Inside eRA for Partners, October 27, 2004 (Volume 4, Issue 4)

e-Application Pilot Underway for May 2005 Council Round

For the October/November 2004 receipt dates (May 2005 Council Round), eRA is conducting its fourth and final pilot for simple, modular R01, R03 and R21 electronic grant applications. eRA plans to achieve a major milestone in January 2005 when the electronic receipt of these grants (new, competing continuation, and revised) goes into full production.

In addition to receiving 25 modular applications for the October due date, eRA received one full-budget application. Since pilot applicants indicated their preference to format their own budget justifications, eRA is accepting the full-budget justification in PDF.

Six Service Providers (SPs), who will assist applicants with their electronic submissions, are participating in the fall pilot. Prior to the pilot, SPs had to demonstrate their capability by successfully submitting an application of each pertinent type to the eRA test database. eRA invites institutions and commercial vendors interested in becoming SPs to send a request to Scarlett Gibb, chief eRA Planning, Communications and Outreach Branch.

Upcoming Pilots

• RFA Pilot –– eRA is developing the capability to handle applications responding to Requests for Applications (RFAs) and Program Announcements (PAs) for supported types and mechanisms. Unlike other competing applications, responses to RFAs do not go to the Center for Scientific Review (CSR) for review; instead, the announcing Institute/Center performs the review. Electronic receipt holds great promise for reducing the processing and review time for these applications. Upon receipt, there is the possibility of referring the RFA applications automatically to the IC review group rather than waiting for CSR to perform the processing and routing. NIH currently is identifying RFAs that are good candidates for an upcoming pilot.   
• February/March 2005 Pilot ––eRA will continue piloting full-budget applications. The pilot also plans to accept supplements and will support some post-receipt corrections (addenda).   
• eRA/Grants.gov Integration Pilot –– eRA has been collaborating with Grants.gov to determine the feasibility of conducting a live pilot in the spring of 2005. To that end, eRA has: 
  • Mapped Standard Form (SF) 424 Research and Related (R&R) data elements to the eRA database. (Grants.gov receives the electronic version of the SF 424.)   
  • Submitted NIH-specific data analysis to supplement the SF 424 R&R.   
  • Defined business validations for Grants.gov applications.   
  • Completed initial eRA/Grants.gov system-to-system testing.

Next steps in preparation for the pilot include:

• Integrate Grants.gov Web service calls with the eRA eXchange (architecture for handling system-to-system transmissions).   
• Implement business validations for Grants.gov applications.   
• Create mechanism to send warnings and error messages to the applicant through the Commons.   
• Finalize and post the NIH-specific application package on Grants.gov.   
• Generate a grant image based on the SF 424 R&R format.   
• Invite Commons Working Group members to participate in tests using previously submitted application data.

Other Activities in Support of Electronic Grant Applications

• Electronic Notice of Grant Award –– The Notice of Grant Award (NGA) will be the first major outgoing electronic transaction for the eRA eXchange. The requirements analysis is underway and development is expected to begin by the end of the year.   
• New Test Environment –– eRA is creating a new test environment for SPs that integrates the eRA eXchange and the Commons demo facility.   
• Electronic Business Extensible Markup Language (ebXML) Standard –– ebXML is an international standard for specifying the electronic exchange of business information between electronic trading partners. With contractor assistance, eRA is comparing the ebXML registry and message service of three off-the-shelf software packages with the current eRA solution.   
• NCRR GCRC Progress Reporting –– The National Center for Research Resources (NCRR) has begun a development effort to support system-to- system transmission of progress reports from the General Clinical Research Centers (GCRCs). The eRA team and NCRR are planning to use the eRA eXchange for this initiative.

More Information

• Information for Service Providers –– Go to http://era.nih.gov/Projectmgmt/SBIR/.  
• Questions about Electronic Applications –– Contact Jennifer Flach, eCGAP team leader, at flachj@mail.nih.gov or 301-435-5092.

CSR Encourages Investigators to Submit Electronic Applications

The Center for Scientific Review (CSR) is urging all investigators to consider submitting their future applications electronically. In an open letter to grantees, Dr. Brent Stanfield, acting CSR director, states that e-applications are vital to improving NIH’s grant application process and shortening the time from submission to potential award.

‘”Not only will you be helping yourself submit an application that conforms to the NIH requirements, you will be doing a service for future scientists and their grant submissions,” argues Stanfield.

