Charities Commission Registration CC22512

New Zealand GenETHICS Essay Competition 2007 Winner Lam Nguyen, Nelson College for Girls

The GenETHICS essay competition for secondary school students in years 11, 12 or 13 is jointly sponsored by NZORD, the Royal Society of New Zealand and the Bioethics Council. This was the fourth annual competition and reflects the importance the three organisations put on good public discussion of the ethical issues associated with genetics and new technologies. Cash prizes for the winning entry and the runners-up are provided by NZORD. The Bioethics Council funds finalists' travel to the judging and the Royal Society provides significant educational and administrative support.

This year's topic was The storage and use of Guthrie card blood spots in New Zealand.

The use and storage of blood spot cards in New Zealand

By Lam Nguyen
Age 15
Nelson College for Girls

The Newborn Metabolic Screening Programme is one of the largest in New Zealand and also one the great successes of public health screening. Every year, over 59 000 newborns are screened for 28 metabolic disorders. By doing this, approximately 45 babies are found annually to have one of the disorders. The Guthrie cards which contain the babies’ blood are currently stored indefinitely in secure storage. However, there is public concern over the use and access to these cards. Therefore, a public consultation on the consent, storage and use is in place, as part of improvements to the programme. There are also the ethical and social implications and resulting questions of privacy, the access by families, police, researchers and other potential users that needs to be considered.

In New Zealand, the law states that when parents and caregivers are informed of the Newborn Metabolic Screening Programme, they can either consent or refuse for the screening and storage and future usage of newborn’s blood spot cards. If the parents or caregivers allow the screening, it involves a testing in which a few drops of blood will be taken from the infant‘s heel, unless there is insufficient blood. This blood test is carried out as soon as possible but within 48 hours, and is sent to the National Testing Centre based in Auckland City Hospital for analysis.

At the National Testing Centre, Guthrie cards are tested for 28 metabolic disorders by looking at the genes and chromosomes of the babies. Genes are the units of inheritance that are passed from one generation to the next, they are located on chromosomes of tightly wound structures composed of DNA. Every newborn has a pair of genes for each enzyme in their bodies. An infant with a metabolic disorder has one enzyme that is either missing or working incorrectly mostly caused by a pair of recessive genes called “autosomal recessive“. Knowing there is may be a chance of abnormalities, early treatment can benefit the child, their family and society.

After samples are taken, they are stored securely in a locked area to which only authorized staffs from the programme who are allowed access. In addition, data are stored in a restricted access area and multiple password systems are in place as added security. In New Zealand, there are legislations which covers this blood-screening programme, this includes the Health and Disability Commissioner Act 1994 which outline the role of the Commissioner and the process for submitting and resolving complaints about Health and disability services. The Code of Health and disability Consumer’s Right 1996, places corresponding obligations on providers of those services. In this case, the consumers who are the parents or caregiver must be fully informed (right 6) and give their informed consent (right 7) before they receive the service which is the screening. In right 7 (10), it clearly stated that no body part or bodily substances are allowed to be removed or obtained in the course of any health care procedure may be stored preserved or used otherwise, unless, there is the informed consent of the consumer or for the purpose of research that has received the approval of an ethics committee. However, under current law, a court can provide a written court order to NMSP requiring the release of a Guthrie card. These are the current arrangements for the Screening Programme.

When deciding an appropriate public policy on the storage time of these Guthrie Cards, we must consider the benefits and risks to the baby, their family and to society on the current arrangement for access, and possible uses that may arise from long term storage. Around 1.8 million Cards are presently stored in an identifiable form. Access to these Cards may be helpful in the understanding of genetics abnormalities and the development of appropriate tests. In other countries, Guthrie cards have been used in an anonymous form. In New Zealand, there are recent cases that these blood spot cards were requested to explain an unexpected infant death. Although very occasionally once a year, the New Zealand Police generally with consent from family will request to a specific blood spot card. This is beneficial as it is to identify a deceased or missing person or for coronial inquiries. They have also been in criminal cases to match biological material found at a crime scene. Not only does this benefit the child, its family but also the wider community. It can be said that although these cases may not cause any harm, they are still uses of the Cards other than those for which they were stored. I believe before giving consent to the screening, parents or caregivers should clearly inform these Cards may be use in such circumstances.

