Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials

Scholars have debated the role that altruistic considerations play—and should play—in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) “the future” and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.

Keywords:

• altruism
• informed consent
• pediatric cancer trials

ACKNOWLEDGMENTS

We would like to thank the multiple institutions, patients, parents, clinicians, co-investigators, and research assistants who helped with this research. We thank Mara Buchbinder and Sarah Schramm for assisting with the coding and analysis. Two anonymous reviewers for the American Journal of Bioethics provided invaluable comments and suggestions on the manuscript. The research was made possible in part by a grant from the National Institutes of Health (NIH RO1 CA83267) and support from the Templeton Foundation, provided through the Institute for Research on Unlimited Love.

Notes

¹. An electronic word search determined that neither term was evident in the most recently available (November 2005) online versions of the Belmont Report (http://ohsr.od.nih.gov/guidelines/belmont.html#ethical) and Code of Federal (Title 45) Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.405).

². We thank an anonymous American Journal of Bioethics reviewer for pointing out this important distinction.

³. We thank an anonymous American Journal of Bioethics reviewer for pointing out this possibility.