Date of Award

5-12-2017

Degree Type

Capstone Project

Degree Name

Master of Public Health (MPH)

Department

Public Health

First Advisor

Douglas Roblin, PhD

Second Advisor

Sheryl Strasser, PhD

Abstract

Researchers must strive to equally distribute both the costs and benefits of human subjects’ research among the population they serve. In the past, research studies disproportionally targeted convenient populations; participants were usually low-income and often minorities. Through a series of controversial and well known studies, protections were developed to better protect participants in research. However, these protections may have inadvertently caused a shift in the populations targeted for research. In recent history, women and minority groups have become under-represented in clinical research, particularly randomized controlled trials. This capstone seeks to explore the implications of under-representation of certain groups in research and how industry (Sponsor and CROs) can better address this disparity to increase the participation of these groups in clinical studies. Current federal and international policies regarding human subjects’ protections are documented and focuses on legislation in the United States that aims to increase the participation of women and minorities in research. The current costs and barriers to conducting a successful clinical trial, particularly as it pertains to recruitment of human subjects are explored. Using this information, the author proposes potential recommendations that could be incorporated at the industry level to successfully increase recruitment of under-represented groups in clinical trials. Sponsors must also consider limitations that may affect recruitment, such as provider implicit bias. Incorporation of comprehensive recruitment strategies are vital to the improvement of under-represented groups in clinical studies.

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