Informed consent competence

This determination requires an examination of both an old and a new line of cases. In the new line of cases, plaintiffs have argued—in the therapeutic context—that health care providers have a duty to provide comparative data about the effectiveness not only of various treatment alternatives, but also about the qualifications, competence, and experience of the provider. In the one case in which plaintiffs have so far succeeded in surviving a motion to dismiss, the Wisconsin Supreme Court held that a neurosurgeon had a duty to disclose his level of experience with a procedure and the morbidity and mortality differences between himself and more experienced neurosurgeons (Johnson v. Kokemoor, 1996). The Wisconsin court s ruling has been labeled the "second revolution" of the informed consent doctrine (Twerski and Cohen, 1999 Ketler, 2001). 

Jeste et al. (1993) emphasized, The potential seriousness of neuroleptic-induced TD warrants obtaining competent, informed consent to treatment from patients or guardians. They recommended that consent be periodically renewed and cited other sources to confirm their position. 

This issue has been addressed in court cases over the years. In one case seven Boston State Hospital patients filed suit to stop the (nonemergency) administration of medications without their informed consent. Belatedly, the patients claimed the right to refuse medication. The psychiatrists faced a dilemma. On the one hand, they knew by experience that certain drugs were able to significantly relieve emotional distress. On the other hand, some of these drugs had unpleasant side effects euid patients understandably might want to avoid these. The court decided in favor of the patients. It ruled that patients (whether voluntarily or involuntarily admitted to the hospital) should be presumed competent to accept or refuse psychotherapeutic medications. The court added that when a patient was not deemed competent, the decision whether to use medications needed to be made by a court-appointed guardian. 

Although discussed in detail elsewhere in this book, the two ethical principles guiding informed consent are those of autonomy and equipoise. Autonomy is the concept that the patient is an individual that is under no duress, whether subtle or obvious, actual or inferred, and is competent to make a choice according to his or her free will. Clinical trials conducted on persons in custody, or on subordinate soldiers, may both be violations of the patient s autonomy. Equipoise is the concept that the investigator, and those sponsoring the trial, are truly uncertain as to the outcome of the study in practical terms, this is a guarantee to the patient that an unreasonable hazard cannot result from unfavorable randomization because the treatment options are not known to be unequally hazardous. 

For children, most ethics committees agree that provision of written informed consent by a parent or guardian is acceptable. If the childis of sufficient age, then his or her concurrence may also be sought although this is not sufficient evidence of informed consent, the refusal to provide concurrence by a child that is likely to be competent to understand the clinical trial conditions should be sufficient to exclude the child from a study. 

The informed consent process answers the moral question, when is it permissible to include competent people as research subjects The answer is, if, and only if, they have given their free and informed consent. Inherent in this statement is the idea that investigators should ask for or request consent, not simply to get or obtain it. The... 

Free and informed consent is essential prior to participation as well as throughout a study and is usually documented in writing. The need for consent may be altered or waived when there is minimal risk or low probability that the action will have negative implications for the subject, when the research is not possible without alteration or waiver, or when such action does not involve therapeutic intervention. After participation, additional information should be provided if possible and appropriate, and consent may be obtained following subject debriefing. For subjects not proficient in the language of the consent form, consent may still be obtained provided an objective competent translator has fully informed the subject as to the contents of the consent form and has assisted the subject in participating in discussion of the study. 

Competence refers to a prospective subject s ability to understand the information provided and its consequences, and make a free and informed decision in accordance with personal values. If a subject is not considered competent, a balance must be sought as to the subject s vulnerability versus the injustice of exclusion from potentially beneficial research. There is a moral preference to use competent subjects. Subjects not legally competent should only be asked to participate when the research question can only be addressed using the identified group, and the risk is minimal when there are no direct benefits. The researcher must also demonstrate how the subject s best interests are protected and the method of obtaining free and informed consent from an objective third party. If the subject should become competent during the study, consent must be obtained for continued participation. Of note, some subjects even if not legally competent may be able to ex-... 

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. 

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. 

Prior Informed Consent (PIC) Prior Informed Consent is the consent of the relevant competent national authority/authorities in the provider coimtry granted for the research and utilization of genetic resources. The consent ofrelevant stakeholders, such as indigenous and local communities, should also be obtained, as required by individual situations and subject to domestic law [18],... 

The person participating in a trial must consent to the scrutiny of personal information during inspection by competent authorities and properly authorised persons, provided that such personal information is treated as strictly... 

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