MUERC Guidelines, Policies and Procedures

1. Application procedures

Applicants are required to submit signed and bound copies of proposals/applications to the MUERC secretariat after paying the prescribed review fees (check the fee charges applicable to you and the account details on the attached review application fee document). All applications /proposals for ethical review must be submitted by the close of business on the posted closing date (check the Ethics Committee meeting schedule attached for closing dates details).

      i. For students (undergraduate, diplomas, certificate), three (3) loose bound copies shall be submitted.

     ii. Other categories (postgraduate [postgraduate diplomas, Masters, Ph.Ds] and other researchers, both from Maseno University or other affiliations) must submit three (3) loose bound copies of the proposal/application.

Maseno University postgraduate students

      i.  Your proposal must be cleared from your Department and School as well as School of Graduate Studies (SGS) before sending an application for ethics review

      ii.  You must obtain and attach a letter of proposal approval from SGS on your application from SGS

      iii. Review fees applicable shall be paid into the designated University account (check the account details on the attached fee charges document) and the bank slip presented to the finance department at Maseno University for issuance of an official Maseno University payment receipt.

      iv.  Download the attached ‘request for review of protocol by MUERC (F1)’ form and complete it as directed.

       v.  Obtain all the other required/supporting documents (payment receipts, proposal approval letter from SGS, CVs, Consent forms etc) alongside the proposal/ protocol and completed review application form. Spiral-bind the documents. Do not present loose copies of any document.

      vi. Make and bind three copies (3) of complete proposal/protocol applications for presentation to MUERC.

      vii. Ensure that all proposals/protocols are signed by all investigators/supervisors and their CVs attached.

      viii.  Submit three (3) bound copies of the proposal/protocols applications to MUERC secretariat. The MUERC Secretariat is located at the Directorate of Research, Publications and Innovation (DRPI), next to School of Graduate Studies (SGS) offices, Maseno University main campus.

      ix.  Check the attached document on ‘guidelines for development of application for MUERC (GF1) document’ for format and content of a proposal/protocol for review. 

2.      Communication procedures

Communication of the Committee’s decision will emanate from the office of the MUERC Secretary.  The notice shall inform the applicant, in writing, the outcome of ethical review within ten (10) working days of the meeting at which the decision was made.

3.      Adverse events – Identification and reporting

The MUERC will be notified immediately the occurrence of any adverse event(s).  The 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 (muerc-secretariate@maseno.ac.ke) within twenty four (24) hours after the applicant becomes aware of the event. The investigator must submit a completed adverse event for alongside a summary of the event.

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 should be submitted as soon as more information becomes available.

4.      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 a protocol amendment for Maseno University-affiliated studies shall be forwarded to the MUERC, by their representatives for considerations.

 5.      Handling complaints

The contact person with regard to complaints or concerns on conduct of studies or projects is the MUERC Secretary. As such, the name and contact information of the MUERC Secretary 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 Secretary. The secretary will notify the MUERC Chairperson of such complaints or concerns and the secretariat shall document, in writing, the basis of the complaint or concerns.

The secretariat will initiate investigations and report to the investigator within 30 working days from the date of receipt of the complaint or concern.

6.      Appeals of decisions

It is the mandate of the applicants to file any appeals against MUERC decision.  Appeals should be addressed to the MUERC Chairperson, in writing, detailing the basis of the complaint or concern.

In addition, applicants may also opt to refer the complaint to the office of DVC-PRI, Maseno University, through the office of the Director of Research, Publications and Innovations (DRPI).

Alternatively, the applicant can appeal to the Director General/CEO of the National Commission of Science, Technology and Innovations (NACOSTI; for non-Maseno study/projects proposals).  However, the procedures for appeal of the MUERC decision shall be guided by the NACOSTI appeal policy.

 7.      Expedited Reviews

Any proposal or applications submitted for expedited review must have undergone thorough review previously and granted approval.

For each expedited review, three (3) copies of the proposal/application must be submitted, one of which has the original signature.

8.      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.  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 (12^th) month preceding the anniversary of the date of the ethical approval.

 9.      Follow up procedure

Approved studies/projects will 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:

  i.   Studies/projects closed to active recruitment/enrollment but participants or groups still in a follow-up phase.

 ii. 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.

  iii.   Proposed studies/projects that have not been initiated within twelve (12) months from the date of ethical approval.

 10.  Monitoring procedure

MUERC has the mandate to monitor progress of all studies/projects with approved ethics clearance 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 submitted annual reports.

11.  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.   

In the event of a deviation from or violation of a MUERC approved 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.

 12.  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 investigator will 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 sort from the Committee.    

 13.  Termination of a study

Any ongoing study/project can be terminated if:

      i. There is misconduct by an applicant or any investigators on the study/project that is evidently confirmed.

     ii. The study/project presents excessive risks to study/project participants.

   iii. An applicant or study/project team members fail to comply with approved regulations.

 14.  Close out of a study

Evaluation of a close-out report will be carried out by the committee.  Upon fulfillment of all regulations, the investigator will be informed, in writing, that the study status is noted as ‘closed’.