IX. Patricia A. Kvochak, JD

Patricia A. Kvochak, JD, Deputy Director, NIH Legal Advisor, advises the National Institutes of Health on their clinical research protocols, which include the legal issues of informed consent. The basic elements that need to be included in informed consent are: (1) understanding of the problem; (2) nature of proposed treatment or intervention; (3) risks and benefits; (4) likelihood of success; (5) feasible alternatives; and, (6) disease prognosis, if research or intervention is not undertaken. She raised a concern about the length and complexity of consent forms and the ability to obtain true informed consent. She also noted that a qualified interpreter is essential to maintain confidentiality, to assure accurate translation, and to avoid undue cultural influence or coercion that may come from use of family members as interpreters.

She reported that it is important to inform the patient of all information related to the decision to participate in a study and of any reasonable foreseeable medical and psychosocial risks. She emphasized that consent is an ongoing process. She noted that if any person lacks the mental capacity to understand, then a legally appointed representative or a durable power of attorney for health care is usually needed to give consent.

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