Informed Consent and Truth-Telling UPHS Bioethics Retreat, May 1999 –Dave Magnus, PhD. preliminary notes: –N.B. --these issues are more problematic with end-of-life decisions

Consent Involves four elements: Competence Disclosure Understanding Voluntariness

Competence Legal sense -- –Competent "in general" ie -- does not need a Psych. consult –Vs. Specific Competence Pt. may not comprehend the specific aspects of their care

Magnus: "the conflict between general and specific competence often stems from a value discrepancy...” (ex.--if the pt. doesn't agree with me, it must be that they are incompetent!)

Competence / Disclosure Disclosure Legal sense -- –The "Reasonable Pt. Standard" (DIFFERENT from the "reasonable person standard") –VS The "Subjective" Standard ex.--if pt. wants/does not want a lot of information, then that is what should be respected

Competence / Disclosure / Understanding Understanding Re:Ingelfinger, "Informed (but Uneducated) Consent” Even when the letter and the spirit of the letter of the law are adhered to by the clinicians involved, "...the chances are remote that the subject really understands what he has consented to..."

Understanding Re:Ingelfinger, "Informed (but Uneducated) Consent” "The difficulty that the public has in understanding information that is both medical and stressful is exemplified by [a report that] only half the families given genetic counseling grasped it's impact."

Understanding Re:Ingelfinger, "Informed (but Uneducated) Consent” Ingelfinger even implies the it may be unethical to present a Pt. with all of the contingencies that may be involved in an experiment (since they are not capable of correctly assessing the risks; ex -- if people read the "fine print" they wouldn't take aspirin)

Magnus' ex. of video: Both Pt. and Dr. knew the purpose of the video (to document informed consent) and the clinicians involved knew and respected both the letter and spirit of Competence and Disclosure as noted above. When asked, "Who made the decision?" prior to viewing the video documentation, Pt. and Dr. both said, "the Pt. did" AFTER viewing the video Pt. and Dr. both STILL said, "the Pt. did" AFTER viewing the video, neutral observers all agreed: "the Dr. did” …!

Comment from Mimi Mahon, PhD. RN. "We present information via our own biases -- –i–it is our responsibility to recognize those biases and mediate them."

Heuristic: (Magnus) if the physician spent most of the time talking, then there was no informed consent! –ASK: "Tell me about what's going on -- what brought you here?

Competence / Disclosure / Understanding / Voluntariness Voluntariness The root of consent, but this has been called into question by the above. If the Pt. is judged not competent or not capable of understanding what has been disclosed, "is it ever legitimate to secure the consent from some third party?”

What about research/procedures involving Children Prisoners Placebos Non-therapeutic benefit to participants Mentally incompetent patients

Mimi Mahon, later addressing DNR consents and Children "Of the children who were dying, 100% knew that they were dying, despite the 'fact' that psychologically kids 'didn't have the capacity to think abstractly." "Kids are used as pawns -- the parent says, 'I'll bring my child here, but only if you do not tell them [the implications]'"

Mimi Mahon, later addressing DNR consents and Children ex.- dramatic effort to re-attach fingers to a child's hand. "We wouldn't have done this to an adult." Mimi: "Then WHY?“ While intending to do the best for children parents and HCP’s sometimes only make things worse… Good intentions are not alone ‘good enough’