Human ethics for health research

Review of health research

Review by the Health & Disability Ethics Committee (HDEC)

Researchers are responsible for finding out whether their project requires approval from HDEC, or whether it may be reviewed by the University of Waikato’s Institutional Ethics Committee, the HREC (Health).

There is an online screening tool for this purpose. Users need to create an account and work through the online screening process.

Generally, projects funded by the Health Research Council require HDEC approval. For projects where it is unclear as to whether an HDEC review is required, researchers should apply for an Out-of-Scope letter. The University of Waikato's HREC (Health) can undertake an ethical review of health research after the researcher provides an Out-of-Scope letter. Researchers should allow around ten working days for HDEC to process Out-of-Scope applications.

For the purposes of HDEC review, Health Research is defined as any research project involving human participants recruited in their capacity as

• Consumers of health or disability support services
• Relatives or caregivers of such consumers
• Volunteers in clinical trials
• Human tissue. Human tissue is material derived from a living or deceased individual and includes cells, body parts, substances including blood, and body products including sputum and urine. A legal definition of human tissue is presented in Section 7 of the Human Tissue Act 2008

Health Research is defined as including any research project involving health information. Health information concerns information

• Linked to an identifiable individual and includes their medical history
• About disabilities and services that are or have been provided to the individual
• Derived from testing or examination of the individual’s body parts and bodily substances
• Any other information that has been collected incidentally during the provision of a health or disability service to that individual (Health research and privacy: Guidance notes for health researchers and ethics committees 1996: 2).

The purpose of health research review is to “check that proposed health and disability research meets established ethical standards that aim to protect participants” (Ministry of Health 2014: 6). Ethical standards are set out in the National Ethical Standards for Health and Disability Research and Quality Improvement by the National Ethics Advisory Committee.

There are four Health and Disabilities Ethics Committees (HDECs), administered by the Ministry of Health, which are responsible for the review of health research.

These committees see applications for

1. Intervention studies (clinical trials)
2. Observational research which is more than minimal risk
3. Studies using identifiable public health data (i.e. where the researchers will have access to identifiable details, even if these will not be reported in the research)
4. Studies where human tissue samples will be taken from patients

Current practice devolves responsibility for research where tissue samples (e.g. blood, sputum, urine) are taken from healthy individuals for observational purposes to institutional ethics committees that are accredited to the Health Research Council. The University of Waikato’s Human Research Ethics Committee (Health) is an accredited institutional ethics committee. There is an expectation that tissue samples will be taken by an appropriately qualified professional.

Masters research projects on health topics are not typically reviewed by HDEC. There is an assumption by HDEC that masters's students should not be engaging in the types of higher-risk research that HDEC reviews. Where there might be higher-risk research at the masters's level, supervision and training provisions for students are scrutinized closely. Responsibility for the review of masters level research is devolved to accredited institutional ethics committees.

Researchers are responsible for finding out whether their project requires approval from HDEC, or whether it may be reviewed by the University of Waikato’s Institutional Ethics Committee, the HREC (Health). There is an online screening tool for this purpose. Users need to create an account and work through the online screening process.

All research that concerns health, but does not require HDEC approval must be reviewed by the University of Waikato’s Health Research Council accredited Institutional Ethics Committee, the HREC (Health).

The following list of questions supports the decision-making process on whether an application requires HREC (Health) review. A positive response to any one of these questions means an application should be submitted to the HREC (Health). If the answer to all of these questions is “no”, then an application can be submitted to a devolved Faculty or School HREC.

• Does the research question investigate a topic that concerns health, disability, or well-being?
• Is the researcher using an instrument intended to assess health, disability, or well-being?
• Is there a reasonable likelihood that participants would be referred to health providers through the process of participation, or as an outcome of the research? (If referral would be unexpected, then review by a devolved HREC is sufficient.)
• Are the participants being recruited in their capacity as DHB employees?
• Is the researcher intending to collect tissue samples (e.g. blood, saliva, urine) from healthy individuals?
• Is the researcher intending to utilize interventions related to exercise and nutrition?

The University of Waikato Human Research Ethics Committee has the Health Research Council Ethics Committee (HRCEC) approval to review some types of health and disability research applications.