Ethics committees. Research ethics: beyond the guidelines. 2001

C C Macpherson
St. George's University School of Medicine, PO Box 7, St. George's, Grenada, West Indies.

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold their guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, very in different settings.

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
D007373 Interinstitutional Relations The interactions between representatives of institutions, agencies, or organizations. Interagency Relations,Interagency Relation,Interinstitutional Relation,Relation, Interagency,Relation, Interinstitutional,Relations, Interagency,Relations, Interinstitutional
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
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
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006805 Human Experimentation The use of humans as investigational subjects. Human Research Subject Protection,Experimentation, Human
D017408 Guidelines as Topic Works about a systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available. Guidelines as Topics
D019425 Grenada An island of the West Indies. Its capital is St. George's. It was discovered in 1498 by Columbus who called it Concepcion. It was held at different times by the French and the British during the 18th century. The British suppressed a native uprising in 1795. It was an associate state of Great Britain 1967-74 but became an independent nation within the British Commonwealth in 1974. The original name referred to the Feast of the Immaculate Conception but it was later renamed for the Spanish kingdom of Granada. (From Webster's New Geographical Dictionary, 1988, p467 & Room, Brewer's Dictionary of Names, 1992, p219)
D026724 Ethical Review A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS). Review, Ethical

Related Publications

C C Macpherson
May 1992, BMJ (Clinical research ed.),
C C Macpherson
June 1992, Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke,
C C Macpherson
March 2006, BMJ (Clinical research ed.),
C C Macpherson
February 1990, BMJ (Clinical research ed.),
C C Macpherson
March 1990, BMJ (Clinical research ed.),
C C Macpherson
February 1990, BMJ (Clinical research ed.),
C C Macpherson
August 2008, The British journal of general practice : the journal of the Royal College of General Practitioners,
C C Macpherson
September 2004, Bulletin of medical ethics,
C C Macpherson
April 1990, BMJ (Clinical research ed.),
C C Macpherson
November 2010, Nursing ethics,
Copied contents to your clipboard!