Ethical approval from an approved ethics committee must be obtained before HRC funding can commence.
Research using animal or human participants, animal or human materials, personal information, or involving clinical trials, or combinations of such studies, requires special consideration. For guidance on what requires ethical approval, and the ethical approval process, read the HRC Research Ethics Guidelines.
How to apply for ethical approval
There are two types of approved ethics committees that conduct ethical review of proposals to be funded by the HRC:
- Health and Disability Ethics Committees (HDECs)
- Institutional Ethics Committees (IECs).
As a general guide, research originating in a tertiary educational institution will normally be reviewed by an ethics committee of that institution (an Institutional Ethics Committee - IEC). That IEC needs to have approval from the Health Research Council Ethics Committee (HRCEC) to review HRC-funded applications.
However, particular types of research proposals received by an IEC may be referred to a HDEC. A research proposal which involves both human and animal subjects will require separate approvals from both human and animal ethics committees.
Below are some specific considerations, and relevant resources, that you may need to take into account for your particular research:
Observational studies: Observational research, audits and related activities
Is your study an observational study? Observational studies include observational research (which primarily adds to generalisable knowledge about a health or disability issue) and also audits and related activities (which primarily improve the delivery of the particular health or disability support service being studied or to control a threat to public health).
Observational studies are where the investigator has no control over study variables and merely observes outcomes, and observational studies differ from intervention or experimental studies in that no intervention other than the recording, classifying, counting and analysing of data takes place. More information on what's required for these studies can be found at the National Ethics Advisory Committee website - Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities
Intervention studies/clinical trials
Is your study an intervention study? In an intervention study, an investigator intervenes to prevent, diagnose or treat illness or disease, and also studies the effects of the intervention for its safety and/or benefit. A clinical trial of a new blood pressure medicine is an example of an intervention study. More information can be found at:
- National Ethics Advisory Committee - Ethical Guidelines for Intervention Studies
- HRC Resource Library - Standing Committee on Therapeutic Trials , Data Monitoring Core Committee, Gene Technology Advisory Committee , GTAC Process and Guidelines - General, GTAC Guidelines - Xenotransplantation.
- Australian New Zealand Clinical Trials Registry
Māori health research
Does your study involve Māori participants or research on issues relevant to Māori health? You should undertake appropriate and relevant consultation with Māori communities that will be involved in the design, development and implementation of the research. Useful resources include:
- Maori Health Advancement Guidelines
- Guidelines for Researchers on Health Research Involving Māori 2010
- Te Ara Tika: Guidelines for Maori Research Ethics: A framework for researchers and ethics committee members
Pacific health research
Does your study involve Pacific peoples living in New Zealand? You may need to consider the Pacific ethical standards of research. Read the HRC's Guidelines for Pacific Health Research
Does your study involve the use of human tissue for future unspecified research purposes? Does your study involve collection and use of human materials? Does your study involve genetic research? Does your study involve children? Does your study involve personal health information? The following documents will be useful:
- Ministry of Health - Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes
- Health & Disability Commissioner - The Code of Rights
- Privacy Commissioner - The Health Information Privacy Code
- Collection and use of human materials
- Genetic Technology Advisory Committee Approval
- Research involving children
- Research involving personal health information