you to complete your Recovery Act funded projects by September 30, 2013. Go science go!

If you are anticipating that your research will extend past September 2013, we will need to know by June 1, 2012. We will work with you to determine ways to accelerate grant expenditure or perhaps pursue other options for your particular situation.

I wanted to let our community know that last week our Office of Laboratory Animal Welfare announced that NIH will adopt the 8^th edition of the Guide for the Care and Use of Laboratory Animals. Since 1985, we have required that institutions base their animal programs on the Guide, and it has been 15 years since the last Guide update. The 8^th edition includes important revisions to ensure the continued humane care and use of vertebrate animals in the research we support.

Beginning January 1, 2012, institutions that receive NIH funding for animal activities must base their animal care and use program on the 8^th edition of the Guide. By December 31, 2012, you must complete at least one of your twice yearly inspections using the new Guide. We understand it will take some time to implement changes, so all the changes need not be complete by the end of next year, but an implementation plan should be in place.

To help clarify how we expect institutions to implement the new Guide, we created position statements and provided the ability to comment on your understanding of those statements. We also posted all the comments received during the public comment period earlier this year.

I encourage you to check out all the updated resources on our website. They are consistent with the 8^th edition of the Guide and include frequently asked questions (updated FAQs are flagged), tutorials, and sample reports.

NIH is committed to the humane care and use of animals involved in research and this requires a collaborative effort of all who participate in NIH programs.