“ 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.

Background There is wide spread biomedical research in developing countries now. As a result, new ethical questions to research participants, researchers & sponsors are coming to the fore. 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) Therefore, this study attempted to fill this gap.

There is wide spread biomedical research in developing countries now.

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

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)

Therefore, this study attempted to fill this gap.

Objectives To improve understanding of cultural attitudes, beliefs and perceptions to biomedical research, community consultation and informed consent process in peri-urban and rural settings. 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. To assess validity of the Western concepts of informed consent and autonomy in a Malawian (African) setting.

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

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.

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

Project plan Duration: 3 years (July2004-August 2007 & extended to June 2008). Location: Bangwe, Mpemba & Madziabango in Blantyre (phase 1) UNC- Lilongwe and QECH (phase 2)

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

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

UNC- Lilongwe and QECH (phase 2)

Study design Three phases: Phase 1 : Qualitative; an anthropological and cultural study of biomedical research. Phase 2 : Quantitative: a sub-study of on going clinical research. Phase 3 : Community Dissemination and comparative study

Three phases:

Phase 1 : Qualitative; an anthropological and cultural study of biomedical research.

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

Phase 3 : Community Dissemination and comparative study

Phase 1 50 FGDs conducted with 494 research participants. 5 categories used: - Refusers,participants,non-participants, local leaders,health workers. Manual and electronic data analysis (N6 used) Results informed design of phase 2 questionnaire

50 FGDs conducted with 494 research participants.

5 categories used:

- Refusers,participants,non-participants, local leaders,health workers.

Manual and electronic data analysis (N6 used)

Results informed design of phase 2 questionnaire

Phase 2 Interviews were conducted with 319 participants drawn from 5 different clinical trials in Lilongwe and Blantyre 250 from 3 trials at UNC Lilongwe 54 from ART/Nutrition Study (QECH) 15 from GLAM Trial (QECH) A semi structured questionnaire was used .

Interviews were conducted with 319 participants drawn from 5 different clinical trials in Lilongwe and Blantyre

250 from 3 trials at UNC Lilongwe

54 from ART/Nutrition Study (QECH)

15 from GLAM Trial (QECH)

A semi structured questionnaire was used .

Phase 3 Involved dissemination of results to research participants & Research Staff of clinical trials used Compared findings from Phases 1 and 2 with findings from Kenya, Zambia/Uganda, and Ghana on similar studies.

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

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

Ethical Considerations Approval for the study was given by COMREC; and any protocol amendments were reported as the study was going on Informed consent of research participants was sought verbally in both phases 1 and 2.

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

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

Results –Phase 1 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. 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) Among the category of participants , the need to receive better medical treatment was said to be their motivating factor to participate in biomedical research.

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.

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)

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

Results – Phase 1 The ‘ refusers’ cited rumours associated with biomedical research projects as the de-motivating factor for refusing to participate in biomedical research. Individual consent was perceived as necessary before one is involved in biomedical research Preferred signing or thumb printing as the best method of giving consent to oral consent A majority of participants said it was customary to consult chiefs before a research project is launched in their community. Biomedical research was perceived to be a useful tool in enhancing their health status.

The ‘ refusers’ cited rumours associated with biomedical research projects as the de-motivating factor for refusing to participate in biomedical research.

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

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

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

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

Results – Phase 2 94.6% (298) of clinical research participants said they understood the study objectives, but only 21.8% (65) were able to state them correctly. 92% (294) of participants understood the informed consent procedure and its meaning. 33% (97) of those who perceived benefits of participation mentioned the care provided to them in clinical research as one of the benefits. 16.6% (52) acknowledged existence of risks to their participation in the clinical research; and were able to name the risks involved

94.6% (298) of clinical research participants said they understood the study objectives, but only 21.8% (65) were able to state them correctly.

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

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

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

Results – Phase 2 While 98% (313) said they joined clinical research freely, only 92% (294) understood the informed consent procedures. 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.” 84.6% (270) had no problem with allowing their samples to be stored for future research.

While 98% (313) said they joined clinical research freely, only 92% (294) understood the informed consent procedures.

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.”

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

Phase 3: Dissemination of Phases 1 & 2 results The Bioethics Team organized dissemination workshops btwn 10th March & 17 th April, 2008. Workshops were held in Madziabango, Mpemba, Bangwe and MLT in BT & UNC Tidziwe Centre in LL. Were attended by 46 health workers/research staff/Researchers & 128 research participants including community leaders.

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

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

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

Objectives of dissemination workshops 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. To discuss results with research participants, researchers & health/research staff of the 3 HCs & UNC. To encourage further discussion on major challenges in conducting biomedical research in areas with limited resources.

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.

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

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

Why do people refuse to 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

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

Conclusions 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. There is a knowledge gap between real and perceived objectives among those who participated or were participating in biomedical research. (Scientific misconception) People are motivated to take part in biomedical research by the “quality of care” provided to research participants. Participants understand their voluntary participation in research with community consultation seen as customary and preceding individual consent But they were against community consent

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.

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

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

Participants understand their voluntary participation in research

with community consultation seen as customary and preceding individual consent

But they were against community consent

Conclusions People accept to participate in clinical research with knowledge of the existence of risks to their participation . Preference of signing or thumb printing is contrary to the Western concepts which allude to oral consent to be sought in illiterate communities. Communities have a good attitude towards biomedical research but are put off by researchers who do not follow customary procedures like community consultation and do not give feedback of results after the research is over.

People accept to participate in clinical research with knowledge of the existence of risks to their participation .

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

Communities have a good attitude towards biomedical research but are put off by researchers who

do not follow customary procedures like community consultation and

do not give feedback of results after the research is over.

Conclusions Researchers have social obligations to provide health service to communities where they recruit participants (in order to improve pple’s lives). Should also feel responsible for improving health center where they operate Researchers have to engage communities b4 initiating clinical research in communities/hc. CE would dispel rumors associated with clinical research. Would encourage community members to participate.

Researchers have social obligations to provide health service to communities where they recruit participants (in order to improve pple’s lives).

Should also feel responsible for improving health center where they operate

Researchers have to engage communities b4 initiating clinical research in communities/hc.

CE would dispel rumors associated with clinical research.

Would encourage community members to participate.

Research Team Prof. J.M. Mfutso-Bengo, Principal Investigator Prof. Malcolm Molyneux, Senior Collaborator/ Advisor Matilda Mkunthi, Research Officer Vincent Jumbe, Assistant Research Officer Francis Masiye, Assistant research Officer Dr. Elsbeth Robson, Social Scientist Dr. Sarah White, Statistician Andrew Kumitawa, Statistician Thandi Kamwendo, Secretary

Prof. J.M. Mfutso-Bengo, Principal Investigator

Prof. Malcolm Molyneux, Senior Collaborator/ Advisor

Matilda Mkunthi, Research Officer

Vincent Jumbe, Assistant Research Officer

Francis Masiye, Assistant research Officer

Dr. Elsbeth Robson, Social Scientist

Dr. Sarah White, Statistician

Andrew Kumitawa, Statistician

Thandi Kamwendo, Secretary

Part of the research staff that attended one workshop

Thandi distributing the handouts

Mr. Masiye stressing a point