GHF2010 – PS16 – Ethics in Biomedical Research: Who is in Charge?

Session Outline

Parallel session PS16, Wednesday, April 21 2010, 11:00-12:30, Room 4
Chair(s): Dominique Sprumont, Institute of Health Law, University of Neuchâtel, Switzerland
Influence of International Sponsors on the Map of Biomedical Research Projects Implemented in Cameroon
Jerome Ateudjeu, Division of Health Operations Research, Ministry of Public Health, Cameroon
WHO's Role in Strengthening Ethics Standards of Research Involving Human Subjects
Marie-Charlotte Bouësseau, Ethics, Equity, Trade and Human Rights, World Health Organization, Switzerland
Offering High Quality Training in Research Ethics Evaluation: The TRREE for Africa Project
Marie HirtleBiotika Inc., Canada, TRREE-for Africa
Conducting Clinical Trials in Developing Countries: Ethical Challenges for the Pharmaceutical Industry
Michel Krumenacker, Sanofi-Aventis, USA

Session Documents

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Session Report

H1N1 virus sometimes called 'swine flue', image: CDC/ C. Goldsmith and D. Rollin

Submitted by: James Reynolds-Brown (ICVolunteers)

A view on ethics and practice in clinical trials from the standpoint of an international body, a training group, a national authority and a pharmaceutical company

Welcoming the audience and addressing the question of ethics and practice, Dominique Sprumont of the Institute of Health Law, University of Neuchâtel, Switzerland, pointed out that this also encompassed the nature of control that should be established for biomedical research, and what principles should be applied.

The first presentation was by Marie-Charlotte Bouësseau of the World Health Organization (WHO). Noting that ethics in public health was within the core function of the WHO, Dr Bouësseau described the current areas of work and what they perceived to be the future challenges. The Ethics Unit, of which Dr Bouësseau is a part, was established in 2002 to address ethical issues across the whole spectrum of WHO work. The main objectives and corresponding areas of work of the unit focused on developing policies of ethical standards, strengthening Member States ethical culture, collecting and disseminating information, and contributing to the international debate on ethics. A future challenge identified by the unit was the ‘grey area’ between clinical research and public health activities. This issue is exacerbated by the notion that the classic model of ethics review is not suitable, and a new system would have to be developed. This, and other future challenges will have to be addressed by seeking greater synergies, as well as improving dialogues and interaction between and including all the stakeholders.

Describing the online training project ‘Training and Resources in Research Ethics Evaluation (TRREE) for Africa’, Marie Hirtle presented its main functions and methodology. The ‘how’ of this project is achieved through collaboration, a collegial effort, a bi-directional system, an African perspective in an international context, and applying universal principles of ethics. “The desire to be non-partisan when it comes to any controversy is key to achieving our goal,” she said. This ambitious project aims to allow national authorities to make their own informed decisions on debates. The next steps for the organization are to seek recognition by professional bodies, add more languages and look to sustained development as membership grows.

Jerome Ateudjeu gave a statistical overview of biomedical research projects in Cameroon from the results of a study to assess the influence of sponsors on clinical trials. Several themes were obvious, not least of which was that the research was not always carried out in correspondence with population centres, instead focusing on accessibility.

The final presentation, by webcam and from the U.S.A., was by Michel Krumenacker of Sanofi-Aventis. A key take-away phrase was the need for transparency in all clinical trials and research. The principles of relevance to the local population, sound science and the application of good clinical practice should be applied regardless of the location of the trial. Mr Krumenacker believes that there should be no difference in standards between developing and developed countries, though he pointed out that specific issues could warrant a difference. He thought that the remoteness of an ethics committee in a host country was a major problem. Standards should be clearly under the host country’s control. On variations in standards, and the need to try and reach the ‘gold standard’, the position of the national ethical committee is very important, as is the need to commit to post-trial work. The integrity of data and the role of good clinical practice are always indispensable. Certainly a clinical trial, in Mr Krumenacker’s opinion, should not be the sole means of access to health care services.

The conclusions of the presentation clearly pointed out that no compromise should be allowed, transparency was vital, but that the whole process should be dynamic and inclusive. In response to a question from Dr Sprumont, Mr Krumenacker stated that no distinction is made between good clinical practice and ethical standards, but that the latter was a practical application of the former. Dr Sprumont agreed, and noted that the two concepts were different views of the same thing, and not contradictory. The issue is to commit to ethically sound practice and standards that will benefit mankind.

In response to a question regarding data ownership from a member of Doctors Without Borders, Mr Krumenacker pointed out that the national authority had to be involved in the use of data, though the global community also held an interest. Industry’s role was to ensure transparency and disseminate information and specimens to regulatory bodies. As a real world example, Dr Ateudjeu pointed out that Cameroon had no regulation regarding data ownership, but an analogy could be drawn with blood transfusion services, when ownership rested with the institution that collected the sample. Nonetheless, this type of ownership had to be for the benefit of public health. Cameroon regularly sought data sharing agreements with international sponsors when formulating its clinical trial agreements.

A question from a member of the University of Geneva highlighted the difficulty for investigators to initiate monitoring systems, and wondered whether any programme or plan acted to enforce this. Dr Bouësseau said her impression was that the enforcement of monitoring and quality control was better in developing countries than in developed ones, and in general she saw an increasing initiative to do this.

Further questions, that could only be addressed briefly, looked at the problem of intellectual property rights and the bridge between multi-national companies and the public sector. Although generally considered outside the scope of ethics, these topics were subsumed into the broader transparency theme

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