Building capacity – research + bioethics

Samba Cor Sarr
Ministry of Health, Senegal

Dr. Samba Cor Sarr Chief of Health Research in the Ministry of Health and Prevention in Senegal and Coordinator of the National Ethical Committee for health Research

Dr. Samba Cor Sarr is Chief of Health Research in the Ministry of Health and Prevention in Senegal and Coordinator of the National Ethical Committee for Health Research. He discusses how capacity for research and bioethics can be build in African countries, and who can help build it.

How can African countries foster and promote debate on research for health from the continent’s perspective?

African countries should not only hope to improve things without getting into action. For example, they can apply the recommendations made during the Ministerial Global Forum on Research for Health, in November 2008 instead of waiting for another conference.

They should organize regulatory international meetings and create websites. The websites, if linking into others, will improve sharing of information between African countries. A core curriculum on research and ethics disciplines that many universities can share is another strategy African countries can employ to foster and promote debate on research for health from the continental perspective. International organizations can support workshops and training in African countries. We have opportunities such as the call for proposals of the European and African Countries Clinical Trials Partnership (EDCTP) to realize several activities that can improve health research in Africa.

What ethics capacity is needed for researchers in Africa?

There is little if any ethical capacity on our continent. Some countries lack national ethics committees which makes it difficult to coordinate and monitor research. These committees are vital for licensing of research. In addition to national ethics committees, Africa needs training in ethics at the Master and Doctoral levels. There are a few universities on the continent such as the University of Ibadan in Nigeria which provide this kind of training.

How can governments and research institutions help build this ethic capacity?

The first step African governments can take is to establish training institutions, at diploma or degree level. Graduates of these institutions will then be qualified to form national ethics committees especially in countries where they are missing. It is also essential to have a monitoring system in place. Such systems are usually supported by research statutes. Governments should have research policies in place that lead to the birth of ethical codes of conduct in research for health. For example, in February this year, Senegal’s National Assembly passed a law entitled: Ethical Code for Health Research. This law was signed by the Head of State in March 2009. The number of this text is 2009-17.

Why is ethics important, to citizens, or other beneficiaries of health research who are not directly involved in health and health research processes? How do good/bad ethical practices affect society?

Respect of ethical considerations extends beyond those directly involved in health research processes, and concerns other groups of society involved in a democratic framework. Indeed, if scientific research is to facilitate progress, it is important to create an environment for democratic exchange of views. This ensures that scientific progress does not generate attitudes of distrust, fear, or even rejection.

What basic requirements are needed for ethical research in Africa? Should these requirements be different from those of the North? Why?

In this second millennium, health is recognised as a fundamental human right, a right that can only be achieved if health care is improved. Basic requirements for ethical research in Africa depend on several factors, such as availability of effective treatment and the implementation of relevant strategies that lead to improved socio-economic conditions. Health research is inseparable from socio-health development.

Biomedical research on humans – while essential for improving the health of populations – must only be done with the utmost respect for the rights and dignity of human beings. Specific legislation and regulatory frameworks should be established and research protocols conducted and monitored closely. Doing this also requires economic independence from the promoters of the research. Research promotion in health necessitates that Africa drives an international debate on ethical issues.

Bioethics is founded on general principles which may be considered universal: respect for persons and their autonomy; good, non harmful actions; justice. Defined in this way, these principles represent minimal consensual aspects in ethics. They are subject to debate when we try to specify the content of these principles and how they should be put into practice in very different cultural and socio –economic context.

For example, the principles of respect for the person through the notion of free and informed consent are simple in concept. But the picture becomes more complex when they are considered in terms of people’s and countries cultural, social and economic realities. Indeed, this notion requires that the consent should come about without any external interference in decision-making, and with out social and material constraints. Meeting these requirements are difficult in societies where the community takes precedence over an individual – in societies where there is a social hierarchy of decision-making.

These limitations, combined with general poverty, illiteracy and weakness of the health system, make it difficult to assess whether free and informed consent has truly taken place. That is a major difference between the North and the South.

Who is responsible for addressing these ethical requirements?

All the members of National Committee for Health Research or its equivalent in each country should be responsible for ensuring that researchers meet and uphold ethical requirements before, during and after research.

How else can low and middle income countries ensure best ethical practices for research?

Many low and income countries have not passed laws on the protection of intellectual property. Governments should ensure that laws are in place to safeguard national researchers against exploitation, so they retain intellectual property rights for their work.

How do we describe ethics in health research?

Ethics in research for health is a system in a country based on the principles of autonomy, justice, beneficence, justice, and is a component of the health research regulation. I will explain further.

Autonomy: ln dealing with people as a part of their work, researchers are expected to acknowledge autonomy of the individual and to protect people whose autonomy may be considered lessened. For example, the autonomy of prisoners is lessened by the fact that they may participate in research given the conditions they live under, or are coerced. Yet under normal circumstances, they would not volunteer for it. An autonomous person should discuss his personal goals and act in the direction of such aims. Respect autonomy in health research ethics is to give weight to each individual’s considered opinions and choices, and refrain from obstructing their actions unless they are clearly detrimental to others. Respecting a person’s autonomy is to provide them with the information necessary to make a considered judgment, when there are no compelling reasons to do so.

Beneficence means that all study participants are to be treated in an ethical manner. Their decisions are respected and they are protected from harm. The researcher should strive to secure the well-being of the study participants; and is expected not to harm them – but also to maximize possible benefits and minimize possible harm as a part of their study.

Investigators and members of institutions on a project are obliged to give specific consideration to how benefits to he participating individual can be maximized, and the risks reduced that might occur from the research. Generally speaking, for scientific research, members of society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the results of the study investigating medicines or a vaccine.

Justice: This principle concerns the fairness in distributing the benefits of research or defining who bears its burden. Selection of research participants should be carefully scrutinized. The researcher should determine if some communities – poor people, ethnic minorities or persons confined to institutions such as hospitals and prisons – are being systematically selected for trials simply because of their easy availability. The selection should also consider whether the proposed study participants are in a compromised position or can easily be manipulated, other than for reasons directly related to the problem being studied.

Justice is also a consideration when research supported by public funds leads to the development of medicines or equipment and procedures. Discoveries should not bring advantages only to those who can afford them. If this is the case, then poor people who cannot the innovations being developed should not be involved in the research.

Nonmaleficence: This principle requires of researchers not to intentionally create a needless harm or injury to study participants, either through acts of commission or omission. The principle requires that the researcher provide participants with a proper standard of care that avoids or minimizes the risk to them.

A lot of clinical research by pharmaceutical corporations is done in developing countries. How should these organisations share the positive results of their trials with the clinical site country?

Pharmaceutical corporations should share their results and profits with the clinical site country. They should communicate the study results to the population in which the research was done first before spreading it to the rest of the country. The population in need should benefit freely from the profits up to a specified period before the results are marketed. To ensure a good share of results, the national ethical committee should recommend that policy makers discuss with pharmaceutical companies before conducting the study. This discussion permits to identify possibilities to equitably share the profit of study on its completion.

How can pharmaceutical organisations build the capacity of national research?

These companies can help build the capacity of national research in several ways:

By financing short training courses in ethics or research activities. These trainings should not exceed six months; promote health research knowledge for the young researchers; and establish health research promotion through incentives such as annual awards or bonuses to the best researchers. Other strategies for building national research capacity include accrediting national research expertise and working with people responsible for research in health departments in areas such as annual or periodical evaluation.