NEWS FROM THE DIRECTOR OF OER:
Fostering New Investigators is a Community Effort

Dear Extramural Community:

I am writing today to highlight both my concern for the ability of newly-trained investigators to become independent investigators and to reiterate NIH’s deep commitment to do all that we can to help them. The biomedical research enterprise cannot continue its remarkable record of discoveries and productivity without a continuous stream of dynamic new investigators.

A 1998 report from the National Academy of Sciences, titled Trends in the Early Careers of Life Scientists, documented the increasing age at which scientists become Principal Investigators on NIH research grants. These trends have continued (Figure 1) along with the age at which new faculty members are hired in medical schools (Figure 2). Because most universities permit only faculty members to apply for grants, the relationship between hiring trends at universities and the age at which new faculty apply for grants is almost certainly causal. The influence of NIH policies on the increasing age of faculty is harder to explain. The Trends report suggests longer periods of training account for these observations, but the rationale for extended training periods is not clear. At least in my view, these changes reflect complex demographic, cultural and economic factors that remain to be identified.

Regardless of the cause, the aging of the workforce is a reason for concern. New investigators bring fresh ideas and technologies to biomedical research, and they pioneer new areas of investigation. Replenishment of the ranks of independent, NIH-funded researchers is essential to the health and vitality of our research mission. Our interest in this area is understandably deep and longstanding.

Over the years, NIH has created multiple programs to assist new investigators in obtaining independent research funding. The overall number of new investigators on research grants (R01, R29, R37 awards) has in fact increased from 1,421 to 1,561 between 1995 and 2005. In spite of our efforts, however, new investigators have remained between 24 and 26 percent of Principal Investigators on competing R01 equivalent awards for more than a decade. Additional information and data are available at the Resources for New Investigators Web page.

We continue to provide investigators advantages and opportunities in the following ways:

Peer Review and Award: Currently, we encourage new investigators to self-identify by checking a box on the face page of their applications. New investigators so identified are given special consideration at peer review and at the time of funding. Peer reviewers are instructed to focus more on the proposed approach than on the track record and to expect less preliminary information than would be provided by an established investigator. At the time of award, NIH Institutes and Centers give new investigators special consideration when selecting applications for funding and some provide longer periods of support. The Center for Scientific Review also is conducting a pilot that will allow new investigators to revise a grant application that missed the funding cut-off and to submit that revision for the next review cycle. The findings from this pilot will become available during fiscal year 2007.

Pathway to Independence Awards: NIH Director Dr. Elias Zerhouni recently announced the development of a new award that bridges research dependence to research independence (see the April 2006 NIH Extramural Nexus). The Pathway to Independence Award includes a one- to two-year mentored phase to complete the period of postdoctoral training, followed by an independent phase of three to four years that will allow the recipient to find a tenure-track or equivalent position and build a record of independent support. The NIH expects to make between 150 and 200 Pathway awards each year as a means of fostering the early independence of new investigators. Nearly 400 applications were received on the first receipt date and some are being considered for award this fiscal year. More information on this program is available at the New Investigators Web site.

The NIH remains committed to identifying and attracting new independent biomedical researchers and will continue to look for additional ways to support new investigators. However, the NIH cannot do it alone. Institutions—our partners in this venture—must continue to look for opportunities to reduce the duration of graduate and postdoctoral training as well as find new ways to permit young scientists to apply for research funding. Certainly, we all need to be more creative in our recognition of the extraordinary achievements of young scientists, even before they are appointed to the faculty.

It will take the combined efforts of NIH staff, working with our extramural partners, to foster innovation at all levels of the research enterprise. I welcome any new ideas you might have. Please feel free to send them by email to DDER@mail.nih.gov.

— Norka Ruiz Bravo, Ph.D. - Director, OER and NIH Deputy Director for Extramural Research

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NIH Roadmap for Medical Research:
NIH to Request Public Comment on Roadmap Initiative Ideas

The July 2006 NIH Extramural Nexus featured the new process for idea solicitation and initiative selection for the NIH Roadmap for Medical Research now managed under the auspices of the Office of Portfolio Analysis and Strategic Initiatives (OPASI).

