Date of Conferral

1-1-2011

Degree

Doctor of Public Health (DrPH)

School

Public Health

Advisor

Michael Schwab

Abstract

African institutions that perform health research need to continuously evaluate their practices in order to ensure compliance with international standards of good clinical practice (GCP). This mixed-methods study, undertaken at one clinical research site in Western Kenya, was an evaluation of GCP compliance at the site, research participants' satisfaction with research procedures, and research participants' comprehension of informed consent. The qualitative portion of the study involved audit of the site's compliance with GCP standards. The quantitative portion was an assessment of participant satisfaction and informed consent comprehension, undertaken through interviews with a sample of 297 participants. Thematic analysis of the qualitative data showed that the site's performance conformed with GCP standards. Descriptive statistical analysis of the quantitative data showed that the majority of study participants were content with study procedures. A majority understood those parts of the informed consent process related to study duration and purpose but not those parts of the informed consent process related to the purpose and benefits of the study. Univariate chi square analysis showed no statistically significant differences in the level of satisfaction by age, occupation, or level of education, and there were no statistically significant differences in the level of informed consent comprehension by duration in the study or staff levels of experience. Implications for positive social change include guiding future health research capacity-building efforts in Africa toward better compliance with GCP standards and development of higher quality of informed consent procedures.

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