The SRA Symposium - College of Medicine

Contextual Difficulties in IRB Deliberations –
Principlist vs. Narrativist Ethical Frameworks
Chris Asmann-Finch, M.S., LNHA
Doctoral student, Medical Humanities
Caspersen School of Graduate Studies
Drew University
36 Madison Avenue
Madison, NJ 07940
Email: asmannfinc@aol.com
Abstract
The Belmont Report identified three principles, respect for persons, beneficence and justice, that
should guide the conduct of research involving human participants. Yet, in the absence of knowing
or understanding the values of participants, whose values do IRB members’ use to evaluate the
ethical principles? How do they apply them operationally to the social interactions that assure participants’
opinions and choices are recognized, respected and unrestrained, or that risk and benefit
have been proportionately balanced in a way meaningful to the participants? Do IRB assumptions,
in fact, safeguard the ethical principles as conceptualized by the participants? These contextual
difficulties, critics claim, are reflective of ethics deliberations that fail to account for social context.
The Report’s three quintessential requirements for ethical conduct in research are shaped within
a principlist framework, a framework that expresses the general values underlying rules in the
common morality. Narrative ethicists, on the other hand, hold the conviction that every moral
situation is unique and unrepeatable, and their meaning cannot be fully captured by appealing to
universal principles. This project will identify the conceptual difficulties faced by IRBs and explore
the contributions each theoretical approach offers to provide greater safeguards to participants of
clinical research.
Text
Papers
The Belmont Report, created in 1974 by the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research and published in 1979, was created to establish
the basic ethical principles that should guide the conduct of biomedical and behavioral research
involving human participants. The Report identified three principles, or “prescriptive judgments”:
respect for persons, beneficence and justice. Respect for persons included two ethical considerations,
“first, that individuals should be treated as autonomous agents, and second, that persons
with diminished autonomy are entitled to protections.” Beneficence included convictions of doing
what is in the best interest of the participant and nonmalfeasance. Finally, justice was defined as
distributive justice, in the sense of “fairness in distribution” or “what is deserved” (National Commission,
1979).
Organizations that conduct clinical research involving humans are required to delegate oversight
responsibility for protection of these ethical imperatives to Institutional Review Boards (IRB). Defined
as an “administrative body” composed of scientists and nonscientists, IRB’s are “established
to protect the rights and welfare of human research subjects recruited to participate in research activities
conducted under the auspices of the institution with which it is affiliated” (Peckman, 2002,
p.17). The IRB conducts reviews of research protocols, prospectively and periodically thereafter for
the duration of the project, to assure the ethical principles have been safeguarded.
2005 Symposium Proceedings Book 27