E6-12230. Request for Information (RFI): Change in Grant Appendix Materials

ACTION:

Notice.

SUMMARY:

The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) are evaluating guidelines for grant application appendixes in an effort to streamline the application and review processes. This RFI requests input from interested applicants, reviewers and other members of the research community regarding the way appendix materials should be used in the grant submission, review and management process. Comments will be considered in the development of new policies on appendix materials for various grant programs.

DATES:

Reponses must be received by September 14, 2006 in order to ensure that NIH and AHRQ will be able to consider the comments in developing new policies on appendix materials for various grant programs.

FOR FURTHER INFORMATION CONTACT:

E-mail inquiries will be accepted at [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The goal of changing the guidelines for grant application appendix materials is to encourage applications to be as concise as possible while containing the information needed for expert scientific review. These changes should make application preparation and handling easier for both applicants and reviewers.

Current NIH and AHRQ policy indicates that the Appendix may not be used to circumvent the page limitations of the Research Plan. Appended publications may not be used to provide further details of methodologies or preliminary data described in the Research Plan. All applications and proposals for NIH and AHRQ funding must be self-contained. NIH application guide instructions note that the Appendix is sent only to those members of the Scientific Review Group (SRG) assigned as primary reviewers of the application. Currently, unless otherwise stated in the solicitation, the following materials may be included in a grant application Appendix:

• Up to 10 publications or manuscripts accepted for publication, using URL links to publicly accessible journal articles.
• Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
• Photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 25-page limit of Items a-d of the research plan. No photographs or color images may be included in the Appendix that are not also represented within the Research Plan.

Investigators spend much time and energy developing applications to Federal Agencies. It is unclear whether appendix material which may or may not be read by members of the SRG improves current applications. Submission of unnecessary materials with grant applications wastes the time, energy and resources of investigators, applicant institutions, reviewers, and the NIH and AHRQ.

Proposed Changes

The following changes are being considered for implementation concurrent with NIH/AHRQ's transition to the electronic grant application process and the SF-424 (R&R):

• Submission of photographs or color images of gels, micrographs, etc., will not be allowed in the Appendix. Use of the SF-424 (R&R) electronic grant application will permit insertion into the body of the Research Plan high resolution images of the same quality found in scientific publications.
• Materials currently submitted in the Appendix which are essential to the review of the application will be submitted as part of the grant application itself. For example, documents such as clinical protocols, informed consent forms, key questionnaires, surveys, and similar items which are needed by the SRG to adequately assess human subjects issues will be submitted as part of the 'Protection of Human Subjects' section of the grant application.
• Reprints or preprints of publications or their PDFs will no longer be allowed as part of the Appendix. Links (URLs) to PubMed Central or publicly available on-line journals will be permitted in the Biographical Sketches, Bibliography & References Cited, and the Research Plan sections of the grant application. Critical information and detail should be included within the Research Plan and cited in the Bibliography & References Cited section and/or figure or table legend(s) to indicate publication status.
• Materials specifically designated in the Funding Opportunity Announcement may be included in the Appendix, within identified page limits. It is anticipated that most FOAs will not permit materials to be included in the Appendix.
• All members of the SRG will receive copies of the full application including any permitted Appendix materials thereby increasing the equity of the review.

Information Requested

Information in the following areas will assist the NIH and AHRQ in developing new policies regarding submission of appendix materials. Respondents will be asked to indicate what perspective(s) they represent, i.e. reviewer and/or applicant, institutional official, etc.

1. Is there a need to reduce the material submitted in the Appendix? If yes, please provide specific types of material that could be eliminated.

2. Is there information essential to the application's review that cannot be included in the body of a grant application as proposed? If yes, please describe the material and identify applicable grant program(s).

3. Is it necessary to include reprint and preprint PDFs as appendix material? If yes, please explain.

4. Do you have concerns about discontinuing the submission of photographs or color images in the Appendix of electronic grant applications? If yes, please explain.

5. Will the proposed changes favor or disfavor any specific group of investigators? If yes, please explain.

Responses

Responses must be submitted electronically at http://grants.nih.gov/​grants/​guide/​rfi_​files/​rfi_​appendix_​add.htm. The responses for each item should be limited to 500 words. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government's assessment of the information received. No basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement. Individual responses will be confidential. Any proprietary information should be so marked.

Dated: July 24, 2006.

Norka Ruiz Bravo,

Deputy Director for Extramural Research, National Institutes of Health.