Date Approved

2009

Degree Type

Open Access Thesis

Degree Name

Master of Science (MS)

Department

Health Sciences

Committee Member

Elizabeth Francis-Connolly, PhD, OTR, Chair

Committee Member

Erich Jensen, BS

Abstract

Clinical research conduct and Good Clinical Practice (GCP) implementation are influenced by local culture. This study examines the experiences of 26 clinical research personnel in Malawi, Africa, in order to define relevant issues, identify solutions, and give voice to local investigators. Qualitative, semi-structured interviews were conducted, audio-recorded, transcribed, and analyzed. Six themes, related to cultural determinants, emerged: 1) communitybased decision-making, 2) illiteracy, 3) patient identifiers, 4) local myths and misconceptions, 5) poverty and disease, and 6) barriers to teamwork. Findings revealed that: 1) Malawians are best at identifying local solutions, 2) operations research is needed 3) greater networking and communication is essential, 4) regulatory requirements should be harmonized, 5) Malawi has made significant progress toward GCP implementation, 6) a ―one-size-fits-all‖ approach to GCP does not work, and 7) Malawians who are engaged in clinical research should be consulted and empowered.

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