(~ Longman Group UK Ltd 1992 ,,
Midwifery
CONFERENCE REPORT
Report of the proceedings of the 26th conference of the Council for International Organisation of Medical Sciences, WHO Headquarters, Geneva, Switzerland, 5-7 February, 1992 T h e Council for International Organisation of Medical Sciences (CIOMS) acts as the ethics watchdog for the World Health Organization. T h e main aim of the conference was to bring together a multidisciplinary g r o u p to enable researchers, ethicists and lawyers to exchange and share views on the ethical issues raised by conducting research on h u m a n subjects. One h u n d r e d and ninety representatives f r o m 35 T h i r d World and Industrialised Nations attended the workshop. T h e conference plan comprised a series of plenary papers which set the agenda for small group discussions. T h e Council produced the first set of guidelines in 1982 based on the Declaration of Helsinki. T h e current revision was considered necessary in the light of the rapid change in the socio-economic climate world wide, and the pace of development of T h i r d World countries in particular. T h e tocus of the discussion in the working groups centred on three main themes: 1. the consent of individuals and agreement o f communities to participate in research; 2. the ethical review processes such as the provision of national and local ethical review committees, their constitution and function; 3. the obligations of sponsors with special attention to care and compensation for injury arising out of the research, the rights o f access to the research findings and the rights of access of participants to medical services. This is of particular relevance in countries where the only way to gain access to health care or to medical treatment is by participation in research.
A number emerged.
of
important
issues
quickly
1. T h e hugely varying situations in the different countries largely hinging on the notion of justice currently prevailing. For example, it e m e r g e d that only 22 of the 45 black African countries has an ethical review committee. In such circumstances, there is no means o f monitoring the ethical conduct o f studies either on a local or national basis. This is left to the integrity of the individual researcher so it becomes very much a hit and miss affair open to obvious abuse. A different situation exists in parts of Asia where lip service may be paid to the existence of an ethical review committee, but in reality ethical principles are often ignored both in normal practice and in the conduct of research. . T h e ethical principles of autonomy, nonmaleficence, beneficence and justice have no universal application. It was acknowledged that in m a n y countries the individual has little or no value, for example, parts of Asia, Africa and South America. In these cultures the individual may have little autonomy; this especially applies to the women. In these circumstances the community represented in the family unit or the tribe is consulted as a means of gaining access but consent rests with the individual. This can, and often does lead to manipulation by tribal leaders or by the men in the group. It was however considered essential that vulnerable groups should he protected; these include children, the mentally handicapped, women of childbearing years and mothers. 89
90
MIDWIFERY
3. It was agreed that the acceptable m i n i m u m is that bad science is, by definition, unethical, but the converse is not necessarily true of good science. 4. T h e need to consider that where communities participate in research, there is an ethical obligation to ensure that they should be the first to benefit f r o m any therapeutic interventions, for example, the recently completed trials in Gambia to test a Hepatitis B vaccine. Although the vaccine has been shown to be effective, the multinational company sponsoring the study maintains that the cost of production of the vaccine makes it too expensive for wide application in under-developed countries. It is important therefore, to strive to ensure that one community is not used, and possibly disadvantaged, in o r d e r to benefit another. Whilst the good of humanity remains a plaudible aim, due regard must be given to the needs of specific and individual cultures. 5. T h e need to disseminate the findings of the research to the study population and to local government (if appropriate). This should apply even when data are potentially sensitive, for example, the prevalence of AIDS or d r u g abuse in a population; otherwise there is a risk that researchers could be accused of ethical imperialism (exploitation) or that information may be suppressed on the grounds of expediency.
