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Protocol Approval Types

When a submission is initially reviewed, the CPHS employs the following approval designations:

APPROVED - the project and its study tools, including the informed consent documents, are approved as submitted.

APPROVED PENDING - the project requires revisions (e.g. the consent documents, protocol, flyers) or questions that require further attention by the investigator.

DEFERRED - more serious deficiencies in the protocol as submitted with major issues to be worked out with the investigator before CPHS can consider the project again.

DISAPPROVED - serious problems in risk/benefit analysis; protocol inadequate in addressing issues of concern.

Note: A principal investigator (PI) receiving a letter advising disapproval, may appeal the decision of the CPHS at the next meeting by notifying the Chairperson of the reasons for this re-review and supplying additional information for consideration. Should the protocol again be disapproved, the PI may appeal to the President who may request an ad hoc IRB be formed for purposes of review of the protocol. Such review will be made available to the CPHS but it may not override the decision of the CPHS.

CONTINUING REVIEW APPROVAL - following satisfactory review of information submitted by PI regarding an ongoing project. Review must occur at least annually but may be more often depending upon the level of risk involved.

 

 

For other questions, please call us at 713-500-7942.

 


 

Copyright © 2008 by The University of Texas Health Science Center at Houston
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Office of Research Support Committees | 6410 Fannin, Suite 1100, Houston, Texas 77030
phone 713.500.7943 | IRIS Support 713.500.7960 | fax 713.500.7951 | email orsc@uth.tmc.edu
last modified March 26, 2008

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