Review of NEAC S Ethical Guidelines for Research and Related Activities

Review of NEAC’s Ethical Guidelines for Research and Related Activities

Objectives of the review

The National Ethics Advisory Committee (NEAC) is undertaking a comprehensive review of its Ethical Guidelines for Observational Studies and Ethical Guidelines for Intervention Studies. The objectives of the review are to ensure the guidelines are fit for purpose and consistent with other relevant guidance. The guidelines will also be updated to address ethical issues associated with developments in research methods and emerging topics.

The key areas of focus for the review include: 1. better incorporating Māori ethical concepts and frameworks 2. reviewing guidance on informed consent, particularly retrospective consent and consent for incompetent participants and vulnerable groups 3. providing additional guidance to address technological advances in the use of health information, particularly the increased use of data linkage and e-research 4. strengthening existing guidance on minimal risk in observational studies and on audit and related activity 5. strengthening existing guidance on scientific peer review and compensation for injury 6. updating and incorporating the Ministry of Health’s Guidelines on the use of human tissue for future unspecified research purposes (2007) into NEAC’s guidelines 7. developing guidance on innovative practice.

Proposed approach

Structure

The starting point for the new guidelines is to combine the observational and intervention guidelines into a single document. This approach recognises that the original production of two separate sets of guidelines was driven largely by historical context and has resulted in unnecessary duplication.

A significant proposed change is to set out more clearly each of the ethical standards. The standards will use directive language (such as “should” and “must”) to be clearer for researchers. Each standard will be followed by a section describing and discussing its application (including relevant examples, where appropriate). The discussion of each of the standards and their application will link back to the relevant ethical principle(s).

Up-to-date definitions will be included within the body of the new guidelines, rather than as a separate glossary.

of 2 Incorporating Māori ethical concepts

The new guidelines will incorporate and discuss Māori ethical concepts and their application, alongside the Western bioethical framework. NEAC’s view is that all health and disability research conducted within New Zealand will impact on Māori and there needs to be a stronger focus, across all research, on improving Māori health and wellbeing.

This approach requires care to ensure Māori ethical concepts are treated with respect and discussed appropriately, and that unique aspects are preserved.

The Research Continuum 2. The revised guidelines will be based on the concept of a continuum, emphasising that all research activities – including audits, quality assurance activities, and innovative practice – need to be conducted ethically.

3. Researchers should consider the ethical issues associated with their proposed research. While not all research activities need to be reviewed by an ethics committee, some level of independent scrutiny may be required, such as peer review to an appropriate level.

4. This approach can accommodate the use of checklists and definitions (eg, ‘audit’, ‘evaluation’ and ‘research’), while still acknowledging that there is always some blurring and overlap. This approach also supports the idea that research, audit and innovative practice belong to the broad family of ‘research activities’.

Guidelines to be electronic document

It is intended that the Guidelines will be published and formatted primarily for use as an electronic document. This will enable: 1. researchers to find specific and relevant portions of the Guidelines more quickly and easily (eg, ethical considerations for intervention research involving children as participants), including ‘quick links’ to definitions and other relevant key documents; 2. easier and more regular updating of references and case studies.

Ethical considerations for specific kinds of participants

Consideration is being given to how to make the current guidelines discussion of ethical considerations specific to vulnerable people more inclusive. For example, rather than the new guidelines including a list of ‘vulnerable groups’, it may be preferable to talk about the sources of vulnerability. This would help to ensure researchers consider what might make a person vulnerable in relation to their particular research project. It might also help to ensure that groups of people are not unnecessarily excluded from research because of their perceived vulnerability.

NEAC CONTACTS

Website: http://neac.health.govt.nz/home

Email: [email protected]