Additional Information on NIH Proposals

Some recent NIH proposals have been delayed in submission to sponsors because of data or information that was missing or incomplete on the proposals. This serves as a reminder of a list of items that need to be included in any new or competitive renewal proposal to NIH.

1) For consortium projects, where MIT is the prime grantee, all consortium participant proposals must be signed by the appropriate Institutional Official. OSP considers the signature on the NIH face page as the most accurate way for all consortium members to make the required certifications. However, OSP will accept a signed statement or email from an authorized institutional official which includes all the certifications that are listed on the NIH checklist. Listed below is a summary from the NIH 3/01/01Grant Policy Manual as it relates to this item.

“The grantee (MIT) is responsible for determining whether a consortium participant has filed assurances with NIH that would cover its activities within the consortium and, if not, for ensuring that any required assurances or certifications are submitted to NIH.
See "Public Policy Requirements and Objectives" (http://grants1.nih.gov/grants/policy/nihgps_2001/part_iia_1.htm)
for the full statement of these requirements and their applicability to consortium
participants.”

2) All projects that have human subject research must follow the guidelines listed in the 398 application instructions. Although the NIH has 6 categories that qualify for exemption from coverage by the regulations, MIT still requires that exempt protocols be approved by COUHES. If COUHES approves the application under one of the 6 categories, the Principal Investigator should check yes on 4.a of the NIH Face Page and include the appropriate Federal exemption number.

3) NIH now requires that all applications that have human subject research must complete the tables on the “Targeted/Planned Enrollment Format Page” or the “Inclusion Enrollment Report Format Page,” as applicable. Specific instructions can be found in the 398 instructions dated 5/2001, but a brief summary follows:

New applications-Complete the “Targeted/Planned Enrollment Format Page.”

Competing Continuation, Supplements and Annual Progress Reports- Complete the “Inclusion Enrollment Report Format Page.”

Last updated 9/23/03