Inside eRA for Partners, December 23, 2003 (Volume 3, Issue 8)

Dr. Norka Ruiz Bravo Appointed NIH Deputy Director for Extramural Research

NIH Director Elias A. Zerhouni, M.D., appointed Norka Ruiz Bravo, Ph.D., to the position of NIH deputy director for Extramural Research on October 30. In her new role, Dr. Ruiz Bravo will be responsible for all policies and guidelines related to extramural research grants, which represent approximately 85 percent of the NIH budget.

The new deputy director fully appreciates the importance of the eRA Project and its progress thus far. “I consider eRA to be the backbone of NIH’s grant operations… Through eRA’s efforts, the federal government provides a user-friendly interface with our grantee community that has already resulted in tremendous efficiencies in operation.” Dr. Ruiz Bravo promises eRA her dedicated support and encourages NIH to explore eRA’s potential beyond its original goal.

Dr. Ruiz Bravo came to the NIH in 1990 as a scientific review administrator in the National Institute of General Medical Sciences (NIGMS). Since then, she also has served as a program director for the Division of Genetics and Developmental Biology, and deputy and acting director for the NIGMS Division of Cancer Biology in the National Cancer Institute. Most recently, she was the associate director for extramural activities at NIGMS, where she oversaw the Institute’s FY2003 $1.7 billion research and research training grant programs from a policy, business, and scientific perspective.

Dr. Ruiz Bravo received her Ph.D. in biology from Yale University in 1983. She then completed an NIH postdoctoral fellowship in physiological chemistry at Johns Hopkins University and biochemistry and molecular biology at M.D. Anderson Cancer Research Center. Prior to coming to NIH, Dr. Ruiz Bravo held faculty positions at M.D. Anderson Cancer Research Center and the Baylor College of Medicine in Houston, Texas.

NIH Prepares to Expand Electronic Application Pilot

The eRA team, benefiting from the experience of the October/November electronic grants pilot, is preparing for the next round of receipt dates. NIH will accept a few dozen e-applications from service providers for new and competing continuation Academic Research Enhancement Awards (due January 25), new research grants (due February 2), and competing continuation research grants (due March 1). The pilot will be limited to simple grants with modular budgets.

eRA also will accept four or five simple grant applications for the March deadline from researchers who use the Grants.gov storefront to download, complete and submit applications. Interested applicants can contact David Wright for more information at david.wright@nih.gov.

Thirteen e-applications submitted for the October/November due dates have been verified by the grantees, successfully processed through the Receipt and Referral office, assigned to a study section or initial review group, and currently are pending review. Two of the original 15 applicants dropped out of the pilot. Members of the eRA team are meeting with scientific review administrators to brief them on the new electronic process and to request feedback from reviewers at the end of the review meetings. The 13 applications will be tracked closely through award to ensure that all processing runs smoothly.

The electronic Competing Grant Application Process (CGAP) software will be upgraded on January 16, in time for the January submissions. Based on lessons learned from the first pilot, the CGAP team will add a validation service to enable submitters to perform a “test run.” The test submission will undergo all the business rule checks required for NIH to generate a database record and a grant image. PIs and service providers will be able to correct errors or update personal profile data before resubmitting the “live” e-application. Hopefully, the validation service will minimize data discrepancy problems that were encountered in the first pilot. 

The eRA team also will improve documentation for grantees and service providers. There will be rules and procedures for submitting and verifying applications online. In addition, NIH will prepare a tool kit for service providers and institutions with instructions on establishing a system-to-system interface with the eRA Exchange. The tool kit also will document NIH validation rules and explain how to handle error messages.

eRA/SBIR Partnership Success Stories

Four recipients of NIH Small Business Innovation Research (SBIR) awards were instrumental in the success of eRA’s October/November electronic grants pilot (see full article in this issue). Awardees partnered with client institutions to prepare digital applications and to transmit them to NIH in the mandated format. Here are their stories.

