Revisions and Modifications

The previous reviewers will be given the following:

1.                   The list of the comments from the previous review

2.                   Copy of revised protocol

Lists of specific documents distributed to primary reviewers, members, and others. 

     In conducting continuing review of research not eligible for expedited review, all KNH/UON-ERRC members shall at least receive and review a protocol summary and a status report on the progress of the research including|:

(i)                   the number of subjects accrued;

(ii)                 a summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review;

(iii)                a summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review; (iv) any relevant multi-center trial reports;

(iv)               any other relevant information, especially information about risks associated with the research; and

(v)                 a copy of the current informed consent document and any newly proposed consent document.)

At least two members of the KNH/UON-ERRC (i.e., primary reviewers) also should receive a copy of the complete protocol including any modifications previously approved by the KNH/UON-ERRC. Furthermore, upon request, any KNH/UON-ERRC members also should have access to the complete KNH/UON-ERRC protocol file and relevant KNH/UON-ERRC minutes prior to or during the convened KNH/UON-ERRC meeting.

Details of any process (e.g., a subcommittee procedure) that may be used to supplement the KNH/UON-ERRC’s continuing review

Timing of document distribution prior to KNH/UON-ERRC meetings

These materials shall be received by members two weeks prior to the meeting in advance of the meeting date to allow review of this material.