Research Ethics

College of Medicine Research Ethics Committee (COMREC)

Research at the Kamuzu University of Health Sciences (KUHeS) is conducted according to the principles of academic excellence, community, integrity, inclusiveness and professionalism.

Read more about COMREC here

Functions

a. To protect the safety of human and animal subjects participating in research by: 

• Determining that the proposed research is both scientifically and ethically sound.
• Continually reviewing the safety of participants.

b. Promoting research in the University and ensure the dissemination of results.

COMREC Responsibilities

a. Review and approval of the science and ethics of proposed research.

b. Review and approval of amendments and modifications made to previously approved protocol.

c. Annual continuing reviews of approved studies running for more than one year.

d. Follow the progress of studies for which a positive decision was reached from the time the decision was taken until termination of the research.

e. Monitor implementation of approved protocol and it’s progression, and report to institutional or regulatory authorities any serious or continuing non-compliance with ethical standards

f. Recommend suspension or termination of approval of research not conducted in accordance with guidelines or that has been associated with unexpected serious harm to subjects.

Membership Information

See the names comprising the committee here

Ethics applications / Submissions

All applications are done through : http://rims.kuhes.ac.mw/

1. Initial submission complete package should contain a merged document of the following;
   1. COMREC checklist (Download here)
   2. Introductory letter from PI
   3. Proposal according to COMREC format (Download here)
   4. Consent/ data tools as appendices (Download here)
   5. CVs for the applicants
   6. Letters of support from KUHes Department &  study site
   7. Certificate of GCP/Human participant protection
   8. Proof of payment of a processing fee of USD 150 ( Download the account details here)
2. Re-submission
   1. Document as in (1) above plus
   2. Introduction letter explaining how queries were resolved
   3. Revised protocol with tracked/highlighted changes
   4. Revised protocol with accepted changes/clean version.
3. Amendment
   1. Cover Letter
   2. Amendment form (Download here)
   3. Revised protocol
   4. Revised protocol clean
4. Annual Progress
   1. Cover letter
   2. Progress forms (Download here)
5. Close Out
   1. Cover letter
   2. Report
6. Adverse events
   1. Cover letter
   2. Report

Submission Dates

Upcoming training

KUHeS Research Ethics Training Online (KRETO)

Support Services

1. Secretariat – comrec@medcol.mw , Phone: 0888310141
2. Comrec Assistant Administrator – comrecassadmin@kuhes.ac.mw
3. Compliance Officer – cofficer@kuhes.ac.mw