Our Ethics Committee

The Zenith Biomedical Ethics Committee is an independent Ethics Committee accredited by the Health Research Council of New Zealand (HRC). The committee reviews clinical study protocols submitted by ZenTech with the studies being conducted on behalf of Pharmaceutical Companies in New Zealand and around the world.

It is the role of the Ethics Committee to ensure that the rights of participants are protected and that they are fully informed about the procedures and risks involved in participating. It is also the role of the Maori Representatives to ensure that the needs of Maori [and other cultures] are being adequately addressed.

The committee is required to have ten members from various backgrounds including an equal balance of medical professionals and lay people. The composition of the ten members includes an HRC requirement for two Maori members.

Our current membership reflects the following backgrounds:

• Pharmacist
• Toxicologist
• General Practitioners (2)
• Drug safety monitor
• Lawyer
• Journalist
• Maori members ¡V lay (2)
• Human Rights and Ethics

Role of the Ethics Committee

The purpose of the Zenith Biomedical Ethics Committee is primarily to safeguard the dignity, rights, safety, and well being of all actual or potential research participants. The basic principle of research involving human participants is respect for the dignity of those persons. While the goals of the research are important, these should never be permitted to override the health, well-being and care of participants.

All studies conducted by ZenTech on behalf of Pharmaceutical Companies are considered to be 'principally for the benefit of the Sponsor Company'. The main benefit to the subjects participating in a study (apart from the monetary remuneration) is to play a role in the development of generic drugs which will be of benefit to the wider community, in terms of choice and price.

The ethics committee is required to provide independent, competent and timely review of research studies. All members of the ethics committee are required to be independent, having no connection with the company in any capacity which may cause a conflict of interest.

The Zenith Biomedical Ethics Committee is accredited by the Health Research Council of New Zealand to review research proposals to be conducted on healthy volunteers. The Committee operate according to the Ministry of Health Operational Standard for Ethics Committees. It also refers to the Guidelines on Ethics in Health Research.