Moving Forward on Consent Practices in Australia
- 399 Downloads
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.
KeywordsInformed consent Research ethics Multimedia consent Consent apps
- 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.Google Scholar
- 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.Google Scholar
- 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.Google Scholar
- Australian Bureau of Statistics. 2008. 4228.0—Adult literacy and life skills survey, summary results, Australia, 2006 (Reissue). January 9. http://www.abs.gov.au/AUSSTATS/abs@.nsf/Previousproducts/4228.0Main%20Features22006%20(Reissue)?opendocument&tabname=Summary&prodno=4228.0&issue=2006%20(Reissue)&num=&view. Accessed February 9, 2018.
- Australian Government National Health and Medical Research Council. 2007. National statement on ethical conduct in human research. Canberra.Google Scholar
- 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.Google Scholar
- 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.Google Scholar
- Cornell University Office of Research Integrity and Assurance. 2015. Institutional review board—Required components of informed consent. https://www.irb.cornell.edu/forms/consent.htm. Accessed July 10, 2017.
- Council for International Organizations of Medical Sciences. 2016. International ethical guidelines for health-related research involving humans. http://www.cioms.ch/ethical-guidelines-2016/.
- Faden, R., and T. Beauchamp. 1986. A history and theory of informed consent. Oxford: Oxford University Press.Google Scholar
- High Court of Australia. 1992. Rogers v Whitaker, 175 CLR 479.Google Scholar
- Johns Hopkins Office of Human Subjects Research. 2007. Informed consent guidance—How to prepare a readable consent form. http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/informed_consent_ii.html. Accessed February 9, 2018.
- National Cancer Institute. 2014. Simplification of informed consent documents. Conducting Clinical Trials. http://www.cancer.gov/clinicaltrials/conducting/simplification-of-informed-consent-docs/page1. Accessed May 19, 2017.
- National Health and Medical Research Council. 2015. Standardised participant information and consent forms. Human Research Ethics Portal. http://hrep.nhmrc.gov.au/toolbox/standardised-forms. Accessed July 10, 2017.
- 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.Google Scholar
- Supreme Court of Western Australia -Court of Appeal. 2008. Hassan v The Minister for Health [No 2] 149. WASCA.Google Scholar
- U.S. Government. 2017. Federal policy for the protection of human subjects. Federal Register. https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf.Google Scholar