New Zealand Organisation for Rare Disorders
PO Box 38-538,
Wellington Mail Centre
Phone: +64 4 471 2226
Charities Commission Registration CC22512
Submission to the Ministry of Health on the Review of the Regulation of Human Tissues and Tissue-based Therapies - June 2004.
This submission is in response to the Ministry of Health's discussion document published in March. It is available online at www.moh.govt.nz
The principles outlined in this submission are based on discussions with a variety of support group leaders and family members, plus knowledge gained at the first community consultation meeting in Wellington on 27 April 2004.
NZORD submitted the following to the Ministry's review:
- That informed consent is an important principle that underpins public confidence in health and disability services and research. Departure from that principle should only be made in carefully controlled and well publicised areas.
- A principle of presumed consent for organ donation, unless the person has specifically opted out, seems to be a well supported approach to the problem of shortage of donor organs. Another approach to that problem that may well hold public acceptance, is a new provision that a family may not over-ride a donor's clearly expressed wish to donate.
- Other principles that should be central to tissue regulation are safety, good ethical practice and privacy.
- Ethics is an important control measure over research and medical practice, and protects the research subjects. However, when patients or families voluntarily donate blood, tissue or organs to researchers or to tissue banks, specifically for the purposes of promoting research into the disease, the approach adopted by ethics committees should be modified, in consultation with support groups, to recognise different dynamics in the researcher/subject relationship.
- Past problems with retention of organs or body parts for research or teaching, should be overcome with the application of proper informed consent in every case.
- Retention of cells or blood samples from diagnostic tests or screening samples, should be regarded as a separate category from organs or body parts. When held on Guthrie cards, in paraffin blocks, on slides or in similar form, and with appropriate protection of the individual's privacy, cells and blood samples should be kept indefinitely. There should be no specific requirement for informed consent to hold these samples and to use them for audit of the laboratory tests or screening programme. Potential future benefit for the patient is another good reason to store them in all cases.