At a recent study section meeting, one of your colleagues reports that he was made aware of the following new NIH practice: If NIH does not receive IACUC approval for animal research within 60 days of new and competing proposal submission dates, it will RETURN THE APPLICATION unreviewed.

This comes on the heels of a 1/8/01 announcement in the NIH Guide for Grants and Contracts which states,

"In an effort to ensure that all applications meet the stated format requirements, NIH is undertaking the following steps:

• Checking competing grant applications for adherence to format requirements. APPLICATIONS THAT DO NOT COMPLY WITH THE SPECIFICATIONS FOR TYPE SIZE, PAGE LIMITS, OR MARGINS WILL BE RETURNED TO THE INSTITUTION WITHOUT REVIEW. THESE APPLICATIONS CANNOT BE SUBMITTED IN A CORRECTED VERSION UNTIL THE NEXT RECEIPT CYCLE.
• Creating a dedicated email address (format@mail.nih.gov) for questions regarding format of applications, including type size, page limits, and margins. Although each application kit clearly delineates these specifications, this will provide an additional opportunity for clarification.

In accordance with Federal regulations, New York University has implemented an on-line tutorial for Human Subjects Research. This tutorial must be taken by all NYU faculty and students engaged in research involving human subjects prior to submitting an application to the Human Subjects Committee. The tutorial takes approximately one hour to complete; 80% represents a passing grade. You will be notified of the results at the end of the tutorial, with an indication of correct/incorrect answers. The University Committee on Activities Involving Human Subjects and the Office of Sponsored Programs will be automatically notified of all individuals who have successfully completed the tutorial. The tutorial can be accessed through the University Committee on Activities Involving Human Subjects website located at http://www.nyu.edu/osp/human.html.

The revised application format, called the Modular Research Grant Application, will apply to most major competing research grant mechanisms, including the individual research project grants (R01), as well to small grants (R03) and exploratory/development grants (R21). Applicants for modular grants will request direct costs in $25,000 increments -- or "modules"-- up to a maximum of $250,000 (for R01s) in any year of a project. (Those applicants requesting more than $250,000 per annum must continue to follow existingapplication procedures.) Only limited budget information will be submitted, in a narrative format, and information on "other support" will not be provided in the level of detail required previously until just prior to award. (The format for the biographical sketch will be expanded however.)

NIH Scientific Review Groups, without access to more detailed budget information, will be expected to recommend any reductions in a proposed project’s budget in $25,000 increments as well, though NIH grants officers will continue to make final award decisions. Although modular awards will be issued without traditional cost categorical breakdowns, awardee organizations will continue to be required to allocate and account for costs related to their NIH awards by budget category in accordance with federal cost principles for universities and NIH grants policy, and otherwise to maintain responsibility for the appropriate stewardship of federal funds.

Consequently, a more traditional budget will have to be prepared internally, prior to application, both as the basis for translating actual cost estimates into a modular format, and for University review and accounting purposes.

For additional information, consult the following documents or NIH's Website <http://www.nih.gov/grants/funding/modular/modular.htm>:

• Addendum to Grant Application Form PHS-398: Instructions for Modular Grants (4/1999)
• Downloadable Modular Grant Budget Narrative - Available in two formats:  PDF | Excel 97/5.0/95 (Windows)

The National Institutes of Health has published a Notice of Legislative Mandates Contained in the Fiscal Year 2006 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act P.L. 109-149 to provide information on the following statutory provisions that limit the use of funds on NIH grant, cooperative agreement, and contract awards:

1. Continued Salary Limitation (Section 204)
2. Anti-Lobbying (Section 503)
3. Restriction on Distribution of Sterile Needles (Section 505)
4. Acknowledgment of Federal Funding (Section 506)
5. Restriction on Abortions (Section 507)
6. Ban on Funding Human Embryo Research (Section 509)
7. Limitation on Use of Funds for Promotion of Legalization of Controlled Substances (Section 510)

NIH has published two important policy announcements in the 11/21/97 issue of the NIH Guide (v. 26, no.38), which we bring to your attention. The announcements are summarized below; the full text is available on the NIH Website at http://www.nih.gov/grants/guide/1997/97.11.21/index.html.

Beginning with the June 1, 1998, deadline for new research grants, NIH will no longer accept applications for the First Independent Research Support and Transition (R29 or FIRST) awards for new investigators. New investigators will now apply for the R01 program, and are encouraged to consider submitting for an R01 award even before June 1. In making this change, NIH is committed to supporting at least the same number of new investigators and, as necessary, directing more resources to their support.

This change in policy is designed to allow investigators maximum freedom in identifying the level and period of support needed for planned work. NIH's Working Group on New Investigators concluded that while new investigators applying for either R01 or R29 funding are similar, they are subject to an artificial division of applicants by program. This has led to grant support mechanisms that can penalize the R29 applicant, the most significant of which is the R29 dollar limitation: $350,000 over a five year period, with no single year exceeding $100,000.

APPEALS OF INITIAL SCIENTIFIC PEER REVIEW

The decision to fund a grant application to NIH lies with the particular NIH Institute or Center to which it has been assigned, and is based upon both (a) the results of the initial scientific peer review and (b) the recommendation of that Institute's National Advisory Council or Board. After examining the summary statement of the initial review, an investigator may have concerns about, and wish to contest a procedural aspect of, the process (e.g., bias, conflict of interest, lack of appropriate expertise, factual errors). NIH has established appeal procedures to address such concerns, as opposed to those concerning differences of scientific opinion with reviewers.

The key to resolution of situations in which an investigator has such concerns lies in discussion with the Scientific Review Administrator and, when appropriate, in submission of an appeal letter that details the perceived flaws in the review. If not resolved by NIH staff with the investigator, the appeal is presented for Council consideration and resolution.

The details of the appeal procedures at different Institutes may vary somewhat, but each provides a means for appeals to be given full consideration by staff and, if necessary, by the Council (or a subset of it). Additional information about an Institute's appeal procedures may be obtained from the full notice of the in the NIH Guide or from OSP. More detailed guidelines will also shortly be posted on the home pages of each institute.