4. Functions of COMREC
• Its main purpose is to protect the safety of human
and animal subjects participating in research –
scientifically valid and ethically sound.
• It aims to promote research in COM and publication
of results
• All research conducted by faculty must be approved
• Research approved by COMREC must be in the full
interest of research participants/communities
• Research approved by COMREC shall be monitored
5. Submission Procedures
• All new proposals must be submitted on or
before the 1st
of every month
• All new proposals must pay a processing fee
and proof of payment must be submitted
• All new proposals are screened for
administrative and regulatory purposes
• COMREC meets on the last Wednesday of
every month excluding December
6. Eligible applicants
• Full time member of staff, COM and their
collaborators/research affiliates
• Honorary members of staff of COM and their
collaborators/research affiliates
• Full time staff members of KCN and their
collaborators
• Students COM/KCN submitting a proposal
through their local supervisor
7. The Review Process
• Full review (proposals
reviewed by a fully convened
meeting)
• Expedited (limited to students
and proposals that have
previously been reviewed by a
fully convened meeting)
• Exemption from Review
(exempted from review by the
full committee)
• Amendments and
Modifications (expedited
review)
• Continuing review
8. Exemption from Review
Section 5.6 of the COMREC Guidelines state:
“Research involving the collection of existing
data, documents, records, program
evaluation, pathological specimens, or
diagnostic specimens, only if the sources are
publicly available or the information is
recorded by the investigator in such a manner
that subjects cannot be linked directly or
through identifiers linked to subjects”
9. COMREC’s Review Jurisdiction: Studies of
National Interest
Studies covering the following areas are
regarded as “National Interest Studies”
• All vaccine trials
• All drug and medical device trials where patent
issues are involved and where safety issues
remain fully unknown
• All stem cell research
• All cloning research
• All genetic studies
• All national health surveys
10. Elements of the Review
The primary focus of the review and approval focus is based on the science and ethics
of the proposed research. The following elements are considered:
• Project title
• Institutional affiliation
• Proposed sector
• Executive Summary
• Introduction/Literature review
• Justification
• Broad and Specific Objectives
• Methodology/Materials and Methods
• Ethical considerations
• An itemized budget and justification for the budget
• Source of funding
• Work plans
• Expected outcomes
• Strategies for dissemination
• References
11. COMREC Application Pack
• 4 hard copies of each proposal and the accompanying documents.
These include:
• COMREC Checklist
• Cover letter from the PI
• CVs of the PI and Co-investigator
• Letters of Support from Department[s] hosting the Research
• Material to be used {including advertisements} for recruitment
• ICFs (English and Chichewa)
• Investigator’s brochure or Product Insert
• If applying for waiver of 10% overhead fee, these letters should be
included
• Other IRB approval letters if COMREC is not the designated IRB
responsible for HSP oversight
12. Materials and Tools
• COMREC Guidelines on Health Research in Malawi
• NCST Regulatory Guidelines
• International ethical guidelines
• COMREC Proposal Format Guidelines
• COMREC Checklist
• Informed Consent Guidelines
• MTA Form
• Progress Report Forms
• FAQ document
For more information, please visit our website
www.medcol.mw/comrec/
