Skip to main content
Erschienen in: Journal of Bioethical Inquiry 2/2018

01.06.2018 | Original Research

Moving Forward on Consent Practices in Australia

verfasst von: Rebekah E. McWhirter, Lisa Eckstein

Erschienen in: Journal of Bioethical Inquiry | Ausgabe 2/2018

Einloggen, um Zugang zu erhalten

Abstract

Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants.
Anhänge
Nur mit Berechtigung zugänglich
Fußnoten
1
Section 4.1 of the National Statement identifies these groups as pregnant women and the human fetus; children and young people; people in dependent or unequal relationships; people highly dependent on medical care; people with a cognitive impairment, intellectual disability, or mental illness; people who may be involved in illegal activities; Aboriginal and Torres Strait Islanders; and people in other countries.
 
Literatur
Zurück zum Zitat Afolabi, M., N. Mcgrath, U. D’Alessandro, et al. 2017. Development and evaluation of a multimedia tool for obtaining informed consent in the Gambia: A mixed method study. BMJ Global Health 2 (S2): A6–A7. Afolabi, M., N. Mcgrath, U. D’Alessandro, et al. 2017. Development and evaluation of a multimedia tool for obtaining informed consent in the Gambia: A mixed method study. BMJ Global Health 2 (S2): A6–A7.
Zurück zum Zitat Afolabi, M.O., K. Bojang, U. D’Alessandro, et al. 2014. Multimedia informed consent tool for a low literacy African research population: Development and pilot-testing. Journal of Clinical Research & Bioethics 5(3): 178. Afolabi, M.O., K. Bojang, U. D’Alessandro, et al. 2014. Multimedia informed consent tool for a low literacy African research population: Development and pilot-testing. Journal of Clinical Research & Bioethics 5(3): 178.
Zurück zum Zitat Albala, I., M. Doyle, and P.S. Appelbaum. 2010. The evolution of consent forms for research: A quarter century of changes’. IRB: Ethics & Human Research 32(3): 7–11. Albala, I., M. Doyle, and P.S. Appelbaum. 2010. The evolution of consent forms for research: A quarter century of changes’. IRB: Ethics & Human Research 32(3): 7–11.
Zurück zum Zitat Australian Government National Health and Medical Research Council. 2007. National statement on ethical conduct in human research. Canberra. Australian Government National Health and Medical Research Council. 2007. National statement on ethical conduct in human research. Canberra.
Zurück zum Zitat Beardsley, E., M. Jefford, and L. Mileshkin. 2007. Longer consent forms for clinical trials compromise patient understanding: So why are they lengthening? Journal of Clinical Oncology 25(9): e13–14.CrossRefPubMed Beardsley, E., M. Jefford, and L. Mileshkin. 2007. Longer consent forms for clinical trials compromise patient understanding: So why are they lengthening? Journal of Clinical Oncology 25(9): e13–14.CrossRefPubMed
Zurück zum Zitat Berger, O., B.H. Gronberg, K. Sand, S. Kaasa, and J.H. Loge. 2008. The length of consent documents in oncological trials is doubled in twenty years. Annals of Oncology 20(2): 379–385.CrossRefPubMed Berger, O., B.H. Gronberg, K. Sand, S. Kaasa, and J.H. Loge. 2008. The length of consent documents in oncological trials is doubled in twenty years. Annals of Oncology 20(2): 379–385.CrossRefPubMed
Zurück zum Zitat Bickmore, T.W., L.M. Pfeifer, and M.K. Paasche-Orlow. 2009. Using computer agents to explain medical documents to patients with low health literacy. Patient Education and Counseling 75(3): 315–320.CrossRefPubMedPubMedCentral Bickmore, T.W., L.M. Pfeifer, and M.K. Paasche-Orlow. 2009. Using computer agents to explain medical documents to patients with low health literacy. Patient Education and Counseling 75(3): 315–320.CrossRefPubMedPubMedCentral
Zurück zum Zitat Breese, P.E., W.J. Burman, S. Goldberg, and S.E. Weis. 2007. Education level, primary language, and comprehension of the informed consent process. Journal of Empirical Research on Human Research Ethics 2(4): 69–79.CrossRefPubMed Breese, P.E., W.J. Burman, S. Goldberg, and S.E. Weis. 2007. Education level, primary language, and comprehension of the informed consent process. Journal of Empirical Research on Human Research Ethics 2(4): 69–79.CrossRefPubMed
Zurück zum Zitat Buccini, L.D.., D. Iverson, P. Caputi, and C. Jones. 2010. An Australian based study on the readability of HIV/AIDS and Type 2 diabetes clinical trial informed consent documents. Journal of Bioethical Inquiry 7(3): 313–319.CrossRef Buccini, L.D.., D. Iverson, P. Caputi, and C. Jones. 2010. An Australian based study on the readability of HIV/AIDS and Type 2 diabetes clinical trial informed consent documents. Journal of Bioethical Inquiry 7(3): 313–319.CrossRef
