The SRA Symposium - College of Medicine

However, while these protections sought to remove undue burdens from vulnerable populations,
much important scientific information was lacking concerning the variability of effects of many
therapies and drugs on women, children, and even some ethnic populations. An intrinsic conflict
exists between ensuring that research benefits are equitably distributed and protecting vulnerable
populations (Amdur, p156). In an attempt to offset these access disparities, in 1994 the National
Institutes of Health (NIH) issued its formal policy and guidelines requiring the inclusion of
women and minorities in clinical research. To assure compliance, the policy requires that federally
funded research protocols must describe the sexual and racial/ethnic composition of the proposed
study population.
The administrative body empowered to monitor the conduct of research with human subjects is
the Institutional Review Board (IRB). One of the essential responsibilities assigned to IRBs when
determining whether a research study is approvable is “the examination of issues of justice and
the determination that the selection of subjects is equitable (45CFR46.111).” While, participation
of vulnerable populations in research requires additional mandatory protections, IRBs also are
instructed not to overprotect to the extent that vulnerable populations are systematically excluded
from the benefits of research (OHRP Guidebook, Chap III). As part of their assessment as to the
equitable selection of subjects, the IRB committee is to take into account “the purposes of the
research and the setting in which the research will be conducted” (OHRP Guidebook, Chap III).
In compliance with the NIH directive Atlantic Health System (AHS) has been collecting subject
composition information for its research studies involving human subjects. However, how or if
this aggregate data required by the NIH should be considered by the IRB as part of their determination
that justice has been satisfied has not been fully explored.
Does this exercise of required reporting support equitable inclusion in research trials? What is the
utility of gender, race, and ethnicity reporting in clinical trials? Can it be a mechanism to support
distributive justice or does it falsely lead to the supposition that equal access automatically translates
into equitable distribution?
Background
Papers
One of the AHS research coordinators was following up on a request from a sponsor and
queried the IRB office, “Do you know the racial and ethnic breakdown of enrollment in research
for AHS?” At the time our “homegrown” database did not record this information, although as
directed by the NIH guidelines, this information was collected for individual research studies during
the time of continuing review and was available in each study file. The coordinator request was
therefore not fulfilled; however, it prompted much discussion and attention to the need for our
organization to have a better understanding of who was enrolling in our research studies and how
well they represented the community we served.
With the help of a research intern, the AHS Office of Grants and Research created a
database including the demographic information of enrollees in all research trials throughout the
system. For comparison, we gathered census information from our catchment area and race/ethnicity/gender
reports from each of our member hospitals. Our plan was to evaluate whether or not
we were serving the principle of justice by a simple equation: if our percentage of minority/gender
enrollment in research matched in equal proportion our institutional data about the public we
served, then our research enrollment was equitable. Or was it?
2005 Symposium Proceedings Book 57