Individual genetic and genomic research results and the tradition of informed consent: exploring US review board guidance
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medical Ethics 38 (7):417-422 (2012)
Background Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond. Objective and methods To explore publicly accessible IRB websites for guidance in this area, using summative content analysis. Findings Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of ‘significant new findings’ (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level. Conclusion IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Gordon R. Mitchell (2001). Defining the Subject of Consent in DNA Research. Journal of Medical Humanities 22 (1):41-53.
Rogeer Hoedemaekers, Bert Gordijn & Martien Pijnenburg (2006). Does an Appeal to the Common Good Justify Individual Sacrifices for Genomic Research? Theoretical Medicine and Bioethics 27 (5):415-431.
Ben Chan, Flavia M. Facio, Haley Eidem, Sara Chandros Hull, Leslie G. Biesecker & Benjamin E. Berkman (2012). Genomic Inheritances: Disclosing Individual Research Results From Whole-Exome Sequencing to Deceased Participants' Relatives. American Journal of Bioethics 12 (10):1-8.
James R. P. Ogloff & Randy K. Otto (1991). Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research. Ethics and Behavior 1 (4):239 – 252.
Asya Al-Riyami, Deepali Jaju, Sanjay Jaju & Henry J. Silverman (2011). The Adequacy of Informed Consent Forms in Genetic Research in Oman: A Pilot Study. Developing World Bioethics 11 (2):57-62.
Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
Janet L. Brody, John P. Cluck & Alfredo S. Aragon (1997). Participants' Understanding of the Process of Psychological Research: Informed Consent. Ethics and Behavior 7 (4):285 – 298.
Timothy Caulfield, Ross Upshur & Abdallah Daar (2003). DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model. [REVIEW] BMC Medical Ethics 4 (1):1-4.
Robert F. Weir & Jay R. Horton (1995). Genetic Research, Adolescents, and Informed Consent. Theoretical Medicine and Bioethics 16 (4).
O. O'Neill (2001). Informed Consent and Genetic Information. Studies in History and Philosophy of Science Part C 32 (4):689-704.
Michelle H. Biros (2007). Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research. Science and Engineering Ethics 13 (3):361-369.
Paulina Tindana, Susan Bull, Lucas Amenga-Etego, Jantina de Vries, Raymond Aborigo, Kwadwo Koram, Dominic Kwiatkowski & Michael Parker (2012). Seeking Consent to Genetic and Genomic Research in a Rural Ghanaian Setting: A Qualitative Study of the MalariaGEN Experience. [REVIEW] BMC Medical Ethics 13 (1):15-.
Sheila McLean (2010). Autonomy, Consent and the Law. Routledge-Cavendish.
Susan E. Wallace (2011). The Needle in the Haystack: International Consortia and the Return of Individual Research Results. Journal of Law, Medicine and Ethics 39 (4):631-639.
A. T. Nuyen (2007). Knowing the Unknown and Informed Consent. International Journal of Applied Philosophy 21 (2):213-223.
Added to index2012-02-24
Total downloads11 ( #136,195 of 1,100,749 )
Recent downloads (6 months)2 ( #176,465 of 1,100,749 )
How can I increase my downloads?