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Cultural Determinants Affect Implementation Of Good Clinical Practice (Gcp) In Human Research Studies In Malawi, Africa, Joann Jeanne Schmidt

Master's Theses and Doctoral Dissertations

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 …