Policy measures and requirements for the improvement of health research co-ordination in malawi
The 2005 Policy Measures for the Improvement of Health Research Co-ordination in Malawi has been in use for over seven years. As a first edition, it performed generally well as a co-ordinatory tool. However, during the period of its performance, a number of co-ordinatory and regulatory complexities,...
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| Format: | Other |
| Language: | English |
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National commission for science and technology
2021
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| Online Access: | http://nkhokwe.kuhes.ac.mw:8080/handle/20.500.12845/212 |
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Add Tag | Summary: | The 2005 Policy Measures for the Improvement of Health Research Co-ordination in Malawi has been in use for over seven years. As a first edition, it performed generally well as a co-ordinatory tool. However, during the period of its performance, a number of co-ordinatory and regulatory complexities, challenges and difficulties in the co-ordination, review and conduct of health research evolved which could no longer be adequately managed and addressed by the 2005 set of policy measures. Therefore, this revised edition which is the second edition entitled “Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi” has been developed to build on the first edition with the aim of objectively managing and addressing the co-ordinatory and regulatory complexities, challenges and difficulties that have evolved over the years for the benefits of the research participants, researchers and other stakeholders planning to conduct health/biomedical research in Malawi.
This revised edition describes a thematic set of measures and requirements at a national level that are required to be adhered to by all stakeholders without let or hindrance. The specific measures and requirements are in the following thematic sections: Structural Relationship of the National Commission for Science and Technology, National Health Sciences Research Committee (NHSRC) and College of Medicine Research and Ethics Committee (COMREC) while clearly describing the respective revised jurisdictions of NHSRC and COMREC; Membership for NHSRC and COMREC; Management of Conflict of Interest; Review and Approval of National Interest Studies; Review and Approval of Multi-Centre Studies; Submission of Protocol for Review by the Drug Regulatory Authority; Validity of the Ethical and Regulatory Approval; and Regulating the Operations of Research Projects, Units and Institutions Established in Malawi.
These measures and requirements apply to all researchers, sponsors and stakeholders who are planning to conduct health/biomedical research involving humans in Malawi. They, however, represent the minimum standards in the co-ordinatory and regulatory governance framework, which stakeholders are required to adhere to. These policy measures and requirements are lawfully made under and enforced by Sections 18 (1) and 48 of the Science and Technology Act No.16 of 2003. |
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