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“ ANTHROPOLOGICAL AND BIOETHICS STUDY OF CLINICAL RESEARCH IN MALAWI” A Wellcome trust research grant Joseph Mfutso-Bengo ...
Background <ul><ul><li>There is wide spread biomedical research in developing countries now. </li></ul></ul><ul><ul><li>As...
Objectives <ul><li>To improve understanding of cultural attitudes, beliefs and perceptions to biomedical research, communi...
Project plan <ul><li>Duration: 3 years (July2004-August 2007 & extended to June 2008). </li></ul><ul><li>Location: Bangwe,...
Study design <ul><li>Three phases: </li></ul><ul><li>Phase 1 : Qualitative;  an anthropological and cultural study of biom...
Phase 1 <ul><li>50 FGDs conducted with 494 research participants. </li></ul><ul><li>5 categories used: </li></ul><ul><li>-...
Phase 2 <ul><li>Interviews were conducted with 319 participants drawn from 5 different clinical trials in Lilongwe and Bla...
Phase 3 <ul><li>Involved dissemination of results to research participants & Research Staff of clinical trials used </li><...
Ethical Considerations <ul><li>Approval for the study was given  by COMREC; and any protocol amendments were reported as t...
Results –Phase 1 <ul><li>A majority of research participants described biomedical research as activities associated with p...
Results – Phase 1 <ul><li>The ‘ refusers’  cited rumours associated with biomedical research projects as the de-motivating...
Results – Phase 2 <ul><li>94.6% (298) of clinical research participants said they understood the study objectives, but onl...
Results – Phase 2 <ul><li>While 98% (313) said they joined clinical research freely, only 92% (294) understood the informe...
Phase 3: Dissemination of Phases 1 & 2 results <ul><li>The Bioethics Team organized dissemination workshops  btwn 10th Mar...
Objectives of dissemination workshops <ul><li>To disseminate Phases 1 & 2 results of Bioethics Research Project to researc...
Why do people refuse to participate in research? <ul><ul><ul><ul><ul><li>Failure to follow traditional customs  </li></ul>...
Conclusions <ul><li>People who refuse to take part in biomedical research do so with an impaired understanding of its mean...
Conclusions <ul><li>People accept to participate in clinical research with knowledge of the existence of risks to their pa...
Conclusions <ul><li>Researchers have social obligations to provide health service  to communities where they recruit parti...
Research Team <ul><li>Prof. J.M. Mfutso-Bengo, Principal Investigator </li></ul><ul><li>Prof. Malcolm Molyneux, Senior Col...
Part of the research staff that attended one workshop
Thandi distributing the handouts
Mr. Masiye stressing a point
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Anthropological and bioethics study of clinical research in Malawi

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Presented by Joseph Mfutso-Bengo PhD (Centre for Bioethics in Eastern and Southern Africa) at the Public Engagement Workshop, 2-5 Dec. 2008, KwaZulu-Natal South Africa, http://scienceincommunity.wordpress.com/

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Anthropological and bioethics study of clinical research in Malawi

  1. 1. “ ANTHROPOLOGICAL AND BIOETHICS STUDY OF CLINICAL RESEARCH IN MALAWI” A Wellcome trust research grant Joseph Mfutso-Bengo PhD Centre for Bioethics in Eastern and Southern Africa, College of Medicine. 29th November, 2008.
