Developing Ethical Strategies to Assist Oncologists in Seeking Informed Consent to Cancer Clinical Trials.

Posted: Oct 25, 2011
Soc Sci Med. 58. 2. 379-90.
KEYWORDS: Staff Experience Level, Provider-Patient Relationship, International, Consent, Verbal Communications, Cancer, Phase 3-4


Specific communication strategies may help physicians ensure ethical consent to participation in clinical trials, potentially leading to higher accrual rates.

Why this item may be useful

Analysis of audiotaped consultations in which oncologists invited patients to participate in Phase II and Phase III clinical trials identified four themes: (a) shared decision making; (b) the sequence of moves in the consultation; (c) the type and clarity of the information provided; and (d) disclosure of controversial information and coercion. The authors developed a set of ethical communication strategies to assist physicians and other health professionals in discussing participation of patients in clinical trials.


  • Audiotape transcripts of 26 physician-patient consultations in which ten oncologists discussed clinical trial participation at two teaching hospitals in Australia were produced.
  • The transcripts were analyzed by a panel including experts in ethics, cancer medicine, and psychooncology. Expert linguists analyzed 7 of the 26 transcripts to explore the type of language used in offering clinical trials as treatment options, in particular coercive and noncoercive elements.
  • Patient participation in decision making was identified as an essential component of seeking informed consent. The authors suggest numerous strategies doctors could use to promote collaborative decision making.
  • The paper proposes a step-by-step model of consultation. The model was developed to promote patient understanding of information, ensure equal weight is given to discussion of standard and experimental treatments, and avoid potential coercion.
  • Type and clarity of information needed to achieve ethical informed consent is described.