NEWS FROM THE DIRECTOR OF OER:
Solicited and Unsolicited Research—Making Choices Balancing Needs, Opportunities, and the Unpredictability of Science

Examples of NIH special initiatives that have benefited the scientific community as a whole abound. A recent example in the basic science category is the Human Genome Project, which in a few short years has completely transformed biomedical research. The sequences and sequencing technologies that were developed as part of the Human Genome Project, and their application, have ushered in a new era in medicine—an era in which the genetic and molecular understanding of human biology and disease is leading to more effective ways to predict and pre-empt the occurrence of disease, and personalize its treatment.

And who among us has not benefited directly or indirectly from the Framingham Heart Study? Since its inception in 1948, the Study has led to the identification of the major risk factors of cardiovascular disease: high blood pressure, high blood cholesterol, smoking, obesity, and physical inactivity among others. Preventive strategies and clinical treatment of these factors have profoundly benefited many, many people. The Study is currently recruiting its third generation of subjects, the children of the Offspring Cohort (i.e., the grandchildren of the Original Cohort), who will be examined in an attempt to learn how genetic factors relate to cardiovascular disease. In this, the Framingham Heart Study stands to benefit greatly from results from the Human Genome Project and in ways that the originators of these studies could not have predicted when the programs began.

NIH continues to engage in special initiatives. Some are trans-NIH, such as the NIH Roadmap for Medical Research; others involve several NIH Institutes and Centers, such as the Blueprint for Neuroscience Research; and some are specific to the mission of single Institutes or Centers. These initiatives are the result of input from many sources—scientific advisors, members of congress, professional societies, and advocates from groups representing specific diseases or disciplines, among others. These constituent groups and individuals identify specific areas of science that are in need of special emphasis or that address a gap in existing research needed to move a field forward. As for the Human Genome Project and the Framingham Heart Study when they began, the return on investment for new NIH initiatives cannot be accurately predicted—serendipity rules even in special initiatives. Nevertheless, with input from its constituents and the advice and consent of its advisory councils and boards, NIH will continue to support special projects and programs—we must continue to invest in the future.

As you know, NIH announces its areas of special research interest in the NIH Guide for Grants and Contracts. New with the advent of electronic grant applications is that all applications must identify a Funding Opportunity Announcement (FOA) in Grants.gov. An FOA can be a very broad description of the general research interests and priorities of an NIH Institute or Center (IC) or it can delineate a specific or even narrow research area to encourage scientists to address an identified gap, answer a specific research question, or develop a needed resource. The FOA simply sets up a funding mechanism-specific application shell within Grants.gov. In response to the requirement that all applications must identify a FOA, NIH has introduced the Parent Announcement, a new type of FOA. The Parent Announcement and the other four types of FOA used by NIH are explained below:

	Program Announcement (PA): A broad description of general research interests and priorities. All PAs involve multiple receipt dates, and applications are reviewed with those that do not cite any announcement.
	Program Announcement with Special Referral Characteristics (PAR): A PA that includes special receipt, referral or review characteristics to accommodate special programmatic needs.
	Program Announcement with a Setaside (PAS): A PA that delineates a specific pool of money to encourage applications in this area.
	Request for Applications (RFA): Used to define a specific area of science that has been identified for special attention by one or more ICs. Usually RFAs have a funding setaside, a specific receipt date, special review criteria, and are generally reviewed by a special peer review committee.
	Parent Announcement: Used to set up a funding mechanism-specific electronic application (e.g. R01). Does not describe research interests or priorities.

In this new age of electronic submissions, all electronic applications must be in response to one of these five funding opportunity announcements. Although this new approach blurs yesterday’s distinction between solicited and unsolicited research, it does not diminish the value of both approaches to NIH’s ability to manage its biomedical research portfolio.

