LWBK1006-47 LWW-Govindan-Review December 12, 2011 20:55
Chapter 47•Societal Issues in Oncology 585ANSWERS
Answer 47.1. The answer is C.
Legal rulings have clarified that essential components of informed consent
include competence (the mental capacity of a person to make health-care
decisions), disclosure (information on the diagnosis, proposed interven-
tion, potential risks and benefits, and alternative treatments), understand-
ing (patient’s grasp of information disclosed), and voluntariness (choice
that is free from interference by others, such as coercion or excessive
pressure).Answer 47.2. The answer is D.
There are two standard principles to guide surrogate decision makers for
patients who cannot give informed consent: substituted judgment and
best interests. Substituted judgment refers to the attempt to determine
the incompetent person’s preferences regarding a decision if that person
were to be competent. The best interest standard refers to an objective
evaluation of benefits and risks, and selection of the treatment in which
benefit maximally outweighs the burdens of treatment of the individual
patient.Answer 47.3. The answer is A.
Ethical requirements of clinical trials on human subjects are meant to min-
imize exploitation of research participants. These ethical principles, stated
in guidelines issued by multiple agencies, include the principles of collab-
orative partnership, social value, scientific validity, fair subject selection,
favorable risk–benefit ratio, independent review, informed consent, and
respect for potential and enrolled subjects.Answer 47.4. The answer is B.
Clinical equipoise is present when there is a legitimate disagreement
among clinicians about optimal treatment, particularly when there is
lack of reliable data and genuine uncertainty about which treatment is
best for a patient. When this principle is met, there is no violation of the
physician–patient relationship, in which the physician is acting on behalf
of the patient’s best interest.Answer 47.5. The answer is C.
Studies sponsored by industry have been found to be at least as method-
ologically rigorous, if not more so, than nonindustry sponsored trials.
Financial incentive for companies to avoid methodologic flaws that dis-
credit study results has been suggested as the reason for this finding.
There is little evidence to suggest that interpretation of data is frequently
biased by financial considerations. Several studies point to the impact of