Health Policy

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Browsing Health Policy by Author "National Commission for Science and Technology"

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    National policy requirement and guidance for the provision of insurance cover for research participants in clinical trials in malawi
    (National commission for science and technology, 2012-12-01) National Commission for Science and Technology
    This 2012 revised edition of the “National Policy Requirement and Guidance for the Provision of Insurance Cover for Research Participants in Clinical Trials in Malawi” includes extensive revisions to certain sections of the 2008 policy document. Such revisions aim at providing stakeholders further guidance and clarity on the policy elements. This revised and second edition has been developed to build on the first edition with the aim of objectively fostering the protection of the safety, rights, and welfare of persons taking part as research subjects in health/biomedical research in Malawi. Specifically, the policy requirement aims at protecting human participants in clinical trials. The requirement calls upon all sponsors and researchers of such trials, unless otherwise stated, to provide insurance cover for potential research participants to be enrolled in clinical trials/studies in Malawi. Obtaining and submitting the required insurance as described in section 2.0 is a requirement and pre-liquisite to obtaining ethical and regulatory approval of clinical trials, besides the fulfilment of other applicable ethical and regulatory requirements that are existent in Malawi. This policy requirement is made pursuant to the Principles of Bioethics and International Law as enshrined in CIOMS, ICH-GCP1, the Universal Declaration on Bioethics and Human Rights, and as enshrined in similar international law documents guiding the conduct of research involving human subjects. This policy requirement and guidance augments similar requirements, guidelines, standard operating procedures, regulations and relevant laws pertaining to the conduct of health research in Malawi. This requirement applies to sponsors, researchers and other stakeholders intending to conduct clinical trials in Malawi to aid them in submitting adequate documentation in their application for the review and approval of their studies. The policy also applies to all health research review committees and applicable regulatory structures for enforcement as well as the insurance industry. This policy requirement and guidance is lawfully made under and enforced by Sections 18 and 48 of the Science and Technology Act No.16 of 2003. Stakeholders are, therefore, called upon to adhere to the contents of this requirement without let or hindrance.
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    Policy measures and requirements for the improvement of health research co-ordination in Malawi
    (National commission for science and technology, 2012-10-01) National Commission for Science and Technology
    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.