Guidelines, Policies & Procedures
• Application Procedures
Following the advent of COVID-19 pandemic in early 2020, amendments in the procedures for review application were implemented. Applicants are now required to submit signed electronic copies of proposals/protocols/applications to the MUERC secretariat (email: firstname.lastname@example.org) after paying the required application review fees. All proposals/protocols/applications for ethics review must be submitted by the close of business on the dates outlined in the annual meeting schedule.
Upon completion of the review process and determination for approval, applicants shall submit an electronic copy and one (1) hard copy of the final revised proposal/protocol. The hard copy should be sent/delivered to the MUERC Secretariat offices at the Directorate of Research, Publication and Innovations.
• Communication Procedures
Communication of the Committee’s review decision shall be sent to the applicants by the office of the MUERC Secretary. The notice shall inform the applicant, in writing, the outcome of ethical review within ten (10) working days, after the meeting at which the decision was made. Final approval letter of ethics to conducted an approved study shall be made by the office of the MUERC Chairman.
• Adverse Events – Identification and Reporting
MUERC shall be notified immediately in case of an occurrence of any adverse event(s). The principal investigator shall notify the secretariat by telephone (+ 254 57 351 622) within twelve (12) hours of the event.
In addition, the adverse event(s) noted during the conduct of a study or project must be reported to the MUERC via email (email@example.com) within twenty-four (24) hours after the principal investigator becomes aware of the event. The investigator must submit a completed adverse event form alongside a summary of the event.
Electronic copies of the events forms shall be forward to the MUERC secretariat within 24 hours. The hard copies of the report must be forwarded to the MUERC Secretariat within three (3) working days of the initial notification. Follow-up reports shall be submitted as soon as more/additional information becomes available.
• Amendments to study/project protocols
Any changes to previously approved study/project protocol/application must be communicated, in writing, to MUERC through the Secretariat, for review prior to initiation.
All requests for protocol amendments shall be submitted by the principal investigator consideration in a scheduled Committees sitting. An electronic copy and one (1) spiral bound copy shall be submitted, at least 2 months before the planned implementation of the amendments. All applications /proposals/protocol amendment requests shall be submitted by the close of business on the posted closing dates as per the MUERC annual meeting schedule.
• Handling complaints
The MUERC Secretariat is the contact entity with respect to complaints or concerns on conduct of studies or projects. As such, the contact information of the MUERC Secretariat shall be included in all Informed Consent/ Assent documents for all studies/projects.
All persons with complaints or concerns about the conduct of a study/project are required to notify the MUERC Secretariat by email (firstname.lastname@example.org). The Secretary shall notify the Chairperson of the complaint or concern and the secretariat shall document, in writing, the basis of the complaint or concerns.
The secretariat shall initiate investigations and report to the investigator within 30 working days from the date of receipt of the complaint or concern.
• Appeals of decisions
It is the mandate of the applicants to file any appeals against MUERC decision. Appeals shall be addressed to the MUERC Chairperson, in writing, detailing the basis of the complaint or concern.
Applicants may also opt to refer the complaint to the office of DVC-PRI, Maseno University, through the office of the Director of Research, Publication and Innovations at Maseno University.
Alternatively, the applicant can appeal to the Director General of the National Commission for Science, and Technology and Innovations (NACOSTI). The procedures for appeal of the MUERC decision shall be guided by the NACOSTI appeal policy (See more details on the NACOSTI website).
• Expedited Reviews
Any proposal or applications submitted for expedited review shall have undergone thorough review previously and granted approval or a new study with minimal risks to study participants or modifications of minimal risk studies/projects.
For each expedited review, an electronic copy and one (1) bound copy of the proposal/protocol/application shall be submitted to MUERC secretariat. The hard copy must contain original inked authorization signatures.
All expedited studies/projects applications will attract a 50% extra fees above the normal review rates for each category of investigators as outlined in the MUERC service fee schedule.
• Progress reporting criteria
All studies or projects granted ethical clearance will be continuously monitored and progress reports assessed to ensure compliance with conditions of approval and the ethical rules and principles contained in the national guidelines and MUERC SOPs.
It is a requirement that investigators/applicants complete and submit annual reports, and a final report at the completion of the study/project′s activities. An extension of the study/project approval will dependent on the investigators/applicant′s submission of an annual report.
Study/project reports should be received in time for consideration by MUERC, at least six (6) weeks prior to the expiration date and no later than the twelfth (12th) month preceding the anniversary of the date of the ethical approval.
• Follow up procedure
Approved studies/projects shall undergo review at least once a year. However, there may be more frequent reviews such as in studies/projects presenting increased levels of risks to participants.
Additionally, all active or open studies/projects must be renewed including:
- Studies/projects closed to active recruitment/enrollment but participants or groups still in a follow-up phase.
- Studies/projects that have completed direct contact with study/project participants/groups but data analysis, report writing or manuscript preparation are the only ongoing activities.
- Proposed studies/projects that have not been initiated within twelve (12th) months from the date of ethical approval.
• Monitoring procedure
MUERC has the mandate to monitor progress of all studies/projects with approved ethics clearance certificates to ensure compliance with conditions of approval and to the ethical rules and principles contained in the MUERC SOPs and National guidelines.
In addition, it is a requirement that investigators/applicants submit annual reports through the MUERC secretariat. A final report at the completion of the study or project is mandatory.
Continuing approval of the study/project is dependent on the submission, review and approval of annual progress reports in a scheduled MUER Committee meeting.
• Protocol deviation
Protocol deviation infers to failure to adhere to defined procedural plans outlined in an approved study/project protocol. This would encompass, but not limited to, planned or inadvertent changes that may or may not impact on the safety of the study/project participants, affect the integrity of study/project data, and/or affect study/project participants' willingness to participate in the study/project previously approved by MUERC, or movement of study materials (eg. specimen) outside the study jurisdiction approved by MUERC.
In the event of a deviation from or violation of a MUERC approved proposal/protocol, the committee shall request, in writing, a detailed report addressed to the MUERC Chairperson, and must be received by the MUERC secretariat within five (5) working days.
• Suspension of a study
A study/project can be suspended if the provisions of approval are violated or reports of non-compliance with the regulatory requirements are documented.
The principal investigator shall receive a notice, in writing, explaining the violation or non-compliance and the subsequent suspension of all activities pending investigations and review of the corrective measures.
Suspended studies/projects can only commence after an approval has been granted by the Committee.
• Termination of a study
Any ongoing study/project can be terminated if:
i. There is misconduct by an applicant or any investigator(s) on the study/project that is evidently confirmed.
ii. The study/project presents excessive risks to study/project participants.
iii. An applicant, principal investigator or study/project team members fail to comply with approved regulations.
• Close out of a study
Evaluation of a close-out report will be carried out by the MUERC in a scheduled committee meeting. Upon fulfillment of all requirements, the principal investigator shall be informed, in writing, that the study status is noted as ‘closed’.