In the future as in the past, individuals and groups will advocate for new programs and for increases or decreases in existing programs. Emerging approaches such as the ability to define with better accuracy the types of research being funded using knowledge management technologies and other approaches may help identify new scientific areas to explore or specific gaps in the portfolio. The proportion of applications responding to RFAs may increase or decrease in response to scientific or public health need and opportunity. NIH will continue to seek broad community input of the type that led to the NIH Roadmap. I can assure you, however, that regardless of the mix of solicited and unsolicited applications, the NIH will continue to look for and fund the very best science.

If you have comments or questions please write to me at DDER@NIH.gov.

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Among the remaining grant programs to transition are Career Development (K), Fellowships (F), Training (T) and complex programs (primarily P and U). The transition of these grant programs to electronic applications was delayed in January (see NIH Guide notice NOT-OD-07-038) as Grants.gov focused all of its efforts on transitioning to Adobe®-based forms and system processing improvements.

NIH is working closely with Grants.gov while they continue to refine forms and systems. We expect to make an announcement soon about the transition of K, F, T and complex grant mechanisms to electronic application submission.

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The NIH Electronic Application Validation Process—Why We Do What We Do

Did you submit your electronic application, check the status in the Electronic Research Administration (eRA) Commons and let out a sigh as you read your errors and / or warnings? Did you think, “Sure, the system flagged an error, but why can’t I just take care of it later, after I get rave reviews and NIH is ready to fund my research?” If you did, you were not alone. In fact, some of you took it one step further and provided specific feedback on the process. We have reviewed your feedback, analyzed the submission results to date, and offer the following response.

Receiving clean and fully compliant applications is a worthy target. However, we must acknowledge the importance of striking a balance between obtaining consistent, error-free application data and preventing an application from going forward due to seemingly small administrative issues. We continue to adjust and refine the NIH validation process with the goal of reaching this important balance.

Although we try to provide a comprehensive list of errors and warnings for a submission, it is not always possible. For example, if the application has missing or incorrect Data Universal Numbering System (DUNS) number or eRA Commons username information, the system will flag those errors and the validation process will not be completed until the items are corrected. The organization and profile data must be verified.

NIH has reviewed all the errors and warnings applicants have received to date. As a result of that review and your feedback, we are taking steps to improve the process. Some of the actions below are already in place, and others will be implemented in June.

	Clarify message text and application guide instructions for the most frequent error and warning messages.
	Remove many warning messages (more than 50 percent of the R01 warnings received have been flagged for removal).
	Increase system tolerance for minor inconsistencies in names provided in the application when compared to names included in the eRA Commons profile.
	When possible, change “errors” to “warnings” to allow the submission to proceed.
	Soften the tone of messages and reserve more explicit language or descriptions for cases where delays in application processing are most likely to occur.
	Critically examine errors and warnings that are not required for review and could be addressed prior to award.

We believe the above listed validation improvements are appropriate and necessary, but understand that shifting requirements also is an issue for applicants. Although minor adjustments will always be needed, we plan to fully implement the overall validation streamlining quickly to provide a stable environment as the next R01 submission dates near. For specifics on the most frequently occurring errors / warnings and some of the actions NIH is taking, see NIH Electronic Submission Validations and the 80-20 Rule.

Grants.gov provides a single location to find and apply for federal grants, develops the forms applicants use for submission, and performs initial processing of applications. NIH, like all other federal grant-making entities, is required to post funding opportunities on Grants.gov. Since Grants.gov services a several agencies, each with their own specific requirements and instructions, it only performs very basic application checks known as validations (e.g., all mandatory forms and fields are completed, email addresses and dates are properly formatted, DUNS number provided on the application matches records on file for the submitting credentials, and virus checks). The grantor agency is responsible for verification of application content and compliance with specific program requirements.

The NIH system validations ensure that:

	Business rules are applied consistently.
	Information of special interest to NIH (e.g. new PI designation, phase III clinical trials, use of human embryonic stem cells) is included.
	Your application is attributed to the appropriate PD / PI and applicant organization to facilitate review and improve reporting, career tracking, etc.
	Information provided on your application can be stored in our databases.
	NIH is better positioned to reduce the time from submission to award by automating some of the effort required to process your application.
	Applications are complete, have all the information needed for peer review, and the information is presented in a consistent way to facilitate the review process.