Stanfield assures grantees that electronic applications are not disadvantaged during referral and review. CSR will assign e-applications to Institutes and Centers (ICs) for funding consideration and review using the same process as for paper applications. For example:

• The electronic Competitive Grant Application Process (CGAP) system enables the applicant to include a cover letter with suggestions for assignment, identification of critical scientific areas, and discussion of potential conflicts of interest. 
• Assigned reviewers and readers will receive paper copies of all applications as well as images of all applications on a CD ROM.

In actuality, electronic applications often present inherent advantages over paper applications. For example:

• CD images of electronic applications are of higher quality than those scanned from paper. 
• CD images of figures and graphs submitted electronically retain their color as initially presented. 
• Business rules defined in CGAP software prevent applicants from submitting applications with common errors that can lead to rejections and delays in review.

CSR also has appealed to members of study sections to concentrate on evaluating the scientific and technical merit of each application. During the transition to electronic grants, reviewers are likely to see a greater variety of formats of applications. Stanfield advises reviewers not to let superficial differences interfere with their evaluation.

Address questions and concerns about the handling of electronic applications in CSR to Dr. Suzanne Fisher, director, Division of Receipt and Referral at fishers@csr.nih.gov or 301-435-0715.

CWG Discusses Commons Enhancements at September Meeting

Representatives from 15 participating grantee institutions met with eRA staff and electronic application Service Providers at the September 19 meeting of the Commons Working Group (CWG) in Washington, D.C. The majority of the agenda items concerned plans for the expansion of Commons capabilities over the next 12 months and ongoing activities related to the electronic submission of competing applications.

Agenda Topics

• Electronic, Competitive, Grant Application Process (CGAP) –– Jennifer Flach, CGAP team lead, presented a comprehensive update. See e-Application Pilot Underway for May 2005 Council Round in this issue for details.      
• Organizational Hierarchy –– In response to CWG requests to modify the current Commons security scheme, Dan Hall, lead Commons analyst, proposed a new organizational hierarchy that will accommodate each institution’s unique structure (i.e., schools/divisions/departments) and the many roles/rights required by large institutions.

The proposed new security scheme:

• Defines “rights” instead of “roles.”      
• Enables institutional officials to define their own organizational hierarchy structure.       
• Enables institutional officials to assign rights at different levels within their hierarchy (historically, institution/school/division/department but this structure can be any combination of levels from 0 to 5 levels of structure). The institution level is known as the “root” level.      
• Enables institutional officials to place a project/grant within their own defined structure affecting current-year NIH rankings.      
• Supports four rights at the root level: 1) Signing Official (SO); 2) Account Administrator (AA); 3) Principal Investigator (PI); and 4) Basic (formerly Assistant). These former roles now will be called institutional rights.      
• Enables institutional officials to assign the following rights at other levels in the hierarchy structure. These will be called hierarchy rights.
  • STATUS DETAIL –– View Status module detail screens      
  • DOCS –– View relevant documents (except summary statements)      
  • FSRDE –– Enter FSR data      
  • FSR –– Enter FSR data and submit FSR      
  • NCE –– Submit No-cost Extension      
  • JITDE –– Enter Just-in-Time data      
  • JIT –– Enter Just-in-Time data and submit JIT      
  • ESIGN –– Sign electronic applications      
  • ESNAP –– Submit eSNAP      
  • FPR –– Submit Final Progress Report      
  • FIS –– Submit Final Invention Statement      
  • AO –– View Status detail and relevant documents; submit eSNAP

The eRA team is creating a prototype for CWG evaluation.

• Commons Update –– There are three Commons upgrades scheduled for this fall. There are plans for a major new release in April/May. Highlights include: 
  • Release 2.6.4 (October 21) — Authorized grantee officials able to register their institutions to submit eSNAPs. System maintenance. 
  • Release 2.7.0 and 2.7.1 (Late Fall 2004) — Grantees able to identify their terminating grants and submit required closeout documents (Financial Status Report, Invention Statement, Final Progress Report) through the Commons. eRA staff able to edit Commons text as needed. Better error handling and IAR enhancements. PIs able to view eCGAP transmission errors using Status. System maintenance. 
  • Release 3.0.0 (Spring 2005) — eRA to replace its current role-based security with a more flexible rights-based security system. Access to WebQT, eRA’s enterprise tool for searching, viewing, printing and exporting data from the eRA production database. Ability to download FSR search results into Excel. Integration with the National Library of Medicine (NLM) PubMed database, enabling the PI to pull article citation information directly from PubMed.
• General Clinical Research Center (GCRC) Progress Reports –– Dr. Peter Highnam, senior advisor to the director of the National Center for Research Resources (NCRR), spoke about the joint eRA/NCRR plan to receive electronic General Clinical Research Center (GCRC) progress reports through the NIH eRA eXchange. There are about 80 GCRCs across the nation that provide clinical resources (e.g., laboratories, staff) to investigators. Complex, annual GCRC progress reports monitor disease-related studies, track GCRC utilization, and collect information on scientific accomplishments.