The first part of the process has begun. Several meetings have taken place to help senior NIH leadership identify crosscutting needs and challenges in biomedical research that meet the criteria for Roadmap initiatives. NIH Institutes, Centers and Offices also have been nominating ideas for Roadmap initiatives this summer. Idea descriptions from both activities will be posted for public comment and input this fall when the NIH launches a Web-based Request for Information (RFI) soliciting a broad range of input and ideas from both science and lay communities. The RFI will be released mid-October 2006 in the NIH Guide for Grants and Contracts, providing an opportunity for respondents to comment on the ideas already suggested and/or submit new ideas.

Information from this idea nomination process will be posted on the OPASI Web site as it becomes available. Please direct your questions or comments to askopasi@od.nih.gov.

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Streamlining the Grant Application and Review Process: NIH Seeks Comment on the Use of Appendix Material and the Optimal Length of the Research Plan Section

The goal of changing the guidelines for grant application appendix materials is to encourage applicants to be as concise as possible while including the information needed for expert scientific review.

Reducing the current 25-page limit for the Research Plan section of the R01 grant application could allow applicants to focus less on experimental detail and more on key ideas and the significance of proposed projects. It also might facilitate the review process and make it easier to recruit qualified reviewers.

A Request for Information (RFI) was published in the Federal Register, and a similar Guide notice was published seeking input from applicants, reviewers and other members of the research community regarding the utility of appendix materials in the grants submission, review and management process. All comments due by Thursday, September 14, 2006.

The NIH will seek public comment on the optimal length of the Research Plan. Look for an announcement in the NIH Guide for Grants and Contracts later this month.

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NIH Announces Request for Input on Proposed Repository for Genetic Information

The proposed GWAS policy covers protections for human subjects, submission of data to a centralized NIH data repository, data access for secondary analyses, publication of findings, and intellectual property issues.

The proposed policy describes the expectation that investigators funded by the NIH for GWAS submit genotypic and phenotypic data to a centralized NIH data repository in a form that will protect the privacy of research participants. The draft policy also outlines the process by which investigators can access GWAS data from the repository, proposes a period of publication exclusivity for investigators who submit the data, and asks that recipients of GWAS data acknowledge the submitting investigator in any published works.

To facilitate research progress, NIH would encourage obtaining a patent for downstream discoveries that would be necessary to develop products to meet public health needs, while discouraging obtaining a patent for early, pre-competitive information that may impede future research.

The NIH hopes to achieve several important goals, including:

	Improve Health: Genome-based research eventually will enable medical science to develop highly effective diagnostic tools, better understand the health needs of people based on their individual genetic make-ups, and design new and highly effective treatments for disease.
	Maximize Public Investment: Centralized access to and broad sharing of genetic information, for appropriate research purposes, maximizes the public’s investment in genetic research.
	Protect Human Subjects: Developing a policy that allows for sufficient protections for the privacy and confidentiality of research participants.

The NIH believes that various and complex interests related to the submission of, and access to, GWAS data must be discussed with the public. Wide and rapid access to GWAS data may have implications for participants in studies (and their families and communities), investigators, institutions and industry. Some of the issues on which public consultation will be solicited include:

	Protections to minimize risks to research participants
	Creation of a central GWAS data repository at the NIH
	Expectations for sharing GWAS data
	Approach to scientific publication
	Approach to intellectual property

The NIH is soliciting comments on the proposed policy through the GWAS Policy Web site. Comments also can be submitted via email to gwas@nih.gov. A town hall meeting also is planned for early December 2006.

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NIH Partners with Journal Publishers to Facilitate Participation in NIH Public Access

	Archive: A central collection of NIH-funded research publications preserves vital published research findings for years to come.
	Advance Science: The repository is an information resource for scientists to mine more easily medical research publications and for NIH to manage better its entire research investment.
	Access: Provide patients, families, health professionals, scientists, teachers, and others electronic access to research publications resulting from NIH-funded research.

Inclusion of articles in PMC increases exposure for NIH authors—PMC is used by several million people per month. Further, content in PMC is not just free and full text, but is fully integrated with other NLM databases, such as PubChem and GenBank. Records in these databases are linked and accessible to articles in PMC, and vice versa.

