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Health research ethics

Source: TropIKA

Title of the session: Health research ethics

Date: 05 November 2009

Agenda item: Symposium 33

Session theme: Ethics

Meeting room: Amphitheatre

Chair(s): Ambrose

Presenters:

• William Mwatu
• Jerome Singh
• Aceme Nyika
• Raphael Mateo
• Wen Kilama

TropIKA rapporteur: George Obeng Adjei

Major topics:

• Professional indemnity and insurance of trial participants
• Material transfer agreements, use of archived specimens and data sharing in collaborative research
• Genetic and genomic research in Africa
• Technology transfer and capacity strengthening in international collaborative research
• Translating research findings into policies, operational guidelines and interventions

Keywords:

• Ethics
• Health research
• Informed Consent
• Institutional Ethics Committee
• Capacity strengthening

Scope:

• Health research
• vulnerable institutions/individuals
• Material transfer agreements
• technology transfer

REPORT ON ORIGINAL SESSION

Overview

The chairman opened the session, stressing among others, the importance of ethics in research, especially aspects of ethics that involve protection of human subjects. This was followed by presentations on Professional indemnity and insurance with emphasis on clinical trial participants, by William Mwatu; presentation on Material transfer agreements, use of archived specimens and data sharing in collaborative research, by Jerome Singh; a presentation on Genetic and genomic research, by Aceme Nyika; followed by a presentation on Technology transfer and capacity strengthening in international collaborative research, by Raphael Mateo; and finally, a presentation on Translating research findings into policies, operational guidelines and interventions, by Wen Kilama.

In the first presentation, definitions of insurance and indemnity; brief overview of ICH guidelines; examples of the top 10 insurance claims from the US in the past decade and the concept of class suits were covered. The speaker of the second session highlighted the challenges that have arisen in multi-institutional and multi-national collaborations partly as a result of the dramatic increase in the amount of research funding to the developed world in the last few years.

An overview of the different types of material transfer agreements and proposed good practices and recommendations on the use of archived samples was given in the third session. The next session focused on the ethical and practical challenges associated with genetic and genomic research in Africa, with a differentiation of the particular challenges associated with whether the research is genetic or genomic, issues of informed consent as well as intellectual property rights issues, with an overview on some of the proposed ways of addressing these challenges. Finally, the session on translating research findings into policies, operational guidelines and interventions, Prof. Kilama began by saying “if you think research is expensive, try malaria”. The speaker then went on to present an overview of the tools available for malaria control; the realities in Africa and ethical problems/issues arising from this reality; highlighting the need for a “needs assessment”, importance of setting a research agenda, necessity to look for alternative sources of funding and the need to advocate for African governments to increase funding for health and research. He also gave an overview of the new mechanisms for making products readily available such as, tiered differential pricing, affordable medicines facility, public-private-partnerships, royalty-free technology transfer and drug donation programmes.

CONTEXT AND ISSUE

Health research leaders encounter real life ethical and practical challenges as they implement health research in the field. The challenges encountered in research conducted in resource-constrained settings are to a large extent different from those that are encountered in the developed world. Consequently, it is critical for topical issues to be discussed by the players in health research who encounter these problems on the ground on a day-to-day basis. These issues are important because approaches that are applicable to the developed world or elsewhere may not apply to the developing world. Further, the massive increase in research funding and the formation of international research collaborations in the last few years has brought together researchers from diverse and heterogeneous backgrounds – a situation that initiates unique ethical challenges. The purpose of the workshop was to provide a forum for clinical research leaders from various areas to deliberate on topical ethical and practical issues that are encountered during their day-to-day work, and to explore ways of meeting the arising challenges.

Key facts and figures

There has been an increase in litigation claims in the areas of malpractice, and claims relating to clinical trials in the last decade in the United States. The weak infrastructure and immense disease burden in Africa makes institutions on this continent liable for undue inducement, which is a threat to compromise voluntariness.

Issues raised, obstacles, difficulties

• The ICH-GCP guidelines, section 5.8.0 states “the sponsor should provide insurance or indemnity to the investigator against claims that arise from the trial” however, this is not a reality in most countries in the developing world

• As investigators in the developing world where insuring trial participants are not the norm, “we cross our fingers and hope things will go right, but what if they don’t?”