Currently, eRA and NCRR are preparing to support system-to-system transmission of annual progress reports from the GCRCs to the NIH eRA eXchange to NCRR processors. A phased delivery is in progress that allows GCRCs to benefit in the near term while aligning future development with eRA. System-to-system technology will reduce the administrative burden, prepare secure informatics groundwork for multi-site collaboration, and pave the way for accepting other complex electronic reports.

In preparation for system-to-system communication, eRA is working with the GCRCs to define the XML-based reports. Testing will follow. NCRR intends to make system-to-system submission an option for FY2005 GCRC progress reports. 

For more information, contact Peter Highnam at highnam@nih.gov or David Wright at david.wright@nih.gov.

• X-Train –– eRA plans to reintroduce X-Train, the NIH Commons interface for tracking National Research Service Awards training appointments. The new version will be more user friendly and more powerful than its predecessor. Trainees must have Commons accounts.

The next CWG meeting will take place on Wednesday, January 12, 2005, in Las Vegas. NIH is holding its meeting in conjunction with the Federal Demonstration Partnership (FDP) Phase IV General Meeting, scheduled for January 13–14. For more information about the FDP meeting, go to http://thefdp.org/Meeting_Info_Jan2005.html. 

Since its formation in January 2001, the CWG has played a critical role in shaping, evaluating and fine-tuning eRA electronic interfaces to the extramural NIH grantee community. CWG meetings are open to all interested persons. For more information, contact David Wright at david.wright@nih.gov or 301-435-1792.

eRA Working Group Explores Technology-Assisted Disease Coding

eRA is collaborating with representatives from seven Institutes and Centers (ICs) to evaluate the use of advanced text-mining technology to improve NIH’s reporting on funding by disease. In his testimony to the House Appropriations Labor/Health and Human Services (HHS) Subcommittee on April 22, NIH Director Elias Zerhouni said that NIH would implement “intelligent data mining” to provide better accounting to Congress and the public on NIH’s investment by disease.

Currently, the NIH Office of the Budget must prepare agency-wide reports on more than 230 diseases and conditions. With the dual objectives of standardizing definitions and automation, the NIH Director’s Steering Committee requested that eRA form a working group to test the feasibility of using specific text-mining tools to accurately and consistently assist with disease coding. The Knowledge Management Disease Coding (KMDC) Working Group, which began meeting in April, presented its findings to the Steering Committee on October 21.

About Collexis® Technology

Collexis® refers to a family of intelligent, text-searching tools for examining vast quantities of data to identify patterns and establish relationships. As bio-medical data grows to petabytes (millions of gigabytes), managing this data becomes increasingly important. Intelligent text mining holds promise for promoting health research and accelerating discoveries by automating the integration of multiple data bases to find linkages and make hypotheses.

In January 2004, after evaluating available systems, NIH procured a site license for Collexis software. This software is based on the principle of “fingerprinting” each piece of text that contains relevant information, such as an article in a scientific journal. The fingerprinting process makes use of the professional terminology of a particular field. For example, the system can fingerprint an article based on the National Library of Medicine Medical Subject Headings (MeSH®) Thesaurus. Collexis then can condense the fingerprints of all of the researcher’s publications into a knowledge profile of that individual.

Once Collexis has completed the fingerprinting/profiling of all sources of input, the system can make associations based on criteria established by the user. Consider this application. A busy Helpdesk receives several hundred e-mails daily that require responses from an expert. KM helps the Helpdesk by building knowledge profiles of all its employees. From then on, routing an incoming email is a matter of matching its fingerprint with the catalog of employee knowledge profiles.

