EGRP Bulletin - Winter 2008-2009

Grantsmanship

NIH Data Sharing Policy In Effect for Genome-Wide Association Studies

The new policy for the sharing of data obtained through NIH-supported or -conducted genome-wide association studies (GWAS) went into effect in January 2008. The policy applies to: competing grant applications that include GWAS and are submitted to NIH for the January 25, 2008, and subsequent due dates; proposals for contracts that include GWAS and are submitted to NIH on or after January 25, 2008; and NIH intramural research projects that include GWAS and are approved on or after January 25, 2008.

The final policy was announced in the NIH Guide, NOT-OD-7-088, after a period of public consultation with representatives from the scientific and lay communities. A followup Notice, NOT-OD-08-013, provides guidance on implementation and instructions for applicants.

The policy's goal is to facilitate broad and consistent access to NIH-supported GWAS data to speed the translation of basic genetic research into therapies, products, and procedures that benefit the public health. NIH believes that the full value of GWAS to the public can be realized only if the resulting genotype and phenotype datasets are made available as rapidly as possible to a wide range of scientific investigators. Rapid and broad data access are particularly important for GWAS—these studies generally require significant resources, present challenges in analyzing the large datasets, and provide extraordinary opportunities for making comparisons across multiple studies.

Refer to the NIH GWAS Web site for guidance on implementing the policy, including developing data-sharing plans for applications and proposals that include GWAS, peer review of GWAS grant applications, submitting data to the NIH GWAS data repository, requesting access to data in the NIH GWAS data repository, oversight of the NIH GWAS initiative, protections for research participants, points to consider for Institutional Review Boards and institutions in their review of data submission plans and institutional certifications, and frequently asked questions and answers.

New NIH Policy To Fund Meritorious Science Earlier

On October 8, 2008, NIH announced that beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009, due dates and beyond, NIH will accept only a single amendment (A1) to the original application. Failure to receive funding after two submissions (i.e., the original and the single amendment) will mean that the applicant should substantially redesign the project rather than simply change the application in response to previous reviews. It is expected that this policy will lead to funding high-quality applications earlier, with fewer resubmissions.

Original new and competing renewal applications that were submitted prior to January 25, 2009, will be permitted two amendments (A1 and A2). For these "grandfathered" applications, NIH expects that any A2 will be submitted no later than January 7, 2011; NIH will not accept A2 applications after that date.

This policy applies to all applications, including those submitted under the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, Career Development Awards, Individual Fellowships, Institutional Training Grants, Resource Grants, Program Projects, and Centers. Currently, no amendments are permitted for applications received in response to a Request for Applications (RFA) unless it is specified in the Funding Opportunity Announcement, in which case only one amendment will be permitted.

Applicants are strongly encouraged to discuss their questions with their NIH Institute or Center contact. For additional information or questions, send an e-mail to: EnhancingPeer Review@mail.nih.gov or contact:

Division of Receipt and Referral Center for Scientific Review
6701 Rockledge Drive, MSC 7720
Bethesda, MD 20892-7720
Voice: 301-435-0715
Fax: 301-480-1987

The new policy was announced in the NIH Guide for Grants and Contracts, NOT-OD-09-003.

NIH Revised Policy Issued on Enhancing Public Access to Archived Publications

The NIH Public Access Policy requires that all final peerreviewed manuscripts arising from NIH funds be submitted to PubMed Central (PMC) on acceptance for publication. As of May 25, 2008, all NIH applications, proposals, and progress reports must include the PMC reference number or NIH Manuscript Submission reference number when citing a paper that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator's NIH award.

Key Public Access Policy Web pages:

Grant Applications Must Tie to Funding Opportunity Announcements

Together with implementation of electronic submission of grant applications, remember that all applications must be submitted in response to specific Funding Opportunity Announcements (FOAs). NIH has omnibus parent announcements for use in submitting what formerly were termed "unsolicited" applications. For help in identifying appropriate FOAs for unsolicited or investigator-initiated applications, see http://grants.nih.gov/grants/guide/parent_announcements.htm, or consult your EGRP Program Director.

