NEWS FROM THE DIRECTOR OF OER:
Update on Fiscal Year 2007 NIH Budget and Plans for Fiscal Year 2008

	The Director’s New Innovator Award Program, which is designed to stimulate highly innovative research and to support promising new investigators.
	The NIH Director’s Bridge Award, which provides one year of funding for competing renewal projects submitted by investigators with little significant other support and whose applications just miss the funding cutoff.
	The Common Fund / Roadmap received funds directly. This makes available the IC funds previously set aside for Common Fund / Roadmap, allowing ICs to apply these funds to their own programs in FY 2007.
	The National Children’s Study, which seeks to examine the effects of environmental influences on human health.

You can find additional information about extramural FY 2007 financial operations through a series of NIH Guide notices, listed as resources on the Financial Operations Web site. The Web site provides links to funding strategies for each of the NIH Institutes and Centers.

Even though we are only about half way through FY 2007, we are well into the budget planning and justification cycle for FY 2008. Dr. Zerhouni, the NIH director, recently provided testimony before the U.S. House and Senate Committees on Appropriations – Subcommittees on Labor, Health and Human Services, Education, and Related Agencies on the President’s FY 2008 NIH budget. The President’s budget request totals $28.86 billion. This would support 10,188 new and competing research grants, one of the highest levels ever. In his testimony, Dr. Zerhouni stressed the extraordinary return on the investment in biomedical research, citing the reduction in disease burden from circulatory diseases and cancer as examples. He emphasized the continuing importance of investigator-initiated research and the importance of maintaining a healthy flow of new investigators into the scientific workforce.

The President’s budget is designed to protect the number of competing research project grants by maintaining a steady average cost for extramural research grants and by forgoing inflationary increases in non-competing grants and in the NIH intramural research program. Dr. Zerhouni, in his testimony, also pointed out that the scientific community must maintain its forward momentum, exploiting opportunities for advances in the treatment and prevention of many diseases.

I know these are difficult times for many in our research community. Although scientific opportunities are everywhere, funding for the foreseeable future is uncertain. Application loads are higher and success rates are lower than during the period of the NIH budget doubling between FY 1998 and 2003 and this has created hardship for investigators and their institutions. We hope that the NIH Director’s New Innovator Award Program will encourage new investigators and that the Bridge Award will help established investigators keep their labs operating. I recognize that we are all facing and making difficult choices so that we can ensure sufficient resources to take advantage of scientific opportunities and maximize scientific progress.

NIH’s Financial Operations and Office of Budget Web sites contain additional information. If you have other questions please write to us at DDER@NIH.gov.

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NO MORE PAPER R01s!

With the receipt of electronic R01 grant applications, NIH took, on February 5, 2007, a giant step towards its goal of transitioning all competing grant applications from paper submission on the PHS 398 to electronic submission on the SF424 (R&R) form through Grants.gov. NIH, Grants.gov and you, the applicant community, worked very hard for over a year preparing for this transition.

“We kept up our end of the deal, with stable systems, good processing times and access to support resources,” stated Dr. Norka Ruiz Bravo, deputy director for extramural research. “Your preparedness, however, is the real success story. We have all come a long way since I announced our transition timeline in 2005. The institutional business process and cultural changes needed to pull this off cannot be overstated. There are more challenges ahead, but we have a solid foundation to build on. Thank you for all you have done to help make this transition happen.”

Our applicants showed they were ready for the February 5 deadline for new R01s and March 5 deadline for renewal (competing continuation), resubmission (amended), and revised (competing supplement) R01 research grant applications in several ways. First, a record number of applications were successfully submitted by the day prior to deadline for February and March. Second, submitted applications were highly compliant with system-enforced NIH business rules. Third, when errors or warnings were identified by the system, many applicants were able to correct their applications without the assistance of the support desks—the total calls to the eRA Commons helpdesk was actually slightly down in February as compared to other recent electronic application submission receipt dates.

