The Ministry of Health in New Zealand has issued new ethical guidelines for clinical trials and related forms of research.
Developed by the National Ethics Advisory Committee (NEAC), the Ethical Guidelines for Intervention Studies are expected “to contribute to better health outcomes by further developing best practice” in the field, the health ministry said.
The new guidelines address key ethical issues such as participation in studies by vulnerable populations (e.g., children, people with severe intellectual disabilities, people with a terminal illness); access to treatments once the study is completed; and compensation for injury.
They were developed following public consultation on a discussion document and draft guidelines, a literature review and independent peer review. The guidelines will operate in parallel to the Ethical Guidelines for Observational Studies, which NEAC launched in 2006.
“The potential harms are generally greater in intervention studies than with other types of study due to the intervention itself,” commented Andrew Moore, chair of NEAC, which was set up in 2001 as the New Zealand Minister of Health’s independent advisor on ethical issues. “Close ethical scrutiny is therefore appropriate.”
A copy of the guidelines may be downloaded from the NEAC website at http://www.neac.health.govt.nz/moh.nsf/indexcm/neac-resources-ethical-guidelines-for-intervention-studies.