• Cayuse, Incorporated as told by Christian Harker, Ph.D., President

Participating in this pilot with NIH was very exciting and something I had been working towards for a long time. For the pilot electronic submissions, the relevant profile data [Institutional Profiles and Professional Profile] were exported from our product GrantSlam in XML format (along with budgets and other critical information collected in the PHS 398 form). During the export process, the XML data were organized and labeled so that the receiving computers at NIH would know exactly how to process them.

Most of the large blocks of text, such as the Research Plan and Biosketches, were included in the electronic submission as PDF files, linked to the XML data…

Once the data were exported and the PDFs in place, GrantSlam wrapped them together as an encoded bundle called a Simple Object Access Protocol (SOAP) document. GrantSlam then used a secure connection to contact a particular server at NIH, identified itself as being associated with Cayuse (a “trusted broker” for NIH), and told the server that the SOAP document was ready to go. Some other key descriptive facts about the bundle were conveyed and NIH issued us a “ticket.”… The use of tickets was instituted to prevent the development of a bottleneck caused by too many electronic proposals coming in to the NIH at the same time. During this pilot, there was no such congestion and the proposal went right through.

…While getting to this point was a major task and plenty remains to be done, once we’d gotten the bugs out, submitting these proposals over the wires was far easier than sending paper. The immediacy of the process is a very welcome change.

Cayuse Customer Testimonial

I [Robert Beattie] teamed with Valerie Smith, the grants manager for the Department of Cell and Developmental Biology, to use the Cayuse product, GrantSlam, to prepare an electronic proposal for Dr. J. Douglas Engel. GrantSlam produced a perfect paper copy of the application and the data in the system were converted into the XML data stream needed for the NIH system. The process went very smoothly in the production stage and, with the close cooperation of the Cayuse team and the NIH eRA group, the transmission was accomplished. University of Michigan staff expect to send a number of applications via GrantSlam for the February, 2004, NIH deadline.

Robert Beattie, managing senior project representative for Electronic Research Administration, Division of Research Development and Administration, University of Michigan.

• ERA Software Systems (ERASS) as told by Dianne Bozler, President

ERA Software Systems successfully submitted two proposals from the University of Massachusetts, Amherst and two from the Pennsylvania State University for the October 1 deadline. For the November deadline, proposals were successfully submitted by UMASS, Penn State, and St. Jude Children's Research Hospital in Memphis.

All proposals were created and generated automatically from the Grants Application and Management System (GAMS) software. The ERASS focus was to verify the accuracy of the Web services running between GAMS servers and NIH servers. These services provide true machine-to-machine or business-to-business communication. We were proud to be a part of the pilot project and feel that the close working relationship with NIH technical professionals has been extremely valuable. Finally, electronic research administration is a reality!

ERASS Customer Testimonial

At the September 20, 2003, Federal Demonstration Partnership meeting in Washington D.C., we (St. Jude Children’s Research Hospital) were invited by ERA Software Systems to use their GAMS software to participate in the NIH Competitive Grant Application Process pilot program. St. Jude was the first institution to successfully submit an electronic Non-Competing application (eSNAP) several years ago. We felt this was an opportunity to continue to be on the leading edge of the new NIH Commons technology.

Initializing the Institutional Profile for St. Jude and creating a Professional Profile for each investigator account went smoothly. Next we entered the face page information, modular criteria, and abstract page information for each application. The next two entries had to be re-worked. First the biographical sketch had to be separated into two separate uploadable sections. The resources page was entered by cutting and pasting each section into the GAMS model separately. The research plan required the most effort; each section had to be separated into an independent uploadable document.

The pilot was a learning opportunity, and we will be able to complete the process with less difficulty in the future. We now understand what issues need to be addressed before we request that our investigators prepare and submit their applications electronically.

Tolliver McKinney, coordinator of Information Technology, Department of Research Administration, St. Jude Children's Research Hospital

• InfoEd International from the press release issued Nov. 3, 2003

InfoEd International, Inc., a provider of software solutions that enable paperless management of research proposals, protocols, clinical trials and related intellectual property disclosures, announced today that it has made history by transmitting the very first electronic grant applications to be accepted by the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. InfoEd achieved this significant milestone with the support of four leading research institutions, which used the Web-based InfoEd solution to submit their own genuine research proposals for NIH's annual October submission deadline for new applications. The participating institutions included the University of Connecticut Health Center, the  of Illinois, the University of Miami, and Virginia Commonwealth University. 