The validations are in place to benefit applicants as well as NIH. Without the NIH validations, many applications would easily pass the submission process only to be deemed non-responsive in the Division of Receipt and Referral. Other applications would proceed to review where reviewers would discover that instructions were not followed. Since all post-submission changes and revisions are provided separately to reviewers, there is no longer the ability to just “replace page 20” in the original application.

We are doing our best to communicate clear requirements and to provide a manageable process with the necessary checks and balances. Thanks to your feedback we are headed in a positive direction. Keep the input coming, we are listening.

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Principal Investigator

The SF424 (R&R) cover component includes a section for the Project Director / Principal Investigator (PD / PI). The information from this section is used to auto-fill other sections of the application including the Senior / Key Person Profile and the R&R Budget forms. The role of PD / PI is automatically set as the default.

Multiple PIs

NIH has chosen the approach recommended by the Office of Science and Technology Policy (published in the Federal Register) that considers all PD / PIs on a multiple PI application to be equal in terms of responsibility, authority and accountability. Therefore, they should have the same role designation on the application. It was determined that designating one individual as the PD / PI and all others as Co-PD / PIs implied some hierarchy that does necessarily not exist. For this reason, PD / PI is the only role that NIH recognizes for PI status and each of the multiple PIs should use this role. Realizing that some other federal agencies may use Co-PD / PI for their multiple PI implementations (e.g., National Science Foundation), NIH provides a warning message when the Co-PD / PI role is used to let you know that if you meant to designate multiple PIs, you have not used the appropriate role for NIH applications. NIH guidance is to avoid the use of Co-PD / PI entirely for NIH applications to avoid confusion. If you choose to ignore the warning, the Co-PD / PI role is stored but no PI status is provided.

Co-Investigators

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dbGaP provides for two levels of access: open (available to anyone with no restrictions), and controlled (requiring preauthorization). NCBI launched the database in December 2006 with the open-access data on two studies; the open-access section allows users to view study documents, such as protocols, as well as summaries of the genotype and phenotype data. The controlled-access portion of the database is just now coming online; with authorization, it provides for downloads of individual-level genotype and phenotype data that have been de-identified (i.e., no personal identifiers, such as name, etc.).

To request access to any of the individual-level datasets within the Controlled Access portions of the database, the Principal Investigator (PI) and the Signing Official (SO) at the investigator’s institution will need to co-sign a request for data access to be reviewed by an NIH Data Access Committee at the appropriate Institute or Center. To complete this step, which uses the SF424 (R&R) form, both will need to have NIH Electronic Research Administration (eRA) Commons accounts. These are the same accounts used to apply for grants, and PIs and SOs who already have such accounts do not need to do anything further to make them applicable to the dbGaP controlled-access authorization process. Visit the eRA Commons Web site for information on establishing an account.

Among the information the PI will provide in these forms is the name of the preferred SO (registered SOs at the PI’s institution are pre-listed on the form), a statement summarizing the proposed research use for the requested data, and a list of collaborating investigators at the same institution. (Collaborators at other institutions will need to submit separate requests for co-submission with their SOs). Submission of the data access request will constitute agreement and acknowledgment by both the PI and the SO to the terms of use for the specific dataset(s) requested, which are detailed in the accompanying “Data Use Certification” (DUC) documents that are provided on the Web site.

After the PI completes the electronic data request process, the SO will be notified by email that a request has been submitted and is awaiting his signoff. The SO then uses his or her eRA name and password to enter the dbGaP authorized access system, where he or she will be presented with the PI’s application to review. The SO has the option of editing the forms, returning the forms to the PI for revision, or signing off that the submitted application is valid. To help ensure applications move through the submission and review process in a timely way, the SO and PI will receive various emails updating them on the status of a request or any required actions. The data access request is then reviewed by the appropriate Data Access Committee(s) at NIH, and both the PI and SO will be notified by email of approval or disapproval.

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Roadmap Update—Initiative Selections Made

The idea selection process for a new cohort of Roadmap initiatives has concluded.

