Within NIH, and within the Extramural Research Community, it is important to remind ourselves of the NIH mission: “science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.” As I assume the role of Acting NIH Deputy Director for Extramural Research, I would like to affirm my unwavering commitment to this mission.

We are optimistic that the critical work of NIH will continue full steam ahead, due to the unfaltering commitment of our Staff and the Extramural Community to science that improves health worldwide. Some of the most pressing issues we will continue to vigorously address as we move forward are:

• • The continued enhancement of the Peer Review process;
• • The maintenance of robust support for New and Early Stage Investigators; and
• • The development of resolutions regarding the NIH oversight of Financial Conflict of Interest issues at extramural grantee organizations.

Finally, I would like to stress that I am very excited about developing a dialogue with NIH staff and the Extramural Community. I hope you will find during my term as Acting Director of OER that I am accessible, and have a good sense of humor and an open mind. I look forward to communicating with you through the Nexus and other channels as together we find solutions to the challenges that await us.

- Sally Rockey, Ph.D.
Acting NIH Deputy Director for Extramural Research

Dr. Sally Rockey joined the NIH in late January 2005 as the OER Deputy Director. Dr. Rockey’s career has been in extramural and electronic research administration. Prior to arriving at NIH, she was the Chief Information Officer at the Cooperative State Research, Education and Extension Service (CSREES), U.S. Department of Agriculture. In that role, she provided leadership for and managed all aspects of the agency’s information technology and software applications, spearheading the successful reconstruction of its IT environment.

Prior to the CIO role Dr. Rockey spent sixteen years in various positions in research administration at CSREES, including leading the competitive extramural research arm of the Agency. With a background in research administration, IT and all things extramural, she was a natural match to OER. In her relatively short time at NIH, Dr. Rockey has either lead or closely participated in an extremely broad array of projects: from leading the transition from paper to electronic applications; acting as the NIH Research Integrity Officer; and contributing to nearly every major initiative set forth by the Office of Extramural Communication. There is little doubt that the diversity of roles Dr. Rockey has held will be of great benefit as she helps NIH and OER address their current challenges.

Dr. Kington spoke on “The Role of Biomedical Research in the Economic Stimulus.” His testimony affirmed that the NIH mission is dedicated to seeking scientific knowledge to improve the health of all citizens. He then described how NIH grant-making and contracting activities support salaries, equipment, and infrastructure in all 50 States and discussed how the enactment of the FY 2009 Budget would enable NIH to focus on priority research areas.

An Early Stage Investigator (ESI) is a New Investigator who is within 10 years of completing a terminal research degree or of completing medical residency (or the equivalent). ESI applications will be identified and the career stage of the applicant will be considered at the time of review and award.  NIH hopes that by providing a focus on ESIs, we will be able to directly encourage earlier application for NIH research grant support. Peer reviewers will be instructed to concentrate more on the proposed method of research and to expect less preliminary data than might be provided by an established investigator. In addition, many NIH institutes and centers will give special consideration to ESI applications; while in some cases, grant periods for ESIs may be longer. For additional details on this new policy please see NIH Guide Notice NOT-OD-08-121.

New Investigators can update degree information in their eRA Commons profile immediately, and after January 17, 2009, the Commons will be ready to accept residency completion dates as well. New investigators who do not yet have an eRA Commons account must work through the sponsored research office or its equivalent at their institution in order to establish an account and complete a profile. Investigators who enter degree and residency completion dates will be notified of their ESI status by e-mail.

• Click here to find out more about updating your personal profile
• Work through your sponsored research office if you need an eRA Commons account
• After January 17, return to your profile to add your residency completion date

Applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. In June 2007, NIH initiated a formal, agency-wide effort to review the NIH peer review system. After careful deliberation and consideration of the recommendations resulting from this year-long effort, an initial implementation timeline for enhancing peer review was announced earlier this year (NIH Guide Notice NOT-OD-08-118). Below is the updated timeline for implementation of key actions in the NIH peer review system.

Questions should be directed to EnhancingPeerReview@mail.nih.gov. For more information on NIH’s Enhancing Peer Review effort visit http://enhancing-peer-review.nih.gov/.

