NIH REINVENTION STATUS REPORT Release Date: October 21, 1998 P.T. National Institutes of Health Introduction This is the sixth status report on NIH electronic research administration (ERA) and reinvention activities. The previous reports were published in the NIH Guide for Grants and Contracts on the following dates: Vol. 23, No. 44, December 16, 1994; Vol. 24, No. 14, April 14, 1995; Vol. 24, No. 40, November 24, 1995; Vol. 25, No. 23, July 12, 1996; and Vol. 26, No. 17, May 23, 1997. The status report provides an update on ERA efforts and the NIH priority reinvention initiatives for 1998 that the NIH Office of Extramural Research (OER) is coordinating in a partnership with the NIH Institutes and Centers (IC). The 1998 NIH priority reinvention initiatives are being pursued along a continuum of activity that ranges from concept development to implementation. Some NIH institutes and centers also may be conducting their own reinvention initiatives or small-scale pilots. Information about these activities may be available on that IC's homepage, and questions may be directed to staff of the particular IC. As the NIH continues to undertake reinvention activities and new initiatives, we recognize the need to establish a framework that guides our efforts. The framework NIH currently references was crafted by a cross-section of NIH officials with input from the extramural community. It delineates four major goals for reinvention: (1) maximize scientific opportunities through optimal use of resources; (2) enhance NIH interactions with the research community; (3) clarify and streamline decision-making processes; and (4) focus internal operations on outcomes and results. Each of these goals is further classified into specific reinvention objectives, and the plan is to use these goals and objectives as guideposts as the NIH moves forward with its reinvention projects. MILESTONE ACHIEVEMENTS In 1994, the NIH extramural programs were designated as a Reinvention Laboratory under Vice President Gore's National Performance Review (now the National Partnership for Reinventing Government) to "create a government that works better and costs less." Since formalizing its involvement in reinvention four years ago, the NIH has achieved a number of milestones in its development of electronic research administration (ERA) and reinvention of its extramural research administration practices. o In Fiscal Year 1995, the NIH implemented SNAP (Simplified Noncompeting Award Process). Because noncompeting awards represent the largest percentage of the grants workload for NIH program and grants management staff, the NIH chose to streamline the amount of information noncompeting grantees are required to report to the agency every year. As a result, noncompeting applicants do not need to submit certain financial reports so long as there are no significant changes in their project's budget. In Fiscal Year 1998, 76 percent of noncompeting awards were processed under SNAP procedures. In 1999, NIH plans to increase the efficiency of SNAP procedures by deploying an electronic version, e-SNAP. o In 1995, NIH fully implemented Streamlined Review a process that all Center for Scientific Review (CSR) study sections now employ to identify those applications that are in the "top half." The rationale for this approach was based on data indicating that almost all investigator-initiated applications reviewed by CSR and selected for funding by the Institutes received scores within the upper half (meaning 50th percentile or better) of all reviewed applications. The use of streamlined review has shortened review meetings and enabled peer reviewers to focus their professional expertise on those applications most likely to be selected for funding. o In conjunction with streamlined review, NIH also implemented the use of simplified summary statements. Applicants now receive the reviewers' raw critiques as opposed to a document that NIH staff once prepared, summarizing all of the reviewers' comments. This practice improves NIH staff efficiency and the amount of information each applicant receives regarding his or her application. o In 1995, the NIH deployed "Edison," a secure, interactive Web site for reporting, monitoring, and tracking inventions derived from Federally funded research. Implementation of this system streamlined the invention reporting process by reducing the average of 15 cycles of paper correspondence for each invention to only four documents with requisite original signatures. As of September 1998, 130 organizations had established accounts to use the Edison system. Over 75 inventions are reported to Edison each week. Further, six other Federal agencies have adopted Edison for their invention reporting and tracking purposes. (http://www.iedison.gov) o In 1996, the NIH began development of the NIH Commons, a web-based client/server environment where the NIH and grantee community will conduct their research administration business electronically by Fiscal Year 2000. In 1998, NIH pilot tested the following features of the NIH Commons system: (http://commons.era.nih.gov/commons/) o Deployed the Status interface of the NIH Commons, which allows institutional officials and principal investigators, with appropriate security, to access the status of pending applications and awards, for testing with institutions participating in the