Essential to the NIH mission of raising healthcare standards worldwide is its maintenance of a robust, cutting-edge biomedical research workforce. With innovative ideas, optimism, energy, and fresh perspectives, early stage investigators are an absolutely critical component for NIH to continue its groundbreaking work in improving the health of the world population.

Our longstanding commitment to attracting and retaining the best new investigators has led to the development of programs geared to cultivate talent and allow individuals to mature into world-class researchers. These programs have resulted in the recruitment of more than 1,600 new investigators in fiscal year 2007, which equates to more than 25 percent of all NIH-funded competing R01-equivalent awards. However, these new investigators are often still many years past their degree-conferral date. Despite our efforts, since 1980 the average age at which an investigator first obtains R01 funding (PowerPoint - 44 KB) has increased to the age of 42 for PhD degree holders and 44 for MD and MD/PhD degree holders.

Looking forward, we are focusing our attention on encouraging earlier transitions into independent research careers by developing programs that focus specifically on early stage investigators (those researchers that are within a set number of years of their terminal degree). This approach is patterned after the NIH Director's New Innovator Award, which both supports singularly creative new investigators at an early career stage and stimulates highly innovative research that has the potential for significant impact. By shifting new investigator incentives to those at earlier career stages, we hope to shorten the prolonged periods of training.

Following the theme of early stage investigators, this issue of the NIH Extramural Nexus highlights several other programs and initiatives designed to attract and retain new scientists in the field of biomedical research. From our efforts to strengthen science education in grades K-12, to our loan repayment programs, to our efforts to track and enhance the careers of staff, we are redoubling our efforts to ensure the next generation of biomedical research scientists is even better prepared to face the inevitable challenges of the future.

As always, I welcome your thoughts about these and other issues affecting extramural research.

— Norka Ruiz Bravo, Ph.D.

OER Director and NIH Deputy Director for Extramural Research

In March 2008, the NIH Extramural Nexus released a special enhancing peer review edition announcing the end of the year-long diagnostic phase and release of the final report. The report drafted by the Advisory Committee to the Director and the NIH Steering Committee identified the most significant challenges and proposed recommendations that would enhance this system in the most transformative manner. Recommendations were developed with the overarching goal to “…fund the best science, by the best scientists, with the least amount of administrative burden…” as summarized by Dr. Elias Zerhouni, NIH Director.

Following the release of the report, Dr. Zerhouni established a Peer Review Oversight Committee (PROC) to solidify a final set of recommendations and initiate implementation of those recommendations. The PROC, chaired by NIH Deputy Director, Dr. Raynard Kington, established Subgroups consisting of NIH program, review, grants management, and evaluation staff to assist with this implementation effort.

The implementation effort is focused around:

• Fulfilling the mission of funding the best science, by the best scientists;
• Developing approaches that minimize administrative burden for the applicant and review community;
• Communicating clearly the changes to policies, processes and guidelines to the applicant community, reviewers and staff at NIH and other federal agencies;
• Defining metrics and developing plans to obtain data to evaluate the impact of proposed policy changes once implemented;

The final set of recommendations is organized into the following four priority areas.

Priority 1 – Engage the Best Reviewers

The excellence of peer review is directly correlated with the ability to recruit and retain the most accomplished, broad-thinking, and creative scientists to serve on NIH study sections. Peer review service should be flexible, gratifying and maximize the ability and interest of qualified scientist to serve. Goals include:

• Developing policies that allow reviewers to adjust their commitment to participate in review sessions across a longer period of time for more flexibility;
• Enhancing review performance by providing additional training and mentoring based on best practices;
• Developing policies that acknowledge all reviewers and their intellectual involvement, particularly those who have demonstrated their commitment with a history of outstanding and sustained service at study section meetings ;
• Defining service expectations for Principal Investigators (PIs) of certain classes of NIH grant awards;
• Enhancing recruitment strategies to attract a greater number of accomplished extramural and intramural investigators to serve as reviewers.

Priority 2 – Quality & Transparency of Review

The peer review process must strive for maximum clarity, fairness, and consistency and help applicants determine a best course of action once reviewed. The process of review should focus on the potential impact, originality, and feasibility of the proposed research. Goals include:

• Realigning the structure of applications, review criteria, summary statements, and the rating processes to assess the potential impact, originality and feasibility of the proposed research;
• Shortening applications starting with R01s and reduce page lengths of other mechanisms appropriately;
• Providing applicants with more detailed feedback from the review process.

