From forest fires in the West, to floods in the Midwest, to hurricanes in the Gulf States, each season reminds us of how destructive the forces of nature can be. Clearly the loss of human life is the most catastrophic result of natural disasters, but the emotional and economic costs of such events can be nearly as devastating. In terms of the loss of biomedical research data and equipment, the lives of research animals, and advances in learning that may have taken years to develop, it is no exaggeration to say that natural disasters have a potential impact on human lives long after the events themselves. It is for this reason that the NIH considers it a top priority that biomedical facilities are prepared for and are quickly able to recover from natural disasters when they occur.

With this goal in mind, the NIH Office of Extramural Research has created a new Web site to assist the biomedical community in its disaster preparedness and recovery efforts. Beyond providing information to investigators and their institutions on NIH’s response to major events as they unfold, the site details prior NIH responses to natural disasters and emergencies affecting the biomedical community. It also provides related resources, such as links to similar Web sites from other federal agencies.

Assistance to the biomedical community during natural disasters is handled on a case-by-case basis in a manner appropriate to the circumstances and in coordination with other federal agencies. In each case, issues specific to the scale of the disaster will be considered. These might include whether a federal disaster is declared; the severity of damage inflicted; the length of time an institution may be required to close or that is required for recovery; the impact on investigators, human research subjects, and research animals; and the overall impact on the community. Details regarding specific responses to natural disasters will be announced as appropriate on the new Web site and in the NIH Guide for Grants and Contracts.

Our two-pronged goal in providing this new resource is first, to promote awareness of disaster and emergency preparedness among the biomedical research community and second, to put in place administrative flexibilities that allow grantees to focus on the restoration of productive research following a natural disaster. It is our hope that although natural disasters may be inevitable, the setbacks they present to medical research perhaps need not be.

- Norka Ruiz Bravo, Ph.D.
OER Director and NIH Deputy Director for Extramural Research

Elias A. Zerhouni, M.D., the director of the National Institutes of Health, September 24 announced his plans to step down at the end of October 2008 to pursue writing projects and explore other professional opportunities.

Dr. Zerhouni, a physician scientist and world-renowned leader in radiology research, has served as NIH director since May 2002. He led the agency through a challenging period that required innovative solutions to transform basic and clinical research into tangible benefits for patients and their families. One of the hallmarks of his tenure is the NIH Roadmap for Medical Research, launched in 2003, after extensive consultations with the scientific community. The NIH Roadmap brought together all of the 27 NIH Institutes and Centers to fund compelling research initiatives that could have a major impact on science, but that no single institute could tackle alone.

Dr. Zerhouni also launched new programs to encourage high-risk innovative research, such as the Director's Pioneer Awards and New Innovator Awards, and focused especially on the need to support new investigators and foster their independence. During his tenure, Zerhouni worked to lower barriers between disciplines of science and encourage trans-NIH collaborations. For a more complete overview of Dr. Zerhouni and his contribution to the NIH, please see the related press release.

Most electronic submissions to NIH on or after Jan. 1, 2009 must use Adobe application forms, with a few exceptions (See NIH Guide Notice NOT-OD-08-117). As NIH waits to incorporate the latest updates to the Adobe forms by December 2008, there are two critical points applicants need be aware of:

1. New Funding Opportunity Announcements released after Sept. 1, 2008, will not have Adobe application forms for downloading until December 2008. At that time, it will be necessary for you to go back to your chosen FOA to download the Adobe-based application packages. Existing FOAs that were released prior to Sept. 1, 2008, will have PureEdge application forms that will remain active and available until they are replaced by Adobe forms in the December timeframe (with the exception of small business and conference grants which will have new Adobe forms in February 2009). Do not wait for the Adobe forms to become available — develop your research plan components and required application attachments now!

2. There are only two versions of Adobe Reader that Grants.gov currently recommends for use with the new application forms — version 8.1.2 and version 9.0.(the versions may change, stay tuned to Grants.gov’s Download Software page for details). Both are available for free download at Grants.gov. Earlier versions of Adobe Reader will not be accepted by the system.

Answers to questions you may have and additional help can be found at the following links:

• Guide Notice #NOT-OD-08-117
• Resources for the Adobe Transition
• Electronic Application Process
• Grants.gov Applicant Resources

Background Information

NIH and Grants.gov have been working toward transitioning electronic grant applications from PureEdge to Adobe forms, which are accessed through Adobe Reader. One reason for the transition is to better accommodate both MAC and PC users; Adobe Reader is cross-platform software. A benefit to this changeover is Adobe Reader’s universality, giving users the advantage of working with a well-known, free, and easily downloaded piece of software.

The transition is now at an impact stage: As stated in the above bullets, many new FOAs will soon be posted online without downloadable application forms. Small business and conference FOAs are not affected at this time. As NIH waits to incorporate the most recent changes to the Adobe application forms, it will also receive submissions from the three Adobe pilots (see related Guide Notice) and examine any glitches encountered by the grant applicants. NIH will work with Grants.gov to correct any issues and fine-tune the Adobe forms prior to their final release in December.

Note: Although the software program has changed, the electronic submission process has NOT. In addition, the new Adobe forms will have the same look and feel as PureEdge forms (except on the budget page, where you will see clear differences).

The Peer Review Oversight Committee and three subgroups consisting of NIH program, review, grants management and evaluation staff have developed an initial implementation timeline for the Enhancing Peer Review activity. The recommendations that are being implemented are based on the results of the diagnostic phase and significant dialogue with both the internal and external communities regarding enhancements to the review system (please see http://enhancing-peer-review.nih.gov for an overview of the Enhancing Peer Review effort).