Federal Demonstration Partnership (FDP) (http://TheFDP.org/); o Granted FDP institutions access to the e-SNAP interface of the NIH Commons a web site designed to facilitate submission of the noncompeting grant applications (PHS form 2590) and the submission of annual scientific progress reports; o Posted an Internet web site where FDP institutions can submit (and NIH can receive) training statement of appointment forms (form 2271). Since 1996, the NIH has received over 2,000 training appointment forms utilizing this technology. In December 1998, the current site will be replaced by the more efficient X-Train Training Appointment System, which will be accessed through the NIH Commons; o Finally, in conjunction with members of the FDP, the NIH Commons staff developed institutional and professional profiles, which will standardize the information collected about applicant institutions and individuals and minimize the redundancy of information collected with every grant application. NIH is also working with other Federal agencies to develop the Federal Commons, a common electronic grant system that will promote flexible technological approaches to accommodate the needs of all Federal grant recipients. In 1998, the NIH received $220,000 from the General Services Administration, on behalf of other Federal agencies, to fund development of the Federal Commons interface. o In 1998, the NIH completed development and began deploying a revised version of its Information for Management, Planning, Analysis, and Coordination (IMPAC) system. IMPAC II is a system, used by internal NIH staff, to track and manage research grants and contracts. IMPAC II has been developed so its information can be migrated to the NIH Commons. Hence, deployment of the IMPAC II system will enhance the amount of information NIH makes available to the public about its research grants and contracts. Through this system, NIH has processed and mailed approximately 6,000 electronic notice of grant awards to institutions participating in the Federal Demonstration Partnership. o In 1998, NIH posted its Computer Retrieval of Information on Scientific Projects (CRISP) system on the NIH Commons. The searchable CRISP database, which includes information regarding federally funded biomedical research projects conducted at universities, hospitals, and other research institutions, enables users to research scientific concepts, emerging trends and techniques, or identify specific projects and/or investigators. Since 1992, CRISP has been located on a Gopher server maintained by the NIH. By relocating the database on the Commons, NIH has improved the public's ability to access and search the CRISP records. (http://commons.era.nih.gov/commons/) o OER hosts numerous Web sites at NIH in an effort to facilitate communications with the public and NIH staff. The OER Grants web site (http://www.nih.gov/grants/oer.htm) provides a service for researchers, research administrators, research organizations and others interested in NIH programs. This site provides information to approximately 35,000 users per month and has become a primary vehicle for dissemination of timely and critical information to the public. A new addition to OER is the NIH Research Training Opportunities web site (http://www.nih.gov/training/), which incorporates information about intramural and extramural training opportunities of all NIH Institutes and Centers. It is expected that this site will play a significant role in providing the NIH community with important and timely training-related information, organized in a user-friendly format. Electronic Research Administration Improving stewardship is a prime ongoing objective at the NIH in the administration of grants and contracts to support research at universities and other research facilities throughout the nation. Improving the efficiency of various administrative business processes and introducing more efficient ways to communicate relevant information to grantee/contractor organizations will maximally leverage appropriations devoted to research, and thereby contribute directly to the productivity of the nation's medical research enterprise. The impressive advances and almost constant changes in Information Technology are being exploited at the NIH to improve stewardship of Federal funds. NIH is currently devoting substantial resources to the design, development, and deployment of an electronic research administration (ERA) system. This ERA system will greatly facilitate preparation of grant applications by research investigators, processing of applications by NIH staff, and management of awards by grantee organizations and NIH staff. Eventually, the ERA system will place the entire grants administration life cycle of business processes within a secure, efficient client-server common file database. For the majority of the ERA functions described below, 1997 is a pilot year; 1998 is a transition year (expanding pilot testing to include 65 Federal Demonstration Partnership Institutions); 1999 is a further expanded pre-production deployment year during which approximately 100-150 organizations will be using the software; and 2000 represents the goal for the full production implementation. Advances in ERA and reinvention, while inter-related, are developing on separate tracks. Therefore, to keep the public apprised of the latest ERA