““ANTHROPOLOGICAL AND ANTHROPOLOGICAL AND BIOETHICS STUDY OF CLINICAL BIOETHICS STUDY OF CLINICAL

RESEARCH IN MALAWI”RESEARCH IN MALAWI”

A Wellcome trust research grantA Wellcome trust research grant

Joseph Mfutso-Bengo PhDJoseph Mfutso-Bengo PhDCentre for Bioethics in Eastern Centre for Bioethics in Eastern

and Southern Africa, and Southern Africa, College of Medicine.College of Medicine.29th29th November, 2008. November, 2008.

BackgroundBackground

• There is wide spread biomedical research in There is wide spread biomedical research in developing countries now.developing countries now.

• As a result, new ethical questions to As a result, new ethical questions to research participants, researchers & research participants, researchers & sponsors are coming to the fore.sponsors are coming to the fore.

• However, to date there is little ethical and However, to date there is little ethical and cultural knowledge derived from empirical cultural knowledge derived from empirical research in ethics in developing countries research in ethics in developing countries such as Malawi. (S. Molyneux, Pauline such as Malawi. (S. Molyneux, Pauline Tindana., Christian Pace & E. Emmanuel, S. Tindana., Christian Pace & E. Emmanuel, S. Banatar)Banatar)

• Therefore, this study attempted to fill this Therefore, this study attempted to fill this gap.gap.

ObjectivesObjectives

To improve understanding of cultural To improve understanding of cultural attitudes, beliefs and perceptions to attitudes, beliefs and perceptions to biomedical research, community consultation biomedical research, community consultation and informed consent process in peri-urban and informed consent process in peri-urban and rural settings.and rural settings.

To provide a base for informing, reforming To provide a base for informing, reforming and improving informed consent policy and and improving informed consent policy and practice by describing the local cultural practice by describing the local cultural attitudes and perceptions to research, attitudes and perceptions to research, autonomy, informed consent process and autonomy, informed consent process and community consultation.community consultation.

To assess validity of the Western concepts of To assess validity of the Western concepts of informed consent and autonomy in a informed consent and autonomy in a Malawian (African) setting.Malawian (African) setting.

Project planProject plan

Duration: 3 years Duration: 3 years (July2004-August (July2004-August 2007 & extended 2007 & extended to June 2008).to June 2008).

Location: Bangwe, Location: Bangwe, Mpemba & Mpemba & Madziabango in Madziabango in Blantyre (phase 1)Blantyre (phase 1)

UNC- Lilongwe and UNC- Lilongwe and QECH (phase 2)QECH (phase 2)

Study designStudy design

Three phases:Three phases: Phase 1 : Qualitative; Phase 1 : Qualitative; an anthropological an anthropological

and cultural study of biomedical research.and cultural study of biomedical research.

Phase 2 : Quantitative: Phase 2 : Quantitative: a sub-study of on a sub-study of on going clinical research.going clinical research.

Phase 3 : Community Dissemination andPhase 3 : Community Dissemination and comparative studycomparative study

Phase 1Phase 1 50 FGDs conducted 50 FGDs conducted

with 494 research with 494 research participants.participants.

5 categories used:5 categories used: --Refusers,participants,non-Refusers,participants,non-

participants, local participants, local leaders,health workers.leaders,health workers.

Manual and electronic Manual and electronic data analysis (N6 used)data analysis (N6 used)

Results informed Results informed design of phase 2 design of phase 2 questionnairequestionnaire

Phase 2Phase 2

Interviews were conducted with 319 Interviews were conducted with 319 participants drawn from 5 different clinical participants drawn from 5 different clinical trials in Lilongwe and Blantyretrials in Lilongwe and Blantyre– 250 from 3 trials at UNC Lilongwe250 from 3 trials at UNC Lilongwe– 54 from ART/Nutrition Study (QECH)54 from ART/Nutrition Study (QECH)– 15 from GLAM Trial (QECH) 15 from GLAM Trial (QECH)

A semi structured questionnaire was usedA semi structured questionnaire was used..

Phase 3Phase 3

Involved dissemination of results to Involved dissemination of results to research participants & Research research participants & Research Staff of clinical trials usedStaff of clinical trials used

Compared findings from Phases 1 Compared findings from Phases 1 and 2 with findings from Kenya, and 2 with findings from Kenya, Zambia/Uganda, and Ghana on Zambia/Uganda, and Ghana on similar studies.similar studies.