  2. 2. Background <ul><ul><li>There is wide spread biomedical research in developing countries now. </li></ul></ul><ul><ul><li>As a result, new ethical questions to research participants, researchers & sponsors are coming to the fore. </li></ul></ul><ul><ul><li>However, to date there is little ethical and cultural knowledge derived from empirical research in ethics in developing countries such as Malawi. (S. Molyneux, Pauline Tindana., Christian Pace & E. Emmanuel, S. Banatar) </li></ul></ul><ul><ul><li>Therefore, this study attempted to fill this gap. </li></ul></ul>
  3. 3. Objectives <ul><li>To improve understanding of cultural attitudes, beliefs and perceptions to biomedical research, community consultation and informed consent process in peri-urban and rural settings. </li></ul><ul><li>To provide a base for informing, reforming and improving informed consent policy and practice by describing the local cultural attitudes and perceptions to research, autonomy, informed consent process and community consultation. </li></ul><ul><li>To assess validity of the Western concepts of informed consent and autonomy in a Malawian (African) setting. </li></ul>
  4. 4. Project plan <ul><li>Duration: 3 years (July2004-August 2007 & extended to June 2008). </li></ul><ul><li>Location: Bangwe, Mpemba & Madziabango in Blantyre (phase 1) </li></ul><ul><li>UNC- Lilongwe and QECH (phase 2) </li></ul>
  5. 5. Study design <ul><li>Three phases: </li></ul><ul><li>Phase 1 : Qualitative; an anthropological and cultural study of biomedical research. </li></ul><ul><li>Phase 2 : Quantitative: a sub-study of on going clinical research. </li></ul><ul><li>Phase 3 : Community Dissemination and comparative study </li></ul>
  6. 6. Phase 1 <ul><li>50 FGDs conducted with 494 research participants. </li></ul><ul><li>5 categories used: </li></ul><ul><li>- Refusers,participants,non-participants, local leaders,health workers. </li></ul><ul><li>Manual and electronic data analysis (N6 used) </li></ul><ul><li>Results informed design of phase 2 questionnaire </li></ul>
  7. 7. Phase 2 <ul><li>Interviews were conducted with 319 participants drawn from 5 different clinical trials in Lilongwe and Blantyre </li></ul><ul><ul><li>250 from 3 trials at UNC Lilongwe </li></ul></ul><ul><ul><li>54 from ART/Nutrition Study (QECH) </li></ul></ul><ul><ul><li>15 from GLAM Trial (QECH) </li></ul></ul><ul><li>A semi structured questionnaire was used . </li></ul>
  8. 8. Phase 3 <ul><li>Involved dissemination of results to research participants & Research Staff of clinical trials used </li></ul><ul><li>Compared findings from Phases 1 and 2 with findings from Kenya, Zambia/Uganda, and Ghana on similar studies. </li></ul>
  9. 9. Ethical Considerations <ul><li>Approval for the study was given by COMREC; and any protocol amendments were reported as the study was going on </li></ul><ul><li>Informed consent of research participants was sought verbally in both phases 1 and 2. </li></ul>
  10. 10. Results –Phase 1 <ul><li>A majority of research participants described biomedical research as activities associated with preventive health measures such as community assessment and health education. This was common among the refusers and non-participants. </li></ul><ul><li>Most research participants could differentiate between biomedical research and standard health care; but the difference was seen in the quality of care, rather than procedures involved (no therapeutic misconception) </li></ul><ul><li>Among the category of participants , the need to receive better medical treatment was said to be their motivating factor to participate in biomedical research. </li></ul>
  11. 11. Results – Phase 1 <ul><li>The ‘ refusers’ cited rumours associated with biomedical research projects as the de-motivating factor for refusing to participate in biomedical research. </li></ul><ul><li>Individual consent was perceived as necessary before one is involved in biomedical research </li></ul><ul><li>Preferred signing or thumb printing as the best method of giving consent to oral consent </li></ul><ul><li>A majority of participants said it was customary to consult chiefs before a research project is launched in their community. </li></ul><ul><li>Biomedical research was perceived to be a useful tool in enhancing their health status. </li></ul>
  12. 12. Results – Phase 2 <ul><li>94.6% (298) of clinical research participants said they understood the study objectives, but only 21.8% (65) were able to state them correctly. </li></ul><ul><li>92% (294) of participants understood the informed consent procedure and its meaning. </li></ul><ul><li>33% (97) of those who perceived benefits of participation mentioned the care provided to them in clinical research as one of the benefits. </li></ul><ul><li>16.6% (52) acknowledged existence of risks to their participation in the clinical research; and were able to name the risks involved </li></ul>
