Adding Funding to an Approved Human Subjects Application

Use the Modification form when adding a new funding source, since that form asks for all necessary information, thus eliminating time that might be spent getting that information before the modification can be reviewed. After July 1, 2002, all proposals to add funding must be on a modification form.

The form should be used as a cover sheet; one copy of a memorandum providing any necessary additional information should be attached to each of the three copies of the form.

Procedure: When adding a new funding proposal or grant application to an existing human subjects application, submit three (3) copies of the form (one signed opriginal and two copies) collated with the memorandum, if one is needed, along with three (3) copies of all revised or additional materials that may be necessary if new or revised procedures or activities will accompany the new funding. Such revisions may require changes in consent forms, instruments, advertisements, recruitment flyers, and so on, and these should be provided for review.

Explanation: The Human Subjects Division must keep two file copies of all material relevant to each Application (they are sent to the reviewers at the time of regular renewal review); the third copy is returned to the investigator for the investigator's records.

Procedure:Also submit one (1) complete copy of the grant proposal (or statement of work, if the funding source is a contract).

Explanation:

Since the Human Subjects Division is asked to certify that what has been approved in a Human Subjects Application is what is being proposed in a grant, contract, dissertation or other proposal, it is necessary to be able to compare one with the other in order to be able to issue the certification.

Procedure:The form or memorandum must be signed by the principal investigator or other authorized person to document that it is in fact an authorized modification.

Explanation:

Since the principal investigator is responsible for the activities of other investigators and staff, and for their compliance with relevant regulations, it is important that modifications to approved procedures be authorized by the PI.


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