GHF2006 – PS14 – Research & Access to Health: Ethical Concerns

Session Outline

Parallel session PS14, Thursday, August 31 2006, 16:00-17:30
Chair(s): Nirmal Kumar Ganguly, India, Alexandre Mauron, Switzerland
Eduardo H. Gotuzzo, Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru 
Ethical Aspects of Clinical Research in Africa: A Positive Experience from Mali
Ogobara K. Doumbo, Professor, Malaria Research and Training Centre, University of Bamako, Mali  
The Importance of the National Laws in the Implementation of International Regulations in Developing Countries
Dominique Sprumont, Institute of Health Law, University of Neuchâtel, Neuchâtel, Switzerland

Session Document

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Session Report

Submitted by: Shibani Bandyopadhyay (ICVolunteers); Contributors: Tatjana Schwabe (ICVolunteers)

The symposium on "Research and Access to Health: Ethical Concerns" has highlighted the fact that strong laws are a powerful tool to protect participants in experimental clinical trials. Presentations on Clinical Research in Latin America and the importance of national laws in the implementation of international regulation in developing countries introduced some of the complexities of ethics involved in clinical trials.

The co-chair, Dr. Alexandre Mauron from the Medical Faculty of the University of Geneva, Switzerland, introduced the topic of ethical concerns in health research, stressing that clinical trials had become a global activity, requiring discussion about ethics in research to be a priority.

Dr. E. H. Gotuzzo from Instituto de Medicina Tropical Alexander von Humboldt in Lima, Peru presented his paper on "Clinical research in Latin America: constraints and opportunities". He pointed out that currently between 11 - 25 % of all clinical trials (CT) are being conducted in Latin America, involving numerous sites and professionals in the trials themselves and the related ethical review work. Dr. Gotuzzo first listed the advantages of conducting clinical trials in Latin America:

  • A vast heterogeneous study population with patients suitable for many CTs available in the mega cities of Argentina, Mexico, Brazil and Colombia;
  • Minimal drop out rates;
  • Trained personnel with good clinical practices;
  • Potential markets for pharmaceutical industries;
  • Possibility to conduct year-round trials on seasonally induced diseases (e.g. diarrhoea or respiratory diseases) in combination with countries in the Northern hemisphere;
  • Dr. Gotuzzo pointed out that most clinical trials in Latin America are being carried out by private industry, while only about 100 trials are being conducted by the US-American National Institutes of Health (NIH), universities or other public institutions. About 80 % of the clinical trials in Latin America analyse new vaccines against rotavirus, papilloma virus or HIV.

However, clinical trials in Latin America face a number of challenges including:

  • Lengthy approvals due to government regulations;
  • Corruption (as large sums of money are often involved in CTs);
  • Forged CT results;
  • Low priority of clinical trial output product;
  • Severe unrest threatening the continuation of  CTs as seen in Argentina (2001), Venezuela or Peru (1990);
  • Ethical issues such as acquisition of study subjects and informed consent.

Regarding the last point, Dr. Gotuzzo explained that in the paternal patient-doctor relationship in Latin America, informed consent of patients was an unfamiliar concept. During the question and answer session, the issue of informed consent by vulnerable, handicapped or mentally ill patient was briefly raised. Answering a question from the audience, the speaker argued that the hope to improve the health situation was the main reason for countries with limited resource and increasing drug resistance to participate in CTs.

In his conclusion, Dr. Gotuzzo urged for more transparency and clear requirements, amongst others through the strengthening of health systems, to determine whether a clinical trial is carried out according to appropriate ethical standards. CT participants-and possibly also the institutions and countries in which these CTs are conducted-should benefit more directly from the CTs as today, frequently, the CTs only benefit western development.

In the absence of Dr. Doumbo from Mali, Dr. Hassan Mshinda, Director of the Ifakara Health Research and Development Centre in Tanzania kindly agreed to talk about his experience regarding ethical is regarding clinical trials in Africa. In partnership with the Special Programme for Research and Training in Tropical Diseases (TDR) and the WHO, skills in applying ethical standards in CTs have been developed by the training of staff in Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and ethics.

Dr. Mshinda pointed out that Tanzania is taking several steps to ensure that ethics standards are applied in clinical trials. Ethical clearance is mandatory and a licence is required for each product to be tested in a CT. The composition of the ethical board has changed to include independent legal and gender representatives in addition to professional scientists and clinicians. Tanzania accepts the responsibility for all research work undertaken in the country, for example by refusing to engage foreign nationals as principal investigators of any research work or by including an independent country representative in the data monitoring safety board of a multi-centric study by a foreign pharmaceutical company. This is crucial, as a local investigator will, unlike most foreign stakeholders, still be there to take responsibility should a problem arise after completion of a research protocol. He also pointed out that in this particular biosocial context, verbal consent was largely prevalent over written consent. Implementation of community consent also raises largely unexplored difficulties. Such socio-cultural issues can pose problems for ethical guidelines requiring individual and written informed consent.

Dr. Dominique Sprumont, Director of the Institute of Health Law at the University of Neuchatel, Switzerland introduced the "Importance of the National Laws in the Implementation of International Regulations in Developing Countries". At the beginning of his talk, he pointed to the complex documents regulating research on an international level such as the Geneva Convention, the Nuremburg Code, the Declaration of Helsinki, the International Convention on Civil and Political Rights, WHO International Ethical Guidelines and European Union (EU) Directives. Both the EU directives and the National Law aim predominantly at protecting the subjects of clinical trials. Another body to issue guidelines on Good Clinical Practice (GCP) was the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In its principle 26, it demands that all CTs be conducted under the supervision of an Institutional Review Board (IRB) and Independent Ethics Committee (IEC), both of which have to be approved by the "competent body". What constitutes a competent body is left open to interpretation in the document and definitions differ from country to country. Another area, where definitions differ is that of informed consent. Dr. Sprumont presented examples from Benin, Mali and Senegal, where the definitions of child, incompetent adult and legal representative vary. Even across Europe, concepts concerning the competent authority for consent and legal competency are not uniform. In the light of the heterogeneous world of many diverse but equal sovereign countries, Dr. Sprumont concluded that national regulation was the only way to provide specific rules on key issues in biomedical research. He stated that the respect for national regulations was essential for partnership in international research and capacity building.

Dr. Mauron concluded the session by emphasising the importance of including only fully informed participants in clinical trials. To avoid the disseminating of misleading information, clinicians and research workers need guidance from other disciplines, including legal experts, to prepare the information that is to be shared with patients.

Clinical trials are the most important tool in medical research to find the best therapy or method for intervention. While CTs have so far been mostly ruled by biostatistics, more emphasis is now being placed on human rights and ethical concerns. Since research is becoming more and more industrialised, national law has to ensure that international regulations and ethics guidelines are implemented in each country and hence the need to ensure that research protocols are compatible with different local laws. This in turn leads to the question of which research institute has the final say in multi-centre research.

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