System-to-system transfer of application data continues to rise. While the majority of applicants relied on the Grants.gov forms solution that allows applicants to download an application package, complete it on their local computer and then upload the completed package to Grants.gov, some institutions have either created their own system-to-system solution or partnered with commercial service providers to submit just the application data elements directly to Grants.gov.

Although NIH has no way to track the total number of applications submitted using Macintosh® computers, we do know that both the free Citrix® service and the Mac-compatible form viewer were used to successfully submit R01 grant applications. Very few computer platform related issues were reported to either the NIH or Grants.gov helpdesks.

For the February 5 receipt date for new R01 grant applications, the Grants.gov and eRA Commons systems handled the application load easily. The eRA Commons helpdesk, armed with additional resources to take support calls, was busy but the average wait time for service remained under three minutes. All in all, the systems and support teams met the challenge.

March applicants did not have the same quick Grants.gov processing times and easy access to helpdesks experienced by their February counterparts. Most applications were processed well within Grants.gov’s 48 hour target. However, many applicants that had grown accustomed to quicker processing times contacted support desks for status or resubmitted their applications, causing additional strain on support and system resources. A thorough lessons-learned review of the March 5 deadline will be conducted over the next few weeks.

Based on applicant feedback already received and a review of errors and warnings encountered by applicants for the February 5 deadline, we have started the process of clarifying error and warning messages and compiling application guide instruction edits. We have identified several eRA system enhancements that will address applicant concerns and have these planned for the April and May eRA software releases.

We are very interested in hearing about your electronic grant application experience. There are some aspects of the electronic application process that NIH has the authority to change (e.g., funding opportunity announcement language, application guide instructions, language of eRA Commons errors / warnings, support concerns, NIH requirements, content of agency-specific forms). There are other application processing characteristics that are not under NIH control (e.g., look, feel, content and navigation of SF424 (R&R) forms, ability to print entire the application or check for agency errors before submission). We encourage you to comment on any aspect of the process. Although we do not have the authority to implement change in every area, we can consider changes to areas under NIH control and raise awareness of concerns in areas outside of NIH control. We are committed to continuous improvements. Keep the feedback coming.

Please send comments or suggestions via email to NIH Electronic Submission at NIHElectronicSubmiss@mail.nih.gov.

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The biomedical research community would like to interact with the NIH as though it were one funding agency, with guidelines and policies applied in common across all of NIH’s component Institutes and Centers (ICs). But in practice, there are many individualized IC variations throughout the entire life cycle of a grant, from submission to closeout. In January, 2006, the FDP Chair, Nancy Wray of Dartmouth College, met with Dr. Ruiz Bravo, NIH deputy director for extramural research, and her committee of IC extramural directors to describe this problem and to suggest the FDP as a venue for change. Dr. Ruiz Bravo and the committee enthusiastically agreed to collaborate with the FDP to identify problems and explore solutions.

Ms. Wray appointed an FDP committee including Dr. Suzanne K. Polmar, Yale University; Dr. Loré Anne McNicol, NIH; and Ms. Gunta J. Liders, Rochester University, to work on the streamlining initiative. The committee developed a survey and polled the FDP membership for examples of problems. Responses were received from 24 of the 90 member academic research institutions. At the May 22-23, 2006 FDP meeting, over 80 members attended a session to review these responses, add additional observations, and prioritize the significance of the problems. The group developed plans for moving forward in a dialog with the NIH. The goals are to determine and eliminate the root causes of variation, particularly in those areas where change is simple or is highly important to stakeholders in the research community.

The FDP committee organized the community’s concerns into three levels of priority—high, medium, and low. Over the summer, NIH further characterized the concerns according to the NIH-internal functional group(s) most able to address the identified problems. For example, there are technical policy issues that the NIH’s grants advisory committee could address through consensus discussion and / or by clarifying policy and guideline documents. There are issues concerning training grant policy which could be best addressed through NIH’s training advisory committee. Broad policy matters will require input from all ICs, and will be conveyed via Dr. Ruiz Bravo’s committee of IC extramural directors. The early NIH responses were discussed at the September 2006 FDP meeting, and the dialog will continue.

