Abstract
The conduct of medical research that involves human subjects has many ethical and legal implications. Great strides in protecting the welfare and safety of research participants have been made in the past 40 years due to a series of unethical events. This chapter will focus on the history and evolution of the ethical and legal measures that have been implemented to safely conduct human research.
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References
Enfeld KB, Truwit JD. The purpose, composition, and function of an institutional review board: balancing priorities. Respir Care. 2008;53:1330–6.
National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants. Report and recommendations of the national bioethics advisory commission Volume I. August 2001. https://bioethicsarchive.georgetown.edu/nbac/human/oversumm.html. Accessed 10 Jan 2014.
Kapp MB. Ethical and legal issues in research involving human subjects: do you want a piece of me? J Clin Pathol. 2006;59:335–9.
United States Department of Health and Human Services. Institutional review board guidebook. http://www.hhs.gove/ohrp/irb/irb_introduction.htm. Accessed 15 Jan 2014.
National Institutes of Health: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. April 18, 1979. http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed 15 Jan 2014.
National Institutes of Health. Office of Human Subjects Research. Code of Federal Regulations Title 45 Public Welfare Part 46 Protection of Human Subjects. Revised June 23, 2005. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed 15 Jan 2014.
Callahan T, Hobbs R. Ethics in medicine. Research ethics. http://depts.washington.edu/bioethx/topics/resrch.html. Accessed 16 Jan 2014.
Frankel M, Siang S. Ethical and legal aspects of human subjects research on the internet. Report of a workshop. June 10–11, 1999. https://nationalethicscenter.org/resources/187/download/ethical_legal.pdf. Accessed 25 Jan 2014.
United States Department of Health and Human Services. Informed consent. http://www.hhs.gov/ohrp/policy/consent/index.html. Accessed 16 Jan 2014.
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Lolis, M.S., Goldberg, D.J. (2015). Legal Issues Related to Human Subjects for Research. In: Nasir, A. (eds) Clinical Dermatology Trials 101. Springer, Cham. https://doi.org/10.1007/978-3-319-09027-6_7
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DOI: https://doi.org/10.1007/978-3-319-09027-6_7
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