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Adults lacking decisional capacity

If a patient is not capable of giving consent, written consent must be obtained from an appropriate proxy or family member (see Box 2). Special care should be taken to ensure that incapacitated individuals’ rights, dignity and welfare are not being compromised by their participation in research, particularly if the research is of no direct benefit to them. If the patient is unconscious, Department of Health guidance stipulates that consent “must be given by others, including relevant statutory authorities” and that they “should be excluded from all but minimally invasive observational research”.29

Box 10: Recruiting dependent patients for research

“When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.”

Source: WMA, Declaration of Helsinki (2008), para 28.