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The shortened cycle pilot offers new investigator R01 grant applicants the option to revise and resubmit amended applications for the very next review cycle, four months earlier than in the past. The ultimate goal is to shorten the review cycle for all applicants and give them the opportunity to submit their applications up to three times in one calendar year, rather than stretching the entire process over two years.

Shorter review cycles will:

	Enable applicants and NIH to advance more quickly the most promising research.
	Allow NIH and the scientific community to keep better pace with the rapid growth of science and evolving health needs, thus accelerating the development of new treatments, cures and preventions.
	Aid promising researchers who frequently do not have the resources to sit out a review cycle.

The initiative began in early 2006 by posting all summary statements of new investigators submitting an R01 grant application within ten days of the study section meeting. In February 2006, 40 study sections piloted the shorter cycle for new investigators submitting R01 applications. One hundred six of the eligible new investigators chose to resubmit for the July 20 receipt date, in time for the October 2006 review cycle. Sixty-six of the amended applications fared very well, scoring within the tenth percentile.

In addition to the recent expansion of the pilot to more than to more than 60 study sections, all study sections will participate by the end of 2007. Hence, by November 2007, all new investigators applying for a R01 grant will have the opportunity to submit an amended application for the next receipt deadline, about four months later than the original application. A trans-NIH committee is conducting surveys of key NIH stakeholders—applicants, reviewers, and NIH / CSR staff—to ascertain success and problems and to analyze the application data to improve and speed the process. The NIH Peer Review Advisory Committee will review the results and recommend next steps. If this pilot is successful, shorter review cycles will be offered to additional groups of applicants.

Additional information is available in the Extension of NIH Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications NIH Guide notice.

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The January Nexus article, Addressing Terror and Violence Related to Animal Research, discussed resources available to help institutional officials and institutional animal care and use committees better protect their institutions and scientists. With passage of the new AETA, both commercial and academic entities now have another avenue of protection available against threat and intimidation from individuals or organizations opposed to animal research and testing.

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Comment #1: I read with great interest your recent article, Women in Biomedical Research, in the last edition of the Nexus and offer the enthusiastic support from our provost and vice president for research. We have some resources that I would like to share broadly with the biomedical research community. I would be most happy to help you in your efforts to improve diversity including the participation of women at all career levels.

Director OER: Thank you. Our discussions on the involvement of women in research, under the leadership of NIH Director Dr. Elias Zerhouni and NIH Associate Director for Research on Women's Health Dr. Vivian Pinn, are in progress and I look forward to keeping everyone informed of our plans. We are very close to launching a Web site and I would be happy to include a link to the resources you have provided.

Comment #2: I read with interest your review of the status of women in science. I hope you will put in place measures that will not only advance those new candidates entering academic research, but also put in place mentoring strategies for those women who are at the professor level, are already funded, and seek to expand their research opportunities. I received a negative review on an NIH grant application when I mentioned an ongoing, co-mentoring relationship with another faculty member. Reviewers felt that this reflected a lack of independence even though I am a full professor. I found the review very discouraging.

Director OER: Thank you for your note. I agree that we can all benefit from mentoring and networking throughout our careers. Mentoring is especially important when we take on new duties or expand into a new area of science. I am surprised that peer reviewers would view this as a sign of weakness. Believe me, there is no NIH guidance that would suggest mentoring should end when one takes a faculty position or becomes a full-professor.

Comment #3: It appears that NIH sees the realities for women as reflected the slow increase in the percentage of R01 awards going to women over the period from 1990 to 2004. Given that the success rates are so similar, this reflects the percentage of applications from women and the slow advancement to faculty positions. From a woman’s (my own) perspective, women accomplish just as much as men until they have children. Childbearing takes a physical toll on one’s energy during pregnancy and breastfeeding. Being involved with one’s child limits the amount of time spent doing scholarship. I think the NIH has a very good program for postdocs and faculty who have children. The reentry grant is very helpful. Women have so much to contribute to science. But it is not a very forgiving career when they lose productivity because they are trying to be a good parent.