Priority 3 – Provide Balanced and Fair Reviews Across Scientific Fields and Career Stages

Peer review should fairly evaluate proposals from all scientists, regardless of their career stage or discipline, and avoid bias towards more conservative and proven approaches at the expense of innovation and originality. Goals include:

• Continuing to support and develop policies that support the unique needs of Early Stage Investigators (ESI), New (to NIH) investigators, and Clinical Researchers;
• For more established investigators, placing significant emphasis on a retrospective assessment of accomplishments as well as a prospective assessment of what is being proposed;
• Encouraging and expand upon the Pioneer, EUREKA and New Innovator awards programs to encourage risk taking by applicants, and continue to grow the Transformative Research portfolio;
• Establishing policies, carefully and progressively, to rebalance and reduce the need for resubmissions, thereby increasing system efficiency and reducing burden on the applicants and reviewers.

Priority 4 – Continuous Review of Peer Review

The last priority is to develop a permanent process for continuous review of peer review. Peer review should continuously adapt itself to the evolution of science. The NIH peer review process will commit to a continuous quality control and improvement process based on a rigorous and independent prospective evaluation that favors innovative approaches to review and program management.

Plans for Implementation

The "peer review enhancement" effort is part of NIH's longstanding commitment to supporting promising and meritorious biomedical and behavioral research using diverse approaches, strategies and mechanisms. In this issue of the Nexus we have highlighted several activities that use dramatically different application and review processes:

• Transformative R01 Program
• NIH Director’s Pioneer Award Symposium

Look for information in the October 2008 edition of the Nexus that will highlight forthcoming changes. We will keep you abreast of developments in future editions of the Nexus and updates to the Enhancing Peer Review Web site.

Without reliable data on all the staff associated with NIH research projects, it is difficult to assess the balance between the number of students and postdocs and the number of fully trained, faculty-level scientific positions in this country.

The NIH maintains a comprehensive data collection on Principal Investigators (PI's) associated with funded research projects and on students and postdocs supported by the Ruth L. Kirschstein National Research Service Award (NRSA) programs. This information permits the NIH to conduct comprehensive career outcome studies on NRSA recipients and analyses on PI's and New Investigators (http://grants.nih.gov/grants/new_investigators/resources.htm).

In contrast, little information is collected on other project staff associated with NIH-funded research grants. The NIH Reform Act of 2006 (P.L. 109-482) requires the NIH to collect identifying and demographic information and report on postdocs who serve as research assistants or associates on research grants. The data will allow an analysis of career outcomes similar to those conducted for NRSA recipients.

Such information can be used to make informed decisions about the appropriate size of NIH training programs, and will permit a better match between the type of training provided and expected career outcomes. All in all, the information will offer a richer understanding of the training necessary and disciplinary composition of the research workforce.

The advent of electronic research administration makes such enhanced data collections possible. Over the next year the NIH plans to require postdocs to register in the eRA Commons which will serve as a repository of personal, career and bibliometric information that can be associated with NIH support.

The NIH will modify the Senior/Key Personnel Report to include all personnel associated with the project for a month or more. Although many grantees provide information on all project-related personnel, the revised form will clarify, simplify, and improve this data collection, and, coupled with the Commons accounts for postdocs, create a reliable linkage of postdocs to research projects.

The more complete data collection will enhance our understanding of the enterprise and allow the NIH to better accommodate the evolving needs of the research community. Additional details will be forthcoming and an opportunity to comment on NIH plans will be provided.

Start preparing now for the Fiscal Year 2009 NIH Extramural Loan Repayment Programs (LRPs), opening September 1 and closing December 1, as announced recently in NIH Guide Notice NOT-OD-08-083. Applicants can begin preparing their applications by using the new LRP Application Guide available on the LRP Web site. Individuals are not required to have an NIH grant in order to apply for or participate in the LRPs.

Each year, some 1,600 research scientists benefit from the more than $70 million NIH invests in their careers through the extramural Loan Repayment Programs (LRPs). The purpose of the LRPs is to encourage highly qualified scientific investigators to pursue careers in clinical, pediatric, health disparities, and contraception and infertility research. Participants receive loan repayment and tax benefits, which serve as one means of retaining them in the scientific workforce and expanding the nation’s pool of researchers. New LRP contracts are awarded for a two-year period and repay up to $35,000 of qualified educational debt annually. Participants may apply for competing renewals, which are issued for one or two years. Undergraduate, graduate, medical school, and other health professional school loans qualify for repayment.

This is a program that works. Physician scientists who receive LRP awards are more likely to be retained in the research workforce than those who do not receive awards. Moreover, these individuals are significantly more likely to apply for subsequent NIH research grants than non-LRP-funded physician scientists.