Through the summer and fall of 2006, NIH solicited ideas for new initiatives from a wide array of constituents to help senior NIH staff identify crosscutting challenges in biomedical research that meet special criteria established for Common Fund (Roadmap) initiatives.

NIH’s Office of Portfolio Analysis and Strategic Initiatives (OPASI) coordinated programmatic review of the submitted ideas and collaborated with NIH Institutes and Centers (ICs) to assess currently funded research related to several of the broad areas highlighted by the ideas. IC Directors then selected the broad areas that were to be pursued as either:

	Major Roadmap initiatives
	Pilot studies
	Coordination areas
	Strategic planning areas

Earlier this month, IC Directors met to review and prioritize specific proposals. Four topics were chosen to move forward as major Roadmap initiatives, with the first two approved for immediate implementation as five year programs and the second two approved for staged implementation:

	Microbiome
	Epigenetics
	Protein capture tools / Proteome tools
	Phenotyping services and tools

The genetic connectivity map was selected as an NIH Roadmap pilot study.

The Working Group on Roadmap Coordination Groups will assess current efforts in regenerative medicine, pharmacogenomics and bioinformatics. The Working Group on Roadmap Strategic Planning Activities will focus on training / careers, health disparities and the science of science administration.

Complete information about the Roadmap emphasis areas is available at the NIH Roadmap for Medical Research Web page.

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Should the NIH R01 Grant Application Be Shorter?

At the recent NIH Peer Review Advisory Committee (PRAC) meeting, co-chairs of the NIH Grant Application Committee presented responses to the NIH’s Request for Information (RFI): Possible Page Limit Reduction For the Research Plan Section of the Research Project Grant (R01) Application submitted by over 5,000 applicants and reviewers.

An initial analysis of the input revealed that the majority supported shortening the grant application. Of the total responses submitted, committee members then analyzed 500 randomly selected responses in detail. Based on this input, the committee made the following recommendations:

	The research plan section of the application should be shortened—a majority favored 15 pages
	Instructions to applicants and reviewers should be modified to emphasize impact
	Sections of the application should be more closely aligned with the review criteria

Additional information and other presentations from the April 19 PRAC meeting are available on the PRAC Web site.

Peer Review Notes, published by NIH’s Center for Scientific Review  also provides information about grant application review policies, procedures and plans.

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North Carolina NIH Regional Seminar Draws Largest Attendance Ever

More than 900 researchers and research administrators from 39 U.S. states, the District of Columbia, and as far away as Africa attended the most recent NIH Regional Seminar on Program Funding and Grants Administration, held in Research Triangle Park, NC from April 24–26. Participation was the largest of any NIH Regional Seminar to date.

The OER has coordinated these two-day seminars since 1979 to clarify federal regulations and policies, provide the fundamentals of the application and review processes, and highlight current areas of special interest, such as electronic submission of grant applications. Policy, grants management, review and program staff members from across the NIH provide a broad array of expertise and encourage a friendly, open dialog with seminar participants.

NIH Electronic Research Administration (eRA) labs for Principal Investigators and administrators were offered in conjunction with the seminar, providing some 200 people with hands-on experience in how to interact electronically with NIH.

Presentation materials from the Research Triangle Park NIH Regional Seminar are now available.

	Diane Dean, director, and Jeannette Gordon, assistant grants compliance officer, OER Office of Policy for Extramural Research Administration, Division of Grants Compliance and Oversight present Common Compliance Pitfalls and Strategies for Success.
(Click image for larger view; image opens in new window)
	Rebecca Claycamp, chief grants management officer, National Institute of Mental Health briefs a full auditorium on Multiple Principal Investigators: Going Where No One Has Gone Before!

In 2008, the OER will conduct Regional Seminars in San Antonio, TX, tentatively March 25-27 and in Chicago, IL, tentatively June 18-20. Formal announcements and additional information about the 2008 Regional Seminars will be published in the NIH Guide for Grants and Contracts.

