The ethics of clinical and epidemiological research. 2011

R Bayer, and D B Greco, and R Ramachandran
Center for History and Ethics of Public Health, Mailman School of Public Health, Columbia University, New York, New York, USA.

The global burden of tuberculosis (TB) demands that research be undertaken. The vulnerability of the populations most at risk for TB demands that such research be subject to ethical review to protect their rights and interests. In this brief article we cannot review the vast and important literature bearing on the ethics of clinical and epidemiological research and public health surveillance. Instead, we have focused on three questions that have been at the center of discussion and debate and which have special relevance for TB. First, we examine a question that has special bearing when wealthy nations or international organizations carry out research in poor countries: what does justice require in the post trial period? Second, we examine the question of how the principles of consent and confidentiality may require modification in record-based epidemiological research. Third, we look at the challenges posed by public health surveillance, which in many cases requires case reporting by clinicians to public health agencies. By way of conclusion, we take note of the centrality of enhancing the institutional capacities for ethical review of research in poor nations.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D011634 Public Health Branch of medicine concerned with the prevention and control of disease and disability, and the promotion of physical and mental health of the population on the international, national, state, or municipal level. Community Health,Environment, Preventive Medicine & Public Health,Environment, Preventive Medicine and Public Health,Health, Community,Health, Public
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003219 Confidentiality The privacy of information and its protection against unauthorized disclosure. Patient Data Privacy,Privacy of Patient Data,Privileged Communication,Confidential Information,Secrecy,Communication, Privileged,Communications, Privileged,Data Privacy, Patient,Information, Confidential,Privacy, Patient Data,Privileged Communications
D003906 Developing Countries Countries in the process of change with economic growth, that is, an increase in production, per capita consumption, and income. The process of economic growth involves better utilization of natural and human resources, which results in a change in the social, political, and economic structures. LMICs,Less-Developed Countries,Low Income Countries,Low and Middle Income Countries,Lower-Middle-Income Country,Middle Income Countries,Third-World Countries,Under-Developed Countries,Developing Nations,Least Developed Countries,Less-Developed Nations,Third-World Nations,Under-Developed Nations,Countries, Middle Income,Countries, Third-World,Country, Least Developed,Country, Less-Developed,Country, Low Income,Country, Lower-Middle-Income,Country, Middle Income,Country, Third-World,Country, Under-Developed,Developed Country, Least,Developing Country,Developing Nation,Least Developed Country,Less Developed Countries,Less Developed Nations,Less-Developed Country,Less-Developed Nation,Low Income Country,Lower Middle Income Country,Lower-Middle-Income Countries,Middle Income Country,Nation, Less-Developed,Nation, Third-World,Nation, Under-Developed,Third World Countries,Third World Nations,Third-World Country,Third-World Nation,Under Developed Countries,Under Developed Nations,Under-Developed Country,Under-Developed Nation
D004813 Epidemiology Field concerned with the determination of causes, incidence, and characteristic behavior of disease outbreaks affecting human populations. It includes the interrelationships of host, agent, and environment as related to the distribution and control of disease. Social Epidemiology,Epidemiologies, Social,Epidemiology, Social,Social Epidemiologies
D006297 Health Services Accessibility The degree to which individuals are inhibited or facilitated in their ability to gain entry to and to receive care and services from the health care system. Factors influencing this ability include geographic, architectural, transportational, and financial considerations, among others. Access To Care, Health,Access to Care,Access to Contraception,Access to Health Care,Access to Health Services,Access to Medications,Access to Medicines,Access to Therapy,Access to Treatment,Accessibility of Health Services,Availability of Health Services,Contraception Access,Contraceptive Access,Medication Access,Accessibility, Health Services,Contraceptive Availability,Health Services Geographic Accessibility,Program Accessibility,Access to Cares,Access to Contraceptions,Access to Medication,Access to Medicine,Access to Therapies,Access to Treatments,Access, Contraception,Access, Contraceptive,Access, Medication,Accessibilities, Health Services,Accessibility, Program,Availability, Contraceptive,Care, Access to,Cares, Access to,Contraception, Access to,Contraceptive Accesses,Health Services Availability,Medication Accesses,Medication, Access to,Medicine, Access to,Medicines, Access to,Therapy, Access to,Treatment, Access to
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006806 Human Rights The right of the individual to cultural, social, economic, and educational opportunities as provided by society, e.g., right to work, right to education, and right to social security. Linguistic Rights,Right to Housing and Shelter,Rights of Indigenous Peoples,Collective Human Rights,Equal Rights,Human Rights, Collective,Indigenous Peoples Rights,Rights, Collective Human,Rights, Equal,Rights, Linguistic
D012935 Social Justice An interactive process whereby members of a community are concerned for the equality and rights of all. Food Justice,Common Good,Justice,Obligations of Society,Good, Common,Justice, Food,Justice, Social

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