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

 

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Amendments to protocol

In the case of a positive decision, the researchers shall be required to:

1.                   confirm the acceptance of any requirements imposed by the KNH/UON-ERRC; submit progress report(s)

2.                   notify the KNH/UON-ERRC in cases of protocol amendments (other than amendments involving only logistical or administrative aspects of the study)

3.                   notify the KNH/UON-ERRC in the case of amendments to the recruitment material, the potential research participant information, or the informed consent form

4.                   report serious and unexpected adverse events related to the conduct of the study

5.                   report unforeseen circumstances, the termination of the study, or significant decisions by other KNH-ERRCs

6.                   provide information the KNH/UON-ERRC expects to received in order to perform on-going review

7.                   provide final summary or final report