Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 9

Special Limitations on Risk When Research Involves Individuals Who Are Not Capable of Giving Informed Consent

When there is ethical and scientific justification to conduct research with individuals incapable of giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for the individual subject should be no more likely and not greater than the risk attached to routine medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an overriding scientific or medical rationale for such increases and when an ethical review committee has approved them.

Commentary on Guideline 9

The Low-Risk Standard: Certain individuals or groups may have limited capacity to give informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed choice may not fully meet the standard of informed consent, ethical review committees must distinguish between intervention risks that do not exceed those associated with routine medical or psychological examination of such persons and risks in excess of those.

When the risks of such interventions do not exceed those associated with routine medical or psychological examination of such persons, there is no requirement for special substantive or procedural protective measures apart from those generally required for all research involving members of the particular class of persons. When the risks are in excess of those, the ethical review committee must find: 1) that the research is designed to be responsive to the disease affecting the prospective subjects or to conditions to which they are particularly susceptible; 2) that the risks of the research interventions are only slightly greater than those associated with routine medical or psychological examination of such persons for the condition or set of clinical circumstances under investigation; 3) that the objective of the research is sufficiently important to justify exposure of the subjects to the increased risk; and 4) that the interventions are reasonably commensurate with the clinical interventions that the subjects have experienced or may be expected to experience in relation to the condition under investigation.

If such research subjects, including children, become capable of giving independent informed consent during the research, their consent to continued participation should be obtained.

There is no internationally agreed, precise definition of a "slight or minor increase" above the risks associated with routine medical or psychological examination of such persons. Its meaning is inferred from what various ethical review committees have reported as having met the standard. Examples include additional lumbar punctures or bone-marrow aspirations in children with conditions for which such examinations are regularly indicated in clinical practice. The requirement that the objective of the research be relevant to the disease or condition affecting the prospective subjects rules out the use of such interventions in healthy children.

The requirement that the research interventions be reasonably commensurate with clinical interventions that subjects may have experienced or are likely to experience for the condition under investigation is intended to enable them to draw on personal experience as they decide whether to accept or reject additional procedures for research purposes. Their choices will, therefore, be more informed even though they may not fully meet the standard of informed consent. (See also Guidelines 4: Individual Informed Consent; 13: Research Involving Vulnerable Persons; 14: Research Involving Children; and 15: Research Involving Individuals Who by Reason of Mental or Behavioral Disorders Are Not Capable of Giving Adequately Informed Consent.)

The Islamic Point of View Concerning Guideline 9

Special Limitations on Risk When Research Involves Individuals Who Are Not Capable of Giving Informed Consent

1. The general concept of the limitations set forth in this guideline are justified from the viewpoint of Islamic jurisprudence(fiqh), on the bases of a principle that is inclined to distinguish between a permission given by a fully competent person, capable of giving informed consent for what concerns him, and the permission given, in case of incompetence or deficient competence, by a legal guardian of an individual incapable of giving informed consent or making an informed choice.

This basis of this distinction is that a permission by a representative of an individual of the second type is legally contingent on its serving the absolute or, in the cases where there is a conflict between benefit and harm, outweighing interest of the charge. This interest is expressed by jurist as "what brings him fortune or pleasure." Therefore, to safeguard the rights and the inviolability of weak persons and protect them from violation, manipulation, or loss, a guardian is not entitled to give any consent that might entail risks of absolute or outweighing injury or harm. The rule here is unlike that in the case of a permission by an individual of the first type, who is less restricted and enjoys greater freedom, based on the respect Islamic Law accords to a person's right to manage his own affairs and freedom to choose what he likes and finds most appropriate for him, even if it involves some risk, as long as he is fully competent and capable of making his own choices.

2. It should be stressed that the four limitations listed in Guideline 9 and the following commentary are technical opinions based on conventional points of view held by professionals and specialists in the field. They can be endorsed by Islamic Law on the basis of the rule of "convention," as long as the conventions of workers in the field admit these limitations. They are, however, subject to modification and change, with any change in the convention, as what is admitted into Islamic Law through convention changes with its change. Islamic Center of Southern California