Informed Consent

In general, the principles are no different with the elderly than with other adult persons; the elderly are just as subject to the relationship to the researcher if the clinician and researcher are one and the same. Not wishing to offend (by refusal) is very strong in the elderly, and also they are also subject to 'therapeutic fallacy', i.e. they find it hard to accept that, despite repeated descriptions of risks and possible benefits, the treating physician could be really offering them treatment of uncertain benefit or risk. The elderly are more likely to have cognitive impairment or mild dementia, and to be living alone, in poverty, or under institutional care. They are also vulnerable to caregiver abuse, often because of indifference, anger, or physical abuse triggered by the patients' behavior and difficulties derived from their disease.

Hearing or vision problems must be expected; bright light and large print, together with honest and simple language, much used for eliciting the informed consent. Research subjects, whether elderly or not, should be able to understand the informed consent process, feel free to refuse or to withdraw from the study without reprisal, and understand the uncertain outcomes of the new drug, the use of placebo and the random allocation of treatment.

The most vulnerable elderly population is found in nursing homes or mental institutions and frequently comprises persons of diminished or fluctuating mental ability. Ironically, regulations governing research in these patients were proposed but never voted upon. The NIH established a policy which allowed a patient, when he/she was still in good cognitive condition, to appoint a 'Health Care Agent'.

For industry, prior written agreement of a family member with the potential subject to act as 'guardian' is preferred but not always attainable. It is best for the researcher him/herself to meet with relatives, nursing staff, and residents and fully explain to them the study purpose, benefit and risks, as well as to the patient. Not infrequently, any of these persons may feel protective of the patient and undermine the research objective. It is wise that all family members who are not involved be sent a letter explaining the research, including a form to be completed if they wish to prevent the patient being involved in research.

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