The Division of Medical
Ethics and Humanities
Responsible Conduct of Research - Human Subjects Research
Howard Mann, M.D., Program Associate
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Session V

Ethical issues in community-based and international clinical research.

Clinical research may be conducted in discrete communities characterized by particular combinations of geographic, demographic, economic, social and ethnic factors. Research may be sponsored and conducted in an under-developed country by individuals from a relatively wealthy, industrialized country.

In these situations (particularly international research), cultural factors may substantially affect the recruitment of participants, and the process whereby informed consent for participation is obtained. If clinical research may lead to the development of new effective therapeutic or diagnostic interventions, concerns may arise about the post-research provision of such interventions to the participants.

Objectives

  1. To explore salient ethical concerns when clinical research is conducted by researchers in cohesive and unfamiliar cultural and ethnic communtities.

  2. To understand what issues need to be addressed and evaluated when research is conducted in other countries.

  3. To explore notions of fair benefits; the social value of clinical research; and justice and exploitation in international research.




Required reading for this session

Fitzgerald DW, et al. Ten Questions Institutional Review Boards Should Ask when Reviewing International Research Protocols IRB 2003; 14:18


Cases for discussion

Case 1.

Research has indicated that two polymorphisms of the beta-2 receptor gene affect an individual's airway responsiveness, or response to acute or chronic beta-2 agonist therapy. The investigator hypothesizes that there is an interaction effect on asthma between the gene polymorphisms and cigarette smoking. He proposes a case-control study using a group of asthmatics and a control group without asthma. The primary investigator is affiliated with a U.S. medical institution, which has a Federalwide Assurance on file with the Federal Office for Human Research Protections. He plans to collaborate with colleagues in China to recruit subjects in a specific Chinese region, which encompasses urban and rural counties. This region was selected because local residents are relatively homogeneous with respect to ethnic origin, environment, occupation, and diet, and because the villages have a stable resident population. Adults and children will be recruited.

The research procedures involve: administration of a questionnaire; standard pulmonary function tests; methacholine challenge test on subjects whose FEV1 is more than 60% of predicted (cases and controls); acquisition of blood samples for DNA extraction and testing. All adult subjects will sign a consent form, and, for children, parents will sign a permission form.


Questions

  1. Which national and/or international regulations and statements of ethical principles governing human subjects research are applicable to this propsed research, and why?
  2. How are the views of citizen and governmental representatives of the local communities in which the research is going to be conducted relevant to an analysis of the permissibilty of this research, and why? To what extent should an analysis of the harm-benefit balance be determined by the local social context in which the research will be conducted? What specific harms and benefits, if any, are identifiable?
  3. What issues are pertinent to the consent process in this situation?
  4. Is the research responsive to the health needs of the host community and country?
  5. Does a local ethics committee need to be involved?
Case 2

A U.S. - based company proposes to conduct a trial of a new Surfactant drug used to treat premature newborns at risk of developing respiratory distress syndrome. The trial is designed as a placebo-controlled trial. Because synthetic suractant is not routinely available in many under-developed countries, the trial will be conducted in four particular Latin American countries.

Questions

  1. Is the research design ethical ? What alternative designs may be considered?
  2. When is a placebo-controlled design justifiable?
  3. What concerns arise when considering Paragraph 30 of the Declaration of Helsinki:
At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. See footnote


Resource for this case:

The F.D.A.'s discussion of the proposed trial.


Additional resources

The Executive summary and recommendations in the National Bioethics Advisory Commission's report on Ethical and Policy Issues in International Research.

Nuffield Council on Bioethics statement concerning issues to be considered when reviewing research proposals related to health care in developing countries.

Moral standards for research in developing countries. From "reasonable availability" to "fair benefits." Hastings Center Report. 2004; 3: 17-27.

London AJ. Justice and the human development approach to international research. Hastings Center Report 2005; 25: 24-37.

Weijer C, Goldsand G, Emanuel EJ. Protecting communities in research. Nature Genetics 1999; 23: 275

Weijer C, Emanuel EJ. Protecting communities in biomedical research. Science 2000; 289: 1142.