Ethical ConsiderationsEthical Considerations

Approval for the study was given by Approval for the study was given by COMREC; and any protocol amendments COMREC; and any protocol amendments were reported as the study was going were reported as the study was going onon

Informed consent of research Informed consent of research participants was sought verbally in both participants was sought verbally in both phases 1 and 2.phases 1 and 2.

Results –Phase 1Results –Phase 1 A majority of research participants described A majority of research participants described

biomedical research as activities associated with biomedical research as activities associated with preventive health measures such as community preventive health measures such as community assessment and health education. This was common assessment and health education. This was common among the among the refusersrefusers and and non-participants.non-participants.

Most research participants could differentiate Most research participants could differentiate between biomedical research and standard health between biomedical research and standard health care; but the difference was seen in the quality of care; but the difference was seen in the quality of care, rather than procedures involved (no therapeutic care, rather than procedures involved (no therapeutic misconception)misconception)

Among the category of Among the category of participantsparticipants, the need to , the need to receive better medical treatment was said to be their receive better medical treatment was said to be their motivating factor to participate in biomedical motivating factor to participate in biomedical research.research.

Results – Phase 1Results – Phase 1 The ‘The ‘refusers’ refusers’ cited rumours associated with cited rumours associated with

biomedical research projects as the de-motivating biomedical research projects as the de-motivating factor for refusing to participate in biomedical factor for refusing to participate in biomedical research.research.

Individual consent was perceived as necessary Individual consent was perceived as necessary before one is involved in biomedical researchbefore one is involved in biomedical research

Preferred signing or thumb printing as the best Preferred signing or thumb printing as the best method of giving consent to oral consentmethod of giving consent to oral consent

A majority of participants said it was customary A majority of participants said it was customary to consult chiefs before a research project is to consult chiefs before a research project is launched in their community.launched in their community.

Biomedical research was perceived to be a useful Biomedical research was perceived to be a useful tool in enhancing their health status.tool in enhancing their health status.

Results – Phase 2Results – Phase 2 94.6% (298) of clinical research participants 94.6% (298) of clinical research participants

said they understood the study objectives, said they understood the study objectives, but only 21.8% (65) were able to state them but only 21.8% (65) were able to state them correctly.correctly.

92% (294) of participants understood the 92% (294) of participants understood the informed consent procedure and its meaning.informed consent procedure and its meaning.

33% (97) of those who perceived benefits of 33% (97) of those who perceived benefits of participation mentioned the care provided to participation mentioned the care provided to them in clinical research as one of the them in clinical research as one of the benefits.benefits.

16.6% (52) acknowledged existence of risks 16.6% (52) acknowledged existence of risks to their participation in the clinical research; to their participation in the clinical research; and were able to name the risks involvedand were able to name the risks involved

Results – Phase 2Results – Phase 2 While 98% (313) said they joined clinical While 98% (313) said they joined clinical

research freely, only 92% (294) understood research freely, only 92% (294) understood the informed consent procedures.the informed consent procedures.

90.9% (290) informed their partners/relatives 90.9% (290) informed their partners/relatives about study participation; rather than seeking about study participation; rather than seeking permission, 64.4% (187) said they did so permission, 64.4% (187) said they did so “to “to let them know what was happening or that let them know what was happening or that they were participating in research.”they were participating in research.”

84.6% (270) had no problem with allowing 84.6% (270) had no problem with allowing their samples to be stored for future research.their samples to be stored for future research.

Phase 3: Dissemination Phase 3: Dissemination of Phases 1 & 2 resultsof Phases 1 & 2 results

The Bioethics Team organized The Bioethics Team organized dissemination workshops btwn 10th dissemination workshops btwn 10th March & 17March & 17thth April, 2008. April, 2008.

Workshops were held in Madziabango, Workshops were held in Madziabango, Mpemba, Bangwe and MLT in BT & UNC Mpemba, Bangwe and MLT in BT & UNC Tidziwe Centre in LL.Tidziwe Centre in LL.

Were attended by 46 health Were attended by 46 health workers/research staff/Researchers & 128 workers/research staff/Researchers & 128 research participants including community research participants including community leaders.leaders.

