KENYATTA NATIONAL HOSPITAL AND UNIVERSITY OF NAIROBI ETHICS AND RESEARCH REVIEW COMMITTEE      
 

 

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Working Procedures

 

Approval Timeframe

 

KNH/UON-ERRC shall establish a follow-up procedure for following the progress of all studies for which a positive decision has been reached.

 

 

1)         The following instances or events require the follow-up review of a study:

 

  1. any protocol amendment likely to affect the rights, safety, and/or well-being of the research participants or the conduct of the study;

  2. serious and unexpected adverse events related to the conduct of the study or study product, and the response taken by investigators, sponsors, and regulatory agencies;

  3. any event or new information that may affect the benefit/risk ratio of the study.

 

2)                   A decision of a follow-up review shall be issued and communicated to the applicant, indicating a modification, suspension, or termination of the EC’s original decision or confirmation that the decision is still valid.

 

3)                   In the case of the premature suspension/termination of a study, the applicant shall notify the KNH/UON-ERRC of the reasons for suspension/termination; a summary of results obtained in a study prematurely suspended/terminated should be communicated to the KNH/UON-ERRC.

 

4)                   KNH-ERRC should receive notification from the applicant at the time of the completion of a study.

5)         The secretariat shall communicate to investigators the KNH-ERRC action regarding any proposed research and any modifications or clarifications required by the KNH-ERRC as a condition for IRB approval of proposed research by a letter

6)         The investigators’ responses (1st re-submissions within 8 weeks) shall be forwarded to the initial primary reviewers to make sure that the comments have been incorporated into the revised proposal.  Three copies will be resubmitted by the investigators.

7)                   If the resubmission is not approved by the committee, a 2nd resubmission (4 weeks) shall be reviewed as above.

8)                   A reminder will be written to the investigators if no response is made within 4 weeks and a response expected within 2 weeks.

9)                   If no resubmissions are made on time the protocol shall be deleted. Appeals shall be lodged within two months and shall be considered on merit.

 

Note:  Reviews of new research must be conducted by the KNH/UON-ERRC at convened meetings at which a majority of the members of the KNH/UON-ERRC are present, including at least one member whose primary concerns are in nonscientific areas (i.e., a quorum), except where an  expedited review is appropriate.  Approval of any research shall be by a majority (half)  vote. Should the quorum fail during a meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures, or absence of a nonscientist member), the KNH/UON-ERRC may not take further actions or votes unless the quorum can be constituted.