In September 2008, the NIH Extramural Nexus announced the upcoming arrival of new Adobe-based application forms for electronic submissions. The article alerted readers that most electronic submissions to NIH on or after January 1, 2009, must use the new Adobe-based forms (see the full Adobe transition timeline for more dates and details). As the winter holidays rapidly approach, we realize that our January transition date is right around the corner. Consequently the time to prepare for the switch from PureEdge to Adobe is NOW!

Adobe-based application packages will become available after the first week of December 2008. Applicants should download the new application from the FOA for which they are applying after December 5, 2008.

We remind you that the new Adobe-based forms require very specific software. To ensure a smooth transition, everyone who will work on an application must download Adobe Reader version 8.1.3 or later – available at no cost from Grants.gov – and use it to open and complete their application(s). Non-compatible versions of Adobe Reader will prevent successful submission to Grants.gov; make sure to install compatible software before you begin your application!

Detailed information about the transition and additional resources can be found at the following links:

• Resources for the Adobe Transition
• Electronic Application Process
• Grants.gov Applicant Resources

NIH initially intended to accommodate multiple form changes in conjunction with January’s move to Adobe; however, a delay in receiving the revised forms has prompted us to modify our schedule. (For a list of planned form changes, see Guide Notice # NOT-OD-08-073). This means that applicants will need to return to their respective FOAs in April to download the latest version of the Adobe-based application forms for receipt dates of May 2009 and beyond.

Remember: Although the software has changed, the electronic submission process has NOT. The new Adobe forms will have the same look and feel as PureEdge forms, and the overall process of finding opportunities, preparing forms and submitting applications will remain the same.

OER has recently added the capability for users to print a certificate of completion of the Financial Conflict of Interest Tutorial; so if you have already taken it, revisit it to print our your certificate. If you have not yet taken the tutorial, do so as soon as possible!

The tutorial, developed to help ensure that research is carried out without bias and with the highest standards of integrity, is designed for use by institutional officials responsible for managing NIH-funded grants, cooperative agreements, and/or contracts and for individuals who are responsible for the design, conduct, or reporting of NIH-supported research. We hope this tutorial proves to be a useful educational tool and, although not a requirement, NIH strongly encourages all NIH-funded investigators to take it.

Even if you have already taken the tutorial, you may want to revisit it, refresh your memory, and print your certificate of completion. The tutorial may be accessed on the Office of Extramural Research Conflict of Interest Page at: http://grants.nih.gov/grants/policy/coi/index.htm. For more information on this important topic, consult the Frequently Asked Questions document on the OER Web site or contact FCOICompliance@mail.nih.gov.

Make plans today for attending one of the 2009 NIH Regional Seminars on Program Funding and Grants Administration. Over 25 HHS and NIH policy, grants management, review and program staff members will be on hand to provide a broad array of expertise and insight related to federal regulations and policies, and provide the fundamentals of the grants process, peer review, NIH initiatives, and more. In addition, optional NIH Electronic Research Administration (eRA) hands-on computer workshops for Principal Investigators and administrators are offered in conjunction with the seminar, providing attendees with hands-on experience in how to interact electronically with NIH. Anyone interested in the NIH grants process should consider attending, including sponsored project office and departmental administrators, PIs, graduate students, etc.

April 16-17, 2009 – Atlanta, GA - (Registration is open.) eRA computer workshops will be offered on Wednesday, April 15, 2009. This seminar is co-hosted by Georgia State University and Georgia Institute of Technology.

June 25-26, 2009 – Las Vegas - (On-Line Registration will be available in mid-December.) eRA computer workshops will be offered on Wednesday, June 24, 2009. Co-ambassadors for this event are the University of Nevada, Las Vegas, and the University of Nevada, Reno.

These seminars provide an opportunity for participants to gain a better perspective of NIH policies and programs, network with their peers, obtain helpful NIH contacts, and to return to their offices and/or labs with inside information into obtaining and managing NIH awards. Since these seminars are only provided twice a year, they traditionally reach capacity prior to the event—so please register early. We look forward to sharing the 2009 seminars with you. For more information, visit the NIH Office of Extramural Research Regional Seminar Web site at: http://grants.nih.gov/grants/seminars.htm.

