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Standards for health research could become less stringent

23 February 2012

Standards for health research could become less stringent

New Zealanders could participate in health research without the chance to give informed consent if draft procedures for health and disability ethics committees are adopted, the New Zealand Law Society said today.

The Law Society has released its submission on the Draft Standard Operating Procedures for Health and Disability Ethics Committees.

The submission says the proposed changes are a significant departure from the current standards for ethics committees developed since the Cartwright Inquiry and from international standards for the protection of human participants in research.

If implemented they will have significant human rights implications.

Section 10 of the New Zealand Bill of Rights Act 1990 provides that every person has the right not to be subjected to medical or scientific experimentation.

“The Law Society is concerned that the proposed changes, together with reducing the membership and numbers of ethics committees, will not provide adequate protection for participants of health and disability research. This particularly applies to the right of patients or participants to give informed consent or refusal to participate in research,” Health Law Committee convener Alison Douglass said.

The Cartwright Inquiry was conducted in 1988 by then District Court Judge Dame Silvia Cartwright into allegations concerning the treatment of women with cervical cancer at National Women’s Hospital.

Information about patients’ abnormal smear results was withheld from them. They were not given the opportunity to provide informed consent and were unaware that they were participating in medical experimentation.

“The withholding of standard treatment of the time from women with cervical cancer was not thought by the researcher to expose them to harm,” Ms Douglass said.

“A key recommendation of the Cartwright inquiry was the establishment of ethics committees to provide independent ethical review of all health research and the development of a national standard for ethics committees.

“The proposed draft procedures will water down the ethical protections developed in standards for ethics committees since the Cartwright Inquiry. They make no mention of the legal requirements of informed consent for the protection of participants in health and disability research.

“The Law Society questions the legal status of the proposed changes and what legal effect they will have on the framework for ethical review of research in New Zealand. It recommends the Government engage in a more comprehensive review of New Zealand’s ethics review system with a view to providing an overarching legal framework, in line with international standards including World Health Organisation (WHO) Standards and the Declaration of Helsinki.”


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