Abstract
Informed consent is obtained from a possible participant in a clinical trial primarily to protect the rights, safety, well being, and interests of those participating in the trial. Written consent has been developed to avoid coercive or deceptive recruitment and the use of unethical enrolling practices.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Similar content being viewed by others
References
ICH Harmonised Tripartite Guideline E6(R1) Guideline for Good Clinical Practice: Consolidated Guidance, ICH June 1996, http://www.ich.org (Accessed 23 March 2008); ICH Guidelines, Efficacy topics: http://www.ich.org/LOB/media/MEDIA482_OnlinePDF.pdf (Accessed 23 March 2008).
FDA Code of Federal Regulations. 21CFR 50.20 and 50.23 and 50.24 and 50.25 at http://www.fda.gov. Database updated April 1, 2007 (Accessed 23 March 2008).
FDA History. http://www.fda.gov/oc/history/default.htm (Accessed 23 March 2008)
The current version of the Declaration of Helsinki, 2004, is the only official one; all previous versions should be used or cited as historical references only. Available at The World Medical Association, http://www.wma.net/e/policy/b3.htm. (Accessed 23 March 2008).
FDA CDER History, http://www.fda.gov/cder/about/history/page32.htm (Accessed 23 March 2008).
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2009 Birkhäuser Verlag Basel/Switzerland
About this chapter
Cite this chapter
Fissekis, J.A. (2009). Informed consent forms. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_10
Download citation
DOI: https://doi.org/10.1007/978-3-7643-8362-6_10
Published:
Publisher Name: Birkhäuser, Basel
Print ISBN: 978-3-7643-8361-9
Online ISBN: 978-3-7643-8362-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)