The SRA Symposium - College of Medicine

Papers
The Utility of Gender, Race, and Ethnicity Reporting in Clinical Trials as an
Indicator of Distributive Justice
Paula Bistak, RN, MS, CIP
Joseph Cosico, RN, MA, CCRC
Atlantic Health System
Office of Grants and Research
95 Madison Avenue, Suite 303
Morristown, New Jersey 07962
(973) 971 -7060
paula.bistak@ahsys.org
Author’s Note: Special thanks to Carol Soricelli for data review assistance and to Christine Asmann-Finch
for unprecedented moral support.
Abstract
The evolving interpretation of what is responsible conduct of research demands that the research
community continually examine its practices, policies, and quite possibly the very values upon
which it is founded. Justice, one of the fundamental ethical principles upon which all human
subject research must be evaluated, perhaps remains the most subjective consideration for Institutional
Review Boards (IRBs).
The paper briefly describes the attempt of the Atlantic Health System, an independent academic
medical center in New Jersey, to ensure its protocol review process adequately addresses issues of
justice and that selection of subjects is equitable.
Introduction
“Who ought to receive the benefits of research and bear it burdens?” Even before the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research posed
this question of justice in its monumental treatise The Belmont Report in 1979, the awareness
of the societal inequities of research participation was impacting the public consciousness. The
exploitation of vulnerable subsets of the population was evident in highly publicized exposes such
as the Tuskegee experiments involving poor, black men from the rural South; the Willowbrook
State Institution hepatitis viral experiments on children with mental impairments; and the tragic
Thalidomide treatments for pregnant women.
History demonstrates while the burdens of human subject research fell largely on the poor and
vulnerable populations, the benefits of such research were enjoyed by the wealthy and powerful
segments of society. (Amdur, p156) This “injustice” of unequal distribution of risks and benefits
prompted federal regulators to impose additional protections for vulnerable populations most at
risk for exploitation. In 1977, the Food and Drug Administration (FDA) issued guidance excluding
women of childbearing potential from participation in early studies of new drugs. Department
of Health and Human Services (DHHS) 45 CFR Part 46 Subparts B, C and D deal with specific
additional requirements for conducting research with pregnant women, prisoner, and children
respectively.
56 2005 Symposium Proceedings Book