New ethical guidelines for clinical trials

30 November 2009
Media Release

New ethical guidelines for clinical trials

New ethical guidelines for clinical trials and related types of health research have been developed to help ensure these studies are ethically sound and protect the interests of participants.

The Ethical Guidelines for Intervention Studies developed by the National Ethics Advisory Committee (NEAC) are expected to contribute to better health outcomes by further developing best practice in intervention studies. NEAC was set up in 2001 to be the Minister of Health’s independent advisor on ethical issues.

“The Guidelines will assist researchers in identifying and addressing the ethical issues in their studies. They will also assist ethics committees, study sponsors, and organisations that host research in assessing whether the investigator has ensured the study would meet established ethical standards,” NEAC chair Andrew Moore explained.

“The potential harms are generally greater in intervention studies than with other types of study due to the intervention itself. Close ethical scrutiny is therefore appropriate,” he noted.

Intervention studies include clinical trials and other studies of healthcare interventions such as medicines, devices or methods of health care delivery.

The Guidelines provide guidance on key ethical issues including participation in studies by vulnerable people (including children, people with severe intellectual disability or those with a terminal illness), access to treatments after the study is completed, and compensation for injury.

The Guidelines were developed following public consultation on a discussion document and draft guidelines, a literature review and independent peer review. They will work alongside Ethical Guidelines for Observational Studies, which NEAC launched in 2006. A copy of the Guidelines can be downloaded from the NEAC website:
http://www.neac.health.govt.nz/moh.nsf/indexcm/neac-resources-ethical-guidelines-for-intervention-studies .

Questions and Answers

1. What is the National Ethics Advisory Committee?

Established in 2001, the National Ethics Advisory Committee – Kāhui Matatika o te Motu (NEAC) is an independent advisor to the Minister on ethical issues concerning health and disability matters.

Members of NEAC bring expertise in ethics, health and disability research, health service provision and leadership, public health, epidemiology, law, Māori health and consumer advocacy. They are appointed by the Minister for a term of up to three years.

2. What are intervention studies?

Intervention studies are undertaken to evaluate the worth of a treatment or a preventive intervention such as screening or immunisation. Studies of this type allow health professionals to: (1) offer a treatment, procedure or a medication intended to prevent, diagnose or treat an illness or disease, (2) study the effects of these “interventions” and (3) assess whether they are safe and effective.

Examples are a clinical trial of a new blood pressure medicine or a clinical research study of a medication for Alzheimer’s disease.

Intervention studies are important because they allow clinician-investigators to exercise the sort of critical thinking, innovation and evidence-based development of practice that improves patient care.

3. Why has NEAC developed these Ethical Guidelines for Intervention Studies?

Intervention studies have the potential both to benefit and harm participants, so it is important that they are scientifically and ethically sound. These Guidelines were developed to assist researchers who conduct intervention studies in identifying and addressing the ethical issues in their studies. The Guidelines will also assist ethics committees, study sponsors, organisations that host research, and others with an interest in intervention studies.

4. Are there related NEAC guidelines?

The Ethical Guidelines for Intervention Studies parallel NEAC’s Ethical Guidelines for Observational Studies, which were launched in 2006 after an inclusive and thorough public consultation.

5. How can you obtain a copy of the Ethical Guidelines for Intervention Studies?

A copy of the Guidelines can be downloaded from:
http://www.neac.health.govt.nz/moh.nsf/indexcm/neac-resources-ethical-guidelines-for-intervention-studies .

ENDS

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