Inside eRA, May 17, 2005 (Volume 6, Issue 2)

NLM and eRA Implement New NIH Public Access Policy

NIH issued new policy in February to enhance public access to publications resulting from NIH-funded research. Beginning May 2, 2005, NIH requests NIH-funded investigators to submit an electronic version of final manuscripts as soon as they are accepted for publication in peer-reviewed journals. These manuscripts will reside in the National Library of Medicine’s (NLM’s) PubMed Central (PMC), a searchable database accessible to the public at http://www.pubmedcentral.nih.gov/.

The official new policy, finalized after a long period of public debate, is available online in the NIH Guide for Grants and Contracts, NOT-OD-05-022. NIH also published its “Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research” in the Federal Register, Vol. 70. No. 26 on February 9.

Background on Policy

By law (42 USC. 286(b)(1)), the NLM is responsible for preserving NIH biomedical literature; NLM and its predecessor organizations have been doing so since 1836. Keeping pace with changing technology is essential to accomplishing NLM’s mission. As the electronic article increasingly becomes the authoritative and most useful document for researchers, the impermanence of publishers' Web sites presents a substantial risk. Maintaining an archive of publications resulting from NIH-funded research is an historical and necessary NLM responsibility. 

In support of the new policy, NIH Director Dr. Elias A. Zerhouni explained, “Congress, patient groups and others let us know that the current system is just not performing sufficiently…The status quo isn’t acceptable in the world of modern communications.”

At present, individuals not affiliated with an academic library or research hospital generally gain access to the peer-reviewed publications of NIH-funded investigators by visiting a medical library or by paying for a subscription to journals. NIH's new public access policy will allow the public to access the peer-reviewed and published scientific works of NIH-funded investigators through the Internet and without a fee. According to Dr. Zerhouni, the PMC archive “ensures and accelerates the public’s access to cutting-edge science.”

Implementation Phase 1

Beginning May 2, 2005, NIH-funded investigators are requested to submit to PubMed Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication. Investigators can access the NLM submission system through the NIH Commons, from the NLM home page at http://www.pubmedcentral.nih.gov/, or directly through the submission site at http://nihms.nih.gov/. To log on, NIH staff will use their NIH login ID. Extramural principal investigators (PIs) must enter their Commons user ID and password to submit manuscripts. If they don’t have an account, they will be able to create one.

After logging on, submitters will enter identification information and link the publication with an NIH grant(s) or intramural funding number. Submitters then will upload their manuscript in a word processing format or PDF. Once the manuscript has been submitted, the system will assign a PMC identification number, and the PI must then agree to a Submission Statement that includes setting the delay period for public release of the manuscript.

Beginning July 6, 2005, others may upload a manuscript on behalf of the PI; however, the PI still must finalize the submission with the Submission Statement.

Implementation Phase 2

Beginning with progress reports submitted on or after August 1, 2005, investigators can include the PMC submission identification number in lieu of submitting a hard copy of the publication (for paper progress reports) or updating their professional profile with citation information (for electronic progress reports). As part of the new automated process, eRA will populate profiles in its database with NLM citations and associate the publications with specific grants.

Note that the NIH still will require a hard copy of “submitted but not yet accepted” manuscripts since PMC archives only manuscripts that have undergone the peer review process and have been accepted for publication.

Implementation Phase 3

In this phase, NIH will be able to take advantage of the information in PMC to improve its investment in research. This searchable archive will enable NIH program officials to manage their research portfolios more efficiently, monitor scientific productivity, and ultimately, set research priorities.

Visit http://www.nih.gov/about/publicaccess/index.htm for more detail on NIH’s public access plan.

e-Notification Pilot Underway

eRA has begun a Phase I pilot of its new e-Notification system for NIH extramural staff and the grantee community. Version 1 includes the infrastructure and administrative facility to support electronic notification of seven grants-related business events. Paperless notification is key to achieving the eRA mission of reducing the costs of grants administration to all stakeholders.

In his presentation to the Extramural Program Management Committee (EPMC) on March 3, Dr. Israel Lederhendler, director of the new Office of Extramural Research and Reports Management (OERRM), stated that, contingent on an official change in policy, eRA will be able to discontinue all paper mailers by January 2007.