The application cycle for the LRPs will open September 1, and applications must be completed online at www.lrp.nih.gov prior to the December 1 deadline. Applicants must possess a doctoral-level degree (except for the Contraception and Infertility Research LRP); be a U.S. citizen, national, or permanent resident; devote 20 hours or more per week to conducting qualified research funded by a university, nonprofit organization, or federal, state, or local government entity; and have qualified educational loan debt equal to or exceeding 20 percent of their institutional base salary.

Several months ago, NIH Director Elias Zerhouni, M.D., candidly addressed the necessity and correlating challenges of enhancing science education among American students in a correlating memo. The NIH Office of Science Education (OSE) is proactively tackling the issue. The OSE engages students and teachers in its mission to foster K-12 education with the ultimate goal of attracting young people to biomedical and behavioral science careers.

OSE Director, Bruce Fuchs, Ph.D., recognizes the importance of establishing a solid science and math background early in the life of a student. “By enhancing education awareness among middle and high school students, we condition them to select the higher path of learning,” said Dr. Fuchs. “If we can persuade students to actively seek challenging courses today, they will have great potential for becoming successful researchers tomorrow.” Fuchs acknowledges that even if students do not choose careers as scientists, the critical thinking and problem-solving skills obtained and refined through higher-level courses, will prepare them for success in a multitude of other careers.

A sixth grader may not be conscious or convinced of the importance of taking a more advanced- level science or math class. “Teachers are a primary conduit for positively influencing students and also for arming them with the necessary tools to help make them successful,” said Dr. Fuchs. It is with this ideology that the OSE has developed and disseminated the NIH Curriculum Supplement Series for teachers to integrate into their lesson plans. The OSE coordinates efforts with specific NIH institutes or centers, utilizes advisory teams to select content and works with curriculum developers to bring plans to fruition. The Supplement Series are 16, interactive teaching units that combine cutting-edge science research discoveries from the NIH, with state-of-the art instructional tools. The Supplement Series is free to science teachers and school administrators and suitable for grades K-12. OSE is aligning every supplement with each state’s standards to assist teachers in integrating the material into their daily curriculum.

While the curriculum supplements are the OSE’s primary product addressing the needs of high-level science education, it also offers Lifeworks – a career exploration tool which provides information on more than 100 careers related to the science and medical fields.

“Whether students are exploring potential career paths or engaging in advanced science and math education, we are confident that the OSE resources will allow them to gain a deeper understanding of the importance of basic research to advances in medicine and personal health,” said Dr. Fuchs. The OSE continues to move forward in its efforts of promoting science education and offering tangible products to students and educators.

To learn more about OSE initiatives, visit http://science.education.nih.gov/.

NIH Director Elias Zerhouni, M.D. recently announced a new program to be conducted through the NIH Roadmap that is designed to stimulate the disruption of existing research paradigms or create research paradigms where none now exist. The idea for such a program has been in the works since its genesis in the 2003 NIH Roadmap planning effort, through discussions at various public workshops, and through suggestions made during the enhancing peer review effort.

The Transformative R01 Program (T-R01s) will allow highly creative, “out-of-the-box” projects to be supported in any area of research that falls within the NIH mission, and in particular, in areas of Highlighted Need. The NIH recognizes that new paradigms are needed in these areas and will highly encourage research that addresses these needs. The broad topics to be highlighted include:

• Understanding and Incenting Behavior Change
• 3-D Tissue Models
• Functional Variation in Mitochondria
• Transition from Acute to Chronic Pain
• Formulation of novel protein capture reagents

The T-R01 Program represents a High Risk/High Reward Demonstration Project in which novel approaches to peer review and program management are to be piloted. Look for a funding opportunity to be published in the next few weeks!

NIH addresses disasters that affect NIH-funded projects by putting into place adminstrative flexibilities to allow grantees to focus on the restoration of productive research, e.g., delays in grant application submissions or reporting requirement deadlines. Grantees are reminded that under such Expanded Authorities they may rebudget, and extend a grant period for up to 12 months without prior approval. Organizational needs will vary depending upon the nature and impact of the disaster, and NIH works with grantee organizations to access their particular individual research needs.

Generally, when recovery will require extensive time and potential resources, NIH appoints a specific Point of Contact who remains in close communication with the affected organization officials and investigators. We also work in partnership with other Federal agencies that support research, as well as the Federal Emergency Management Agency and the Office of Science and Technology Policy.

Every disaster situation has distinct features and impact. NIH is committed to working in concert with organizational officials and their investigators as they access the affects of damage caused by disasters, and taking steps to facilitate the rapid recovery of NIH supported research projects.

