Results of the Inquiry and Citation Review

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Bioethics issues in human studies

Informed consent

Treatment of vulnerable subjects

State of discussion

Where consent to the collection and use of a research sample is sought from a person who is unable to give a valid consent on the grounds of minority or on the grounds of mental incapacity, then the consent should be obtained from any person legally authorized to give such consent on behalf of the minor or incapable person after full account has been taken of the present and future impact which the test might have upon the tested person. Such consent should only be given if any adverse implications for the tested person are negligible and if this conduct of research in these circumstances is permitted by national law [13].

Guidelines 13, 14 and 15 of the International Ethical Guidelines for Biomedical Research Involving Human Subjects [11] deal with research involving vulnerable persons, research involving children, and research involving individuals who by reason of mental or behavioural disorders are not capable of giving consent.

Other groups of vulnerables are [11]: Elderly (with various degrees of dementia), socially disadvantaged, such as homeless, unemployed etc., institutionalized subjects, such as nursing home inhabitants, prisoners, refugees etc.

Generally, ethical justification of research on vulnerables are given when

Experiences with Ethics Committees

Most scientists had no experience with research on vulnerable subjects.

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