6. Discussion arose a r o u n d the contentious issue of payment to both the participants and to the researchers. It was agreed that those who took part in studies should be reimbursed for any expenses incurred by participation but that they should not be offered inducement sufficient to persuade them to take part in the first instance. Representatives f r o m the UK and USA raised concerns related to the financial inducement offered to researchers to recruit subjects to participate in commercially sponsored research, usually d r u g trials. This may be open to abuse especially in the current climate of resource constraints. Conversely, African representatives considered p a y m e n t to the researcher to be a necessary means of securing an essential income for the investigator. It was agreed that in the light of these discussions, considerable re-drafting of the guidelines would be necessary in o r d e r to provide a flexible framework appropriate for international use. Unlike the industrialised nations, the final document may be the only ethical guidance available in many under-developed countries so it is important that all the issues are resolved. T h e Steering G r o u p m e m b e r s agreed to circulate a re-draft for comment before the end of 1992 with a view to finalising the guidelines during 1993. JENNIFER SLEEP BA, RM, MTD, on behalf of the ICM
Midwifery
CONFERENCE REPORT
Report of the proceedings of the 26th conference of the Council for International Organisation of Medical Sciences, WHO Headquarters, Geneva, Switzerland, 5-7 February, 1992 T h e Council for International Organisation of Medical Sciences (CIOMS) acts as the ethics watchdog for the World Health Organization. T h e main aim of the conference was to bring together a multidisciplinary g r o u p to enable researchers, ethicists and lawyers to exchange and share views on the ethical issues raised by conducting research on h u m a n subjects. One h u n d r e d and ninety representatives f r o m 35 T h i r d World and Industrialised Nations attended the workshop. T h e conference plan comprised a series of plenary papers which set the agenda for small group discussions. T h e Council produced the first set of guidelines in 1982 based on the Declaration of Helsinki. T h e current revision was considered necessary in the light of the rapid change in the socio-economic climate world wide, and the pace of development of T h i r d World countries in particular. T h e tocus of the discussion in the working groups centred on three main themes: 1. the consent of individuals and agreement o f communities to participate in research; 2. the ethical review processes such as the provision of national and local ethical review committees, their constitution and function; 3. the obligations of sponsors with special attention to care and compensation for injury arising out of the research, the rights o f access to the research findings and the rights of access of participants to medical services. This is of particular relevance in countries where the only way to gain access to health care or to medical treatment is by participation in research.
A number emerged.
of
important
issues
quickly
1. T h e hugely varying situations in the different countries largely hinging on the notion of justice currently prevailing. For example, it e m e r g e d that only 22 of the 45 black African countries has an ethical review committee. In such circumstances, there is no means o f monitoring the ethical conduct o f studies either on a local or national basis. This is left to the integrity of the individual researcher so it becomes very much a hit and miss affair open to obvious abuse. A different situation exists in parts of Asia where lip service may be paid to the existence of an ethical review committee, but in reality ethical principles are often ignored both in normal practice and in the conduct of research. . T h e ethical principles of autonomy, nonmaleficence, beneficence and justice have no universal application. It was acknowledged that in m a n y countries the individual has little or no value, for example, parts of Asia, Africa and South America. In these cultures the individual may have little autonomy; this especially applies to the women. In these circumstances the community represented in the family unit or the tribe is consulted as a means of gaining access but consent rests with the individual. This can, and often does lead to manipulation by tribal leaders or by the men in the group. It was however considered essential that vulnerable groups should he protected; these include children, the mentally handicapped, women of childbearing years and mothers. 89
90
MIDWIFERY
3. It was agreed that the acceptable m i n i m u m is that bad science is, by definition, unethical, but the converse is not necessarily true of good science. 4. T h e need to consider that where communities participate in research, there is an ethical obligation to ensure that they should be the first to benefit f r o m any therapeutic interventions, for example, the recently completed trials in Gambia to test a Hepatitis B vaccine. Although the vaccine has been shown to be effective, the multinational company sponsoring the study maintains that the cost of production of the vaccine makes it too expensive for wide application in under-developed countries. It is important therefore, to strive to ensure that one community is not used, and possibly disadvantaged, in o r d e r to benefit another. Whilst the good of humanity remains a plaudible aim, due regard must be given to the needs of specific and individual cultures. 5. T h e need to disseminate the findings of the research to the study population and to local government (if appropriate). This should apply even when data are potentially sensitive, for example, the prevalence of AIDS or d r u g abuse in a population; otherwise there is a risk that researchers could be accused of ethical imperialism (exploitation) or that information may be suppressed on the grounds of expediency.
6. Discussion arose a r o u n d the contentious issue of payment to both the participants and to the researchers. It was agreed that those who took part in studies should be reimbursed for any expenses incurred by participation but that they should not be offered inducement sufficient to persuade them to take part in the first instance. Representatives f r o m the UK and USA raised concerns related to the financial inducement offered to researchers to recruit subjects to participate in commercially sponsored research, usually d r u g trials. This may be open to abuse especially in the current climate of resource constraints. Conversely, African representatives considered p a y m e n t to the researcher to be a necessary means of securing an essential income for the investigator. It was agreed that in the light of these discussions, considerable re-drafting of the guidelines would be necessary in o r d e r to provide a flexible framework appropriate for international use. Unlike the industrialised nations, the final document may be the only ethical guidance available in many under-developed countries so it is important that all the issues are resolved. T h e Steering G r o u p m e m b e r s agreed to circulate a re-draft for comment before the end of 1992 with a view to finalising the guidelines during 1993. JENNIFER SLEEP BA, RM, MTD, on behalf of the ICM