• The informed consent document should not make, unnecessarily high or unreasonable expectations

• The difficulties of finding insurers for trial participants in Africa

• The adequacy of legal and other institutional systems in Africa to address the issue of insurance for trial participants

• Most of the major guidelines (e.g CIOMS, Helsinki declaration) do not adequately address the issue of data sharing and material transfer

• Potential issues concerning material transfer agreements include, confidentiality; delays in publication; loss of control over intellectual property; conflicts with existing agreements; and the use of materials in sponsored research projects.

• Using archived samples for studies for which informed consent was not originally obtained; and the difficult(y)ies of explaining some scientific concepts, especially to non-literate populations

FINDINGS AND CONCLUSIONS

From formal presentations

• It is critical for researchers and trial participants in developing countries to have insurance and indemnity against loss

• Institutions in developing countries should have a system in place to protect trial participants; should identify areas of competitive advantage; and establish knowledge translation systems

• Subjects in trials should be informed using clear unambiguous language, and informed consent should be seen as a staggered process

• There is a need to address the ethical challenges arising from conducting research in developing countries; there is also a need for continued communication between researchers and trial participants; however, poverty or illiteracy should not be used as an excuse for the inability to obtain informed consent or for engaging in practices that are not in the interest of subjects.

• Institutions in the developing world should avoiding creating situations that lead to monopolization of geographical areas by collaborating partners

From open discussions/debates

• There is a need to find solutions that are tailored to the specific ethical challenges that arise out of conducting research in resource-poor settings in the developing world and among vulnerable populations

• The existing ethical and other guidelines do not adequately address some of the issues that arise out of north-south, or other international collaborations

• There is also a lack of clear guidelines on obligations of sponsors/researchers to participants after the trial

Identified conclusions

The immense disease burden, poor health infrastructure and weak research institutions in Africa makes those vulnerable, liable to inducement and potential exploitation and compromised voluntariness –key pre-requisites for equal partnership(s)

Main points of agreement

• The need to develop guidelines to address the ethical challenges emerging from collaborative research and conducting research specifically in developing countries

• Good Clinical Practice (GCP) guidelines emphasize obligations of the principal investigator to the sponsor – this could exacerbate the already unequal relationship

Main points of divergence

• Whether individuals living in countries without requisite jurisdiction could sue in other countries with the appropriate jurisdiction in cases of perceived or real harm

• What the specific role(s) and/or prerogatives of researchers are in advocacy/development or ethical/other guidelines relating to the ethics of research in respective countries

• The issue about none-existent, or scarce availability of insurers for trial participants in Africa is changing; these should be available in the next few years, especially if the issue continues to be debated

• The issue of whether material transfer agreements could be made retrospectively for samples collected from the times when ethics committees were non-existent in most developing African countries

Recommendations

• There should be continued communication between researchers, trial participants and institutional ethics committees, even after subject recruitment – as informed consent should be seen as a process, rather than a one-time event

• If a clear rationale and justification as to why prospectively-collected samples cannot be obtained is made, it should be permissible to use archived samples for future research, should this become necessary

• There are few guidelines on material and data transfer between institutions in the developing world, but an early discussion and negotiation on this subject should reduce unnecessary tensions that could arise later

• The local community should have a say in the management and use of data resulting from samples collected from that site

• Authorization to publish data collected within a collaborative research program should be obtained from a specially-constituted committee

• Consent forms for studies in which samples and data is intended to be used for future studies should ideally compose of three independent parts: consent for i) screening, ii) enrollment, and iii) future use.

• Information that is critical in making a decision on whether to enroll in a study should be conveyed: although the underlying science or jargon may not necessarily understandable, the benefits or risks should be unambiguous

• There is a need for a clear needs assessment, research agenda and alternative funding sources from the traditional assumed north-south funding arrangements

• Researchers should advocate for African governments to adhere to stated obligations e.g. the Abuja declaration

Personal observations from rapporteur

This seems to be a virgin area and the issues are far from resolved. There is therefore, a need to refrain from dogmatic positions on such emerging/difficult issues

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