Skip to main content

Consent in Biomedical Research

  • Chapter
Balanced Ethics Review

Abstract

Consent, at its heart, is a process—an exchange of information capped by subject agreement. The form is not the consent (Lidz et al. 1988; Davis and Hurley 2014, p. 18). Nonetheless, IRBs pragmatically use the consent form as the primary tool to determine how subjects will be informed about a study. Consent honors subjects’ right to choose and promotes their best interests as they define them.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

eBook
USD 14.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 19.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • Advisory Committee on Human Radiation Experiments. Final report of the advisory committee on human radiation experiments. New York: Oxford University Press; 1996.

    Google Scholar 

  • Amdur R, Bankert EA. Placebo-controlled trials. In: Amdur R, Bankert EA, editors. Institutional review board member handbook. 3rd ed. Sudbury, MA: Jones and Bartlett; 2011a. p. 171–6.

    Google Scholar 

  • Amdur R, Bankert EA. The consent process and document. In: Amdur R, Bankert EA, editors. Institutional review board member handbook. 3rd ed. Sudbury, MA: Jones and Bartlett; 2011b. p. 53–8.

    Google Scholar 

  • Baron J. Against bioethics. Cambridge, MA: MIT Press; 2006.

    Google Scholar 

  • Ben-Shahar O, Schneider CE. More than you wanted to know: the failure of mandated disclosure. Princeton, NJ: Princeton University Press; 2014.

    Book  Google Scholar 

  • Burman W, Breese P, Weis S, Bock N, Bernardo J, Vernon A, et al. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials. 2003;24(3):245–55.

    Article  Google Scholar 

  • Candilis PJ, Lidz CW. Advances in informed consent research. In: Miller FG, Wertheimer A, editors. The ethics of consent: theory and practice. Oxford: Oxford University Press; 2010. p. 329–46.

    Google Scholar 

  • Chalmers I. Regulation of therapeutic research is compromising the interests of patients. Int J Pharm Med. 2007;21(6):395.

    Article  Google Scholar 

  • Davis AL, Hurley EA. Setting the stage: the past and present of human subjects research regulations. In: Cohen IG, Lynch HF, editors. Human subjects research regulation: perspectives on the future. Cambridge, MA: MIT Press; 2014. p. 9–26.

    Chapter  Google Scholar 

  • Epstein LC, Lasagna L. Obtaining informed consent: form or substance. Arch Intern Med. 1969;123(6):682.

    Article  Google Scholar 

  • Fost N. Consent as a barrier to research. N Engl J Med. 1979;300:1272–3.

    Article  Google Scholar 

  • Greene SM, Geiger AM, Harris EL, Altschuler A, Nekhlyudov L, Barton MB, et al. Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes. Ann Epidemiol. 2006;16(4):275–8.

    Article  Google Scholar 

  • Hochhauser M. Memory overload: the impossibility of informed consent. Appl Clin Trials. 2005;14(11):70.

    Google Scholar 

  • Humphreys K, Trafton J, Wagner TH. The cost of institutional review board procedures in multicenter observational research. Ann Intern Med. 2003;139(1):77.

    Article  Google Scholar 

  • Levine RJ. Ethics and regulation of clinical research. 2nd ed. Baltimore, MD: Urban & Schwarzenberg; 1986.

    Google Scholar 

  • Lidz CW, Appelbaum PS, Meisel A. Two models of implementing informed consent. Arch Intern Med. 1988;148(6):1385.

    Article  Google Scholar 

  • Mazur DJ. Evaluating the science and ethics of research on humans: a guide for IRB members. Baltimore, MD: Johns Hopkins University Press; 2007.

    Google Scholar 

  • Menikoff J, Richards EP. What the doctor didn’t say: the hidden truth about medical research. Oxford: Oxford University Press; 2006.

    Google Scholar 

  • Morahan PS, Yamagata H, McDade SA, Richman R, Francis R, Odhner VC. New challenges facing interinstitutional social science and educational program evaluation research at academic health centers: a case study from the ELAM program. Acad Med. 2006;81(6):527–34.

    Article  Google Scholar 

  • National Cancer Institute. Consent to participate in a clinical research study: Evaluation of the natural history and management of pancreatic lesions associated with Von Hippel-Lindau. On file with author; 2011.

    Google Scholar 

  • Penslar RL. The institutional review board’s role in editing the consent document. In: Bankert EA, Amdur RJ, editors. Institutional review board: management and function. 2nd ed. Burlington, MA: Jones & Bartlett; 2006. p. 199–201.

    Google Scholar 

  • Ramsey P. The patient as person: explorations in medical ethics. New Haven: Yale University Press; 1970.

    Google Scholar 

  • Ravina B, Deuel L, Siderowf A, Dorsey ER. Local institutional review board (IRB) review of a multicenter trial: local costs without local context. Ann Neurol. 2010;67(2):258–60.

    Article  Google Scholar 

  • Smith T. Ethics in medical research: a handbook of good practice. Cambridge, UK; New York: Cambridge University Press; 1999.

    Google Scholar 

  • Wertheimer A. Rethinking the ethics of clinical research: widening the lens. New York: Oxford University Press; 2011.

    Google Scholar 

  • Wertheimer A, Miller FG. Payment for research participation: a coercive offer? J Med Ethics. 2008;34(5):389–92.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Whitney, S.N. (2016). Consent in Biomedical Research. In: Balanced Ethics Review. Springer, Cham. https://doi.org/10.1007/978-3-319-20705-6_5

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-20705-6_5

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-20704-9

  • Online ISBN: 978-3-319-20705-6

  • eBook Packages: Social SciencesSocial Sciences (R0)

Publish with us

Policies and ethics