- What is the KEMRI format for writing a proposal?
- How long does it take to review and approve a proposal at KEMRI SERU?
- What is a minimal risk study?
- What is the difference between quick turnaround and expedited review?
- What is the average turnaround time for an expedited review?
- What are the review charges/fees at SERU/
- When do we need to close out a study?
Answer: Please click on the following link SERU Guidelines for Writing Project Proposals
Answer: It takes approximately six weeks to get the first response which can either be an approval or a request to the study investigators to make further revisions.
Answer: A minimal risk study is a study in which the likelihood of harm posed to the research participants in a study is no more than they would encounter in their daily lives or during routine medical or psychological care/examination.
A proposal qualifies for a Quick Turn Around review if it requires a faster than usual review due to a major public health concern e.g. an epidemic. A proposal qualifies for expedited review if it is not more than minimal risk and involves only procedures listed in one or more of the set-out categories.
NB- Expedited review does not mean quick review of the proposal. It means the application will not be reviewed by a full committee because it involves minimal risk on the participant.
Answer: The expedited review process and quick turnaround shall take no longer than (10) working days.
Answer: NON-KEMRI investigators are required to pay KSH 100,000/= for an initial protocol review. However, expedited review requests attract a fee of KSH 200, 000. Please note that this is a one-off fee for each study.
Answer: The PI should submit the request for study closure when there is no more contact with the participant, data set has been closed and the main findings of the study have been published.
NB- Investigators conducting multi-site studies reviewed by multiple IRBs should comply with all IRBs providing oversight.