news, NIH has developed a web site solely devoted to it. The latest 1998 ERA Status Report can be accessed on the ERA homepage. (http://era.nih.gov/) The 1998 NIH Priority Reinvention Initiatives MODULAR RESEARCH GRANTS AND AWARDS In 1998, pending the approval of Dr. Varmus and the NIH Institute and Center directors, NIH is implementing the modular research grant application and award concept. Modular application, review and award procedures will apply to most research project grant mechanisms (totaling no more than $250,000 in direct costs) for the June 1, 1999, receipt date. The modular research grant initiative, which has undergone extensive development and pilot testing since 1994, builds upon previous activities in just-in-time submission of information and modular budget proposals. Under just-in-time procedures, selected information or forms are not required at the time of application; instead, this information is requested prior to award from just those applicants with a likelihood of funding. Under modular budget proposals, applicants are instructed to prepare the budget request in direct cost "modules" (multiples) usually up to a maximum direct cost level. This process eliminates the need for much of the budget detail, thereby relieving administrative burdens on both NIH staff and grantee organizations and simplifying cost management by NIH program staff. Just-in-time procedures have been applied to several mechanisms, including selected Career (K), AREA (R15), and SBIR Phase I (R43) awards. In the past four years, modular budget procedures have been extensively pilot tested in over 34 application solicitations, covering a wide variety of award mechanisms issued by the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Disease (NIAID). The initial goal of the modular research grants initiative has remained constant: to refocus the application and award process on the proposed science by reducing unproductive attention to budget details. Consistent with this goal, a trans-NIH committee, comprised of grants management, review, and program officials, has developed a final recommendation for implementing the modular research grant concept. The committee's recommendation has been thoroughly reviewed and commented on by groups inside and outside of the NIH. Based on public reaction and input, the final proposal recommends allowing future applicants to request total direct costs in $25,000 increments up to $250,000. (Applications requesting more than $250,000 in any year would be required to follow current application instructions). The proposal also envisions applicants submitting simplified budgets absent of detailed categorical budget information on a revised, streamlined form. Additional budget detail would be requested only under unusual circumstances. The just-in-time features of the proposed modular scheme would allow applicants to postpone the submission of other support information until just prior to award. If the committee's recommendation for implementing the modular research grant application and award proposal is approved by NIH Director Harold Varmus and the NIH Institute and Center Directors, an announcement unveiling the details of the modular proposal will be published in the NIH Guide for Grants and Contracts. The first full year of implementation will be a period for comment. A thorough evaluation will be conducted in the three years following implementation of the modular proposal. Throughout the initial implementation phase, NIH will welcome input from investigators, reviewers, applicant organizations, and staff and will consider appropriate modifications. Inquiries and comments will accepted at: grantsinfo@nih.gov EXPEDITED RECEIPT TO AWARD Since 1996, NIAID, in a partnership with the Center for Scientific Review (CSR) and the OER, has been pilot testing an initiative designed to shorten the time from receipt of application to award for the most meritorious applications. This initiative has been pilot-tested with all applications that are reviewed by the CSR Tropical Medicine and Parasitology (TMP) study section and assigned for potential funding to NIAID. The pilot test has involved streamlining five features of the application-to- award process. (For the full details, see the notice published in the NIH Guide for Grants and Contracts, January 10, 1997.) First, the internal NIH process for assignment of applications for review and potential funding is by-passed, so that investigators self-assign their applications to the TMP study section and NIAID. Second, NIAID has developed a World Wide Web-based electronic review system, which allows study section members to submit their electronically encrypted reviews to a password-secured Web server prior to the study section meeting. However, the essential components of the peer review system remain unchanged, and as under current procedures, independent scoring of applications is done by each reviewer at the meeting. Third, applicant institutions have the option of deferring submission of the institutional review board (IRB) human subjects certification; for fundable applications, this certification will be requested by NIAID immediately after peer review. Fourth, selected applicants (those whose applications exhibit only minor problems) will be invited to submit an abbreviated application amendment (three to five pages) in