Zurück zum Zitat Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. 2010. Tri-Council policy statement: Ethical conduct for research involving humans. Ottawa. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. 2010. Tri-Council policy statement: Ethical conduct for research involving humans. Ottawa.
Zurück zum Zitat Castelnuovo, B., K. Newell, Y.C. Manabe, and G. Robertson. 2014. Multi-media educational tool increases knowledge of clinical trials in Uganda. Journal of Clinical Research & Bioethics 5(January): 165. Castelnuovo, B., K. Newell, Y.C. Manabe, and G. Robertson. 2014. Multi-media educational tool increases knowledge of clinical trials in Uganda. Journal of Clinical Research & Bioethics 5(January): 165.
Zurück zum Zitat Christopher, P., M. Foti, K. Roy-Bujnowski, and P. Appelbaum. 2007. Consent form readability and educational levels of potential participants in mental health research. Psychiatric Services 58(2): 227–232.CrossRefPubMed Christopher, P., M. Foti, K. Roy-Bujnowski, and P. Appelbaum. 2007. Consent form readability and educational levels of potential participants in mental health research. Psychiatric Services 58(2): 227–232.CrossRefPubMed
Zurück zum Zitat Emanuel, E., D. Wendler, and C. Grady. 2000. What makes clinical research ethical? JAMA 283(20): 2701–2711.CrossRefPubMed Emanuel, E., D. Wendler, and C. Grady. 2000. What makes clinical research ethical? JAMA 283(20): 2701–2711.CrossRefPubMed
Zurück zum Zitat Faden, R., and T. Beauchamp. 1986. A history and theory of informed consent. Oxford: Oxford University Press. Faden, R., and T. Beauchamp. 1986. A history and theory of informed consent. Oxford: Oxford University Press.
Zurück zum Zitat Falagas, M., I. Korbila, K. Giannopoulou, B. Kondilis, and G. Peppas. 2009. Informed consent: How much and what do patients understand? The American Journal of Surgery 198(3): 420–435.CrossRefPubMed Falagas, M., I. Korbila, K. Giannopoulou, B. Kondilis, and G. Peppas. 2009. Informed consent: How much and what do patients understand? The American Journal of Surgery 198(3): 420–435.CrossRefPubMed
Zurück zum Zitat Flory J., and Emanuel E. 2004. Interventions to improve research participants’ understanding in informed consent for research: A systematic review. JAMA 292(13): 1593–1601.CrossRefPubMed Flory J., and Emanuel E. 2004. Interventions to improve research participants’ understanding in informed consent for research: A systematic review. JAMA 292(13): 1593–1601.CrossRefPubMed
Zurück zum Zitat Grady, C. 2015. Enduring and emerging challenges of informed consent. New England Journal of Medicine 372(9): 855–862.CrossRefPubMed Grady, C. 2015. Enduring and emerging challenges of informed consent. New England Journal of Medicine 372(9): 855–862.CrossRefPubMed
Zurück zum Zitat Grady, C., S. Cummings, M. Rowbotham, M. McConnell, E. Ashley, and G. Kang. 2017. Informed consent. New England Journal of Medicine 376(9): 856–867.CrossRefPubMed Grady, C., S. Cummings, M. Rowbotham, M. McConnell, E. Ashley, and G. Kang. 2017. Informed consent. New England Journal of Medicine 376(9): 856–867.CrossRefPubMed
Zurück zum Zitat Harmell, A., B. Palmer, and D. Jeste. 2012. Preliminary study of a web-based tool for enhancing the informed consent process in schizophrenia research. Schizophrenia Research 141(2-3): 247–250.CrossRefPubMedPubMedCentral Harmell, A., B. Palmer, and D. Jeste. 2012. Preliminary study of a web-based tool for enhancing the informed consent process in schizophrenia research. Schizophrenia Research 141(2-3): 247–250.CrossRefPubMedPubMedCentral
Zurück zum Zitat High Court of Australia. 1992. Rogers v Whitaker, 175 CLR 479. High Court of Australia. 1992. Rogers v Whitaker, 175 CLR 479.
Zurück zum Zitat Jefford, M., L. Mileshkin, J. Matthews, et al. 2011. Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem. Supportive Care in Cancer 19(3): 371–379.CrossRefPubMed Jefford, M., L. Mileshkin, J. Matthews, et al. 2011. Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem. Supportive Care in Cancer 19(3): 371–379.CrossRefPubMed
Zurück zum Zitat Jeste, D., B. Palmer, S. Golshan, et al. 2009. Multimedia consent for research in people with schizophrenia and normal subjects: A randomized controlled trial. Schizophrenia Bulletin 35(4): 719–729.CrossRefPubMed Jeste, D., B. Palmer, S. Golshan, et al. 2009. Multimedia consent for research in people with schizophrenia and normal subjects: A randomized controlled trial. Schizophrenia Bulletin 35(4): 719–729.CrossRefPubMed
