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Research that involves children or other populations that cannot consent (e. g. vulnerable populations) should seek consent from an appropriate person and assent from the participant. Research involving participants who are physically or mentally incapable of giving consent may be undertaken only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. Informed consent / assent must include the; a) aims of the research, b) methods, c) sources of funding, d) confl icts of interest, e) institutional affi liations, f) anticipated benefi ts and potential risks, g) potential discomfort and h) right to refuse to participate or withdraw consent without reprisal. 5. Conduct. Research must be conducted; a) in accordance with appropriate risk management b) by appropriately qualifi ed researchers and support staff c) with skill and care d) in an appropriate setting e) in order to protect the privacy of participants and confi dentiality of their personal information f) in accordance with laws and regulations of the country or countries in which the research is to be performed as well as international norms and standards. Specifi c laws relevant to research ethical may regulate the collection, use and / or storage of human tissue; the protection of individuals that lack the capacity to consent; data protection; and the use of drugs in research. 6. Governance. Serious adverse events occurring during the study must be reported to the ethics committee that ethically reviewed and approved the research.
Harriss et al. (Thu,) studied this question.
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