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Ethical Issues of Research In Developing Countries

Lead Author(s): Bernard Lo, MD

Research in resource-poor countries is essential in order to develop affordable treatments and preventive measures for malaria, HIV infection, and other diseases whose burdens fall heaviest on these countries. In addition, pharmaceutical manufacturers are increasingly carrying out clinical trials in resource-poor countries, because of lower costs and a larger number of patients who have not received any previous treatment.

However, research in resource-poor countries raises special ethical concerns. The two primary means of protecting participants--Institutional Review Board (IRB) review and informed consent--may be inadequate. IRBs in developing countries may lack training, experience, and resources. U.S. IRBs probably are not familiar with conditions in the host country.

Informed consent may be problematic because physicians in clinical practice do not usually tell patients their diagnosis, admit uncertainty, or obtain consent. Participants may not accept Western models of disease. Furthermore, participants may hear rumors and other misinformation about a research study. In several highly publicized cases, researchers from developed countries allegedly carried out inappropriately risky studies in resource-poor countries without adequate consent. For these reasons, researchers carrying out international studies need to be particularly sensitive to ethical concerns.

Issues With Informed Consent

With low-literacy populations, detailed consent forms may be counterproductive. While careful translation and back-translation of consent forms are necessary for informed consent, they are not sufficient when participants cannot read. Furthermore, insisting on signing consent forms or obtaining thumbprints may alarm some participants, who fear that the document could be used against them. Participants may suspect that they are giving away something, or that they might be harmed later if there is a change in government. Instead of requiring a signature, researchers might have persons independent of the study witness the consent process.

Additional steps can enhance informed consent from poorly educated persons in resource-poor countries. By consulting with stakeholders in the host country, such as community-based organizations, investigators can identify common misconceptions and concerns about the trial and obtain suggestions for improving the consent process and explaining difficult terms. Researchers have also used innovative means to communicate information, such as street theatre and group meetings where people can ask questions. Most importantly, researchers have asked participants questions to check that they understood key features of the study. If potential participants failed to show adequate comprehension, the researchers held additional discussions with them until they gained an acceptable level of understanding. Although disclosing information about a research study is necessary, the key ethical issue is whether or not participants comprehend the information that has been disclosed.

Issues With the IRB Review

The IRB review process can be protracted if the IRB asks researchers to provide additional information that was not included in the original submission. This may occur, for instance, if the IRB has questions about conditions in the country where the study will be conducted.

Researchers can facilitate IRB review and shorten the review process if they take the initiative to provide the IRB with information they will need to carry out their review. The general issue is that the IRB needs to understand how differences between the host country and the U.S. alter their judgments about the risks and benefits of the research and about the informed consent process. Specific information investigators might provide includes:

1 What are the options for care for the condition being studied in the country where research will be carried out?
  1. What increased risks to participants in the host country face, compared to risks participants would face if the study were carried out in the U.S.? For example, risks may be different because of attitudes towards confidentiality or the stigma associated with the condition being studied. How will the investigators minimize these additional risks?
  2. What barriers to informed and free consent exist in the host country, which are not present in the U.S.? Potential issues include low literacy, non-Western beliefs about illness and health care, attitudes towards contracts and signatures, and the role of third parties such as spouses or village elders in decision-making. There may be sources of undue influence or coercion that would not be present in the U.S. How will the investigators minimize these barriers?
  3. If subjects will be paid for participating in the study, it is helpful to indicate what the amount means in terms of an average or living wage in the host country.

An Example of Ethics Consult: Isoniazid Preventive Therapy in HIV Infected Children in Kenya

The investigator was planning a clinical trial of administering INH to HIV+ children in Kenya; controls were to be historical controls.

  1. Frame issues in terms of Subpart D, the federal regulations for research involving children. Her study offers the prospect of direct benefit and is more than a minor increase over minimal risk.
  2. Assent from children is not required (one parent or guardian may enroll the child even if he or she objects). So need to decide if they will enroll children who do not assent, or whether they will treat teenagers differently than younger children (may be difficult for parents to make them take the medicine).
  3. Will children who are orphans but have no legal guardian be eligible for the study, for example if they have an adult relative who is caring for them but not the legal guardian? There may be a discrepancy between Kenyan and U.S. standards regarding formal guardianship.
  4. Investigators need to consider the possibility that family members may share the INH pills.
  5. Some suggestions to wording of consent document.
  6. Advised the investigator to ask senior staff person at CHR to review the submission before submitting protocol.
  7. Advised the investigator to clarify responsibility and authorship with Kenyan collaborators before the study begins.

Share your own experience with ethical issues in developing countries by adding a comment to this article

 
Topic revision: r11 - 05 Apr 2010 - 13:29:04 - MaryBanach
BERDpedia.DevelopingCountriesEthics moved from Main.DevelopingCountriesEthics on 08 Feb 2008 - 05:53 by MichaelGold?
 
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