The use of blood spot cards by third parties other than the police is uncommon in New Zealand. However, a recent American study from Stratham, Green and Snowden in 1993 showed several screening facilities would release the cards to an insurance company, employer, a law enforcement agency and other states agencies. New Zealanders are protected from such an event by the Code of Health and Disability Consumers’ Right 1996 plainly state that no body part or bodily substances are allowed to be removed or obtained with the consent of consumers. Therefore, it is illegal in New Zealand for any screening facility to allow access to Guthrie Cards without the informed consent from parents or caregivers. However, even with this legislation, there will always be a risk that these blood cards can be access for commercial purposes.

Possible future users of these cards that may arise from long term storage are scientists or medical clinics. The risks and benefits depend on the purpose for using the cards. If it is to find a cure for these metabolic abnormalities, then this would benefit future babies that may be diagnosed. However, there are risks, some scientific research may not necessarily benefit the child or family but instead harm them. Programmes such as this always carry risks but what are important are the reviews and controls put on the screening programme. , Monitoring the honesty and the reliability of staff and the effectiveness of legislation which covers the programme, I believe can reduce these risks. We live in a society where not everyone is entirely trustworthy, therefore there will be those who can misuse these cards for wrongful purposes.

On the whole I trust that the existing governance arrangements and policies give adequate protection to the interests of the baby, their family and society however there should be strict monitoring that policy is in fact being followed. Under current law, a court can provide written court order to NMSP requiring the release of a specific Guthrie card without the informed consent from whanau. Such instances have been made in the last seven years have been regarding paternity cases. Courts decisions may not give adequate protection the interests of the baby since what is beneficial to the courts may not be beneficial to the individual. Right 7 of the Health and Disability Consumer’s Right Code), every consumer has the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a health care procedure, in this circumstances, it is the blood spot cards. Before any use of these stored Guthrie cards, it is required by law that the informed consent of the parent is obtained. Even with the best legislation and conditions, without strict continuous monitoring, it would not give adequate protection to the interests of the baby, their family and society.

At present, the Guthrie cards are stored indefinitely in secure storage. I believe this policy should be altered to the enhance benefits and reduce the risks. The Newborn Metabolic Screening Programme states one of its reasons for storage is the Programme audit which is done, to double check the accuracy of the screening tests or to confirm a result. Yet, 20 years after the screening, if the accuracy of the testing is poor, the metabolic disease would have been identified from other signs and medical conditions of the infant. Therefore, the accuracy is confirmed and the indefinite storage of these blood spot cards is no longer required and ought to be altered.

My advice to the Newborn Metabolic Screening Programme on the use of these Guthrie cards is that these cards should only be used in a way that benefits individuals or the wider community. I also would like to advice the Programme to have strict continuous monitoring on use by any party. Also, reviews of employees in the programme will help show the reliability of these people. By doing so, this will give more protection for the programme and also beneficial society.

In my opinion, the current access by the New Zealand Police is appropriate, however I do suggest a change to the current arrangements. On the Newborn Screening Programme, it states that New Zealand police, generally with the consent from family will request access to specific blood spot. In terms of privacy, however, I believe it should be compulsory for any party other than either the child or family who requests access to these cards, to obtain the person’s consent. Although, the Police work in the interest of society, they may not work in the best interests of the individual. By making it compulsory to obtain informed consent from whanau, there will be additional protection for the child.

To minimize risks to the baby from the long term storage of theses Guthrie card, storage time in my viewpoint should be change to 18 years. After 18 years of storage, I believe these cards should be destroyed. This would benefit the child’s interests, in cases such as blood spot card request by employers or insurance companies.

I also believe that the proposed dual notification and approval process for potential future use of these cards give adequate protection for the programme however I think parents should be clearly informed of the risk and benefits that may arise from their consent. Therefore, parents or caregivers can make an appropriate decision based on the benefits and risks.

References

Duke University School of Medicine (2007). http://pediatrics.duke.edu/modules/div_medgen_labsvcs/index.php?id=7

Katie Elkin. Guthrie Cards: Legal and Ethical Issues

Sandy Oliver. (2005) The Storage and use of newborn’s blood spot cards

Sue Thomas. A general practitioner in Nelson. 15 Mt Vernon Place. 35457545

http://www.ich.ucl.ac.uk/newborn/glossary/index.htm  (Note: This link is no longer active - NZORD, 12/2008)