Zurück zum Zitat Joffe, S., E. Cook, P. Cleary, J. Clark, and J. Weeks. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. The Lancet 358(9295): 1772–1777.CrossRef Joffe, S., E. Cook, P. Cleary, J. Clark, and J. Weeks. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. The Lancet 358(9295): 1772–1777.CrossRef
Zurück zum Zitat Mahnke, A., J. Plasek, D. Hoffman, et al. 2014. A rural community’s involvement in the design and usability testing of a computer-based informed consent process for the personalized medicine research project. American Journal of Medical Genetics Part A 164(1): 129–140.CrossRef Mahnke, A., J. Plasek, D. Hoffman, et al. 2014. A rural community’s involvement in the design and usability testing of a computer-based informed consent process for the personalized medicine research project. American Journal of Medical Genetics Part A 164(1): 129–140.CrossRef
Zurück zum Zitat Nishimura, A., J. Carey, P. Erwin, J. Tilburt, M. Murad, and J. McCormick. 2013. Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics 14(1): 28.CrossRefPubMedPubMedCentral Nishimura, A., J. Carey, P. Erwin, J. Tilburt, M. Murad, and J. McCormick. 2013. Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics 14(1): 28.CrossRefPubMedPubMedCentral
Zurück zum Zitat Olver, I., L. Buchanan, C. Laidlaw, and G. Poulton. 1995. The adequacy of consent forms for informing patients entering oncological clinical trials. Annals of Oncology 6(9): 867–870.CrossRefPubMed Olver, I., L. Buchanan, C. Laidlaw, and G. Poulton. 1995. The adequacy of consent forms for informing patients entering oncological clinical trials. Annals of Oncology 6(9): 867–870.CrossRefPubMed
Zurück zum Zitat Paasche-Orlow, M., F. Brancati, H. Taylor, S. Jain, A. Pandit, and M. Wolf. 2013. Readability of consent form templates: A second look. IRB: Ethics & Human Research 35(4): 12–19. Paasche-Orlow, M., F. Brancati, H. Taylor, S. Jain, A. Pandit, and M. Wolf. 2013. Readability of consent form templates: A second look. IRB: Ethics & Human Research 35(4): 12–19.
Zurück zum Zitat Paasche-Orlow, M., H. Taylor, and F. Brancati. 2003. Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine 348(8): 721–726.CrossRefPubMed Paasche-Orlow, M., H. Taylor, and F. Brancati. 2003. Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine 348(8): 721–726.CrossRefPubMed
Zurück zum Zitat Rowbotham, M., J. Astin, K. Greene, and S. Cummings. 2013. Interactive informed consent: Randomized comparison with paper consents. PLOS ONE 8(3): e58603.CrossRefPubMedPubMedCentral Rowbotham, M., J. Astin, K. Greene, and S. Cummings. 2013. Interactive informed consent: Randomized comparison with paper consents. PLOS ONE 8(3): e58603.CrossRefPubMedPubMedCentral
Zurück zum Zitat Simon, C., D. Klein, and H. Schartz. 2016. Interactive multimedia consent for biobanking: A randomized trial. Genetics in Medicine 18(1): 57–64.CrossRefPubMed Simon, C., D. Klein, and H. Schartz. 2016. Interactive multimedia consent for biobanking: A randomized trial. Genetics in Medicine 18(1): 57–64.CrossRefPubMed
Zurück zum Zitat Supreme Court of Western Australia -Court of Appeal. 2008. Hassan v The Minister for Health [No 2] 149. WASCA. Supreme Court of Western Australia -Court of Appeal. 2008. Hassan v The Minister for Health [No 2] 149. WASCA.
Zurück zum Zitat Tamariz, L., A. Palacio, M. Robert, and E. Marcus. 2013. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of General Internal Medicine 28(1): 121–126.CrossRefPubMed Tamariz, L., A. Palacio, M. Robert, and E. Marcus. 2013. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of General Internal Medicine 28(1): 121–126.CrossRefPubMed
Zurück zum Zitat Taylor, H., and D. Bramley. 2012. An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand. Anaesthesia and Intensive Care 40(6): 995–998.PubMed Taylor, H., and D. Bramley. 2012. An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand. Anaesthesia and Intensive Care 40(6): 995–998.PubMed
Zurück zum Zitat World Medical Association. 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 310(20): 2191–2194.CrossRef World Medical Association. 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 310(20): 2191–2194.CrossRef
Metadaten
Titel
Moving Forward on Consent Practices in Australia
verfasst von
Rebekah E. McWhirter
Lisa Eckstein
Publikationsdatum
01.06.2018
Verlag
Springer Singapore
Erschienen in
Journal of Bioethical Inquiry / Ausgabe 2/2018
Print ISSN: 1176-7529
Elektronische ISSN: 1872-4353
DOI
https://doi.org/10.1007/s11673-018-9843-z

Weitere Artikel der Ausgabe 2/2018

Journal of Bioethical Inquiry 2/2018 Zur Ausgabe