Selection of special groups as research participants

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(From: Ethical Guidelines for Biomedical research on human participants. Indian Council of Medical Research New Delhi 2006)

SELECTION OF SPECIAL GROUPS AS RESEARCH PARTICIPANTS

Pregnant or nursing women: Pregnant or nursing women should in no

circumstances be the participant of any research unless the research carries no

more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new knowledge about the foetus, pregnancy and lactation.

As a general rule, pregnant or nursing women should not be participants of any clinical trial except such trials as are designed to protect or advance the health of pregnant or nursing women or foetuses or nursing infants, and for which women who are not pregnant or nursing would not be suitable participants.

Example of such trials are, to test the efficacy and safety of a drug for reducing perinatal transmission of HIV infection from mother to child, trials for detecting foetal abnormalities and for conditions associated with or aggravated by pregnancy etc.

Children: Before undertaking trial in children the investigator must ensure that -

Children will not be involved in research that could be carried out equally well with adults

The purpose of the research is to obtain knowledge relevant to health needs of children. For clinical evaluation of a new drug the study in children should always be carried out after the phase III clinical trials in adults. It can be studied earlier only if the drug has a therapeutic value in a primary disease of children

A parent or legal guardian of each child has given proxy consent;

The assent of the child should be obtained to the extent of the child’s capabilities such as in the case of mature minors from the age of seven years up to the age of 18 years.;

Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual child participant as any available alternative interventions

Vulnerable groups: Efforts may be made to ensure that individuals or communities invited for research be selected in such a way that the burdens and benefits of the research are equally distributed.

Research on genetics should not lead to racial inequalities

Persons who are economically or socially disadvantaged should not be used to benefit those who are better off than them

Rights and welfare of mentally challenged persons who are incapable of giving informed consent or those with behavioral disorders must be protected. Appropriate proxy consent from the legal guardian should be taken after the person is well informed about the study, need for participation, risks and benefits involved and the privacy and confidentiality procedures. The entire consent process should be properly documented;

Adequate justification is required for the involvement of participants such as prisoners, students, subordinates, employees, service personnel etc. who have reduced autonomy as research participants, since the consent provided may be under duress or various other compelling reasons.

Dr. Smita

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