Progress of Disease Coding Working Group

The KMDC Working Group, led by Richard Morris, has made significant headway over the past four months. The group completed the following tasks:

• Established contracts with Collexis and Mitretek to support the KMDC initiative. Patti Gaines is the eRA task order manager.   
• Set up a policy sub-group to draft an NIH KM basic principles and implementation document.   
• Created a test database, comprising the research plans for FY2003 R01 competing applications.   
• Fingerprinted 12 disease categories using a variety of methods:

1. Grants that IC-experts had previously assigned to the disease codes   
2. Articles by experts in each disease category   
3. Trans-NIH definitions   
4. MeSH Thesaurus   
5. Combination of method 1 and method 4   
6. Method 1 modified by IC coding experts

• Tested the accuracy of the fingerprints in several trials. Used lessons learned from successes and failures to fine tune the fingerprinting process.   
• Established a Web portal where group members can test the KMDC system.   
• Developed draft algorithms for converting the percent relevant of disease-code fingerprints to dollar amounts for budget reporting.

The KMDC policy group, comprised of representatives from the participating ICs and led by Izja Lederhendler, began meeting to consider basic principles of operation and options for governance. With technical assistance from Patti Gaines, Archna Bhandari, and Chanath Ratnanather who prepared the data, the policy group will present its findings to the NIH Steering Committee. Throughout the process, Norka Ruiz-Bravo (NIH deputy director for Extramural Research) and Richard Turman (director, NIH Office of the Budget) worked with Richard Morris, Izja Lederhendler, Della Hann, and Lee Pushkin to guide the effort. 

Previous NIH Pilots

Several earlier pilots at NIH demonstrated proof of concept of KM’s promise for optimizing eRA knowledge assets and shortening grant cycle times. According to a statement by CSR Division of Biologic Basis of Disease Director Elliot Postow on May 17, the introduction of electronic grant applications and referral technologies could reduce the review cycle by six to eight weeks.

• KM-Assisted Reviewer Selection (1) –– In the spring of 2003, Dr. Arthur Petrosian, a scientific review administrator at the Center for Scientific Review (CSR), used his Computerized Reviewer Assignment and Search Program (CRASP) to assist scientific review administrators (SRAs) in locating reviewers for specific ad hoc diagnostic imaging study sections. CRASP matches fingerprints based on keywords in CRISP and PubMed with reviewer profiles. Although there was no systematic evaluation of this pilot, SRAs found the tool encouraging.   
• KM-Assisted Reviewer Selection (2) –– Mitretek Systems developed a Grant Reviewer Selection (GRS) prototype using 60,000 candidate reviewers drawn from CRISP and MedLine and 30,000 FY2003 R01 research proposals. Collexis software generated fingerprints for each reviewer and for each proposal. GRS then served as a user interface to match: (1) reviewers to a given proposal, (2) other reviewers to a given reviewer; and (3) other proposed or funded research to a given proposal. Mitretek demonstrated GRS at the Third Annual eRA Symposium in April 2003. See presentation materials for more details.   
• KM-Assisted Referral –– In the spring of 2003, CSR used KM to fingerprint 86 randomly selected R01 research plans for the October 2003 council round. KM technology then matched the fingerprints to CSR Integrated Review Group (IRG) descriptions to generate referral recommendations. In 35 percent of cases, the top-ranked KM referral matched the top-ranked human referral. In 64 percent of cases, one of the top three KM recommendations matched the top-ranked human referral. Testers believe that they will achieve better results using study section descriptions, which are more specific.   
• KM-Assisted Self-Referral ––Last winter, Tom Tatham led a CSR effort to explore the possibility of using Collexis to profile study sections. The ultimate goal is to enable principal investigators (PIs) to input their abstract or research plan and have Collexis return a list of suggested study sections. Using KM to help PIs recommend a study section will save time and promote appropriate referrals.   
• KM-Assisted Scientific Trends Detection –– In the spring of 2004, Mitretek Systems developed several KM prototypes to identify trends among 206 scientific poster proposals submitted to the Biomedical Information Science and Technology Initiative (BISTI) Symposium, “Digital Biology: the Emerging Paradigm” (November 2003). The prototypes include: (1) data visualization (graphic representation) of emerging concepts and their inter-relationships; (2) individual poster-level analysis, aimed at identifying concepts present in each poster for descriptive and comparative purposes; (3) author profiling to create a composite profile of an author's expertise by mining his/her poster abstracts; and (4) distribution of major concepts in a collection of documents, as well as the relative frequency of their occurrence. Mitretek’s presentation about these prototypes received favorable comments from the BISTI user group.

