Abstract
This chapter elaborates on some of the existing concerns and ethical issues that may arise when biomedical research protocols are proposed or funded by research institutes (private or public) in developed countries but human subjects are recruited from resource-poor countries. Over the last two decades, clinical research conducted by sponsors and researchers from developed countries to be carried out in developing countries has increased dramatically. The article examines the situations in which vulnerable populations in developing countries are likely to be exploited and/or there is no guarantee of any benefit from the research product, if proven successful, to the local community. By examining the structure and functions of ethics committees in developing countries, the article focuses on the issues which a local ethics committee should take into account when reviewing externally-sponsored research. In conclusion, by emphasizing capacity building for local research ethics committees, the article suggests that assigning the national ethics committee (if one exists) or an ethics committee specifically charged with the task of reviewing externally-sponsored proposals would bring better results in protecting human subjects as well as ensuring benefit-sharing with the local community.
TopHistorical Background
The long history of medicine is glorified by the fight against diseases through new innovations, methods, and drugs which cure millions of patients. However the short history of research ethics started with scandals of abuse and exploitation of human subjects. The bitter history of clinical research is full of vulnerable individuals who participated in medical experiments unwittingly.
Key Terms in this Chapter
Standard of Care: Treatment regimen or medical management based on state of the art participant care.
Clinical Trial: a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Human Subject: a living individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual or Identifiable private information
Control Group: The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
Placebo: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.
Informed Consent: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants.
Externally-Sponsored Research: refers to research conducted, in whole or in part, by a foreign sponsor. It also can be part of a collaborative multinational or bilateral research project to be carried out in a developing country. The common feature of these projects is that the research protocol has been designed or funded in a developed country while human subjects are recruited from a developing country.