Inside eRA for Partners, April 30, 2005 (Volume 5, Issue 2)

eRA and NLM Implement New NIH Public Access Policy

NIH issued new policy on February 3, 2005 to enhance public access to publications resulting from NIH-funded research. Beginning May 2, 2005, NIH requests grantees 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 and has 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' websites 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 the NIH Manuscript System (NIHMS) an electronic version of the author’s final manuscript upon acceptance for publication. Investigators can access the submission system at http://www.nihms.nih.gov. To log on, submitters must enter their Commons user ID and password. If they don’t have an account, they will be able to create one.

After logging on, submitters will enter identification information and associate the publication with an NIH grant(s). A search screen will enable users to select the correct grant(s) from a list. Submitters then will upload their manuscript in a word processing format or PDF. Once the manuscript has been submitted, the system will assign an NIHMS identification number and generate an email to the author(s) confirming the submission. If the submitter is not the author, then the author must verify the submission by accessing the document through a link provided in the notification email.

Implementation Phase 2

Beginning with progress reports submitted on or after August 1, 2005, investigators can include the NIHMS 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 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 exploit 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.

eRA to Implement One View for All Users

“One View” is eRA’s vision for a consolidated system designed to present grants administration data, accept requests, and process transactions in a consistent way throughout the grant lifecycle. Senior Requirements Analyst Dan Hall briefed the eRA team in January on specific 2004 accomplishments and 2005-2006 strategic plans for achieving One-View goals.

One View means that all Department of Health and Human Services (DHHS) extramural staff and grantee users ––grants specialists, scientific review administrators, program officials, principal investigators, signing officials and others–– will interact with the eRA system in the same way. They will use the same or similar interfaces and facilities to view grants administration data, receive notifications, enter requests, and execute transactions.

First Step: One Technology Platform for all Software Applications

At the current time, eRA comprises 13 internal-facing and 8 external-facing program modules that access a common database. A prerequisite for One View is a single technology platform for all software. To this end, in 2004, eRA began converting existing client/server applications to Internet-based applications using Java 2 Enterprise Edition (J2EE) technologies. During the first half of CY 2005 (J2EE Conversion Phase 2.1), eRA intends to deploy production pilots for Institute and Center Operations, Committee Management, and Review. The remaining modules (Receipt and Referral, Training Activities, Population Tracking, and CRISP Plus) will migrate to J2EE in the second half of the year (Conversion Phase 2.2).

During 2004, eRA also collaborated productively with five DHHS Operating Divisions (OPDIVs) to centralize their research grants processing under the NIH eRA system. This effort results from the August 2003 selection of eRA as the Department’s enterprise system for research grants management. Establishing a One-View environment will greatly simplify the OPDIV migration process and ongoing support for eRA’s projected 100,000 internal and external users. 

One View Objectives for 2005

• Single Login for All eRA Applications (IMPAC II and Commons)

One objective of One View is to enable NIH staff to access and navigate to all eRA applications through a single login.

Another objective is to permit seamless navigation across eRA components without the need to authenticate each user action. For example, many eRA applications rely on a common component to modify information about a person. In the client/server environment, the system invokes the Persons module without requiring another user logon. Accomplishing the same task in a transparent manner is more complex in J2EE. 

Eventually, eRA intends to use a portal or similar technology for seamless navigation across all applications. With a single logon, the user will be able to choose from a menu of applications.

• Single Method for Notification (See complete article.)

As part of One View, eRA intends to send all user notifications electronically through standard email messages and posting to a single login page. Notification events include:

• Assignment of institute, scientific review group and council   
• Release of score, summary statement, notice of grant award and award   
• Notification to approve, route, or process an electronic request such as an eSNAP, request for extension, change of institution

eRA will maintain a log of all notification events associated with a grant, most likely in the electronic grant folder. This information will become part of the public record.

• Standard User Interface for the Initiation and Processing of Requests

eRA intends to standardize the method for submitting, approving and processing all requests. This involves using the same interface and program code regardless of who initiates the request, where it originates, when it occurs in the grant cycle, and who issues the approval. In 2005, eRA will implement One View for the following electronic requests:

• Program officer and grants specialist approvals for Just-in-Time, eSnap, and Closeout requests   
• Other Prior Approval requests such as Change of Institution, Change of Principal Investigator, Request for No-Cost Extension, and Administrative Supplement   
• Internally initiated “901” requests such as Change of Institute   
• Post-submission changes to applications (eCorrections) through the eRA eXchange

One View Objectives for 2006

• Terminate support for paper requests from grantees   
• Integrate all OPDIV grantees into the Commons   
• Implement One View for remaining eRA requests

eRA staff currently are evaluating a One View demo. For more information, contact Dan Hall at hallda@mail.nih.gov.

eRA Prepares for PHS 398 Changes

eRA is preparing to accept new and modified data fields on the revised “Application for a DHHS Public Health Service Grant” (PHS 398, rev. 9/04). Beginning on May 10, 2005, all applicants must begin using the updated form.

