In her presentation at the Research Symposium, Professor Catherine Peckham from the Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health, University College London, described the Nuffield Council on Bioethics’ 2002 report, entitled ‘The ethics of research related to healthcare in developing countries,’ which provided a framework for those crafting or implementing global health research projects in developing countries.

Presentation (PDF):  Peckham Catherine Ethics May 2008

The four main principles of this ethical framework are:

  1. the duty to alleviate suffering
  2. the duty to show respect for persons
  3. the duty to be sensitive to cultural differences
  4. the duty not to exploit the vulnerable

The report also underscored the immense importance of applying these principles with the social, cultural and economic contexts of the community in mind.

Within the ethical framework, the key issues highlighted in the report are a) consent, b) standards of care, c) ethical review of research, and d) what happens when the research is over.

a) Consent — As the purpose of consent is to inform and protect the study participants, it must be locally appropriate, forms must be simple and having the trust of the participants is paramount. The report also encouraged finding innovative ways or deriving consent.

b) Standards of Care — This issue remains the most controversial of those highlighted here, as some experts argue that the standard of care received by study participants in developing countries should be equivalent to those that would be provided in developed countries, even if that treatment is not feasible in the developing country. A universal standard of care was defined as: “the best current method of treatment available anywhere in the world for a particular disease or condition.” A non-universal standard of care was defined as, “the treatment available in a defined region.” The report noted that beneficial research may be precluded by aiming to provide a universal standard of care when the necessary technology, treatment or conditions to provide it in were not available in the developing country. Other requirements that may preclude beneficial research include unrealistic requirements over placebos or the requirement of sponsors to pay for the universal standard of care. Professor Peckham said that each case should be evaluated individually and that provision of the local standard of care was indeed acceptable in some situations.

c) Ethical Review — This review process is designed to protect study participants. Prof. Peckham argued that research ethics committees (RECs) must review the ethical and scientific aspects of proposed studies. The Nuffield report also recommended that RECs keep in mind the relevance of the study to the healthcare priorities within the developing country. One of the main problems encountered with the issue of ethical review is that developing countries may or may not have RECs, or the capacity to thoroughly evaluate research proposals. Prof. Peckham underlined the need to increase the efficiency of RECs and improve communication between RECs. Equally important are initiatives to develop expertise in ethical review through training and capacity building.

d) After the Research is Over — Post-research trial access to treatment for disease must be considered for participants. When interventions are shown to be effective, they should be available to the wider community. Prof. Peckham noted several long-term benefits of research for communities in developing countries — the increase in the no. of health workers, the development of scientific expertise and the potential for sustained improvement in health care in the communities.

In the discussion group that followed Prof. Peckham’s presentation, several other relevant questions and issues were raised. Among them, it was stated that more research is needed on the effects of a study in a given community. The example provided was on Dr. Ahbay Bang’s selection of certain women from the community to deliver healthcare. What effect did that have on these women and the larger community?

With regards to the consent issue, the group reiterated the importance of informed consent and argued that study participants should be encouraged to ask questions, researchers should put consent forms in simple language and that more research is needed to investigate the level of understanding among participants both before and after a trial. The group described conflicting standards/focus for different Institutional Review Board (IRB) reviews in multinational studies as problematic.

The group mentioned the need for a protocol or method for adjudicating discrepancies between different IRBs and the need for more education and training of IRBs in developed countries related to cultural and context sensitive issues facing those trials to be conducted in developing countries.

Some questions to stimulate discussion raised by the group include:

When the success of an intervention is demonstrated, what happens to the control group, what provisions are made for them to access the successful intervention? Does the researcher have greater responsibility for advocating implementation of the new intervention for the control community first as opposed to others?

What are the responsibilities of researchers involved in community- based research at the policy level?

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