  13. 13. Results – Phase 2 <ul><li>While 98% (313) said they joined clinical research freely, only 92% (294) understood the informed consent procedures. </li></ul><ul><li>90.9% (290) informed their partners/relatives about study participation; rather than seeking permission, 64.4% (187) said they did so “to let them know what was happening or that they were participating in research.” </li></ul><ul><li>84.6% (270) had no problem with allowing their samples to be stored for future research. </li></ul>
  14. 14. Phase 3: Dissemination of Phases 1 & 2 results <ul><li>The Bioethics Team organized dissemination workshops btwn 10th March & 17 th April, 2008. </li></ul><ul><li>Workshops were held in Madziabango, Mpemba, Bangwe and MLT in BT & UNC Tidziwe Centre in LL. </li></ul><ul><li>Were attended by 46 health workers/research staff/Researchers & 128 research participants including community leaders. </li></ul>
  15. 15. Objectives of dissemination workshops <ul><li>To disseminate Phases 1 & 2 results of Bioethics Research Project to research participants & research staff in Madziabango, Mpemba, Bangwe and MLT in BT & UNC Tidziwe Centre in LL. </li></ul><ul><li>To discuss results with research participants, researchers & health/research staff of the 3 HCs & UNC. </li></ul><ul><li>To encourage further discussion on major challenges in conducting biomedical research in areas with limited resources. </li></ul>
  16. 16. Why do people refuse to participate in research? <ul><ul><ul><ul><ul><li>Failure to follow traditional customs </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Fear of strangers </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Superstition and blood drawing </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Poor informed consent procedure </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Lack of study benefits </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Ignorance of health research </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Lack of cultural sensitivity </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Poor timing </li></ul></ul></ul></ul></ul>
  17. 17. Conclusions <ul><li>People who refuse to take part in biomedical research do so with an impaired understanding of its meaning and objectives due to rumours associated with biomedical research. </li></ul><ul><li>There is a knowledge gap between real and perceived objectives among those who participated or were participating in biomedical research. (Scientific misconception) </li></ul><ul><li>People are motivated to take part in biomedical research by the “quality of care” provided to research participants. </li></ul><ul><li>Participants understand their voluntary participation in research </li></ul><ul><li>with community consultation seen as customary and preceding individual consent </li></ul><ul><li>But they were against community consent </li></ul>
  18. 18. Conclusions <ul><li>People accept to participate in clinical research with knowledge of the existence of risks to their participation . </li></ul><ul><li>Preference of signing or thumb printing is contrary to the Western concepts which allude to oral consent to be sought in illiterate communities. </li></ul><ul><li>Communities have a good attitude towards biomedical research but are put off by researchers who </li></ul><ul><ul><li>do not follow customary procedures like community consultation and </li></ul></ul><ul><ul><li>do not give feedback of results after the research is over. </li></ul></ul>
  19. 19. Conclusions <ul><li>Researchers have social obligations to provide health service to communities where they recruit participants (in order to improve pple’s lives). </li></ul><ul><li>Should also feel responsible for improving health center where they operate </li></ul><ul><li>Researchers have to engage communities b4 initiating clinical research in communities/hc. </li></ul><ul><ul><li>CE would dispel rumors associated with clinical research. </li></ul></ul><ul><ul><li>Would encourage community members to participate. </li></ul></ul>
  20. 20. Research Team <ul><li>Prof. J.M. Mfutso-Bengo, Principal Investigator </li></ul><ul><li>Prof. Malcolm Molyneux, Senior Collaborator/ Advisor </li></ul><ul><li>Matilda Mkunthi, Research Officer </li></ul><ul><li>Vincent Jumbe, Assistant Research Officer </li></ul><ul><li>Francis Masiye, Assistant research Officer </li></ul><ul><li>Dr. Elsbeth Robson, Social Scientist </li></ul><ul><li>Dr. Sarah White, Statistician </li></ul><ul><li>Andrew Kumitawa, Statistician </li></ul><ul><li>Thandi Kamwendo, Secretary </li></ul>
  21. 21. Part of the research staff that attended one workshop
  22. 22. Thandi distributing the handouts
  23. 23. Mr. Masiye stressing a point

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