Abstract
Informed consent is the process of fully informing potential study subjects about the study and obtaining their voluntary agreement to participate or (if already enrolled in the study) to continue their participation. Informed consent is an ongoing process and a key responsibility of researchers using information or biological samples provided by human subjects. Ethics committees play vital roles in ensuring that necessary steps are taken to fulfill the ethical obligations linked to the informed consent process, but even with the best intentions, the informed consent process can be mismanaged. The chapter outlines the principles and the stages of the informed consent process, and it highlights issues to consider when managing and executing the informed consent process.
Yes and No are very short words to say, but we should think for some length of time before saying them.
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References
Clayton EW (2005) Informed consent and biobanks. J Law Med Ethics 33:15–21
Council for International Organizations of Medical Sciences (2009) International ethical guidelines for epidemiological studies. CIOMS, Geneva, pp 1–128. ISBN 929036081X
Council for International Organizations of Medical Sciences (2010) International ethical guidelines for biomedical research involving human subjects. CIOMS, Geneva. http://www.cioms.ch. Accessed Sept 2012
Flory JH, Wendler D, Emanuel EJ (2008) Empirical issues in informed consent for research. In: Emanuel EJ et al (eds) The Oxford textbook of clinical research ethics. Oxford University Press, Oxford, pp 645–660. ISBN 9780195168655
UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance (2005) Guidelines for measuring national HIV prevalence in population-based surveys. WHO, Geneva, pp 1–67. ISBN 9241593709
Van Diest PJ, Savulescu J (2002) No consent should be needed for using leftover body material for scientific purposes: for and against. BMJ 325:648–651
Wendler D (2008) Research with biological samples. In: Emanuel EJ et al (eds) The Oxford textbook of clinical research ethics. Oxford University Press, Oxford, pp 290–297. ISBN 9780195168655
White RM (2000) Unraveling the Tuskegee study of untreated syphilis. Arch Intern Med 160:585–598
World Medical Association (2010) The declaration of Helsinki. http://www.wma.net/en/10home/index.html. Accessed Sept 2012
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Willie, D., Van den Broeck, J., Brestoff, J.R., Sandøy, I.F. (2013). Managing the Informed Consent Process. In: Van den Broeck, J., Brestoff, J. (eds) Epidemiology: Principles and Practical Guidelines. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-5989-3_16
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DOI: https://doi.org/10.1007/978-94-007-5989-3_16
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