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.
","abstract_html":"<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>","abstract_has_math":false,"creators":["Schmidt, Joann Jeanne"],"institution":null,"degree_name":"Master of Science (MS)","degree_level":"Open Access Thesis","degree_discipline":"Health Sciences","degree_department":null,"school":null,"contributors":["Elizabeth Francis-Connolly, PhD, OTR, Chair","Erich Jensen, BS"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2009,"date_issued":"2009-01-01T08:00:00Z","date_published":"2009-01-01T08:00:00Z","updated_at":"2026-07-24T02:16:36Z","subjects":["Analytical, Diagnostic and Therapeutic Techniques and Equipment","Health and Medical Administration","Investigative Techniques"],"languages":[],"rights":[],"rights_urls":[],"identifier_entries":[]},"links":{"outbound_url":"https://commons.emich.edu/theses/274","outbound_label":"Repository record","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Elizabeth Francis-Connolly, PhD, OTR, Chair","Erich Jensen, BS"]},{"key":"dc:creator","label":"Author","values":["Schmidt, Joann Jeanne"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date.available","label":"Dc Date Available","values":["2010-11-18T08:00:00Z"]},{"key":"thesis:degree_discipline","label":"Discipline","values":["Health Sciences"]},{"key":"thesis:degree_level","label":"Degree Level","values":["Open Access Thesis"]},{"key":"thesis:degree_name","label":"Degree Name","values":["Master of Science (MS)"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Analytical, Diagnostic and Therapeutic Techniques and Equipment","Health and Medical Administration","Investigative Techniques"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://commons.emich.edu/theses/274"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["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.
"]},{"key":"dc:title","label":"Title","values":["Cultural determinants affect implementation of good clinical practice (GCP) in human research studies in Malawi, Africa"]}]}],"canonical_facts":{"dc:contributor":["Elizabeth Francis-Connolly, PhD, OTR, Chair","Erich Jensen, BS"],"dc:creator":["Schmidt, Joann Jeanne"],"dc:date.available":["2010-11-18T08:00:00Z"],"dc:description.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.
"],"dc:identifier":["https://commons.emich.edu/theses/274"],"dc:subject":["Analytical, Diagnostic and Therapeutic Techniques and Equipment","Health and Medical Administration","Investigative Techniques"],"dc:title":["Cultural determinants affect implementation of good clinical practice (GCP) in human research studies in Malawi, Africa"],"thesis:degree_discipline":["Health Sciences"],"thesis:degree_level":["Open Access Thesis"],"thesis:degree_name":["Master of Science (MS)"]},"updated_at":"2026-07-24T02:16:36Z"}