Consultation on Draft Operational Standard for Health and Disability Ethics Committees

Consultation on Draft Operational Standard for Health and Disability Ethics Committees

Date of publication: June 2001

New Zealand actively promotes high ethical standards to ensure that the rights, health and welfare of participants in research and innovative practice are protected. To this end, Health and Disability Ethics Committee ("HDECs") have been established to ensure that research and innovative practice conducted in the health and disability sector is independently reviewed in a fair and consistent manner. HDECs currently operate in accordance with the 1996 National Standard of Ethics Committees.

In 1999, the Ministry of Health began the process of reviewing the 1996 Standard by establishing a Working Group tasked with providing advice to the Ministry on the review. Throughout the following year a number of significant issues were identified. Many of these issues were later raised in the context of the Ministerial Inquiry into the Under-Reporting of Cervical Smear Abnormalities in the Gisborne Region ("the Gisborne Inquiry").

The Gisborne Inquiry made a number of significant recommendations regarding ethics committees. The Minister of Health has decided that the most far reaching of these recommendations should be addressed by the National Advisory Committee on Health and Disability Support Services Ethics ("the National Ethics Committee") which the Minister of Health is required to establish under section 16 of the New Zealand Public Health and Disability Act 2000. The National Ethics Committee will have an oversight role of all ethical matters in the health and disability sector by promoting ethical standards and ensuring the quality and consistency of ethical review.

The first task of the National Ethics Committee will therefore be to:

review the operation of ethics committees and the impact their decisions are having on independently funded evaluation exercises and on medical research generally in New Zealand;

develop guidelines on conducting observational studies in an ethical manner and establish parameters for the ethical review of observational studies (including guidance regarding weighing up the harms and benefits of this type of health research).

Because it will be some time before the National Ethics Committee will make recommendations on its review of the operation of ethics committees, it has been decided to proceed with the review of the 1996 National Standard by developing an Operational Standard. The draft Operational Standard specifically addresses the following recommendations:

The procedures under which ethics committees operate need to be re-examined. (recommendation 11.23)

There needs to be change to guidelines under which ethics committees operate to make it clear that any (external or internal) audit, monitoring and evaluation of past and current medical treatment does not require the approval of ethics committees. (recommendation 11.18)

Ethics Committees require guidance regarding the application of the Privacy Act and the Health Information Privacy Code. Ethics Committees need to be informed that the interpretation of legislation relating to personal privacy is for the agency holding a patient’s data to decide. They would, therefore, benefit from having at least one legally qualified person on each regional committee. (recommendation 11.20)

It is intended that if any contentious issues are raised as the result of consultation on the draft Operational Standard, they will be referred for inclusion as part of the wider review to be undertaken by the National Ethics Committee. The National Ethics Committee will also undertake future reviews of the Operational Standard.

The draft Operational Standard has been developed to provide a consistent framework for the operation of ethics committees within the health and disability sector. It sets out the ethical principles that should be considered when reviewing proposals and establishes administrative procedures common to all health and disability ethics committees. In addition, the Operational Standard recognises the role and functions of the National Advisory Committee on Health and Disability Support Services Ethics, the National Ethics Committee on Assisted Human Reproduction, and the Health Research Council Ethics Committee.

Submissions have now closed.

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