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PubMed1989

Informed consent and moral integrity.

Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact.

Communication↗
PubMed2005

Evaluating the quality of informed consent.

CONTEXT: Although informed consent is a critical means of protecting the rights and interests of participants in clinical research, effective and efficient means of evaluating the quality of consent are needed. Having such means will be important to monitoring consent and testing potential improvements in the consent process. OBJECTIVE: To develop and test a practical and general means of evaluating the quality of informed consent for clinical research. Methods We developed and tested the Brief Informed Consent Evaluation Protocol (BICEP), a short telephone-based assessment of informed consent. As soon as patient-participants completed the informed consent process for a participating VA Cooperative Studies Program clinical trial they called an interviewer who administered the BICEP. RESULTS: 632 participants completed BICEP, representing eight ongoing studies from 14 VA and one non-VA medical centers across the country. Site coordinators reported little to no difficulty implementing BICEP. The average duration of BICEP was 8.8 minutes (SD 3.6). Overall, patient-participants evaluated the informed consent process positively. A reliable coding system was then developed to analyze the verbatim responses of the final 191 participants. An Informed Consent Aggregate Score (ICAS) had a mean score of 8.23 (SD 1.17) with a range of 0-10, with 10 a perfect score; and a Therapeutic Misconception Aggregate Score (TMAS) had a mean of 1.62 (SD 0.93) with a range of 0-5, with 5 a perfect score. CONCLUSIONS: The BICEP is an efficient means of evaluating informed consent that is acceptable to research participants and research personnel. While participants tend to be satisfied with the informed consent process, the BICEP indicates there is room for improvement in the informed consent process for research.

Consent Forms↗
PubMed1998

The legal and ethical aspects of telemedicine. 3: Telemedicine and malpractice.

This paper reviews the difficulties raised by the need to obtain valid consent from telemedicine patients to the treatment that they receive and evaluates the legal principles that the courts will apply to an allegation of negligence brought against a teleconsultant or telemedicine service by a patient. While many of the processes that take place during a telemedical consultation will be unique, it is suggested that the legal principles that apply to the conventional, face-to-face, doctor-patient relationship are equally as valid in the context of the practice of medicine at a distance.

Consent Forms↗
PubMed1985

Informed consent in dentistry.

This article discusses the doctrine of informed consent and its impact on the practice of dentistry. It summarizes relevant case and statutes, and stresses the uncertainty that prevails in this area of the law. A procedure is set forth for dentists to follow on an everyday basis that will assist them in the event that they become involved in litigation based on allegations of uninformed consent.

Consent Forms↗