The Office of Laboratory Animal Welfare (OLAW) Director, Dr. Patricia Brown, Captain USPHS, received the distinct honor of being named the PHS Commissioned Corps Veterinarian of the Year for 2008 and was recognized at the American Veterinary Medical Association annual meeting on July 20. This award recognizes veterinarians whose professional careers and work performance have resulted in significant contributions to public health and to the mission of the Department’s Agency/Operating Divisions and other programs where Commissioned Corps veterinarians serve.

Dr. Brown was recognized for her career leadership in fostering humane animal care and use. In addition to leading OLAW, Dr. Brown has a variety of responsibilities including mentoring, representing OLAW at professional conferences, and providing guidance to grantees. As was noted in a supporting reference for the award, “with Captain Brown at the helm of OLAW, we should rest assured that PHS Policy is implemented impeccably thus fostering appropriate animal care and use so that the resultant research findings can best lead to better public health.”

The NIH has published a Web-based tutorial to help ensure that research is carried out without bias and with the highest standards of integrity. The goal of the training is for the research community to familiarize itself with the requirements of, and the Institutional and Investigator responsibilities for, compliance with federal regulations regarding objectivity in research. The tutorial is designed for use by Institutional officials responsible for managing NIH-funded grants, cooperative agreements, and/or contracts; and for individuals who are responsible for the design, conduct or reporting of NIH-supported research.

For more information on this important topic, consult the Frequently Asked Questionsdocument on the OER Web site or contact FCOICompliance@mail.nih.gov.

When citing their NIH-funded papers in NIH applications, proposals or progress reports, authors must include the PubMed Central reference number (PMCID) for each paper that falls under the Public Access Policy. The National Library of Medicine has created a new utility (http://www.ncbi.nlm.nih.gov/sites/pmctopmid) that uses PubMed IDs (PMIDs) to look up PMCIDs, and vice versa. Users can enter PMIDs from their PubMed clipboard. The utility will provide a table of PMIDs with corresponding PMCIDs. For example, an author could look up all their publications in PubMed, save them to the clipboard, and use the utility to see which ones will be posted to PubMed Central.

Authors sometimes get confused between PubMed Central and PubMed. PubMed Central is a full text archive. Its identifer, the PMCID, is composed of the letters ‘PMC’ followed by digits. PubMed is an indexing service and its identifer, the PMID, is only composed of digits. Authors can find PMCIDs for a paper in the abstract plus view of PubMed. See http://publicaccess.nih.gov/FAQ.htm#c9 for more information.

National Library of Medicine has a suite of other utilities as well, at http://www.pubmedcentral.nih.gov/about/PMC_Utilities.html. For more information about the Public Access Policy please visit http://publicaccess.nih.gov/.

xTrain is now open to all FDP institutions. By using this electronic system, training grant directors and administrators can reduce the flow of paper forms across their desks and appoint most graduate students and postdoctorates to NIH research training grants electronically.

All eRA Commons registered FDP institutions can use xTrain, and there are no further steps necessary to start using the program. Training grant PD/PIs and administrators should review the information at http://era.nih.gov/services_for_applicants/other/xTrain.cfm, and follow the steps described. Review of the “Training Material” presentation can be particularly helpful. Additionally, PD/PIs may wish to explore the option of delegating their xTrain authority to an assistant or departmental administrator.

Regarding training grant appointments and re-appointments, xTrain accepts amended appointments, termination notices, and provides pre-filled payback agreements for eligible postdoctorates. Once a training grant appointment (or other action) has been initiated, xTrain provides institutional and NIH users a record of its progress to Agency acceptance.

Further xTrain assistance is available from the eRA Commons Help Desk.

You are invited to attend the fourth annual NIH Director's Pioneer Award Symposium on September 22-23, 2008. The event will feature a keynote address by NIH Director Dr. Elias A. Zerhouni plus research talks by the 2007 Pioneer Award recipients (http://nihroadmap.nih.gov/pioneer/Recipients07.aspx), poster sessions by Pioneer and New Innovator Award recipients and members of their labs, roundtable discussions on highly innovative research, and announcement of the 2008 Pioneer awardees.

The NIH Director's Pioneer and New Innovator Award programs--key components of the NIH Roadmap for Medical Research--support exceptionally creative scientists who take highly innovative, and potentially transformative, approaches to major challenges in biomedical or behavioral research.

The symposium, in the Natcher Conference Center (Building 45) on the NIH campus, begins at 8:30 a.m. each day. An agenda is posted at http://nihroadmap.nih.gov/pioneer/symposium2008. Attendance is free and no registration is required. The event will also be videocast live and archived at http://videocast.nih.gov.