Approval process for conducting a trial

All research involving human participants is subject to regulation and approval by KEMRI, Ministry of Health and/or secondary Institutional Review Boards. It is the responsibility of the Principal Investigators to familiarize themselves with these policies and regulations prior to commencing any research and be aware of any changes thereafter. A record of decisions of the technical committees and any responses should be maintained in the main study file.

There are multiple steps of review before a trial can begin with an average turnaround time of about 6 months.

> STEP 1:

KEMRI Kilifi review committees

KEMRI Kilifi Programmet Management Committee (PMC) - (Meetings held every first Friday of the month)
The Kilifi PMC reviews all concepts intended for trial implementation. The concept proposal is written in standardized format. This review involves an overview of the study i.e. investigators, funding, study objectives, population, study design, duration and strategic implications and how protocol fits in the whole program. The concept is reviewed for potential interaction with ongoing or planned studies. After PMC approval the study can start the protocol approval processes described below. If the protocol is still in early development, the team can continue the protocol development process and later submit the protocol as described below at a later date.

> STEP 2

KEMRI Kilifi Scientific Review

KEMRI Wellcome Trust Kilifi - Scientific Centre Committee (SCC) Meetings held every first Friday of the month after PMC and KEMRI Wellcome Trust Kilifi - Consent and Communications Committee (CCC).

This committee does an indepth review of protocols which must be presented in a standard structured format, unless the sponsors/collaborators require a different format. The committee goe through a systematic review of all aspects of the proposed trial (Protocol, Investigator Brochure, Questionnaires, CRF, Information sheet and Lay Summary). The standard form has been developed to facilitate ethics and science review at the Kilifi SSC and anticipate areas of ethical and scientific discussion.

Protocols must be submitted to Kilifi SCC at least two weeks before the meeting. As per KEMRI guidelines, Kilifi SCC provides thorough review to protocols generated at the centre and ensure that protocols receive appropriate scientific and ethical input. The KEMRI Wellcome Trust Kilifi unit has two committees for this purpose, the SCC which mainly reviews scientific integrity and ethics and the CCC which reviews consents After review at the Kilifi SCC, the informed consent is reviewed by the Kilifi CCC on the following Tuesday. Where the Kilifi SCC decision is favorable to continue IRB/ERC reviews, the investigator will complete a KEMRI Forwarding Form for submission to KEMRI SSC. In addition to the protocol, informed consent and translations (except if exempt), and where applicable, Investigator Brochure, any recruitment material including videos for approval by KEMRI IRB/ERC.

> STEP 3

KEMRI Nairobi Scientific Review

A protocol approved by the Kilifi SCC is submitted to the KEMRI Nairobi SSC through the Centre Director using the official KEMRI Forwarding Form. KEMRI also specifies who qualifies as an investigator. These reviews are also conducted monthly at pre-scheduled meetings. (The dates for their meetings are available upon request)
The decision of the KEMRI SSC may be to approve the protocol and forward it to KEMRI ERC or obtain the investigator's specific responses to reviewer comments before approving the protocol. After review by KEMRI SSC, the protocol is given a KEMRI SSC study number which should be referenced for any future correspondence with KEMRI.

The investigator may notify the KEMRI SCC if there are
any new amendments to the protocol. Depending upon the changes required you may need to change the version of the protocol or informed consent.

> STEP 4

KEMRI Ethics Review Committe

KEMRI ERC meetings are held monthly, usually two weeks after KEMRI SSC meetings and their meetings schedule is also available upon request. KEMRI Nairobi ERC reviews all research protocols that involve human subjects. The KEMRI ERC mainly reviews the ethical aspects of the protocol, storage of samples, exportation of samples, future research and also any other aspects of the proposal relevant to KEMRI. The decision of the ERC may be approval to start the study or further correspondence with the investigator prior to approval.

After receiving the KEMRI ERC approval non-clinical trial research may be able to recruitment, however, clinical trials involving medicinal products must go through the fifth and final review.

> STEP 5

Pharmacy and Poisons Boards Review

Pharmacy and Poisons Board Expert Committee on Clinical Trials (ECCT) reviews and approves all clinical trials in Kenya and providing import licenses for study drugs. A checklist of required documents and schedule of meetings is available on the web site http://www.pharmacyboardkenya.org/. They PPP does not have a fixed submission schedule, but generally completes their review within about a month.

After approval - (Continuing Review and Renewal Request)
After receiving all approvals as required for the study, field or hospital recruitment activities may then start. Please check the expiry dates of the approvals. Usually approvals are given for one year or less depending on the type of research. Approvals are subject to renewal upon submission of annual Continuing Review Report and request for approval renewal.

It is the responsibility of the PI to report any changes in research activity and provide amendments and consent form changes to KEMRI for approval prior to initiating these changes unless the changes impact on safety of participants.

Failure to comply with regulatory authority policies and regulations can result in study suspension, termination and possible disciplinary action on the part of the investigator.