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Managing the Informed Consent Process

  • Douladel Willie
  • Jan Van den Broeck
  • Jonathan R. Brestoff
  • Ingvild Fossgard Sandøy
Chapter

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.

Keywords

Consent Process Informed Consent Process Voluntary Consent Therapeutic Misconception Vulnerable Person 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Clayton EW (2005) Informed consent and biobanks. J Law Med Ethics 33:15–21PubMedCrossRefGoogle Scholar
  2. Council for International Organizations of Medical Sciences (2009) International ethical guidelines for epidemiological studies. CIOMS, Geneva, pp 1–128. ISBN 929036081XGoogle Scholar
  3. 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
  4. 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 9780195168655Google Scholar
  5. 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 9241593709Google Scholar
  6. Van Diest PJ, Savulescu J (2002) No consent should be needed for using leftover body material for scientific purposes: for and against. BMJ 325:648–651PubMedCrossRefGoogle Scholar
  7. 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 9780195168655Google Scholar
  8. White RM (2000) Unraveling the Tuskegee study of untreated syphilis. Arch Intern Med 160:585–598PubMedGoogle Scholar
  9. World Medical Association (2010) The declaration of Helsinki. http://www.wma.net/en/10home/index.html. Accessed Sept 2012

Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Douladel Willie
    • 1
  • Jan Van den Broeck
    • 2
  • Jonathan R. Brestoff
    • 3
  • Ingvild Fossgard Sandøy
    • 2
  1. 1.Epidemiology Research Unit, and Department of Child Health and PsychiatryUniversity of the West IndiesMonaJamaica
  2. 2.Centre for International Health, Faculty of Medicine and DentistryUniversity of BergenBergenNorway
  3. 3.Perelman School of MedicineUniversity of PennsylvaniaPhiladelphiaUSA

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