For more information about the eRA KM initiative, contact Richard Morris at RMorris@niaid.nih.gov.

Send Paper Non-competing Progress Report to New Central Address

NIH has centralized the receipt and initial processing of all paper, non-competing progress reports due on/after October 1, 2004. Guide Notice NOT-OD-04-054, dated July 23, 2004, announced this business process change. On September 2, NIH issued a separate Guide Notice (NOT-OD-04-063), providing grantees with the new, central mailing address for the submission of forms PHS 2590 and 416-9 to all Institutes and Centers (ICs). This fiscal year, NIH will receive nearly 37,000 Type 5 (non-competing continuation) progress reports.

When NIH receives non-competing progress reports at the new address, NIH will scan and store them in the eRA database. Extramural staff will be able to view the scanned images in the Grants Folder; grantees will be able to view them through the Commons Status module. The scanning of incoming progress reports, like the scanning of paper grant applications, is an interim step toward the goal of end-to-end electronic research administration.

Centralized receipt, logging and scanning offer several advantages:

• Enable NIH staff and grantees to display progress reports from a shared database within six business days of receipt  
• Ensure the consistent indexing of all NIH progress reports  
• Reduce addressing errors and misdirected progress reports  
• Facilitate the expanded use of electronic, Simplified Non-competing Application Process (eSNAP) progress reports and the eventual transition to electronic submission of all progress reports  
• Simplify follow-up on overdue progress reports  
• Standardize quality control  
• Help to achieve the migration of functions to the Division of Extramural Activities Support (DEAS)  
• Enable Institutes and Centers (ICs) to develop one, consistent, paperless business process for all Type 5s

The centralization initiative is a collaborative endeavor of the NIH Grants Management Administrative Restructuring Advisory Committee (ARAC), eRA, and the new DEAS. Mike Loewe, eRA advocate for Grants Management, was part of the team that drafted the new DEAS Standard Operating Procedures and has conducted a Type 5 pilot at his IC, the National Institute of Neurological Disorders and Stroke. Joe Ellis, as head of ARAC, provided policy guidance for the consolidation.

DEAS will assume responsibility for receiving and opening progress reports, entering receipt information into the eRA system, and routing a paper copy to the Office of Research Services (ORS) for scanning. The Office of Policy for Extramural Research (OPERA) has negotiated with ORS to expand its current scanning, indexing and optical character recognition (OCR) services to include Type 5s. Costs will be charged back to the ICs.

Grantees that report to other Department of Health and Human Services agencies that use the PHS 2590 and/or 416-9 forms must continue to send their forms directly to those agencies.

For additional information, see the IC Information sheet found on the Grants Management Infonet at: http://odoerdb2.od.nih.gov/gmac/sources/pol_centralizing_T_5_receipt.doc or contact grantspolicy@mail.nih.gov.

DHHS Enterprise Grants Management System Board to Meet in November

The Department of Health and Human Services (DHHS) will begin holding monthly meetings of the Enterprise Grants Management System (EGMS) Board on November 13. The EGMS Board will coordinate and resolve issues related to the integration of the Department’s research grant administration systems into eRA. 

The EGMS Board recently approved an additional $2 million in funding to subsidize the costs of migrating data into eRA and modifying the system to accommodate OPDIV requirements. NIH Chief Information Officer Al Graeff and eRA Director Dr. Israel Lederhendler will represent NIH on the EGMS Board.

For the past year, eRA has been collaborating productively with four DHHS Operating Divisions (OPDIVs) to centralize their research grants processing under the NIH eRA system. The Centers for Disease Control and Prevention (CDC) and the Agency for Healthcare Research and Quality (AHRQ) already are using eRA; the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are in the preliminary stages of integration.

The Department-wide integration initiative follows the August 2003 DHHS selection of eRA as the enterprise system for research grants management. A central system should achieve the following objectives:

• Streamline work processes to provide improved services to citizens.  
• Capitalize on existing advanced technology and best practices.   
• Create an opportunity for cost-effective, intra-agency sharing and elimination of redundant spending.   
• Provide a single point of interface with Grants.gov and the DHHS Unified Financial Management System (UFMS).   
• Maintain reliable and common data across OPDIVs.   
• Simplify the implementation of new policies and regulations.

AHRQ Integration Update

AHRQ has been a user of the NIH system since the days of the mainframe IMPAC system. “Overall, we are satisfied with our migration,” states Skip Moyer, AHRQ advocate on the eRA team. AHRQ representatives attend eRA project and lead users meetings, where they actively participate in all discussion.