Director OER: I really appreciate your comments and I know that the NIH and academic institutions need to think hard about how to accommodate the demands of child rearing, which commonly fall to women. The NIH Reentry Supplement (this program expires in early July, 2007, and is expected to be reissued and updated) and the Mentored Research Scientist Development Award are useful support options. But we recognize that young parents need flexibility in goal attainment, access to good child care and other types of support to facilitate their staying in science during their reproductive years.

Comment #4: Here in my medical school nearly 50 percent of graduate students and postdocs are women, yet only 30 percent of applicants for faculty positions are women. A lot of women drop out during postdoctoral training and do not apply for academic positions. I may decide to leave academia because the system makes it difficult to stay in what I call a ‘holding position.’ A year after having my first child I concluded that working full-time was next to impossible, so I took a new position with the stipulation that I could drop my work schedule back to four days per week. For some reason, my university would not allow me to extend my postdoc years to accommodate this part-time approach. Is my university responding to some kind of NIH policy? I would like to point out that my mother is currently a full time faculty member at my university. When she was a young faculty member, she was allowed to work around her hectic home life and ‘stay in the pipeline.’ Why are universities more rigid now than they have been in the past?

Director OER: Universities are in charge of the policies governing their employees. Most of the NIH career awards and fellowships permit part-time experiences to accommodate issues associated with raising a family. We have no policies that would prevent universities from offering similar part-time experiences or that would limit the duration of postdoctoral training.

Comment #5: I read the Beyond Bias summary with great interest. While a postdoc I conducted a survey that basically agrees with the report—there is no pipeline problem in the biological sciences or chemistry, but there is still one in engineering, astronomy, physics, and math. I also support the premise that bias in the grant and hiring process is a factor in women’s retention in academe, but there are also cultural issues that make it less attractive. I think many women are put off by the macho, cowboy, individualist culture that they see in academe.

It is interesting to compare the participation of women in universities at about 30 percent of the faculty with the participation of women in the biotech and pharmaceutical industry, which can exceed 50 percent. I currently work in a biotech company and supervise a team of three research associates with plenty of funding, a forty-hour work week, childcare on site, and support from a research group. In this division, most of the scientists have children. No one thinks twice about leaving early for a soccer game or to attend a recital. We support one another in a collaborative, positive environment that many women are drawn to. Academe provides a sharp contrast with its high stress, competitive, low reward environment. I would encourage us all to take a hard look at the culture of academe and how we can change it to make it more appealing to women.

Director OER: Thank you for your comments. It is important to consider biotechnology or pharmaceutical enterprises as alternatives to an academic career.

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Center for Scientific Review to Host Open House Workshops to Improve the Review of NIH Grant Applications

The six open houses, running from early March through December, will assess various CSR integrated review groups.

Comments from each of these workshops will be posted online, and all those interested will be encouraged to submit additional input for consideration and action.

Visit the CSR open house workshop Web page for more information.

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NIGMS Announces New “Pharm.D. Gateway to NIH” Online Resource

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OLAW Director Appointed

Dr. Brown received her BSc degree in animal science (1974) from Pennsylvania State University and her veterinary degree (1978) from the University of Pennsylvania.

She served in the U.S. Air Force for eight years and while on active duty, earned a MSc in laboratory animal medicine from the M.S. Hershey Medical Center, Pennsylvania State University, Hershey, PA.

She joined the U.S. Public Health Service in 1986 and has served in a variety of positions at the NIH within the Veterinary Resources Branch of the National Cancer Institute and the Office of Animal Care and Use. In 2001, she became the deputy director in the Office of Animal Care and Use, NIH Office of Intramural Research. She served as acting director of OLAW from July 2006.