InfoEd Customer Testimonials

“eRA represents an opportunity for grantors and grantees to yield significant efficiencies from transforming paper-based processes into seamless electronic communications. As a result we can focus on our research instead of paperwork, and optimize the return for our sponsors."

Dr. Norman Altman, vice provost for Research at the University of Miami

"VCU was delighted to have the opportunity to participate in the successful test of a pioneering system for electronic proposal data transmittal to NIH."

Herbert Chermside, director of Sponsored Programs Administration at Virginia Commonwealth University

"We were very pleased to have partnered with InfoEd to submit one of the first proposals to NIH e-submissions. Preparation and submission of the electronic files went very smoothly. We look forward to doing business with NIH this way in the future."

Jack Kamerer, director of Grants and Contracts at the University of Illinois Urbana/Champaign

• Research and Management Systems (RAMS) from the press release issued on Oct. 10, 2003

On September 1, 2002, RAMS received a Phase I grant from the NIH to help develop an innovative solution for NIH grantees to submit proposals and interact electronically with NIH’s e-Grant effort (NIH Commons). Based on the successful research effort involving local control of professional profiles and the electronic submission of the NIH 398 competitive application via the Web ––using ASP, SQL, XML and SOAP–– RAMS was selected for a Phase II award.

Working with two of its customers ––Children's Mercy Hospital and Oregon Research Institute–– RAMS successfully submitted the competitive 398 grant applications electronically to NIH for their October 1st deadline. With successful completion of Phase I and Phase II of the eRA SBIR award, NIH will certify that the applications and services developed by SBIR companies, like the RAMS ecGrant product, will enable grantee institutions to submit electronic grant applications and communicate with the NIH eRA Commons.

RAMS Customer Testimonials

“Oregon Research Institute was excited about taking part in this NIH electronic submission pilot, and we found the process to be very simple. We're looking forward to the time when electronic submission is the norm.”

Virginia Osteen, Grants Specialist 

“It was the smoothest and easiest electronic submission we've done. After going through this once, I don't want to go back to paper again.”

Bill Caskey, Ph.D., director, Research and Grants Administration, Children’s Mercy Hospital.

Work Continues on New Ad Hoc Query Tool for Commons Status Users

The eRA Commons team has improved the prototype of a new ad hoc query and reporting tool planned for Status module users. The changes were made in response to the comments and suggestions of a Commons Working Group (CWG) focus group that met in conjunction with the November session of the National Council of University Administrators. The revised prototype is available at http://era.nih.gov/UI/Commons/StatusQuery2/index.asp.

The new query and reporting tool will take advantage of Web QT, an application recently developed for internal eRA staff users. Web QT combines the best features of multiple existing reporting tools into a single interface. The ad hoc query option of Web QT will be prioritized with other Commons initiatives for a future release.

eRA Bids a Fond Farewell to George Stone

George Stone, Ph.D., whose vision and leadership made Interagency Edison and the eRA Commons a reality, will depart from the government to pursue outside interests. During his eleven years at the NIH, Dr. Stone lobbied for improving research grants administration through business-process reengineering and the use of information technology. He was a vocal supporter of the extramural community, an active participant in professional organizations, and a dedicated contributor to NIH outreach activities. “His commitment and loyalty will be greatly missed,” stated Dr. John McGowan, former eRA project manager.

In 1997, Dr. Stone and his Edison Invention Reporting Team won the prestigious Hammer Award. This honor was bestowed by the National Partnership for Reinventing Government, Vice President Gore’s initiative to recognize federal employees and their partners whose work results in a government that works better and costs less. U.S. federal law mandates that all recipients of federal grants or contracts report details of inventions and patents funded by these awards. To fulfill this requirement, Dr. Stone and his NIH team developed Edison, an on-line Extramural Invention Information Management System, the first Web-based electronic system in the government to support administrative requirements. In 1997, Dr. Stone and his colleagues launched Interagency Edison (iEdison), which currently services 550 grantee and contractor organizations and 20 federal agencies that fund the creation of inventions.

