Navigating the realm of health research within the University of Malawi - College of Medicine requires a meticulous preparation process, one that is critically underscored by the submission of a research proposal to the College's Research and Ethics Committee (COMREC). This crucial step mandates that researchers adhere to a comprehensive checklist designed to ensure that all proposals meet the stringent guidelines established for health research. This checklist, an essential part of the proposal submission process, encapsulates several key components, including but not limited to, inclusion of a covering letter from the investigator, support letters from relevant departments, registration proof from the Medical Council of Malawi for all investigators involved in clinical research, and a detailed breakdown of the research proposal covering various aspects such as the study's objectives, methodology, sample size determination, and ethical considerations. Additionally, the checklist demands attention to details like budget justification, indemnity cover, and the need for material transfer agreement documents, ensuring that every facet of the proposed research is scrutinized for compliance and ethical standards. The meticulous detail required by the COMREC checklist underscores the College's commitment to upholding high standards in health research, emphasizing the importance of a well-prepared and thoroughly vetted proposal before any research endeavor is embarked upon.
| Question | Answer |
|---|---|
| Form Name | Comrec Form |
| Form Length | 2 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 30 sec |
| Other names | comrec pdf, comrec, comrec malawi, comrec online |
UNIVERSITY OF MALAWI - COLLEGE OF MEDICINE RESEARCH and ETHICS COMMITTEE (COMREC)
CHECKLIST TO ACCOMPANY RESEARCH PROPOSALS SUBMITTED TO THE COMMITTEE When you submit a research proposal for the Committee to approve, first read the document entitled General Guidelines on Health Research (Revised in September 2010). Make sure that your proposal is in the format outlined in the Guidelines.
Before sending or giving the proposal to the Committee, complete the following
TITLE OF PROPOSAL:
________________________________________________________________________________________________________
_______________________________________________________________________________________________________
Name of Principal Investigator: __________________________________________________________________
Name of Sponsor and amount of sponsorship______________________________________________________
(tick boxes)
Have you applied for a waiver of 10% COM overhead fee from the Office of Postgraduate Dean of Studies and Research? If yes,
please attach a waiver letter. |
Yes or No |
Have you submitted this proposal to another Ethics Committee? |
Yes |
or No
If yes, please specify whether approval has been given, and if approval has been awarded, please submit a copy of the approval letter with this
________________________________________________________________________
The following are included in or with this proposal:
1. Covering letter of introduction from Investigator
2. Letter of support from Head of Department(s) in which work will be done
(a) Principal Department hosting the research
(b) each other Dept. in which any work will be done
3. A copy of registration from Medical Council of Malawi for Principal Investigator and other investigators which are involved in clinical research
4. Submit an electronic copy and 4 hard copies of the proposal and attached documents (which should include:
Title
Investigators
Brief CV of each investigator, Institution involved, Executive Summary
Background/Introduction
Rational/J justification
Objectives of the study
Methods
-Type of study - place of study
- Study population
-Study period Sample size
- Data collection [NB: include data proformas] - Data management/analysis
Presentation of results Dissemination of results Ethical considerations
1 | C O M R E C C h e c k l i s t v e r s i o n 2 . 0 d a t e d 1 5
t o a c c o m p a n y p r o t o c o l s u b m i s s i o n s , t h A p r i l , 2 0 1 3 .
- NB: include consent forms in both English & Chichewa |
|
Possible constraints |
|
Requirements |
|
Training provided for |
|
Budget and Justification of budget |
|
References |
|
Material transfer agreement forms/documents |
|
Indemnity cover |
yes |
If any item is not ticked, explain why this is not included with the submission. |
|
Signed: ________________________Name (print): _________ |
Date: |
_____________________________________ |
|
or no
2 | C O M R E C C h e c k l i s t v e r s i o n 2 . 0 d a t e d 1 5
t o a c c o m p a n y p r o t o c o l s u b m i s s i o n s , t h A p r i l , 2 0 1 3 .