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INITIAL AND CONTINUING REVIEW PROCEDURES BY THE COMMITTEES
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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INITIAL AND CONTINUING REVIEW PROCEDURES BY THE COMMITTEES[2]

TIMING OF REVIEW

The committee will meet as often as the need arises. Research described in applications and contract proposals shall, whenever possible, be given institutional review and approval prior to submittal to the sponsor.

There may be occasions when a second review by the committee will be required before the research project is initiated. Also, the committee shall require the project or program director to report for review any emergent problems or proposed procedural changes which might affect the status of the research with regard to the committee's review criteria. No such changes, except those necessary to eliminate apparent immediate hazards, will be allowed without prior approval of the committee.

Prior to submittal of a grant application to the committee, the principal investigator should discuss his application with his department head during its preparation, and submit it to the review committee before the application is sent to the sponsor. The proposal or application should be appropriately marked in the spaces provided or, when missing, the following statement should be typed on the lower or right-hand margin of the page bearing the name of the institutional official signing the application or proposal for the institution:

HUMAN SUBJECTS---REVIEWED AND APPROVED ON (date). (This date should be no more than 90 days prior to the submittal date and must not be more than 12 months prior to the proposed starting date).

If it is necessary to delay the review, the proposal should be appropriately marked in the spaces provided on the forms or, if missing, the following statement should be typed in the lower or right-hand margin of the page bearing the name of the institutional official authorized to sign or execute applications or proposals for the institution:

HUMAN SUBJECTS---REVIEW PENDING ON (date). (This date should be at least one month earlier than proposed starting date of the project to avoid possible conflict with the award date).

Pending reviews will be completed as much in advance of the stated pending review date as is practicable. If the final action is disapproval, or is approval contingent on substantive changes in the proposal, the Director of the Office of Sponsored Programs will be asked to so notify the operating agency and, where appropriate, will formally withdraw the application from further consideration by that agency.

 
[2]

Unless specifically noted otherwise, procedures are equally applicable to both the Clinical Research Committee and the General University Committee.