Dr. Stone also was the driving force behind the eRA Commons, a virtual meeting place on the Web where NIH extramural grantee organizations, grantees, and the public receive and transmit information pertaining to the administration of biomedical and behavioral research. Leading the project since 1995, Dr. Stone wrote the statement-of-work for the initial 5-year, $10 million contract to develop the Commons. Under his guidance, the eRA Commons has matured into a state-of-the-art Web interface where registered, authorized grantees are able to review the status of their applications and awards, create and maintain accounts, submit progress reports and financial status reports, and create new trainee appointments, and where registered peer reviewers are able to submit critiques and initial scores. In the future, the Commons will be the vehicle for all notifications and correspondence between the NIH and the grantee.

Throughout his career at the NIH, Dr. Stone has worked very closely with the grantee community to respond to user requirements, facilitate the grant-making process, and promote electronic research administration. According to Jerry Stuck, executive director of the Federal Demonstration Partnership (FDP), “George Stone truly defines what it means to be an eRA advocate. He represents the highest ideals of the government-university partnership.”

In retrospect, Dr. Stone believes that “selling” the eRA concept to grantees and serving as their advocate were his greatest contributions to the project. To this end, he formed the Commons Working Group (CWG), comprising representatives from 18 grantee institutions and served as its chair from 2001 until recently. The CWG has played a critical role in shaping, evaluating and fine-tuning new eRA Web-based Commons applications. According to Dr. McGowan, “Providing institutions a seat at the table ensured that we produced a product that worked.”

Dr. Stone would like to thank the members of the CWG for “their trust in [his] abilities to understand their requirements and somehow translate them into Commons’ functionality.” He asks his NIH colleagues to forgive his stubbornness and “attempts to circumvent methodology…all in the name of wanting to make things instantly better for the users.”

In addition to his work with the CWG, Dr. Stone participated in numerous other outreach and interagency activities. He was a frequent presenter at NIH Regional Seminars on Program Funding and Grants Administration and at meetings of the Council on Government Relations, the National Council of University Research Administrators, the FDP, the NIH Small Business Innovation Research and Small Business Technology Transfer Program, and others. He also headed an interagency working group devoted to invention reporting, and recently co-chaired a subcommittee of the post-award working group of the Chief Financial Officer Council whose efforts resulted in a new government-wide data definition for summary/interim invention reporting.

eRA Is in the News

Following are excerpts from articles about eRA in recent publications.

• The Chronicle of Higher Education –– Published weekly, with a circulation of 450,000, a news source for college and university faculty members and administrators.

Electronic Grant Applications Make Their Debut at NIH by Jeffrey Brainard, Oct. 24, 2003

The agency’s switch [from paper to electronic submission] is expected to benefit colleges by cutting the waiting time between when scientists submit grant applications and when they hear the results. That wait was typically more than six months, a delay that researchers have long complained was unreasonable… In addition, the system now allows the NIH to speed up the process of notifying those who receive awards and transferring funds to them, which used to take up to a month using letters and paper checks.

• The Washington Fax –– Daily science policy news service that tracks activities in Washington that affect the scientific research enterprise.

Interagency Grants Data Set Submitted to OMB by Shirley Haley, Oct. 29, 2003

[According to Brad Stanford, co-chair of the Federal Demonstration Partnership’s Committee on Electronic Research Administration], we have a public law that says that agencies will provide an electronic option. We have an administration that says this is part of the President’s management agenda. So agencies are paying attention and OMB is cracking the whip… For example, National Institute of Allergy and Infectious Diseases Division of Extramural Activities Director John McGowan expounded on the agency’s readiness in the e-grant area, stating, “the plan now is for next year to be doing your grant submission to NIH for single-project grants… through the NIH Commons or a variety of other [electronic] means.”

• Science Magazine –– A weekly publication of the American Academy for the Advancement of Science, the world’s largest general scientific society. Science Magazine reaches over 83,000 individual paid subscribers and hundred or thousands of life science readers worldwide.