Although some eRA modules do have limited e-notification capabilities, the current solution is not efficient. The new system will address the following limitations of the old system:

• There is no common solution. The existing notifications are process-specific and therefore neither flexible nor extensible. 
• Adding a new notification or modification to existing notifications is labor intensive because it requires custom coding. 
• With the current notifications, users cannot easily sign up or remove themselves from a recipient list. 
• There is no audit trail. Once a notification is sent by the current system, there is no way to track whether the message was received. 

Under the new, central system, a “notification recipient” can be an internal end user (e.g., a program official (PO)), a group of end users or an entire Institute/Center; a recipient also can be an external end user (e.g., a principal investigator), a group of grantees or an entire research institution.

Each business area will appoint a “notification administrator” and a “content administrator” to manage e-notification. Notification recipients will be able to view a list of their messages from the system’s “My Events” interface. Users will be responsible for reading the text of their messages, which will arrive by email. In later releases, recipients will be able to add/remove themselves from optional notifications. 

To participate in the e-notification system, grantees must be registered in the Commons. Since only 65-70 percent of awardees currently are Commons users, an increase in registration is vital to realize the full benefits of the new system.

The Phase I pilot includes the following seven notifications. With the exception of PO Approval (which will be issued by the new e-Notification System and the current, on demand, Access-based method), the process will be paperless. Several grants specialists from different ICs (NINDS, NIDCD, NIBIB, NIAID, and NIAAA) are participating in the pilot.

• Review Outcome (Percentile and Priority Scores Changed) 
• Just-in-Time Scores Released 
• PO Approval of the Award 
• Institute Assigned 
• Scientific Review Administrator (Scientific Review Group Assigned) 
• Council Date Changed 
• Summary Statement Released 

During Phase II, scheduled for FY 2006, eRA will identify and include all existing mailers into the e-Notification System. These include:

• Receipt and Referral (R&R) Mailers –– The current system produces letters in Oracle Reports and sends them to Central Printing for later distribution. 
• Summary Statement Mailers –– This is a back-end function that prints un-scored summary statements for the day at the central printer. 
• Program Official (PO) eMail Notifications –– Currently, this is a back-end process that sends emails about available summary statements to the assigned POs. 
• Notice of Grant Award (NGA) Mailers –– Currently, there is a Microsoft Mail-based system that generates email as well as Oracle Forms. 
• Other eMail Messages –– Some mailers are generated using Oracle database email capabilities. Other mailers are generated by Java Mail using message text managed within each sub-system.

Secretary’s Award for Distinguished Service Goes to eCGAP Team

The NIH electronic Competitive Grant Application Process (eCGAP) team, under the leadership of eRA Analyst Jennifer Flach, has won the prestigious Department of Health and Human Services (DHHS) 2005 Secretary’s Award for Distinguished Service. The Department will honor the team for its contribution to medical discovery and science management at a special awards ceremony on May 25.

Dr. Israel Lederhendler, director of the Office of Electronic Research and Reports Management, offered his sincere congratulations. “Your efforts and dedication have initiated the next era in DHHS grants management.”

Fifteen NIH employees from four Institutes/Centers will receive recognition for their role in using information technology to reduce the costs of research grants administration to research institutions and the federal government.

Over the past two years, the members of the eCGAP team have been responsible for planning and supervising the development, testing and implementation of an electronic grants-receipt system. When planned systems are fully deployed, eRA will save 200,000,000 pieces of paper per year and countless hours of human effort. These savings mean more money and more time to dedicate to scientific discovery.

In his message of congratulations, Dr. Lederhendler gave credit to eRA’s contractor personnel. “This important award goes to federal staff, but I would like to recognize the critical contributions of our contract staff that made this accomplishment possible.” He also thanked other contributors to the eCGAP effort who earned honorable mention:

Ammar Albadarneh, Laheeb Alsarraf, Jim Cain, Sushma Chand, Ngoc Cao, Mendus Chelapurath, Raghunath Chintalapati, (Asif) Muhammad Chowdhury, Alex Coleman, Krishna Collie, Sheri Cummins, Al D'Amico, Glen Evans, Vickie Fadeley, Rick Falls, Steve Fitzgerald, David George, Dan Hall, Choudhury Hasan, Steve Hughes, Abhi Jain, Sandra Karen, Param Kompella, Izja Lederhendler, Richard Liu, Peter Liu, Kelly Long, Peggy Lynch, JJ Maurer, Gerald Momplaisir, Madeline Monheit, George (Skip) Moyer, Christopher Myers, Edward Myrbeck, Ramesh Nagella, Kalpesh Patel, Raghavan Peketi, Valerie Prenger, Harsha Rao, Brad Sachar, Jody Schraden, Sandy Seppala, Li-Ming Shen, George Shi, Sara Silver, Everett Sinnett, Brad Sneade, Stephanie Song, Vishal Sood, Tracy Soto, Carin Sprick, Don Stallone, Melissa Stick, Manju Subramanya, Ashique Tanveer, Jean Taylor, Jim Tucker, Tim Twomey, Cecilia Vann, Nancy Waters, Janna Wehrle, Changqing Zhen, Sherry Zucker