In the summer of 2003, AHRQ adopted CDs for its five study sections, largely eliminating reliance on paper copies of applications. The agency plans to implement Internet Assisted Review (IAR) for all study sections this month. According to Anthony Freeman, AHRQ’s OPDIV integration representative, “the use of these tools has improved the efficiency, effectiveness and economy of our peer review processes. The overwhelming response from reviewers has been positive and supportive.”

For the spring 2004 meetings, AHRQ had some difficulty entering rosters into the system. The problem turned out to be a training matter. Freeman reports that the eRA Helpdesk was very helpful in resolving the underlying Commons registration issues; however, lack of formal training in the use of eRA modules is a serious area of concern for AHRQ.

AHRQ grants management (GM) staff are fully involved in using IMPAC II for awards processing, monitoring and closeout. Although the GM module has greatly streamlined grants administration, AHRQ still relies on its own extension systems to perform some functions.

Next steps include full use of the eRA Commons by AHRQ grantees. The Commons will allow grantees to submit requests and reports to AHRQ electronically, greatly reducing the need for paper. Institutions that do business with NIH and AHRQ will have a consistent means of communication with both agencies. 

For more information about AHRQ/eRA plans, contact Skip Moyer at smoyer@ahrq.gov or Anthony Freeman at afreeman@ahrq.gov.

CDC Integration Update

CDC successfully integrated all new FY2004 research awards using the IMPAC II Receipt and Referral and Review modules. Thus far, CDC has entered 1,523 applications into eRA and has made 445 awards for FY2004. According to Teresa Kinley, CDC representative on the eRA team, CDC received “outstanding support from the eRA Helpdesk and technical analysts.” 

Due to the implementation of the UFMS, CDC's year-end closeout had to occur one month early, which required a focused effort for all CDC program and grants users. For FY2005, CDC would like to revisit the possibility of maintaining their own data (i.e., CDC account numbers, institutional profiles and employer identification numbers) and performing human-subject code changes.

CDC also is anxious to migrate its active grants from previous years. Representatives currently are meeting with eRA analysts to discuss data mapping and migration procedures.

“Although the eRA team has been great,” reports Kinley, “CDC still requires numerous system changes to support its business processes.” In FY2004, CDC had to perform manual workarounds to add more approvals to the business flow. CDC also is eager to begin using the eRA Commons and Financial Status Report (FSR) modules. 

For more information about the CDC integration, contact Teresa Kinley at tik1@cdc.gov.

HRSA Integration Update

HRSA is not yet using eRA but has begun exploring the possible interface of HRSA grants management processes with eRA. HRSA demonstrated its Electronic Handbook (EHB) system to NIH grants and program staff; eRA is considering building some of the EHB capabilities into eRA.

HRSA deployed the EHB system in July 2003 and began receiving electronic submissions in January 2004. Approximately 10 percent of HRSA’s 15,000 annual grant applications arrived electronically in FY2004. HRSA makes about 7,000 awards each year.

For more information about HRSA plans, contact Libby Harnett, HRSA representative to the eRA team at libby.hartnett@hrsa.hhs.gov.

FDA Integration Update

Last year, the FDA processed 30 applications with eRA. Earlier this month, FDA staff entered their own applications into IMPAC II using the Receipt and Referral module. Coming soon is Review and Grants Management modules training for FDA staff. eRA also is planning meetings with FDA to determine FDA requirements for financial transactions.

For more information about the FDA integration, contact Caroline Dean at cdean@oc.fda.gov or Rosemary Springer at rspringe@oc.fda.gov.

Send questions about the overall DHHS OPDIV research grant processing integration to Mark Siegert at siegerm@mail.nih.gov or 301-435-0986.

eRA Implements Roadmap Tracking and Changes to JIT Mailers

On August 20, 2004, eRA released a mandatory new version of the Review Module (REV) in support of changes to Just-in-Time (JIT) mailers. These updates accommodate the processing and tracking of NIH Roadmap-associated grants. 

In accordance with a request from the Extramural Program Management Committee, NIH will issue hardcopy score/percentile mailers to all applicants one day after their score is released or changed. If an award is likely (less than or equal to the 20^th percentile), NIH will request “Just-in-Time” information by email to the Principal Investigator, institution business office and other specified recipient 15 days after the score is released.

