English — NIH-hosted Ministry of Health copy

REPUBLIC OF MALAWI MINISTRY OF HEALTH RESEARCH UNIT SUMMARY OF PROCEDURES AND GUIDELINES FOR THE CONDUCT OF HEALTH RESEARCH IN MALAWI 1. Introduction Considering the increasing number of research activities in the country and the efforts by the Ministry of Health to accelerate health research especially among local professionals, there is need to develop and disseminate procedures and guidelines for the conduct of health related research in Malawi. All researchers wishing to conduct health related research in Malawi must submit their research proposals and related materials for scientific and ethical review to the National Health Sciences Research Committee or its subsidiary, The College of Medicine Research and Ethics Committee (COMREC). COMREC reviews proposals from the faculty and students of the College of Medicine and Kamuzu College of Nursing. Proposals from all other researchers and institutions, including those from COM and KCN with national interest, are reviewed by the NHSRC. 2. General objective An overall objective of the procedures and guidelines is to accelerate implementation of quality health research in Malawi with the ultimate goal of improving the health and well being of Malawians. 3. Specific objectives • Develop/appraise proposals • Standardize review of proposals • Ensure proper management of research information • Promote health research among local professionals • Promote coordination between NHSRC and COMREC 4. Procedure and requirements

Scientists wishing to carry out research in Malawi should ensure that the proposed studies: • Conform to generally accepted ethical principles • Are based on adequate knowledge of the relevant scientific information • Are consistent with acceptable research practice 5. Research protocol A detailed research protocol may have the following sections: (1) Cover Page. This contains title of project, name, address and qualifications of researchers (2) Abstract It is a summary of the proposed research project. This covers type of study, research topic, objectives, methodology and plans for dissemination of findings. (3) Background and justification It provides clear justification of the problem or research question. This should demonstrate the relevance and importance of the problem. (4) Literature review This should provide an update review of literature related to research. (5) Hypothesis The research hypothesis under investigation should be clearly stated. This is not mandatory in research. (6) Objectives The objectives should be relevant to the research problem. (7) Methodology This includes study site, study subjects, type of research, sample size and sample determination, inclusion and exclusion criteria, ethical considerations, limitations or constraints, data collection, data management and analysis. (8) Dissemination of findings State how the findings will be disseminated and how the results will be reported. (9) Personnel This should describe the research team and their responsibilities.

(10) Work-plan/Gantt chart This should inform the timing of research activities and duration of the research project. (11) Budget This is the cost of activities related to the research project. (12) Bibliography This stipulates the literature used in research. It covers author of the literature, source of publication, publisher and date. (13) Appendices Other relevant information such as curriculum vitae questionnaire and consent form should be attached to the research proposal as appendices. *For Additional information contact the Research Unit in the Ministry of Health 6. Submission of research protocols and relevant materials Protocols of research studies must be submitted to the: The Chairperson National Health Sciences Research Committee Ministry of Health P.O. Box 30377 Lilongwe 3 MALAWI Tel: +265 1 789 400/414 Fax: +235 1 789 527/536 Email: doccentre@malawi.net 7. Date of review meeting and deadline ⇒ NHSRC meets once every two months while COMREC meets every month. ⇒ Submission of application materials to both committees should be done at least 3 weeks before the date of the review meeting.

8. Fees • Application fee is $150 or its equivalent. A 10% Contribution fee (of the total budget indicated in the proposal) for institutional support and strengthening is paid upon approval of the study. • There are special rates for Malawian students. For information, contact the Research Unit. 9. Essential elements for review The following elements will be carefully examined during review: • Scientific design • Recruitment of research subjects • Care and protection of research subjects • Ethical consideration • Community consideration 10. Expedited review Arrangements can be made to expedite review in cases such as: • Research proposals from Malawi students • Review of modified research protocols 11. Conduct of Research Researchers should stick to the procedures outlined in the approved protocol when conducting their studies. The NHSRC has the responsibility to investigate any violation of code of ethics and bring violator to justice. 12. Biological specimen Collection and handling of specimens should follow the internationally acceptable ethical guidelines.