To achieve this interconnectivity, authors must submit manuscripts to PMC through the Manuscript Submission System, which converts word- processing files and portable document format (PDF) files into an archival format that can be integrated into the NLM family of databases. This conversion process, known as tagging, requires author verification to ensure the integrity of the article in a process similar to reviewing galley proofs.

NIH has been involved in extensive discussions with a variety of publishers to simplify compliance for authors. Three models of journal/author effort have emerged:

Models of Publisher Facilitation of Public Access

PMC journals (journals that deposit material in PMC on a routine basis and generally make all their published articles available through PMC) submit tagged, copy-edited versions of all their articles to PubMed Central. PMC (NIH Portfolio) journals are similar to PMC journals, but deposit only articles funded by NIH. Both sets of journals eliminate the need for authors to take any action to comply with the Public Access Policy.

Under the Public Access Policy, NIH investigators are free to publish in any journal they choose. We encourage authors to read their copy transfer agreements carefully and ensure that they do not waive their right to submit articles to PubMed Central. Journals often indicate their level of facilitation of Public Access in these agreements. The Public Access Frequently Asked Questions Web page provides sample language for amending transfer agreements.

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Research Training Grant and Fellowship News: New NIH Tuition/Fees and Health Insurance Policy Q&As

In August, NIH announced a new policy for tuition, fees and health insurance costs on Ruth L. Kirschstein National Research Service Awards (NRSA) Institutional Training Grants and Individual Fellowships. A revised notice corrected minor errors and clarified some questions raised by the community in response to the original notice. The Office of Extramural Research (OER) has since developed a set of Questions and Answers that provide further clarification. Note that these are a subset of the larger body of training-related Q&As on the OER NIH Research Training and Research Career Opportunities Web page.

Changes also are in progress to the PHS398, PHS2590, PHS 416-1 and PHS416-9 forms and instructions to bring them into compliance with the announced policy changes. Check the NIH Web site for updated versions of these application forms. Older Program Announcements (PAs) and Requests for Applications (RFAs) may continue to refer to the older policies. Be sure to check the NRSA Policy Issues Web page for updates before submitting any applications in response to any Kirschstein-NRSA training-related program announcement.

Key policy changes that were announced:
  

	The formula for calculating awards was changed from $3,000 plus 60 percent of the amount requested over $3,000 to a straight 60 percent of the requested amount. Note that institutions should request their full tuition/fees. NIH will apply the relevant formula.
	Health insurance costs are no longer considered in the category of Tuition/Fees/Health Insurance and so are not subject to the above formula. Rather, these costs have been shifted to the Training Related Expenses Category (training grants) or the Institutional Allowance Category (individual fellowships).
	Training-Related Expenses (training grants) or Institutional Allowance (fellowships) have been adjusted to include NIH contributions toward health insurance for NRSA mechanisms and for both predoctoral and postdoctoral levels of training.

Many of the questions from the community have dealt with the phase-in of these changes. Different policies will apply to different grants based on the Fiscal Year (FY) (October 1–September 30) of the most recent competing award. The Q&A site includes a table illustrating how this will work. This table shows:

	Competing Awards issued in FY05 or earlier: Nothing is changed for any years. Current and recommended budgets will not be adjusted. The awards will continue to be administered under the policy in effect at the time of the last award.
	Competing Awards issued in FY06: FY06 awards will not be adjusted. FY07 Non-Competing Continuation years will be adjusted to the new policy levels and future Non-Competing Continuation years will be shown at the adjusted level. Note this adjustment will be made by NIH staff and will be based on the tuition/fees requested in the FY06 Competing Application.
	Competing Applications submitted for FY07: should use the New Policy to make their budget requests. FY06 stipend levels should be used until FY07 stipend levels are announced, but the new policy for tuition/fees and training-related expenses (including health insurance) should be used.

For answers on how the new policies affect any specific grant award, contact the NIH program and grants management staff members whose names were listed in the most recent Notice of Award that you received. Also available are general listings of NIH Institute and Center Chief Grants Managements Officers and Training Contacts.

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ELECTRONIC Submission News: Mark Your Calendars, We’ve Come a Long Way! “Lessons Learned—Preparing for Electronic Grant Applications”

To prepare the applicant community for the upcoming transition of NIH Research Project Grant Program R01s to electronic submission in February 2007, NIH will hold a training event on December 5, 2006, geared toward extramural grant applicants. With a year of electronic submission under our belt, our focus will be on lessons learned and sharing our advice on best practices for submitting applications online.