NIH has extensively rewritten the PHS 398 in accordance with the agency’s commitment to plain language. Changes also reflect other NIH goals including electronic processing, effective monitoring of stem cell and human-subjects research, and collecting more data on significant contributors.

Changes of Note to eRA

For eRA, supporting the four-digit SSN is the most complex task. This change impacts almost every internal and external business module and all search and reporting facilities. The eRA database must store both 9-digit and 4-digit SSNs, and eRA code must accommodate both formats. In particular, programmers need to develop new SSN-matching algorithms. 

For more information on changes to the PHS 398, see NIH Guide Notice NOT-OD-05-006. Contact eRA analyst Tina Milner with questions about changes to eRA.

DHHS Issues New Ethics Rules to Prevent Conflict of Interests

The Department of Health and Human Services (DHHS), with the concurrence of the Office of Government Ethics, issued new supplemental ethics rules for federal DHHS employees restricting outside activities, financial holdings and awards. The new rules took effect on February 3, 2005. 

The complete regulation, "Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services," which appeared in the Federal Register, Vol. 70, No. 22, is available online. A summary is posted at http://www.nih.gov/about/ethics/020105COIsummary.pdf.

NIH Director Dr. Elias A. Zerhouni expressed his full support for the new rules. “This regulation is critical to restoring the integrity of the NIH and the public trust…” In a memorandum to employees on September 23, 2004, Dr. Raynard Kington, NIH deputy director for Extramural Research, stated “we have identified vulnerabilities in our system that give us pause…we will need a substantially expanded system of oversight to assure Congress and the public that conflicts of interest are prevented.”

Prohibitions

The new regulations restrict three types of relationships between NIH employees and outside organizations including pharmaceutical and biotechnology companies, NIH-supported research institutions (grantees and contractors), healthcare providers and insurers, and professional and trade associations:

1.  Outside Activities

Compensated or uncompensated employment, including consulting and advisory or other board service, and compensated teaching, speaking, writing, or editing are now prohibited. Employees must terminate these outside activities by March 5, but can request an extension. See the regulation for specific exceptions.

2.  Financial Holdings

NIH employees who file public (SF 278) or confidential (OGE 450) financial disclosure reports are prohibited from acquiring or holding financial interests, such as stock, in affected companies. Employees who do not file either of these reports are subject to a $15,000 cap on holdings in such companies. Violators must dispose of their investments by October 3, 2005.

3.  Awards

Senior staff and employees, whose responsibilities involve the donor, may not receive gifts with an aggregate market value of more that $200. There is an exception for highly prestigious awards such as the Nobel Prize.

Permitted Activities

The new regulations do not affect the agency’s authority to conduct official business with outside entities. As assigned and approved, NIH employees may:

• collaborate with a university researcher      
• be involved in a cooperative research and development agreement (CRADA) with a pharmaceutical company       
• be involved in a material transfer agreement (MTA) with a biotechnology company      
• serve as an officer or board member of a professional or trade association      
• peer review grant applications

DHHS released the new regulations in “interim final” status. Comments by employees were due to ConflictofInterest@od.nih.gov by April 4, 2005. Based on agency input and analysis of the first year of implementation, DHHS will decide which, if any, provisions of the new supplemental regulations to revise.

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

Next CWG Meeting Scheduled for May 22

Representatives from participating grantee institutions will meet with eRA staff and e-application service providers at the May Commons Working Group (CWG) meeting in Washington, D.C. 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.

The tentative agenda includes the following items:

• Electronic Competing Grant Application Process (eCGAP), scheduled pilots and next steps    
• Commons Enhancements    
• eRA and the New NIH Public Access Policy

The upcoming CWG meeting will take place on Sunday, May 22 from 9 a.m. to 4 p.m. at the National Academy of Sciences, located at the intersection of C and 21^st Streets in Washington, D.C. NIH is holding its meeting in conjunction with the Federal Demonstration Partnership (FDP) Phase IV General Meeting, scheduled for May 22-24. Go to http://thefdp.org/Meeting_May2005.html for more information about the FDP meetings.

CWG meetings are open to all interested persons. For more information, contact David Wright at david.wright@nih.gov or 301-435-1792.

The Electronic Application Process: Overview and Update

As the NIH and Grants.gov progress toward accepting e-applications for more types of research grants, an increasing number of grantees have expressed interest in electronic submission. The purpose of this article is to provide a high-level overview of the process (current and planned) and links to resources for additional information.

Prerequisites for Submitting e-Applications

To submit electronic grant applications to the NIH, grantee institutions and applicants must be registered in the NIH eRA Commons. Also, in the current process, institutions need to choose a service provider or create a system-to-system interface with NIH from their in-house grants system. 

Preparing and Submitting Electronic Grant Applications (See Flowchart)

By the end of the year, there will be several means of submitting e-applications to NIH: by transmitting data to NIH in system-to-system mode; by uploading Pure Edge forms to Grants.gov; or by using the Grants.gov system-to-system interface.

1.      Current Process: System-to-System Transmission to NIH

a.  By Service Providers

Presently, six commercial service providers are certified to submit electronic applications on behalf of client research institutions. These companies 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.