The Departmental Awards ceremony will be held on Wednesday, May 25 at 2:00 p.m. in the Great Hall of the Hubert H. Humphrey Building. A reception will follow.

Jim Cain Departs from eRA

After more than 24 years at NIH and 9 years as director of the Division of Extramural Information Systems (DEIS), Office of Policy for Extramural Research Administration, James Cain left the agency on April 11. Under his leadership, the NIH eRA initiative made great progress in achieving its objective of end-to-end electronic grants administration. 

Former eRA Program Manager Dr. John J. McGowan expressed admiration for Cain’s honesty, loyalty, competence and commitment to the mission of NIH. “Jim is a fantastic person with broad knowledge of IT. He was willing to make the tough decisions required to advance the eRA system and the people who support it. eRA’s success during my tenure depended heavily on Jim. NIH will miss the knowledge and experience of this good man.”

In 2004, Cain received the Department of Health and Human Services (DHHS) Secretary’s Award for Distinguished Service. Each year, the Secretary bestows this honor on leaders and teams that have best advanced the Department’s mission.

As DEIS director, Cain was responsible for eRA’s architecture, including requirements, analysis, design, development, deployment, and maintenance of system hardware and software. His purview encompassed both IMPAC II, eRA’s internal-facing component, and the NIH Commons, eRA’s interface to the grantee community. He also oversaw computer operations, network communications, security, disaster recovery, user support, communications/outreach, and quality assurance activities. In addition to six branches, he managed multiple support contracts with more than 100 technical contractor staff.

Prior to joining DEIS, Cain served as associate chief of the Information Systems Branch, Division of Research Grants. There, he managed the redesign and migration of the legacy IMPAC and CRISP systems to IMPAC II, which is built on relational database management system architecture.

During the 1980s, Cain worked for the NIH National Library of Medicine (NLM). Among his achievements as an administrative librarian, Cain managed the in-house development of DOCLINE, an automated interlibrary loan request system that still is in use nationwide. He also headed the Circulation and Control section. Cain earned a Master of Librarianship (M.Ln.) at Emory University. He also holds a Master of Education (M.Ed.) degree from Auburn University.

Cain will spend eight months on detail to Grants.gov and then will retire from the federal government at the end of 2005.

NIH and Grants.gov Prepare for Pilot

Members of the Commons Working Group (CWG) will participate in the first round of user acceptance testing between Grants.gov and NIH. On May 25, CWG volunteers will complete Grants.gov forms with previously submitted application data to simulate applying for NIH grants through the federal site. 

For the past year, NIH has worked to integrate eRA with Grants.gov, the main federal Web site for finding and applying for grants. With the exception of the 2004 NIH Director’s Pioneer Awards, applicants for NIH grants have not yet been able to use the PureEdge™ downloadable electronic grant application forms available at Grants.gov. 

eRA also is collaborating with other Department of Health and Human Services (DHHS) Operating Divisions (OPDIVs), such as the Agency for Healthcare Research and Quality (AHRQ), to enable the OPDIVs to accept their research applications through Grants.gov.

New Standard Form 424 Research and Related

The federal site requires a new standard form, SF 424 Research and Related (R&R), which was developed by a multi-agency Grants.gov work group and approved by the Office of Management and Budget. NIH currently uses the Public Health Service (PHS) 398 application form but plans to adopt the new standard form in the future. 

eRA and Grants.gov created PHS-specific forms and schema to supplement the SF 424 R&R. In addition, eRA developed business validations for Grants.gov and the means to generate a grant image based on the 424 R&R format.

The Role of the eRA eXchange

NIH will retrieve applications submitted through Grants.gov using the eRA eXchange. The eXchange is the computer architecture that manages system-to-system grants-related communication between the NIH and the external community. 

