Doing ethical disability research: minimising harm for participant and researcher Australasian Association of Bioethics and Health Law Conference 14 July 2012 Dr Hilary Stace Research Fellow Health Services Research Centre Victoria University of Wellington

New NZ ethics process for health (and disability) research from 1 July 2012 Several categories of research no longer require review eg most student work, most qualitative research, and those involving ‘low risk’ interventions. Very limited criteria for full review. Scientific review is no longer the role of the ethics committee. Purpose: robust, efficient, transparent, consistent 4 ministerially-appointed committees of 8 people replace the previous 1 multi-regional and 6 regional committees of 12 people (half lay with lay chair) which had members with specific roles including Maori representation.

‘This person suffering from hereditary defects costs the community 60,000 Reichsmark during his life time. Fellow Germans, that is your money too.’ c1940 From R.L. Wagoner ‘Speaking for the unfit’ Historical background

Legacy 1947 Nuremberg code of ethical principles and 1964 Helsinki declaration and updates Each country own framework and variations eg Treaty of Waitangi and consideration of Maori in NZ US Tuskagee Experiment and 1979 Belmont Report Principles: respect (informed and ongoing consent); beneficence (minimising risk and maximising benefits for participants); and justice (well-designed research and fair treatment of participants) NZ Cartwright Inquiry – led to Privacy Commissioner, Health and Disability Code and Commissioner and system of ethical review including strong role for lay membership

‘Vulnerable’ People National Ethics Advisory Committee, Ethical Guidelines for Intervention Studies, p. 13 Vulnerable people include those who have restricted capability to make independent decisions about their participation in the study. Restricted capability does not apply to all individuals in these groups and may only apply intermittently. Examples of potentially vulnerable people include: Children People with mental illness People with serious intellectual disability People with English as a second language and/or a different cultural background to the investigators (for studies whose details are primarily, or are only, stated in English) People whose freedom to make independent choices is restricted (eg prisoners, employees of a sponsoring company or students) People with serious illness for which the study treatment offers potential benefits that substantially exceed those of any other available treatment.

Examples of poor ethical practice and ‘vulnerable’ participants Project on adults with Down Syndrome that was not going to consult the adults themselves – ethics committee asked researcher to remedy this. Evaluation of service provision - parents or carers spoke for the disabled person. Didn’t enable the disabled person to speak for themselves in a safe environment. Public on-line survey which re-traumatised participant. Student work with no ethical accountability/complaints pathway for participant. Participating in drug trial the only way to get any attention for autistic children ineligible for any government support.

New Zealand Disability Strategy (2001) “Underpinning the New Zealand Disability Strategy is a vision of a fully inclusive society. New Zealand will be inclusive when people with impairments can say they live in: ‘A society that highly values our lives and continually enhances our full participation’ ” ( page 1 ) Objective 10: Collect and use relevant information about disabled people and disability issues

United Nations Convention on the Rights of Persons with Disabilities (NZ ratified 2008) Article 15 - Freedom from torture or cruel, inhuman or degrading treatment or punishment 1. No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his or her free consent to medical or scientific experimentation. 2. States Parties shall take all effective legislative, administrative, judicial or other measures to prevent persons with disabilities, on an equal basis with others, from being subjected to torture or cruel, inhuman or degrading treatment or punishment. Article 31 - Statistics and data collection 1. States Parties undertake to collect appropriate information, including statistical and research data, to enable them to formulate and implement policies to give effect to the present Convention.

As a researcher I would like to be reassured that my potential research participants are fully protected by the New Zealand Health and Disability Ethics Committee approval process