At the current time, service providers transmit the XML data streams directly to the eRA eXchange. The eXchange is the computer architecture that manages system-to-system grants-related communication between the NIH and the external community. Among its tasks, the eXchange checks for viruses, validates format, maps the XML data to fields in the eRA database, acknowledges application receipt, and routes the application data to the eRA grants administration system for processing. 

b.  By Research Institutions

Grantee institutions may 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.

2.      Grants.gov

NIH is working to integrate eRA with Grants.gov, the main federal Web site for finding and applying for grants. To do business at Grants.gov, users must register according to instructions at http://grants.gov/GetStarted.

With the exception of 2004 NIH Director’s Pioneer Awards, applicants for NIH grants have not yet been able to use forms at Grants.gov. The federal site offers 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. eRA has been working with Grants.gov to develop PHS-specific forms and schema to supplement the SF 424 R&R. This is a critical step toward NIH’s adopting the new SF 424 R&R application. In addition, eRA has created business validations for Grants.gov and plans for generating a grant image based on the 424 R&R format.

Once NIH has developed the capability to process applications via Grants.gov and system-to-system testing between NIH and Grants.gov is complete, it will be possible to transmit applications to NIH via Grants.gov. When NIH applications arrive at Grants.gov, the eRA eXchange will retrieve the applications in system-to-system mode. Then, NIH’s systems will perform validations according to NIH business rules and either save the application for user verification and eRA processing or return error messages to the applicants via the eRA Commons. If errors exist, the applicant must resubmit via Grants.gov.

a.  Grants.gov PureEdge Forms 

Grants.gov provides PureEdge™ downloadable electronic grant application forms. PureEdge software (available without cost to Grants.gov registered users) supports off-line application preparation, including extensive data edit and validation at the user’s desktop and the automated propagation of data among forms. The grantee institution can store work-in-progress and submit the final application forms and attachments to Grants.gov.

At the Grants.gov site, Northrop Grumman InFlowSuite™ software authenticates the submitter, enforces role-based security rules, checks for viruses, verifies data format, sends acknowledgement to the submitter, and converts PureEdge XML-enabled forms into XML datastreams with included documents. Grants.gov then packages the XML stream as a Simple Object Access Protocol (SOAP) message and notifies the appropriate agency that the application is ready for retrieval.

A pilot with Grants.gov using the PureEdge SF 424 R&R and PHS-specific forms is planned for late spring/early summer 2005. Once testing is completed, NIH users will be able to download and submit PureEdge forms to apply for select NIH grants. 

eRA also is collaborating with other Department of Health and Human Services 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.

b.  Applicant System-to-System Transmission to Grants.gov

In addition to establishing system-to-system interfaces with NIH and other federal agencies, Grants.gov is working on similar interfaces with applicant organizations, such as the Massachusetts Institute of Technology (MIT), and service providers that offer commercial products and services to grantees.

When Grants.gov has finalized the applicant system-to-system interface, NIH service providers will be able to begin submitting applications directly to Grants.gov. Over time, all grant applications will be submitted to NIH via Grants.gov. It is anticipated that some applicants will rely on service providers to perform front-end business validations to ensure successful submissions. eRA also intends to route application error messages to service providers.

Applicants working from Macintosh computers that are not compatible with the PureEdge Viewer system also may seek service provider assistance.

Verification by Submitter

Upon receipt of an e-application, NIH notifies the principal investigator and signing official to verify the application online through the Commons Status interface. Planned enhancements to the Status module include a new inquiry function that will allow submitters to track the progress of their electronic applications through the system.

Pilot Testing Schedule

Since the beginning of pilot testing in 2003, more than 30 research institutions have participated as early adopters. 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.

Additional Information

• Information for Applicants–– For information about Service Providers, go to http://era.nih.gov/Projectmgmt/SBIR/sbir_grants.htm.     
• 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.

e-Notification System Pilot Begins

eRA began a Phase I pilot of its new e-Notification system for NIH extramural staff and the grantee community on April 1, 2005. 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 current Phase I pilot includes the following seven notifications. With the exception of PO Approval (which will be issued electronically and in hardcopy during the pilot), 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 (SRG 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 via 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.

For more information about the new e-Notification system, contact eRA Analyst Inna Faenson at faensoni@mail.nih.gov.

New Commons Release Now Available

Commons Version 2.7.1.3 and 2.7.2.3, released this month, offer several significant enhancements, including support for the new NIH Public Access Policy (see full article in this issue).

New Features

• Ability for National Library of Medicine (NLM) users to create a Commons account, required to submit manuscripts through the NLM submission system.  
• Capability to submit closeout documents, i.e., the Final Invention Statement (FIS) and the Final Progress Report (FPR), through the Status module.  
• Inclusion of the FIS and the FPR in the Commons Grant Folder.  
• Access to Appendix materials from the Commons Grant Folder.  
• Ability to disperse meeting materials in Internet Assisted Review (IAR).

Release Notes

If you have questions, contact the Helpdesk at 866-504-9552 or commons@od.nih.gov.