Consent incompetence

Although prisoners do not enjoy the same rights as nonincarcerated Americans, prisoners retain their right to give informed consent before being the subject of a medical procedure or treatment. Thus, unless a court has determined that a prisoner is mentally incompetent, the informed consent requirements discussed in the previous section retain their validity within the prison context. 

When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 

The principle of justice states that individuals should be given what they deserve, be that benefit or burden. Cases that are alike should be treated similarly, and relevant distinctions should be drawn consistently. The principle of justice does not specifically state what distinctions are fair or which criteria are reasonable it simply requires that, once criteria are determined, they be applied fairly. Justice is important in many areas, such as recruitment of research subjects for pharmaceutical studies. For example, researchers must guard against distributing the burdens of participation disproportionately among populations that are poorly equipped to give informed consent, such as children or the mentally incompetent. 

In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. 

Collection of human tissue for use in research requires the researcher to demonstrate to the REB that free and informed consent will be obtained from competent donors, or from an authorized third party for incompetent donors or deceased donors without advance directive regarding the topic. Minimally, researchers must provide the research purpose the type, location, and amount of tissue to be taken the manner of acquiring the tissue with respect to safety and invasiveness of the procedure the uses of the tissue and how its use could affect privacy. Consent is also necessary for use of previously collected tissues when identification is possible. 

Can you get informed consent from a schizophrenic man (Yes, unless dear behavioral evidence that he is incompetent)... 

The Declaration of Helsinki, published in 1964, established free and informed consent, preferably written, for research subjects, or consent by a legal representative if a subject is legally incompetent. It also required research to be supervised by competent medical persons. 

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