The SRA Symposium - College of Medicine

A Profile of the IRB Infrastructure at Comprehensive and Predominantly Undergraduate
Institutions in the South: Project Initiation and 2005 Update
Kristy Hoyman, B.S. in Education
Graduate Assistant working towards MPH in Biostatistics
Office of Research Services and Sponsored Programs
Georgia Southern University
Office of Research Services and Sponsored Programs
Georgia Southern University
P.O. Box 8005
Statesboro, GA 30460 USA
(912)681-0843
khoyman@georgiasouthern.edu
Author’s Note
The author would like to thank the co-author, Julie Cole, for her dedication to this project, as well
as her kindness and understanding.
Abstract
The research community has both an ethical and publicly mandated responsibility to adhere to
the strictest standards of compliance when conducting research with human subjects. Universities
are being challenged to develop and maintain organizational infrastructures that ensure compliance,
while providing a supportive atmosphere for research productivity. Clearly this is a concern
among the large research institutions and organizations as the cost of compliance becomes
a pressing issue of both scale and quality. For the smaller, less research intensive institutions,
this dilemma is exacerbated by additional factors: awareness among senior administrators of the
necessity and requirements for human subjects’ research; limited staff in research offices; limited
access to the national dialogue relating to issues in human subjects’ protections; and other similar
concerns. What is the state of human subjects’ compliance among predominantly undergraduate
institutions? What infrastructure exists to support appropriate monitoring? How effective is
the oversight provided? How well informed are researchers in the social sciences, education, and
other non-medical fields? How invasive and potentially harmful is student-directed research at
predominantly undergraduate institutions? In answering these questions and other related issues,
a convenience sample from predominantly undergraduate institutions in the South is surveyed for
use in this profile.
Background of Human Subject Research
Papers
Throughout the past several decades, the protection of human subjects in research has gained
extraordinary attention. Historical events, such as the Nuremberg trial and the Tuskegee study,
caused the government to examine research in such a way that the protection of research participants
became a major issue. Since 1991 when the Common Rule was mandated by the federal
government, the expectations of protecting humans in research have continued to increase dramatically
in academia. While research protections at one time applied to clinical trials and medical
universities, predominantly undergraduate universities are noticing a trend to comply to these
federal regulations as well. These less research intensive institutions recognize the need and importance
to protect research participants, although the capacity of the research may not be medical
in nature. There has also been a greater awareness after the closing of university research due to
non-compliance, such as gene therapy studies at the Institute for Gene Therapy at the University
2005 Symposium Proceedings Book 127