Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 10

Research in Populations and Communities with Limited Resources

Before undertaking research in a population or community with limited resources, the sponsor and the investigator must make every effort to ensure that:

the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and

any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.

Commentary on Guideline 10

This guideline is concerned with countries or communities in which resources are limited to the extent that they are, or may be, vulnerable to exploitation by sponsors and investigators from the relatively wealthy countries and communities.

Responsiveness of Research to Health Needs and Priorities. The ethical requirement that research be responsive to the health needs of the population or community in which it is carried out calls for decisions on what is needed to fulfill the requirement. It is not sufficient simply to determine that a disease is prevalent in the population and that new or further research is needed: the ethical requirement of "responsiveness" can be fulfilled only if successful interventions or other kinds of health benefit are made available to the population. This is applicable especially to research conducted in countries where governments lack the resources to make such products or benefits widely available. Even when a product to be tested in a particular country is much cheaper than the standard treatment in some other countries, the government or individuals in that country may still be unable to afford it. If the knowledge gained from the research in such a country is used primarily for the benefit of populations that can afford the tested product, the research may rightly be characterized as exploitative and, therefore, unethical.

When an investigational intervention has important potential for health care in the host country, the negotiation that the sponsor should undertake to determine the practical implications of "responsiveness", as well as "reasonable availability", should include representatives of stakeholders in the host country; these include the national government, the health ministry, local health authorities, and concerned scientific and ethics groups, as well as representatives of the communities from which subjects are drawn and non-governmental organizations such as health advocacy groups. The negotiation should cover the health-care infrastructure required for safe and rational use of the intervention, the likelihood of authorization for distribution, and decisions regarding payments, royalties, subsidies, technology and intellectual property, as well as distribution costs, when this economic information is not proprietary. In some cases, satisfactory discussion of the availability and distribution of successful products will necessarily engage international organizations, donor governments and bilateral agencies, international nongovernmental organizations, and the private sector. The development of a health-care infrastructure should be facilitated at the onset so that it can be of use during and beyond the conduct of the research.

Additionally, if an investigational drug has been shown to be beneficial, the sponsor should continue to provide it to the subjects after the conclusion of the study, and pending its approval by a drug regulatory authority. The sponsor is unlikely to be in a position to make a beneficial investigational intervention generally available to the community or population until some time after the conclusion of the study, as it may be in short supply and in any case cannot be made generally available before a drug regulatory authority has approved it.

For minor research studies and when the outcome is scientific knowledge rather than a commercial product, such complex planning or negotiation is rarely, if ever, needed. There must be assurance, however, that the scientific knowledge developed will be used for the benefit of the population.

Reasonable Availability. The issue of "reasonable availability" is complex and will need to be determined on a case-by-case basis. Relevant considerations include the length of time for which the intervention or product developed, or other agreed benefit, will be made available to research subjects, or to the community or population concerned; the severity of a subject's medical condition; the effect of withdrawing the study drug (e.g., death of a subject); the cost to the subject or health service; and the question of undue inducement if an intervention is provided free of charge.

In general, if there is good reason to believe that a product developed or knowledge generated by research is unlikely to be reasonably available to, or applied to the benefit of, the population of a proposed host country or community after the conclusion of the research, it is unethical to conduct the research in that country or community. This should not be construed as precluding studies designed to evaluate novel therapeutic concepts. As a rare exception, for example, research may be designed to obtain preliminary evidence that a drug or a class of drugs has a beneficial effect in the treatment of a disease that occurs only in regions with extremely limited resources, and it could not be carried out reasonably well in more developed communities. Such research may be justified ethically even if there is no plan in place to make a product available to the population of the host country or community at the conclusion of the preliminary phase of its development. If the concept is found to be valid, subsequent phases of the research could result in a product that could be made reasonably available at its conclusion. (See also Guidelines 3: Ethical Review of Externally Sponsored Research; 12, Equitable Distribution of Burdens and Benefits; 20: Strengthening Capacity for Ethical and Scientific Review and Biomedical Research; and 21: Ethical Obligation of External Sponsors to Provide Health-Care Services.)

The Islamic Point of View Concerning Guideline 10

Research in Populations and Communities with Limited Resources

1. That the sponsor and the investigator should make every effort to guarantee the responsiveness of the research to the health needs and priorities of the population or community of limited resources in which it is carried out is a requirement recognized in Islamic Law. As already pointed out, one of the aims of that law is to take priorities in consideration and place all things in proper order, based on reality and its requirements, so that what needs to take priority may not be postponed and what needs to be postponed may not be given priority.

2. Making the research outcome reasonably (i.e. in a fair manner) available to the host population or community is a requirement of Islamic Law, for justice and charity are required by virtue of God's order: "God enjoins justice and charity" (Al-Nahl XVI: 90). In application of this injunction, whenever a new medicine results from the finings of research conducted in a certain country, equity dictates that in exchange for the burdens shouldered by its citizens in being research subjects, they should benefit from the material gains from that medicine. Islamic Center of Southern California