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

• The research could not be carried out equally well with less vulnerable subjects;
• The research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of diseases or other health problems characteristic of the vulnerables;
• The vulnerables and other members of their class will ordinarily be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a consequence of this research;
• The risk attached to the intervention or procedures will not exceed those associated with routine medical or psychological examination of such persons unless an ethical review committee authorizes a slight increase over this level of risk; and
• The agreement of the vulnerables will be supplemented by the permission of their legal guardians or other appropriate representatives.
• The refusal of a vulnerable to participate or to continue to participate will have to be respected.

Experiences with Ethics Committees

Most scientists had no experience with research on vulnerable subjects.

• Of those who did have experience, research involved children, pregnant women, women who plan pregnancy, or children with learning difficulties. All reported that the parents or a legal representative had to sign the informed consent after all relevant information had been explained at an understandable level to the respective subject.
• In the Netherlands, law prescribes that research on vulnerable subjects, such as children, mentally retarded, or demented, has to be evaluated by a Central Ethics Committee (CCMO).
• Information about planned tests and procedures must be simplified as much as possible and no predictive testing must be done in children unless it has a clear therapeutic or diagnostic value (Poland).
• The Ethics Committee demands that research on vulnerable subjects must have direct benefit for them and the risk being minimal (Sweden).
• In some cases informed consent may be obtained from close relatives, otherwise research on groups not able to consent is not permitted (Norway).