After Grants.gov receives an application for an NIH or DHHS OPDIV grant, the eRA eXchange will pull the application, validate format, check it against NIH/OPDIV business rules, and map the XML data to fields in the eRA database. If the application passes validations, it will appear in the eRA Commons where the principal investigator (PI) and signing official (SO) will verify the data. If there are errors, the Commons will display warning and error messages. The applicant must correct the application and resubmit it through Grants.gov.

On May 25, CWG testers will provide NIH with feedback on submitting the SF 424 R&R and PHS-specific forms and the process for viewing the grant image and errors in the Commons. This feedback will help eRA to improve user instructions, train the eRA HelpDesk, and identify potential enhancements to the eRA-Grants.gov system-to-system interface. 

System-to-System Application Submission

Once testing with Grants.gov is complete, NIH grantees will have another option for submitting grant applications electronically. Currently, NIH accepts system-to-system XML data stream submissions from service providers and research institutions.

Certified commercial service providers may submit electronic applications on behalf of client research institutions. To become certified for a specific grant type (e.g., simple, modular, competitive R01), the provider must successfully submit a test application of that type to NIH’s test environment. Whenever there are significant changes to eCGAP software, service providers must renew their credentials. Therefore, companies certified for this year’s February/March round must become recertified for the June/July round.

Service providers have developed various methods for capturing application input, including downloadable forms, Web-based interactive forms, word processing forms and others. After receiving application data and attachments from clients, the service provider formats the data as an XML file with attachments and transmits the file to the eRA eXchange.

Grantee institutions can choose to develop their own systems to convert application input to data streams using published XML schemas for computer-to-computer transmission to the eRA eXchange and ultimately, to Grants.gov. Interested institutions can go to http://era.nih.gov/Projectmgmt/SBIR/getting_started.htm for more information.

Since the beginning of pilot testing in 2003, more than 30 research institutions, assisted by service providers, have submitted electronic applications. NIH accomplished a major milestone in January 2005 when the eRA eXchange began accepting an unrestricted number of electronic, modular, non-consortia R01, R03 and R21 grant applications (new, competing continuation, and revised) from certified service providers.

eRA has scheduled additional pilots in 2005 to test R01, R03 and R21 grant applications with full budgets.

For more information on the electronic grant application process, contact eRA Analyst Jennifer Flach at flachj@mail.nih.gov.

eRA Pilots New Deployment Web Page

eRA has created a new, central Web page at http://impacii.nih.gov/deployment/ to communicate “behind the scenes” deployment information to eRA staff and IMPAC II users. Beginning on May 13, the pilot page will provide comprehensive status information on CY 2005 current and future releases.

Designers have organized the site for ease of use. Release Bullets provide a succinct list of upcoming maintenance changes to eRA modules. Release Notes offer detailed, step-by-step explanations of newly released features. In the future, the site will include a searchable archive of past deployments.

The point of contact for the new deployment page is Scarlett Gibb, chief, eRA Planning, Communications and Outreach Branch (PCOB).

Grants Management Community Honors Cathy Walker and Steve Paugh

The Grants Management (GM) Vision Steering Committee (VSC) will honor Cathy Walker and Steve Paugh with 2005 Special Recognition Awards for improving the operations and efficiency of NIH grants management and research administration. Ms. Walker is an eRA software analyst; Mr. Paugh is an LTS contractor who does technical writing for eRA.

Dr. Israel Lederhendler, director of the Office of Research and Reports Management, offered his personal congratulations. “I am delighted to hear that your customers recognize the fantastic job you have done.”

Pamela Mayer of the IMPAC II GM Lead Users Group nominated Walker and Paugh. “Cathy should be recognized for the daunting task of redesigning the GM module for the Web.”

Walker is the eRA task order manager for GM/OneView and the business analyst for GM, checklists, and grant closeout. Before joining eRA three years ago, she worked for 17 years in grants management at the National Cancer Institute and the National Institute of Allergy and Infectious Diseases. Cathy graduated from Loyola College with a degree in Speech Pathology and Audiology. 

Mayer nominated Paugh for “consistently recording and providing complete, concise minutes of all the GM Lead Users meetings.”

According to Paugh, his position at NIH is his “first real job.” He earned a B.A. degree in English literature at James Madison University, where he served at the Helpdesk. He also holds an M.Sc. degree in literature from the University of Edinburgh. While overseas, he worked in a medical library. Paugh currently is writing a graphic novel.