National policy requirement and guidance for the provision of insurance cover for research participants in clinical trials in malawi
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Date
2012-12-01
Journal Title
Journal ISSN
Volume Title
Publisher
National commission for science and technology
Abstract
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.