Objectives of Objectives of dissemination workshopsdissemination workshops To disseminate Phases 1 & 2 results of To disseminate Phases 1 & 2 results of

Bioethics Research Project to research Bioethics Research Project to research participants & research staff in participants & research staff in Madziabango, Mpemba, Bangwe and MLT Madziabango, Mpemba, Bangwe and MLT in BT & UNC Tidziwe Centre in LL.in BT & UNC Tidziwe Centre in LL.

To discuss results with research To discuss results with research participants, researchers & participants, researchers & health/research staff of the 3 HCs & UNC.health/research staff of the 3 HCs & UNC.

To encourage further discussion on major To encourage further discussion on major challenges in conducting biomedical challenges in conducting biomedical research in areas with limited resources.research in areas with limited resources.

Why do people refuse to Why do people refuse to participate in research?participate in research?

Failure to follow traditional customs Fear of strangers Superstition and blood drawing Poor informed consent procedure Lack of study benefits Ignorance of health research Lack of cultural sensitivity Poor timing

ConclusionsConclusions People who refuse to take part in biomedical People who refuse to take part in biomedical

research do so with an impaired understanding of research do so with an impaired understanding of its meaning and objectives due to rumours its meaning and objectives due to rumours associated with biomedical research.associated with biomedical research.

There is a knowledge gap between real and There is a knowledge gap between real and perceived objectives among those who perceived objectives among those who participated or were participating in biomedical participated or were participating in biomedical research. (Scientific misconception)research. (Scientific misconception)

People are motivated to take part in biomedical People are motivated to take part in biomedical research by the “quality of care” provided to research by the “quality of care” provided to research participants.research participants.

Participants understand their voluntary Participants understand their voluntary participation in researchparticipation in research

with community consultation seen as customary with community consultation seen as customary and preceding individual consent and preceding individual consent

But they were against community consentBut they were against community consent

ConclusionsConclusions People accept to participate in clinical research with People accept to participate in clinical research with

knowledge of the existence of risks to their knowledge of the existence of risks to their participationparticipation..

Preference of signing or thumb printing is contrary Preference of signing or thumb printing is contrary to the Western concepts which allude to oral consent to the Western concepts which allude to oral consent to be sought in illiterate communities. to be sought in illiterate communities.

Communities have a good attitude towards Communities have a good attitude towards biomedical research but are put off by researchers biomedical research but are put off by researchers who who – do not follow customary procedures like do not follow customary procedures like

community consultation and community consultation and – do not give feedback of results after the research do not give feedback of results after the research

is over.is over.

ConclusionsConclusions Researchers have social obligations to provide Researchers have social obligations to provide

health service to communities where they recruit health service to communities where they recruit participants (in order to improve pple’s lives).participants (in order to improve pple’s lives).

Should also feel responsible for improving health Should also feel responsible for improving health center where they operatecenter where they operate

Researchers have to engage communities b4 Researchers have to engage communities b4 initiating clinical research in communities/hc.initiating clinical research in communities/hc.– CE would dispel rumors associated with CE would dispel rumors associated with

clinical research.clinical research.– Would encourage community members to Would encourage community members to

participate.participate.

Research TeamResearch Team Prof. J.M. Mfutso-Bengo, Principal Prof. J.M. Mfutso-Bengo, Principal

InvestigatorInvestigator Prof. Malcolm Molyneux, Senior Prof. Malcolm Molyneux, Senior

Collaborator/ AdvisorCollaborator/ Advisor Matilda Mkunthi, Research OfficerMatilda Mkunthi, Research Officer Vincent Jumbe, Assistant Research OfficerVincent Jumbe, Assistant Research Officer Francis Masiye, Assistant research OfficerFrancis Masiye, Assistant research Officer Dr. Elsbeth Robson, Social ScientistDr. Elsbeth Robson, Social Scientist Dr. Sarah White, StatisticianDr. Sarah White, Statistician Andrew Kumitawa, StatisticianAndrew Kumitawa, Statistician Thandi Kamwendo, SecretaryThandi Kamwendo, Secretary

Part of the research staff that Part of the research staff that attended one workshopattended one workshop

Thandi distributing the handoutsThandi distributing the handouts

Mr. Masiye stressing a pointMr. Masiye stressing a point