Ethics and Research with Children: A Case-Based Approach

By Eric Kodish | Go to book overview

10
Behavioral Research With Children: The Fenfluramine Challenge

Gerald P. Koocher


CASE DESCRIPTION

Although psychosocial and behavioral science research rarely present serious medical hazards or threats to the physical well-being of participants, such studies can raise a wide range of ethical dilemmas and controversies. When children participate in such research some special concerns related to their unique developmental vulnerabilities, relative social and financial dependency on others, and status as minors under the law demand particular consideration. One recent set of studies based on a “fenfluramine challenge” protocol provides an interesting model for discussion in this context.

The research in question involved a behavioral science drug study, carried out at prestigious institutions. The studies had no therapeutic benefit or intent, used child participants from impoverished families, and employed a set of questionable recruitment practices. Many people in the lay and scientific communities saw the research as inappropriate or misguided. The investigators, wellintentioned and competent scientists, felt unfairly assailed by their critics. A government investigation of very limited scope determined that required regulatory oversight and informed consent procedures were followed. The study's authors (Wasserman & Pine, 2004) believe that description of the investigation of the Federal Office of Protection from Research Risk of their work as being of limited scope constitutes a mischaracterization. Their written rationale, in response to reading this chapter, rests on finding that IRB review attended to “the requirements of 45 CFR Part 46, Subpart D.” Sadly, this response overlooks the fact that focusing almost exclusively on Subpart D precludes review of many of the issues raised in this chapter, such as distributive justice issues. Readers will have to decide the ethical appropriateness of the study and adequacy of regulatory oversight for themselves.

In the fall of 1997, a group known as Citizens for Responsible Care and Research, co-founded by Professor Adil Shamoo of the University of Maryland,

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