New Zealand has a legal framework which sets out your rights regarding giving informed consent. The framework flows from the Health and Disability Commissioner Act 1994 (the Act), and the Code of Health and Disability Services Consumers' Rights 1996 (the Code).
Code of Health and Disability Services Consumers’ Rights
The Code includes three rights that together form the elements of informed consent. The three rights are:
- the right to effective communication (Right 5);
- the right to be fully informed (Right 6); and
- the right to make an informed choice and give informed consent (Right 7). Consumers (and in this case, their parents/guardians) must be fully informed (Right 6) and give informed consent (Right 7) before they receive this service.
The Act outlines the process for submitting and resolving complaints about health and disability services.
Please note: The Code gives rights on consumers who receive health services. In the case of newborn metabolic screening, the consumer is the baby. However, as a baby is not competent to consent, consent to blood tests and storage must be given by the parents or other persons entitled to consent on behalf of the baby. Later, when the consumer (baby) becomes competent to consent, he or she will be entitled to exercise his or her rights directly.
The Privacy Act and the Health Information Privacy Code
The Privacy Act 1993 and the Health Information Privacy Code (HIPC) 1994 cover the blood spot cards.
In 2003, the former Privacy Commissioner Bruce Slane issued a report following his inquiry into the collection, retention, use and release of newborn metabolic screening test samples. The report identified areas of concern and recommendations for the programme
What other safeguards are in place for the programme?
The laboratory which performs the screening for the programme must be International Accreditation New Zealand (IANZ) accredited against the international standard ISO 15189. This is the highest accreditation programme available. Accreditation by IANZ ensures the laboratory that carries out these tests is technically competent, has appropriate processes and is using up-to-date technology. More information is available from the IANZ website: www.ianz.govt.nz
Samples are stored securely in a locked area
Blood spot cards are stored securely and confidentially by the laboratory.
DNA and stored data
As part of metabolic screening, about 1 percent of samples are currently tested for a change in DNA (mutation) associated with cystic fibrosis. No other DNA testing is done on samples unless authorised by the parents/guardians/individual or through legal avenues (eg a court order).