In fiscal year 2008, eRA registered 3.7 million logins to its eRA Commons system from 171,000 users around the world.

In that period, the NIH Electronic Research Administration (eRA) unveiled an extensive number of high impact business process changes to benefit the extramural user community and internal NIH staff, including:

• Allowing grantees to electronically report identification of Financial Conflict of Interest (FCOI), which will help grantee institutions analyze and track FCOI reports (October 2008). See previous Nexus article: NIH Encourages Use of New Electronic Process for Reporting Financial Conflicts of Interest
  
  
• Providing a decision tool to aid in the assignment of grant applications (October 2008): eRA, in partnership with the Center for Scientific Review (CSR), launched a pilot to provide a decision tool to aid in the assignment of grant applications to CSR Integrated Review Groups. The Automated Workflow Referral System suggests CSR review committees that might be a good match for a particular application.
  
  
• Processing of electronic training grant appointments through xTrain (June 2008): xTrain is an electronic tool for processing training grants appointments, also known as National Research Service Award institutional research training grants, that support predoctoral and postdoctoral research training.
  
  
• Securing grant application information (May 2008): Implemented password protection and encryption of the compact disks containing grant application information given to reviewers.
  
  
• Permitting multiple simultaneous active applications until time of award (January 2008): Allowed more than one active grant application to be in the eRA system, thereby allowing both the original and the amended application to be in play for funding consideration
  
  
• Introducing electronic reporting of reviewers’ conflict of interest (December 2007): Introduced electronic Conflict of Interest forms for reviewers to indicate whether they have a conflict with the grant applications they are reviewing.
  
  
• Moving NIH a step closer to paperless grant files (October 2007): Introduced the ability for review, receipt & referral and grants management staff to upload supplemental material to the grant folder.

In fiscal year 2009 eRA will accommodate electronic submission of Career Development Awards (Ks), Fellowships (Fs) and Training (Ts) grant program applications; implement Peer Review changes and more!  Look to a future Nexus for details.

• Lisa Evans, Esq., has joined the NIH Office of Extramural Research as the agency’s first Scientific Workforce Diversity Specialist. For the past six years, Ms. Evans served as the Senior Advisor for Policy at the National Center on Minority Health and Health Disparities. Ms. Evans is an experienced litigator who worked in the Civil Rights Division of the Department of Justice for six years, and was a Pro Se Law Clerk in the U.S. Court of Appeals for the Second Circuit in New York City. Ms. Evans earned her B.A. from Amherst College and her J.D. from Columbia University.
  
  
• Della Hann, Ph.D., will be joining the Office of Extramural Research to serve as Interim Deputy Director. Dr. Hann brings over 17 years of NIH experience, first serving as a program officer and most recently as Director, Office of Science Policy, Planning and Communication in the National Institute of Mental Health.
  
  
• Ann Hardy, Ph.D., has been appointed Extramural Human Research Protection Officer in the Office of Extramural Programs (OEP), Office of Extramural Research (OER). Dr. Hardy will provide leadership on the overall administration of human subject protection issues related to NIH extramural research and will advise senior OER and NIH leaders on relevant human subject policy issues. Prior to joining OER, Dr. Hardy served as a Scientific Review Officer in NIH’s Center for Scientific Review for 7 years, in the Health of the Population Integrated Review Group (HOP IRG) where she established the Biostatistical Methods and Research Design study section. She also served for 3 years as the Deputy Chief of the HOP IRG. Before coming to NIH, Dr. Hardy spent 17 years at the Centers for Disease Control and Prevention working in the HIV/AIDS Program and at the National Center for Health Statistics.
  
  
• Mr. Pete Morton has been appointed as the Acting Director for the OER Office of Research Information Systems. He previously served as the Acting Program Manager of eRA. Mr. Morton’s new position adds the responsibilities of the ORIS Division of Information Systems (DIS) and the ORIS Security Office. Before arriving at NIH, Mr. Morton completed his Master’s Degree in Theoretical Solid State Physics. He joined NIH as a health physicist in the Clinical Center and, after several years, moved to the Center for Information Technology (CIT). At CIT for 30 years, Mr. Morton managed the development of the original Electronic Council Book and the QVR systems.