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ANNOUNCEMENTS:

In Memoriam Stephen E. Straus, M.D. First Director of NIH’s National Center for Complementary and Alternative Medicine and Internationally Recognized Physician-Scientist

The National Center for Complementary and Alternative Medicine (NCCAM) has published a notice about the recent death of Stephen Straus, M.D. The release details Dr. Straus' NIH career and achievements, and provides further information about NCCAM's condolence message board.

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OER Web Site Gets a Facelift

OER announces exciting changes coming during the week of July 9 to the OER Home Page, a frequently used Web site for grants process information and links to various NIH grant resources and information.

	What is new for you, applicants and grantees?
	The new site will offer a user-friendly layout, valuable content areas, a new color scheme, updated links, revised content throughout and much more.
	A section with a summary of and helpful links to elements of the NIH Grants Process (e.g., Grant Basics, an interactive NIH Grants Process At-A-Glance chart, an activity code search, expanded funding mechanism chart, etc.)
	A revamped, customer-focused Electronic Research Administration (eRA) home page that provides helpful facts and links for busy users inside and outside of NIH. Look for newly developed fact sheets on commonly used electronic applications (e.g., streamlined noncompeting award process (SNAP), no cost extension notification, financial status report submission, etc.), easy access to Commons support pages, quick links to databases and more.
	Updated commonly visited OER Web pages, including active and helpful links, text, and contact information.
	What about current links?
	In general, the changes are cosmetic and will not affect current links. If a current Web page link is changed, however, a screen will appear in its place providing users with a redirect and/or alternate resources.  The purpose of the new design for each site is to be helpful, accurate, and user-friendly, so if you have any technical problems, feel free to contact the OER Webmaster.
	OER Web page updates will be ongoing. Plans include an interactive and comprehensive glossary, and helpful charts and tools to aid the extramural grants community and general public in understanding the NIH grants process and effectively locating NIH resources. The eRA Web site will continue to evolve over the next several months as we continually evaluate and improve the resources available to NIH customers.
	Who was involved in the redesign process?
	The new OER site format, language, content, colors, and other attributes are the result of an extensive evaluation of the current site content, affiliated Web pages, and navigation system performed by a consulting firm that specializes in Web site usability.
	Input was gathered from grantees and NIH users and formal usability testing was also conducted with grantees and NIH users, leading to recommendations used by OER in the new site design.
	The eRA pages of the OER site are in the stages of the redesign process based on an internal evaluation and review of user comments and needs, as well as discussions with applicant users.
	Look for the OER Web site on a new NIH Home Page
	The launch of the OER and eRA Web sites will coincide with the unveiling of the new NIH home page. These sites will go live within days of one another; additional notification will be sent to you at that time.

The OER is working diligently to provide the NIH extramural community with the tools necessary to navigate the grants process. Email any questions or comments to the OER Webmaster.

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NIH Investment in Extramural Research and Training Programs Slide Set Now Available

Now posted on the OER Award Data Web site is the NIH Investment in Extramural Research and Training Programs (PowerPoint®) slide set.

The presentation, titled Facts and Figures on National Institutes of Health Extramural Programs is produced by the OER Division of Information Services, Office of Research Information Systems. It includes frequently requested information on NIH extramural programs, organized by major program areas.

Each January, an update of the slide set will be published and will reflect data collected shortly following the end of the prior fiscal year.

Data associated with the slide set’s tables, charts and graphs are linked within the publication and can be accessed by right clicking the slide, selecting “edit slide” then double clicking the graphic.

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NIH Launches New Web Site to Promote the Advancement of Women in Biomedical Research Careers

The NIH Working Group on Women in Biomedical Careers was created to respond to the challenges issued to federal funding agencies by the National Academies report, Beyond Bias and Barriers: Fulfilling the Potential of Women in Academic Science and Engineering, and also to promote the career advancement of women in the intramural research community. The Web site provides information about the Working Group, including the list of members, the subcommittee tasks and members, and the initial charge.

The NIH invites you to explore the Women in Biomedical Careers Web site and contact us at womeninscience@nih.gov.

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