response to specific questions and concerns raised during the initial review; these brief amendments will be reviewed at the very next meeting of the study section. Finally, under the TMP pilot, the second level of peer review, performed by the National Advisory Council, is expedited for the most meritorious applications (as determined by peer review) so that it occurs electronically prior to the actual Council meeting, thus allowing awards to be made sooner. A preliminary evaluation of the NIAID expedited receipt-to-award pilot has demonstrated that the combination of electronically-assisted peer review and the NIAID expedited council review process cuts the time from application receipt to award from nine months to five or six months. Given these promising results, the NIH has expanded pilot testing to four additional institutes (NHLBI, National Institute on Aging (NIA), National Institute of Child Health and Human Development, and National Institute of Neurological Disorders and Stroke (NINDS)). In 1998, these institutes, acting as "model institutes," are instituting policies and procedures to initiate implementation of certain components of the NIAID experiment, including expedited council review and the use of just-in-time procedures. These model institutes are also planning to pilot test pre-award, pre-council grants management review procedures. These procedures authorize grants management staff to calculate total costs and conduct business reviews of the most meritorious applications (those with scores within a predetermined payline) prior to, as opposed to after, the Advisory Council meeting. At NHLBI, NINDS, and NIA, where this initiative has been pilot-tested, pre-award, pre-council grants management review has helped cut more time from the overall receipt-to-award process. The model institutes are also being encouraged to develop and experiment with their own procedures for expediting the receipt- to-award process. Over the next year, the NIH will be tracking the progress of this initiative and evaluating its effectiveness. If the results are encouraging, the NIH plans to further expand implementation of the expedited receipt-to-award initiative. PROGRESS REPORTING In 1998, the NIH will continue its in-depth review and analysis of issues related to the annual scientific progress reports submitted by grantees. The primary objective of this initiative is to ensure that NIH staff receive necessary and useful information related to scientific research progress in a timely manner. As NIH prepares to receive progress reports electronically for the majority of noncompeting applications (See March 1998 ERA Status Report regarding e-SNAP initiative), the time is ripe to reconsider the purpose, timing, content, and format of the annual progress information. Further, given the progress that has been made towards building the "Federal Commons" (an interagency electronic interface where grantees will be able to conduct electronic research administration transactions), the time is ideal for NIH to coordinate its electronic progress reporting initiatives with other research agencies. In this spirit of interagency coordination, the NIH has met with other Federal research agencies to exchange information about their respective progress reporting procedures and to identify common data elements in their progress reporting formats. The goal for 1998 is for the NIH, working with other Federal research agencies, to develop a pilot that will enable a subset of NIH grantees to submit their progress reports electronically ideally, through the Federal Commons interface. SCIENTIFIC CODING The NIH is continuing to review and analyze issues related to its scientific coding process. Scientific codes are those key terms assigned to each project that appears in the NIH database of funded research. NIH has been working to improve the accuracy, quality, and assignment process of its scientific codes to ensure that NIH systems accurately reflect the NIH-supported research. The NIH Office of Extramural Research (OER) is sponsoring a variety of experiments aimed at improving the NIH scientific coding process. Specifically, this year, OER is testing the feasibility of using alternative source documents, such as an application's abstract and/or specific aims to expedite and enhance the indexing process. OER is also experimenting with automated indexing software to compare the quality of machine-indexed versus human-indexed abstracts and the retrieval of machine versus human-indexed projects. Finally, OER is working with the NICHD to synchronize the NICHD project coding system with the NIH CRISP database that the public accesses to retrieve scientific project data. If OER and NICHD are able to develop a common coding system, this effort will be expanded to include other NIH Institutes and Centers. COMMENTS Input from NIH staff and the extramural research community is essential to the success of the NIH reinvention effort. Therefore, comments or suggestions on the implemented changes and pilot experiments discussed in this report are welcome and may be sent to the following email address: DDER@nih.gov INQUIRIES Dr. Wendy Baldwin Deputy Director for Extramural Research National Institutes of Health Building 1, Room 144 Bethesda, MD 20892-0162 Email: DDER@nih.gov

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