As a bonus, we will host “hands-on” computer labs giving applicants the opportunity to practice the submission process with eSubmission experts. The training event will take place on Tuesday, December 5  (labs will be offered on Tuesday and Wednesday), at the Natcher Conference Center (Building 45), Main Auditorium, NIH Main Campus.

A preliminary agenda is available. Additional details and registration are coming soon! Subscribe to the Listserv for updates on the Electronic Submission Program to be notified when registration becomes available.

Complete information about the electronic grant application submission is available at the Electronic Submission Web site.

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Modular Myths You Can Muse

FACT #1: Detailed budgets for consortia are not required by the NIH; however, applicant institutions must be able to reasonably estimate the total (direct, facilities and administrative) cost of the consortium arrangement to the nearest $1,000. Therefore, applicant institutions may request from consortium participants information necessary for making this estimate, but should only provide the following for each Consortium in the application:

	Estimate of total costs (direct plus facilities and administrative) rounded to the nearest $1,000
	For each key individual/organization listed, the role and percent effort
	Whether each collaborating institution is foreign or domestic

MYTH #2: When calculating the $250,000 direct-cost level for modular grant applications, all consortium costs (direct and indirect) should be included.

FACT #2: In calculating the $250,000 direct-cost level, the applicant should not include the facilities and administrative (F&A) costs associated with any consortium/contractual arrangements. Those costs may be requested above the normal $250,000 direct cost limit. Fields are provided to separately capture consortium F&A costs for each budget year. See NIH Guide notice NOT-OD-05-004.

MYTH #3: When transferring a grant, a detailed budget must be submitted from the new institution even though the original application was awarded in the modular format.

FACT #3: If the original award used the modular format, then the application from the new institution should use the application instructions and forms for a modular grant.

MYTH #4: The modular format is applicable to Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) applications.

FACT #4: Although the modular format was previously available to SBIR/STTR applicants, the modular format was excluded from SBIR/STTRs beginning with the 2005 Omnibus Solicitation (see the 2006 Solicitation). Therefore, all competing SBIR and STTR applications must be submitted with a detailed, categorical budget.

You can find more interesting facts at the newly revised Modular Research Grant Application Frequently Asked Questions (FAQ) Web page. In addition, check out the NIH Modular Research Grant Applications Grant Web site, which has a new look with updated links, data charts on IC modular funding trends, evaluative information and more.

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The $500K Delay! Any investigator-initiated application requesting exactly $500,000 or more in direct costs for any year of the project must seek agreement from IC staff at least six weeks prior to the anticipated submission date. It does not include indirect costs associated with any subcontracts. Without NIH prior approval, an application may be returned to the applicant without review. This policy does not apply to Requests for Applications (RFAs) or responses to other announcements that include specific budgetary limits. See NIH Guide notice: NOT-OD-02-004.

What’s Your Type? Just a reminder: font typefaces for grant applications are restricted to Arial, Helvetica™, Palatino™ Linotype, or Georgia®. The “Insider” recommends Georgia font for grantees who like the look of Times New Roman. The font size should be 11 points or larger and applies to all text portions, including the Biosketch, Literature Cited, etc. It also applies to all text sections of paper submissions and all portable document format (PDF) files for electronic submissions. You can use a smaller font size for the following (ensuring that it is readily legible and follows the font typeface requirement): figures, graphs, diagrams, charts, tables, figure legends, and footnotes. The “Insider” suggests that you follow the Golden Rule and submit an application that you would find easy to read if you were in the reviewer’s chair.

Moving Day? If you’re a Principal Investigator planning to transfer from your current institution, don’t wait until the last minute to make arrangements for transferring your grant. Start early and begin communication with both your institution’s research administration offices and the assigned grants management specialist in your awarding NIH IC as soon as possible. The transfer process at NIH  requires prior approval and takes time to process. You can find more information in the NIH Grants Policy Statement (12/03) at Part II: Terms and Conditions of NIH Grant Awards - Subpart A: General -- File 4 of 5 (“Change of Grantee Institution”).

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