Draft ethical guidelines for intervention studies
11 June 2008
Feedback sought on draft ethical guidelines for intervention studies
The Minister of Health’s independent advisor on ethical issues today launched public consultations on its proposed ethical guidelines for clinical trials and related types of health research.
The National Ethics Advisory Committee (NEAC) said the public can submit their comments on the Discussion Document and draft Ethical Guidelines for Intervention Studies until 23 July 2008.
New Zealand policy does not presently provide full and up-to-date guidance for the conduct of intervention studies. These include clinical trials and other studies of healthcare interventions such as medicines, devices or methods of health care delivery.
“The proposed guidelines are being developed to identify ethically sound pathways, in accordance with best international standards, to help investigators to conduct these beneficial studies,” NEAC chair Andrew Moore explained.
“Intervention studies have huge potential benefits to society, but they also entail potential harm. The guidelines aim to help secure these benefits and to ensure these studies are ethically sound and protect the interests of participants,” he said.
“Insight gained from the public consultations will be used by NEAC to revise the draft guidelines, make recommendations to the Minister of Health and establish agreed national ethical standards to work alongside other established NEAC guidance.”
Among the key ethical issues addressed by the proposed guidelines are the 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 Discussion Document and draft Guidelines can be downloaded from http://www.neac.health.govt.nz.
Questions and Answers:
What is the National Ethics Advisory Committee?
Established in 2001, the National Ethics Advisory Committee - Kâhui Matatika o te Motu (NEAC) is an independent advisor to the Minister of Health 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, Mâori health and consumer advocacy. They are appointed by the Minister for a term of up to three years.
What are intervention studies?
Intervention studies 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.
Why has NEAC produced this Discussion Document and draft Ethical Guidelines for Intervention Studies?
New Zealand policy does not presently provide full and up-to-date guidance for the conduct of intervention studies. One of the aims of the Discussion Document and draft Guidelines is to identify ethically sound pathways, in accordance with best international standards, to help investigators to conduct these beneficial studies.
NEAC is seeking feedback on this publication from individuals and groups with a particular interest in health and disability matters and from the general public, including potential study participants.
After taking into account the insights gained from the public consultation, NEAC will revise the draft Guidelines, make recommendations to the Minister of Health and establish agreed national ethical standards.
Who is the Discussion Document and draft Guidelines for?
This publication is primarily for investigators who conduct intervention studies, as good study conduct is their core professional responsibility. A way to help investigators address these issues, which has been established both nationally and internationally, is to develop ethical guidelines for study conduct. The work may also be of interest to others involved in these studies, including study participants and their families, ethics committees and healthcare providers.
What is in the Discussion Document and draft Guidelines?
* identifies ethical issues for intervention studies in New Zealand
* considers how these issues are currently addressed
* identifies which issues need to be addressed more effectively, and
options for addressing these issues more effectively.
Among the key issues addressed are the participation in studies by vulnerable people (e.g. children, people in institutional care, prisoners and refugees), access to treatments after study completion and compensation for injury.
Are there related NEAC guidelines?
The draft Guidelines parallel NEAC’s Ethical Guidelines for Observational Studies, which were developed through inclusive and thorough public consultation between 2002 and 2005 and launched in 2006.
How can your input help make the draft Guidelines better?
NEAC is interested in your comments on any aspect of the Discussion Document and draft Ethical Guidelines for Intervention Studies. You might like to consider the following questions (which are in the document) when you are preparing your comments:
* Have the key issues been identified and addressed thoroughly?
* How useful would you find these guidelines for assisting your work in intervention studies?
* Have the key issues been identified and addressed thoroughly?
* Are there any points made in the Discussion Document that should be better reflected in the final Guidelines?
* What other
suggestions do you have for improving the draft Guidelines?
How can you obtain a copy of this publication?
You can download the Discussion Document and draft Guidelines from: www.neac.health.govt.nz
You can also request a hard copy of the document by emailing NEAC at email@example.com
How can you have your say?
You can comment on NEAC’s Discussion Document and draft Ethical Guidelines for Intervention Studies by:
1. completing the questions in the Discussion Document as an electronic Word document and sending it to NEAC at the relevant address below
2. writing your comments as an email or as a letter that you can send to NEAC at the relevant address below.
PO Box 5013
Email: neac[at]moh.govt.nz (Please put "Intervention Studies" in the subject line).