NIH Summarizes Policy on Late Grant Applications

NIH describes its policy on late grant applications in a Notice in the NIH Guide, consolidating information from previous Notices. Investigators are reminded that no NIH staff member, whether in the Center for Scientific Review (CSR) or any of the other Institutes/Centers, has the authority to give permission in advance for a late application. Contacting the Division of Receipt and Referral or any other component of the NIH will not lead to either permission to submit late or an evaluation of the acceptability of the reasons for a delay. Inquiries may be directed to the Division of Receipt and Referral, CSR, NIH, tel.: 301-435-0715; fax: 301-480-1987.

Access the Notice: NOT-OD-08-027
List of standard receipt dates

Standing NIH Study Section Members Offered Modified Grant Application Procedures

NIH is implementing an alternate plan for submission and review of research grant applications from appointed members of chartered NIH Study Sections to recognize their outstanding service and minimize disincentives to Study Section service. The timing of Study Section meetings and most standard due dates for grant applications overlaps. Thus, reviewers are under pressure to review applications and prepare their own applications simultaneously.

Beginning February 5, 2008, the alternate submission and review procedures described below became available for appointed members of NIH Study Sections. This alternate process is limited to (1) appointed members of chartered standing Study Sections and (2) applications that normally would be received on standard submission dates (but not special receipt dates). Depending on the timing of the submission and the number of other similar applications received during the premeeting time window, NIH staff will decide if the application will be reviewed in a different standing Study Section or in a Special Emphasis Panel (SEP). These applications will be processed and assigned to NIH Institute Review Offices or CSR Integrated Review Groups (IRGs) using the standard referral guidelines.

The continuous submission process will enable appointed members of chartered NIH Study Sections to submit their applications as soon as they are fully developed. Applications will be reviewed no later than 120 days after receipt. For complete information, refer to the NIH Guide Notice, NOT-OD-08-026.

Reminder for NIH Study Section Members: Consult With NIH Program Directors if Planning to Submit Grant Applications With Budgets ≥$500,000

Despite the alternate submission and review procedures for appointed study section members and ad hoc members (see article above and NIH Guide Notice NOT-OD-08-027), the Awaiting Receipt of Application (ARA) process still applies when budget requests are likely to be submitted with direct costs ≥$500,000 in any given year. Applicants who are eligible for the alternate grant application submission procedures still must seek agreement from Institute/Center staff to accept assignment prior to the anticipated submission of any application (see NIH Guide Notice NOT-OD-02-004). Therefore, EGRP recommends that current and prospective grantees who serve on NIH Study Sections continue to contact EGRP Program Directors well in advance to discuss their submission plans and timelines for grant applications. Contact information for EGRP Program Directors.

Review of Key Web Pages

NIH Center for Scientific Review News Flash, NIH Gives Chartered Reviewers New Flexibility Submitting Applications
Standard NIH Due Dates for Competing Applications

NIH Issues New Application Forms: Relinquishing Grant, Noncompeting Continuation Progress Report

EGRP grantees may wish to take note of two recently revised NIH grant forms:

Official Statement Relinquishing Interest and Rights in a PHS Research Grant (PHS 3734, rev. 11/07). The form is accepted immediately. There are no changes to the data elements or instructions in this revision of the form. Refer to NIH Guide Notice, NOT-OD-08-029.
Noncompeting Continuation Progress Report for a DHHS Public Health Service Grant (PHS 2590, rev. 11/07). This form is accepted immediately, and all progress reports received on or after March 1, 2008, MUST use the new instructions and form. Read the instructions carefully. This edition of PHS 2590 implements a number of important policy changes, including the NIH Policy for Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies, and registration of clinical trials as required by Public Law 110-85. One significant change to PHS 2590 is the business process for submission of the continuation progress report. As of March 1, 2008, only the signed original continuation progress report is required to be submitted to the centralized mailing address. (No additional copies are required.) Refer to the NIH Guide Notice, NOT-OD-08-030, for further information.