Although the subgroups are continuing to work out specific details of the implementation plans, the preliminary implementation plans for the 2009 through 2010 calendar years are as follows:

Priority Area 1 – Engage the Best Reviewers

• Improve Reviewer Retention: In 2009, new reviewers will be given additional flexibility regarding their tour of duty, and other efforts will be undertaken to improve retention of standing review members.
• Recruit the Best Reviewers: A toolkit, incorporating best practices for recruiting reviewers, will be made available to all ICs in 2009.
• Enhance Reviewer Training: In spring 2009, training will be available to reviewers and Scientific Review Officers related to the changes in peer review.
• Allow Flexibility through Virtual Reviews: Pilots will be conducted in 2009 on the feasibility of using high-bandwidth support for review meetings to provide reviewers greater flexibility and alternatives for in-person meetings.

Priority Area 2 – Improve the Quality and Transparency of Review

• Improve Scoring Transparency and Scale: Review criteria-based scoring on a 1 to 7 scale commences in May 2009. Reviewers will provide feedback through scores and critiques for each criterion in a structured summary statement.
• Provide Scores for Streamlined Applications: In 2009, streamlined applications will receive a preliminary score.
• Shorten and Restructure Applications: Shorter (12-page research plan) R01 applications (with other activity codes scaled appropriately) will be restructured to align with review criteria for January 2010 receipt dates.

Priority Area 3 – Ensure Balanced and Fair Reviews across Scientific Fields and Career Stages, and Reduce Administrative Burden

• Fund the Best Science Earlier and Reduce Need for Resubmissions: To ensure that the largest number of high quality and meritorious applications receive funding earlier and to improve system efficiency, NIH is considering separate percentiling of new and resubmitted applications and permitting one amended application.
• Review Like Applications Together: NIH is establishing an Early Stage Investigator (ESI) designation. In 2009, NIH will evaluate clustering ESI applications for review. The same approach will be considered for clinical research applications.

The Enhancing Peer Review activity has been an intensive year-long effort. Many of you have contributed valuable feedback. Thank you for your participation. Updates and details will be posted to the Enhancing Peer Review Web site (http://enhancing-peer-review.nih.gov) and published in the monthly Extramural Nexus (http://grants.nih.gov/grants/nexus.htm) as they are known.

The House Judiciary Subcommittee on Courts, the Internet, and Intellectual Property on September 11 heard testimony on HR 6845, the “Fair Copyright in Research Works Act.” The act would amend current law, established in the 2008 Consolidated Appropriations Act, which is the basis of the NIH Public Access Policy.

Although the bill to reverse the current law has just been introduced, the NIH Public Access Policy remains unchanged. As such, 100 percent compliance is expected from all NIH-funded researchers, both external and internal.

New and early stage investigators are essential to the vitality of health-related research. For this reason, the NIH will begin explicitly to encourage the transition of early career investigators to research independence. While it is clear that identification and special consideration of applications submitted by new investigators has protected the flow of previously unfunded investigators into the NIH PI pool, there have been few incentives to encourage early transition to independence. Many new investigators have spent many years in predoctoral and postdoctoral training.

Accordingly, the NIH has issued a new policy to adopt more broadly the approach used by the NIH Director’s New Innovator Award. Under this policy, the NIH will identify those new investigators who are within 10 years of completing their terminal research degree or within 10 years of the end of medical residency. Those individuals will be called Early Stage Investigators and their career status will be considered at the time of review and award. For a full description of the new policy and an implementation schedule, please see the corresponding Guide Notice.

According to the September issue of Peer Review Notes, the Center for Scientific Review’s (CSR) national database of volunteer reviewers now includes over 3,000 highly qualified investigators to serve on review groups. CSR is continuing its recruitment efforts, inviting scientific societies to recommend reviewers based on the following qualifications:

• Substantial and broad independent research experience
• Recipient of major peer-reviewed grants either from NIH or an equivalent agency
• Understanding of the review process
• Willingness to consider serving in the future for four years

To find out more, please visit the CSR Registry Web page.

A recording of the Office of Laboratory Animal Welfare IACUC Staff Online Seminar, "Freedom of Information Act Policies," held on September 18, 2008, is now available for viewing from the OLAW Web page http://www.grants.nih.gov/grants/olaw/e-seminars.htm.

The National Institutes of Health (NIH) invites all Federal Demonstration Partnership (FDP) members to participate in a pilot of a Financial Conflict of Interest (FCOI) Module, a new feature of the NIH electronic Research Administration (eRA) Commons. The FCOI Module provides institutional users the ability to electronically prepare and submit FCOI reports and other required documents through the Commons. Currently, the FCOI reports are submitted to the Chief Grants Management Officer of the NIH awarding component.

The FCOI Module will allow institutional users to 1) initiate and prepare FCOI reports, 2) electronically submit reports and supporting documents, 3) search and view FCOI reports previously submitted through the Commons, 4) edit or rescind submitted reports with NIH involvement and 5) access history of actions.

The FCOI Module is part of the eRA Commons, an online interface where grantees and federal staff share information. The current version of the FCOI Module incorporates feedback from a small-scale pilot test performed in the summer of 2008 with nine institutions that are members of the Commons Working Group. Based on feedback from the initial pilot participants, NIH now expands the pilot to all FDP members and a small sample of non-FDP members.

Additional information, resources, and a User Guide for the FCOI Module can be found on the eRA Commons page.