In support of the Roadmap initiative, eRA has collaborated with the Query/View/Report (QVR) team to make the following accommodations:

• Created a virtual Institute/Center called “RM.” Roadmap applications will have an RM secondary assignment.   
• Devised new five-character Program Class Codes (PCCs) for the RM secondary assignment. The format of the RM PCC code is as follows:

• Set up a unique set of Common Account Codes (CANs) for each IC for the funding of Roadmap applications.   
• Added the following statement to Roadmap Notices of Grant Award (NGAs): “THIS AWARD IS FUNDED AS AN NIH ROADMAP INITIATIVE.”   
• Created a new Roadmap section on the Grant Snapshot Report.

For more information, see the eRA NIH Roadmap overview.

NIH Names First Director’s Pioneer Awardees

On September 29, NIH Director Dr. Elias Zerhouni announced the recipients of the first NIH Director’s Pioneer Award (NDPA), a program to support innovative researchers from multiple disciplines in conducting high-risk, high-impact research related to the improvement of human health. The nine awardees will receive $500,000 per year for five years for direct costs.

The 2004 NDPA winners are listed below. For more information on their research, see http://nihroadmap.nih.gov/highrisk/initiatives/pioneer/Recipients04.aspx.

• Larry Abbott, Ph.D., Brandeis University, Waltham, MA   
• George Daley, M.D., Ph.D., Children’s Hospital Boston, Boston, MA   
• Homme Hellinga, Ph.D., Duke University Medical Center, Durham, NC   
• Joseph McCune, M.D., Ph.D., J. David Gladstone Institutes, San Francisco, CA   
• Steven McKnight, Ph.D., University of Texas Southwestern Medical Center, Dallas, TX   
• Chad Mirkin, Ph.D., Northwestern University, Evanston, IL  
• Rob Phillips, Ph.D., California Institute of Technology, Pasadena, CA  
• Stephen Quake, Ph.D., California Institute of Technology, Pasadena, CA   
• Sunney Xie, Ph.D., Harvard University, Cambridge, MA 

In addition to introducing a new grant mechanism, the DP1, the NDPA introduced an entirely new grant application process. (See article in previous issue.) NDPA applicants used PureEdge™ software, available at Grants.gov, to download, complete and electronically submit the required SF 424 (Application for Federal Assistance) form and attachments. The NIH then retrieved the application packages, created online grant images, and assigned reviewers. NIH continues to work with the federal initiative to establish a single, effective electronic entry point for all applicants at Grants.gov.

For more information about the NDPA award, visit the NIH Roadmap site.

NIH Director Proposes Moratorium on Consultation Agreements

NIH Director Dr. Elias Zerhouni seeks to prohibit consulting agreements between NIH staff and pharmaceutical and biotechnology companies for one year. During this period, NIH will revamp its ethics program to improve the management of these relationships and preclude conflicts of interest.

Dr. Raynard Kington, NIH deputy director for Extramural Research, announced the proposed moratorium in a memorandum to extramural employees on September 23. According to Kington, “we have identified vulnerabilities in our system that give us pause…it is clear to us that if these [consulting] activities are to continue, we will need a substantially expanded system of oversight to assure Congress and the public that conflicts of interest are prevented.”

On June 22, 2004, Dr. Zerhouni presented testimony to the House Oversight and Investigations Subcommittee, Committee on Energy and Commerce. He pledged to strengthen the ethics system at NIH by changing rules, practices and procedures regarding outside activities.

Following an inquiry by several members of the Subcommittee about gaps in data on NIH approved-activities, the NIH conducted extensive internal and external investigations. “I have reached the conclusion,” testified Zerhouni,” that drastic changes are needed.”

The following principles will guide improvements to the NIH ethics program:

1. Enhance public trust in NIH by preventing conflicts of interest through the restriction of financial relationships that employees may have with outside organizations.  
2. Increase levels of transparency in the NIH ethics program by requiring much more internal as well as public disclosure of the details of financial relationships that employees have with outside organizations, including consulting arrangements and awards.  
3. Balance NIH’s ability to recruit and retain the best scientific expertise while expediting the translation of research advances.  
4. Establish effective monitoring and oversight of employee activities.

During the period of the proposed moratorium, NIH will complete its review of specific cases, develop effective information systems to track outside activities, and improve ethics training programs for staff. 

For more information on the NIH Ethics Program, visit http://ethics.od.nih.gov/.