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

 

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Termination of Research

 

            1.         If the sponsor terminates/suspends a trial, then the institution should:

(i)                   promptly inform and provide the KNH/UON-ERRC with detailed written explanation of   the termination or suspension.

 

2.                   If the KNH/UON-ERRC terminates or suspends its approval of a trial, then the Institution should:

(i)       promptly notify and provide the sponsor with a detailed written explanation of the termination or suspension.

(ii)     any suspension or termination of KNH/UON-ERRC approval shall be reported to :

·        Director of KNH

·        Section Heads of Departments KNH

·        Deans Directors of respective faculties and schools

·        Supervisors in case of  students

·        Ministry of Health or employer of the investigators

·        National Council for science and Technology (NCST)

·        Funding agencies

 

3.                   The KNH/UON-ERRC shall write a report detailing the following:

1.       a description of reasons for terminating or  suspension of  KNH/UON-ERRC approval including lists of specific documents distributed to primary reviewers, members, and others for review

2.       office(s) or institutional official(s) responsible for taking action

3.        unanticipated problems involving risks to subjects or others;

4.       any serious or continuing noncompliance

5.       criteria for KNH-ERRC determinations