Net News: NIH Tests First E-Grants, Oct. 31, 2003

…plunging into the digital age, the National Institutes of Health (NIH) is testing an online grants application that will end the frenzied ritual of mailing off stacks of paper copies… scientists applying to NIH [will] have several options, including custom software –– sort of like TurboTax –– that makes it easy to package graphics and text. Already, principal investigators (PIs) can see their grant status and peer-review scores on NIH’s Web site.

• The Blue Sheet –– Founded in 1957, “The Blue Sheet” is designed for executives, managers and investigators involved in biomedical research. Weekly issues cover the full spectrum of funding and R&D activities at NIH, the academic research community, private research foundations, the National Science Foundation, the National Academy of Sciences and the Centers for Disease Control and Prevention.

Interagency Grants Data Set Submitted to OMB By IAEGC Subcmte., Nov. 3, 2003

University research administrators whose institutions and principal investigators are not yet oriented toward the world of electronic grants are behind the curve, other speakers warned SRA members [at the Society of Research Administrators International meeting held October 18-22]... NIH received its first 14 pilot electronic applications in October… ”they’re our first stage to gear up for full production next year [noted Dr. John McGowan].”

PHS 398 Form Undergoing Revision

eRA is preparing to accept additional information that may be required on the 2004 revision of the Public Health Service (PHS) 398 grant application. NIH plans to change the standard form to reflect policy changes implemented since 2001. In addition, the PHS 398 is being extensively rewritten with a focus on clarity, simplicity and plain language. Some changes were specifically proposed by eRA to help keep paper and electronic submissions consistent.

Among the changes under consideration that have eRA implications are adding the “Commons User Name” as a distinct field and creating a separate section for Human Embryonic Stem Cell information. When the revised PHS 398 form is ready, NIH will issue a Guide Notice detailing the modifications.

Commons Working Group to Meet in January

Representatives from participating grantee institutions will meet with eRA staff to exchange news about electronic applications and the Commons at the January 11 meeting of the Commons Working Group (CWG) in San Antonio, Texas. For more than two years, the CWG has played a critical role in shaping, evaluating and fine-tuning eRA electronic interfaces to the extramural NIH grantee community.

The upcoming CWG meeting will take place from 8:30 a.m. to 1:00 p.m. at the Hilton Palacio del Rio in conjunction with the Federal Demonstration Partnership Conference, scheduled for January 12-13. Go to http://thefdp.org/Meetings/FDP-Meeting-January-2004.html for more information about the FDP meetings.

NIH Roadmap: Implications for the eRA Project

The eRA team has begun assessing its role in support of the NIH Roadmap, which will be implemented in FY2004. Conceived by NIH Director Elias A. Zerhouni and developed with input from more than 300 nationally recognized leaders in academia, industry, government and the public, the Roadmap provides a framework of priorities for sponsoring research in the 21^st century.

At eRA’s third annual symposium last spring, Dr. Ronald N. Germain, deputy chief of NIAID’s laboratory of immunology, explained that major advances in medicine are not likely to come from small single-PI laboratories. “Rather, larger teams comprising expert biologists, computer programmers, mathematicians, engineers, chemists and others are needed to collect and assemble the vast amount of data into predictive models of biological behavior.” The NIH Roadmap responds to this new trend in biological research by seeking to deepen the understanding of biological systems, stimulate interdisciplinary and public/private sector collaboration, and reshape clinical research to accelerate medical discovery and improve health worldwide. These goals correspond to the three core themes of the Roadmap: New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise.

Undoubtedly, NIH will need to establish new and more complex funding mechanisms to achieve Roadmap goals. In particular, the tracking of a widening network of co-investigators and key personnel will impact eRA’s responsibility. The eRA Project already has introduced new efficiencies that speed up the grant-making enterprise and reduce the administrative burden on researchers. Electronic applications and the Internet-assisted review process are expected to shorten the time from receipt to award by two months.

The Roadmap plan will be funded at a level of about $130 million in FY2004 but expected to reach a total of $2.1 billion over the next 5 years. All NIH Institutes and Centers (ICs) have made a corporate decision to create a common pool of resources to achieve Roadmap initiatives. ICs already have issued numerous Requests for Applications (RFAs) in support of Roadmap objectives. See the NIH Guide for details.