Informed consent for pediatric leukemia research - Clinician perspectives

BACKGROUND. Good, fully informed consent is critical to the ethical conduct of clinical cancer research. The authors examined clinician perspectives o n informed consent for pediatric research by surveying clinicians at five m ajor medical centers that routinely enroll patients in Children's Cancer Gr oup studies. METHODS. Building on a pilot study, a questionnaire was designed to elicit clinicians' general opinions, approaches, and suggestions related to inform ed consent in pediatric leukemia trials. Questionnaires were mailed to 132 clinicians. Eighty-nine questionnaires were returned, along with 13 nonpart icipant forms notifying us of the clinician's inability to participate beca use of a lack of experience in pediatric informed consent. The response rat e was 75%. RESULTS. Providing information so that families can decide about study entr y was ranked as the most important goal of the informed consent process, wh ereas parents' state of shock was rated the most significant obstacle to go od informed consent. Clinicians cited high levels of parental comprehension of key aspects of clinical research studies and reported information overl oad and increased anxiety as effects of the informed consent process on par ents. Several key items were associated with clinicians' gender, race, and professional experience. Finally, one open-ended question yielded 126 sugge stions for how to improve the informed consent process that were grouped in to 10 meaningful categories. CONCLUSIONS. Clinicians report a range of approaches, opinions, concerns, a nd suggestions for improving the informed consent process. The article prop oses that their views and suggestions be integrated with those of parents a nd patients in attempts to survey and improve informed consent in pediatric oncology. Cancer 2001;92:691-700. (C) 2001 American Cancer Society.