Clinical trials of drugs

Ethical and legal issues

UNICRI United Nations Interregional Crime and Justice Research Institute	Italian Medicines Agency GCP Promotion Unit, GCP and Pharmacovigilance Inspectorate

Biomedical Research in Developing Countries:
the Promotion of Ethics, Human Rights and Justice

INTERNATIONAL ROUND TABLE
ROME, ITALY, 15-16 December 2008

FIRST ANNOUNCEMENT

Over recent years, clinical research with human participants has proliferated in developing countries. This has raised concern over the ethical and legal implications of misconduct related to violations of human rights and welfare of participants due to inadequate scientific and ethical reviews of protocols, as well as poor or absent drug regulatory systems.

UNICRI, the United Nations Institute specialized in research and training in the areas of justice administration; human rights protection; and crime prevention and control, is carrying out research in collaboration with the Italian Medicines Agency, GCP Promotion Unit, GCP and Pharmacovigilance Inspectorate. The research includes a survey on the main training and educational activities at an international level, as well as an analysis of the ethical and legal issues that can arise in the various stages of a clinical trial process, from the assessment of the protocols to the various phases of the trials themselves. The research project will also include a focus on Africa, with a survey of the current national legislations and guidelines regarding the protection of human participants in biomedical research and status of ethical review capacity in the Region. The analysis aims to assess the situation in the field and to identify those countries where there is a more urgent need for specific training on ethical review, GCP inspections, legal and law enforcement issues.

In order to further contribute to the knowledge and increase awareness of the phenomenon, the results of the research study have been presented and discussed at an international Round Table, that took place on 15 and 16 December 2008 in Rome, Italy, where the main experts were invited to participate.

This International Round Table presented the opportunity to compare and exchange expertise and experiences between national and international institutions on the issue of the protection of human participants in biomedical research.

It also aimed:

To increase knowledge and diffusion of the instruments and guidelines developed by the United Nations, the international and the national organizations involved in the ethical and legal protection of human participants in biomedical research.

To stress the importance of building capacity for biomedical ethics review processes, in developing countries, by supporting education and training curricula for health professionals and members of the community, in order to facilitate the creation of institutional Research Ethics Committees. Well functioning RECs would ensure the strict adherence of protocols to the international ethical and legal standards governing research involving human participants, and would be capable of recognizing and dealing with violations of human rights, ethical conduct and of breaches of the law.

To foster the development of systems for regular site inspections and for the improvement of regulatory capacity. On the one hand, these would verify the accuracy of data from clinical trials during their entire duration, and on the other hand would ensure that the necessary authorization processes are in place for subsequent marketing of new drugs. Both these elements are necessary to ensure the widest availability of treatment options to citizens and to protect them from poor quality control of drugs.

To promote the process of international harmonization in the application of good clinical practice (GCP) guidelines and standards, by fostering awareness of biomedical ethics issues among legislators and policy makers, and by assisting in the formulation of specific legislation for the protection of human participants in biomedical research.

To contribute to improving awareness, specifically of the situation in Africa, where development efforts in the field of public health need to be supported by good governance and the creation of a climate of trust in biomedical research.

The purpose of the meeting is mainly to provide an arena for facilitating the expression of needs, expectations and proposals that arise from the experience of professionals working in the field, to better plan training programmes. At the same time, the meeting aims to highlight the work done by international and civil society organizations in their efforts in coordination and cooperation activities and towards the possibility of elaborating a universal instrument on biomedicine, which could be effective in regulating medical research.

Lectures included the following topics:

1. The founding principles of research ethics and its guidelines. How far is the international community from reaching a consensus on a global strategy for the protection of human participants in biomedical research?
2. Strengthening of ethical review processes and regulatory capacities in medical research with human participants in developing countries: current programmes and future perspectives.
3. A focus on the current legislation in Africa regarding the protection of human participants in biomedical research and the status of ethical review capacity in the Region.
4. Presentation by experts from selected countries: Cameroon, Ghana, Kenya, Nigeria, Senegal, South Africa.

For further information please contact the Clinical Trials and Ethics Group at: cte@unicri.it.

Outcomes of the round-table:

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