Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 15

Research Involving Individuals Who by Reason of Mental or Behavioral Disorders Are Not Capable of Giving Adequately Informed Consent

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Before undertaking research involving individuals who by reason of mental or behavioral disorders are not capable of giving adequately informed consent, the investigator must ensure that:

such persons will not be subjects of research that might equally well be carried out on persons whose capacity to give adequately informed consent is not impaired;

the purpose of the research is to obtain knowledge relevant to the particular health needs of persons with mental or behavioral disorders;

the consent of each subject has been obtained to the extent of that person's capabilities, and a prospective subject's refusal to participate in research is always respected, unless, in exceptional circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and

in cases where prospective subjects lack capacity to consent, permission is obtained from a responsible family member or a legally authorized representative in accordance with applicable law.

Commentary on Guideline 15

General Considerations. Most individuals with mental or behavioral disorders are capable of giving informed consent; this Guideline is concerned only with those who are not capable or who, because their condition deteriorates, become temporarily incapable. They should never be subjects of research that might equally well be carried out on persons in full possession of their mental faculties, but they are clearly the only subjects suitable for a large part of research into the origins and treatment of certain severe mental or behavioral disorders.

Consent of the Individual. The investigator must obtain the approval of an ethical review committee to include in research persons who by reason of mental or behavioral disorders are not capable of giving informed consent. The willing cooperation of such persons should be sought to the extent that their mental state permits, and any objection on their part to taking part in any study that has no components designed to benefit them directly should always be respected. The objection of such an individual to an investigational intervention intended to be of therapeutic benefit should be respected unless there is no reasonable medical alternative and local law permits overriding the objection. The agreement of an immediate family member or other person with a close personal relationship with the individual should be sought, but it should be recognized that these proxies may have their own interests that may call their permission into question. Some relatives may not be primarily concerned with protecting the rights and welfare of the patients. Moreover, a close family member or friend may wish to take advantage of a research study in the hope that it will succeed in "curing" the condition. Some jurisdictions do not permit third-party permission for subjects lacking capacity to consent. Legal authorization may be necessary to involve in research an individual who has been committed to an institution by a court order.

Serious Illness in Persons Who because of Mental or Behavioral Disorders Are Unable to Give Adequately Informed Consent. Persons who because of mental or behavioral disorders are unable to give adequately informed consent and who have, or are at risk of, serious illnesses such as HIV infection, cancer or hepatitis should not be deprived of the possible benefits of investigational drugs, vaccines or devices that show promise of therapeutic or preventive benefit, particularly when no superior or equivalent therapy or prevention is available. Their entitlement to access to such therapy or prevention is justified ethically on the same grounds as is such entitlement for other vulnerable groups.

Persons who are unable to give adequately informed consent by reason of mental or behavioral disorders are, in general, not suitable for participation in formal clinical trials except those trials that are designed to be responsive to their particular health needs and can be carried out only with them. (See also Guidelines 8: Benefits and Risks of Study Participation; 9: Special Limitations on Risks When Subjects Are Not Capable of Giving Consent; and 13: Research Involving Vulnerable Persons.)

The Islamic Point of View Concerning Guideline 15

Research Involving Individuals Who by Reason of Mental or Behavioral Disorders Are Not Capable of Giving Adequately Informed Consent

This type or group of individuals fall, in Islamic Law terminology, under the category of demented or feebleminded people. A demented person is one that has little comprehension and does not understand the terms denoting actions or the consequences of these actions. A feebleminded person is an idiot who is unable to choose the proper, propitious, or beneficial option. Persons of both groups have imperfect of flawed competence that prevents, in Islamic legal principle, their being involved in biomedical research. The right of a human being to live his life and have a sound body is protected by Islamic Law, and therefore no research should involve him without his permission, i.e. his informed consent and full approval, based on adequate comprehension of what he is consenting to and approving.

Since such individuals lack adequate comprehension and awareness and do not have the required faculty to appreciate consequences and protect themselves and their interests, it is not enough to obtain their informed consent to get involved in research, though that consent is required in as much as their mental condition allows. Such consent is based on deficient approval and, therefore, has to be combined with permission from their legal guardians in the following exceptional cases:

1. when an absolute or an outweighing benefit is involved, or there is a pressing need for this type of subject in particular;

2. when this category of people have a special health need to participate in the research and the expected risk is not greater than, or slightly exceeds, that involved in routine medical or psychological examination, and is, therefore, cleared by an ethical review committee; and

3. when the need is certain in the sense that no reasonable medical alternative is available. If the goal can be reached by involving ordinary, fully competent persons in the research, that need, which justifies the exception, would no longer exist. Islamic Center of Southern California