Cultural determinants affect implementation of good clinical practice (GCP) in human research studies in Malawi, Africa

<p>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.</p>

Name thesis:degree_name

Master of Science (MS)

Level thesis:degree_level

Open Access Thesis

Discipline thesis:degree_discipline

Health Sciences

Year dc:date.available

2009

Author dc:creator

• Schmidt, Joann Jeanne

Contributors dc:contributor

• Elizabeth Francis-Connolly, PhD, OTR, Chair
• Erich Jensen, BS

• Analytical, Diagnostic and Therapeutic Techniques and Equipment
• Health and Medical Administration
• Investigative Techniques

Repository record dc:identifier

https://commons.emich.edu/theses/274

OAI identifier oai:identifier

oai:commons.emich.edu:theses-1273