Informed Consent Forms
This form must be completed by all persons/teams intending to conduct health/medical research in Uganda. Upon completion by the investigator(s) it should be submitted to the School of Medicine Research and Ethics committee (SOM-REC). Upon completion of the relevant section by the REC, the form should be submitted to the Administrator, School of Medicine Research and Ethics committee Makerere University College of Health Sciences P. O Box 7072, Kampala, Uganda. The required registration fee should accompany each application.
It is the policy of the REC (Research and Ethics committee) that in the continuing review of ongoing research, the entire study will be reviewed to ensure the continued protection of the rights and welfare of the human subjects.
The REC follows, at minimum, the regulations set forth in the CIOMS Guidelines as the criteria for continuing review. The Continuing Review process must be no less stringent than the initial review.
The Principal Investigator is responsible for timely submission of a continuing review application to prevent any lapse in REC approval. REC regulations do not provide for exceptions to the requirement for continuing review.
Therefore, failure by the Principal Investigator to ensure timely review is a serious matter that may lead to suspension or withdrawal of approval. NO EXTENSIONS CAN BE GRANTED.
This form will constitute your notice of termination and final report to the REC and UNCST. Submit this form and the information requested prior to the expiration date for the protocol.
Note: In order to terminate REC approval, all research related to this protocol must have ceased, including subject enrollment, subject follow-up, and work with identifiable information related to the study subjects, including medical or research records.
Data analysis utilizing identifiable data collected from study subjects requires REC approval. If you are performing data analysis, you must submit the Continuing Review application.
It is the responsibility of the Principal Investigator to notify all study personnel associated with this protocol that it has been terminated.
This checklist will be filled for clinical trials at the time of submission of the protocol to SOMREC. It should be filled in addition to the application checklist.