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Informed Consent Issues in International Research Concerns

Published online by Cambridge University Press:  29 July 2009

Joan P. Porter
Joan P. Porter
Affiliation:
Currently with the Department of Defense, and has also recently served as the Health Research Policy Officer at the Office for Protection from Research Risks (OPRR), National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.
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Extract

No discussion of the informed consent process would be adequate without attention to dilemmas and challenges arising in research in foreign countries, particularly in the less developed countries. In an era of the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS), for example, much attention to research issues concerning devastating health conditions in developed and less developed countries has occurred with renewed vigor.

Type
Special Section: Issues in Consent
Information
Cambridge Quarterly of Healthcare Ethics , Volume 5 , Issue 2 , Spring 1996 , pp. 237 - 243
Copyright
Copyright © Cambridge University Press 1996

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References

Notes

1. Office of Science and Technology Policy. Federal Policy for the Protection of Human Research Subjects; Notices and Rules (5GFR28002). Washington, DC, June 18, 1991.

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5. The basic elements of informed consent include: a statement that an activity involves research; an explanation of the purposes of the research and the expected duration of the subject's participation; a description of the procedures to be followed, and identification of any procedures that are‘experimental; a description of foreseeable risks and discomforts to the subject and of any benefits to the subject or to others reasonably expected from the research. There must be a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be useful to the subject. A statement describing the extent to which confidentiality of records identifying the subject will be maintained. In addition, there is an explanation that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled; the participant must also be told that he or she may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. For research that is greater than minimal risk, the extent to which compensation is available for injury must also be explained (Title 45 Code of Federal Regulations. Pt46:116; Title 21 Code of Federal Regulations. Pt50.116). The Institutional Review Board with oversight responsibility for the research can also add elements that are appropriate [45CFR, Pt46.116(b) (l)–(6)], or under certain conditions associated, in part, with minimal risk and impracticability, can modify or waive informed consent, altogether.

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