TABLE 1

Included Studies

Study by CountryMedical Condition Focus of Trial(s)Sponsor of Qualitative StudynParticipantsMethodologic FrameworkData CollectionAnalysisTopic
ChildrenParentsCommunityClinical/ Research TeamRegulatorsSponsors
Bangladesh
 Rahman et al, 201012Newborn careFoundation/ charity/society, government6900Qualitative designOpen-ended questions, in-depth interviews, focus groupRecruitment and retention of community health workers
Ghana
 Abbey et al, 201413FeverFoundation/ charity/society350035000Mixed methods/ ecological behaviors modelFace-to-face interviews, focus groups, informal discussions; field reportsIterativeRetention of community health workers
 Febir et al, 201314MalariaFoundation/ charity/society, government159014410500Qualitative designFocus groups, in-depth interviews; cross-sectional surveyThematic analysisKnowledge and perception of malaria vaccines
  Onvomaha Tindana et al, 200615NonspecificGovernment90070101000Qualitative designIn-depth semi-structured interviews, focus groupsThematic analysisInformed consent process
 Tindana et al, 201116NonspecificFoundation/ charity/society136024104800Qualitative designIn-depth interviews, focus groupsCommunity engagement in biomedical research
Haiti
 Coreil et al, 199817HIVGovernment239016772000EthnographyFocus groups, in-depth interviewsContent and thematic analysesCultural feasibility of trial
India
 DeCosta et al, 200418NonspecificHospital, university, government575700000Qualitative designStructured interviewsInformed consent and motivation for participation
Kenya
 Angwenyi et al, 201319InfectionGovernment, industry trust332500800Mixed methods/multimethod social scienceIn-depth interviews, focus groups; observationsThematic analysisPractical and ethical implications of involving community health workers
 Angwenyi et al, 201420MalariaGovernment, industry trust5701983000Mixed methodsIn-depth interviews, focus groups; surveys, observations, document reviewsFramework analysisInformed consent and community engagement activities
 Chantler et al, 201321InfectionUniversity, industry trust119027741800EthnographyObservations, interviews, focus groupsThematic analysisCommunity engagement of paid volunteers
Gikonyo et al, 200822MalariaGovernment, industry trust20301980500Qualitative designStructured interviews, focus groupsInformed consent practices
 Gikonyo et al, 201323MalariaGovernment, industry trust∼40000EthnographyObservation, meeting minutes; interviews, focus groupsFeedback of trial findings to participants
 Kamuya et al, 201324NonspecificGovernment, industry trust240024000Qualitative designFocus group, in-depth interviews; reports, self-administered questionnairesEngaging communities to strengthen research ethics
 Lairumbi et al, 201125NonspecificGovernment, industry trust5200271510Qualitative designFace-to-face, in-depth interviewsGrounded theoryUnderstanding of benefit-sharing in health research
 Lairumbi et al, 201226aNonspecificGovernment, industry trust5200271510Qualitative designFace-to-face, in-depth interviewsGrounded theoryResearch benefits expected by participants
 Molyneux et al, 200427NonspecificGovernment, industry trust14208950300Qualitative designObservation; hypothetical case vignettes, informal and semi-structured group interviewsUnderstanding of informed consent
 Molyneux et al, 200528aNonspecificGovernment, industry trust14208950300Qualitative designObservation; hypothetical case vignettes, informal and semi-structured group interviewsContent analysisInformed consent process
 Molyneux et al, 200529aNonspecificGovernment, industry trust14208950300Qualitative designObservation, hypothetical case vignettes, focus groups, interviewsContent analysisNotion and practice of informed consent
 Molyneux et al, 201230Perfusion, HIV, tuberculosis, respiratory infections, malaria, immunologyGovernment, industry trust870008700Qualitative designCase vignettes, in-depth interviews, focus group, consultative workshop; e-mail surveyBenefits and payments for research participants
 Okello et al, 201331MalariaFoundation/ charity/society, government, industry trust,4202000Qualitative designObservation, in-depth interviews, focus groupsChallenges of consent and community engagement in a school-based trial
 Vreeman et al, 201232NonspecificGovernment10806048000Qualitative designTraditional community assemblies/focus groupCommunity perspectives on informed consent and research participation
Lebanon
 Nabulsi et al, 201133MeningitisUniversity330330000Qualitative designIn-depth interviewsThematic analysisParental motivation for participation
Malawi
 Corneli et al, 200734HIVGovernment133010033000FormativeSemi-structured interviews, focus group, observationsContent analysisCommunity engagement informing design of protocols
 Masiye et al, 200835MalariaGovernment810810000Qualitative designFocus groupsMotivation for participation and role of relatives in decision-making
 Piwoz et al 200636HIVGovernment190001900FormativeIn-depth interviewsContent analysisFeasibility of intervention to inform trial design
Multinational
 Hyder and Wali, 200637bNonspecificGovernment780007800Qualitative designFocus groups, in-depth interviews; open-ended questions in surveyDeveloping countries’ research perspectives of informed consent and collaborative research
 Kass et al, 200538cInfectious diseaseGovernment260260000Qualitative designIn-depth interviewsThematic analysisParticipant motivations, understanding and voluntariness
Puerto Rico
 Pérez-Guerra et al, 201239DengueIndustry313111145391800Grounded theoryInterviews, focus groupsContent analysisCommunity views of placebo-controlled dengue vaccine trial
South Africa
 Essack et al, 201040HIVGovernment310016735Qualitative designSemi-structured in-depth interviewEthical challenges in HIV vaccine trials
 Jaspan et al, 200841HIVGovernment200575192000Qualitative designFocus groupThematic analysisEthical issues of adolescent involvement in HIV vaccine trials
 Jaspan et al, 201042aHIVCollaborative group, government200575192000Qualitative designFocus groupsThematic analysisAttitudes toward the inclusion of adolescents in HIV vaccine trials
 Mahomed et al, 200843TuberculosisFoundation/ charity/society, government, industry7240320000Qualitative designFocus group; self-administered surveyContent analysisKnowledge and attitudes of adolescents to tuberculosis trials
Tanzania
Liheluka et al 201344MalariaIndustry550496000Qualitative designIn-depth interviews, focus groupThematic analysisSecondary health benefits of malaria vaccine trials
The Gambia
 Fairhead et al, 200645Pneumonia, meningitisGovernment>6001000EthnographyObservations, narrative and semi-structured interviewsThematic analysisEngagement of parents in vaccine trial
 Geissler et al, 200846MalariaFoundation/ charity/society9308001300Qualitative designSemi-structured interviewsRelational ethics and material exchanges
 Leach et al, 199947InfluenzaGovernment18901890000Qualitative designSemi-structured interviewInformed consent procedure
Uganda
 Crane, 201048HIVFoundation/ charity/society5000500Qualitative designSemi-structured interviewsScience and ethics in HIV transnational research in Africa
Zambia
 Kingori et al, 201049MalnutritionUniversity>300>250500Qualitative designFace-to-face in-depth interviews, focus groupMisconception of clinical trials
Zimbabwe
 Power et al, 200450dSexual healthQualitative designObservation, in-depth interviews, focus groupsThematic analysisFeasibility study targeting adolescent sexual health
  • − not stated, unclear, or unable to ascertain.

  • a Excluded from the total number of participants because they have the same participants as another study in this review by same author.

  • b Countries of study: China, India, Thailand, the Philippines, South Africa, Tanzania, Kenya, Brazil, Colombia, and Mexico.

  • c Countries of study: Africa and Caribbean.

  • d Number of participants not reported and thus not included in the total number of participants.