Dr. Brown is a diplomate of the American College of Laboratory Animal Medicine (ACLAM), has served on the Board of Directors of ACLAM, is a past president of the American Society of Laboratory Animal Practitioners (ASLAP) and has served on the Association for Assessment and Accreditation of Laboratory Animal Care International Board of Trustees representing ASLAP.

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Recurring Lectures and Seminars are Open to the Public

Did you know that the NIH hosts a recurring series of lectures and seminars on a variety of subjects? These offerings, listed below, are available to the public and may be of particular interest to NIH grantees. Select lectures and seminars are also available live via NIH VideoCasting, and some may be archived for later viewing.

	NIH Director’s Wednesday Afternoon Lecture Series: Weekly scientific talks by some of the top researchers in biomedical sciences worldwide. The lectures are geared toward advanced students and practitioners in biomedical fields, healthcare professionals, and doctoral-level scientists who seek to update and broaden their understanding of contemporary biomedical research and the environment in which it is conducted.
	NIH Neuroscience Seminar Series: Ongoing lecture series highlighting advances in basic and clinical neurosciences to enable physician researchers to develop innovative strategies for research on understanding or treating disorders of the nervous system, as measured by research outcomes.
	Clinical Center Grand Rounds: Grand Rounds provide (1) options and alternatives that will guide clinical practice, (2) practical information about clinical research principles based on state-of-the-art scientific discovery and clinical advances, and (3) information and opportunities to increase and improve collaboration among investigators.
	Distinguished Lectures in the Science of Complementary and Alternative Medicine: Biannual lectures offer a unique perspective on the evolution of complementary and alternative medicine (CAM) practice and research, as well as current use of CAM by the public.

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NIH Director’s New Innovator Award

The application period opens on April 25 and closes on May 22, 2007. NIH expects to make at least 14 awards in September 2007. Each grant will be for five years and up to a total of $1.5 million in direct costs plus applicable facilities and administrative costs.

New investigators who have not yet obtained an NIH R01 or similar grant are eligible to apply. In addition, applicants must hold an independent research position at an institution in the U.S. and must have received their most recent doctoral degree (such as a Ph.D., M.D., D.D.S., D.V.M., or equivalent) or completed their medical internship and residency in 1997 or later. NIH particularly encourages applications from women and members of groups that are underrepresented in biomedical or behavioral research.

The proposed research may be in any scientific area relevant to the NIH mission. The project description in the grant application will be briefer than that required for R01 grant application and will emphasize the significance of the research, what makes the approach exceptionally innovative, how the applicant will address challenges and risks, and the applicant’s qualifications for the grant. The review criteria will emphasize the importance of the scientific problem, the potential impact of the project, the novelty of the approach, and evidence of the applicant’s potential for innovative and creative research. Applicants are allowed, but not required, to present preliminary data relevant to the project. Letters of reference will not be accepted.

Visit the NIH Director’s New Innovator Award Web page for more details, including the request for applications, frequently asked questions and more. Send questions to newinnovator@nih.gov or call 301-594-4469.

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Peer Review Caught on Tape

Application Submission Schedule Gets a New Look

A reformatted and expanded application due date table on the Standard Due Dates for Competing Applications Web page now includes more mechanism types and an “application form” column (reflecting the appropriate application form to use based on the electronic transition schedule). These additions will help prospective NIH grant applicants during the transition to electronic application submission.

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NHLBI Clinical Research Guide Now Available

Are you an investigator who needs assistance with preparing, submitting and managing a clinical research grant? The National Heart, Lung, and Blood Institute (NHLBI) has created a new Clinical Research Guide Web site that combines policies and procedures with practical guidance on grant application, review, funding and oversight. The guide is an excellent resource for the new investigator and provides easy access to specific information for the more experienced investigator. Take a moment to visit the site and to share it with colleagues who may find it useful.

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These FAQs provide guidance on OHRP’s current thinking on research involving prisoners and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word “must” in OHRP guidance means that something is required under HHS regulations. The use of the word “should” in OHRP guidance means that something is recommended or suggested, but not required.

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