Principles and Guidelines for Newborn Screening
I write to you on behalf of the Queensland Council for Civil Liberties (“The QCCL”) which thanks you for the opportunity to make a submission in relation to this important issue.
We will address each of your questions serially: -
1. Agree.
2. Agree. In this regard we approve of the guidelines on page 13 of the consultation draft and accept that it would be appropriate to record the consent in the mothers’ medical notes.
3. Agree.
4. Agree.
5. On the basis of the factual assertion that it is not possible to offer choices within the screening test panel to enable parents to opt out of particular tests we agree with this proposal.
6. The information should be provided both prenatally and postnatally.
7. Although it is difficult for us to assess this issue without specialist knowledge it would appear that the information proposed to be given to parents about newborn screening is adequate.
8. In our view the proposed information pamphlet for parents should include information on the additional topics listed here.
9. We agree.
10. Once again it is difficult for us as non-specialists to assess whether the guidelines for health professionals are too prescriptive but on the surface they appear adequate.
11. You ask how long the cards should be retained by laboratories in an identified form. The consultation draft proposes a period of ten years which appears to be on the basis of data about present usage. We are concerned about the data remaining identified for what appears to be such a long period of time. In order to assess this properly we would need to have more information about how long the cards are likely to remain useful both from a purely physical point of view i.e. do they deteriorate and from a clinical point of view. However, we do note that in Western Australia the period has been set at two years[1] and in the absence of other compelling considerations we would suggest that time limit.
12. The answer to question 12 follows from the answer to question 11. In the absence of compelling considerations we would think two years would be appropriate.
13. We do not see any reason for de-identified cards to be destroyed.
14. We would be of the view that it would not be appropriate to make the de-identification reversible. This is because it opens up the opportunity for the de-identification process to be reversed for inappropriate purposes.
15. See above.
16. We are of the view that identified screening cards should only be available for research purposes with the consent of the parents or the child. We have no problem with de-identified cards being made available for research purposes given approval by the Human Research Ethics Committee.
17. See above.
18. see above
19. We agree that the use of newborn screening cards should be the subject of uniform national regulation.
20. At the present time the use of this information by police would presumably not have been in the contemplation of those who provided the samples or approved the provision of the samples. We agree with the views of the Federal Privacy Commissioner that the MOU entered into between NSW Health and the NSW police was an entirely unsatisfactory mechanism for dealing with this issue and that if police are to be allowed access to this material legislation needs to be introduced. [2] Like the Federal Privacy Commissioner we would adopt the views of the Victorian Privacy Commissioner[3]:
It should be a matter for thorough public debate and considered parliamentary decision before collections of infant DNA or research volunteers’ tissue are tapped for law enforcement purposes. If approved expressly under statute, any such use should:
a. Be subject to clear purpose limitations;
b. Be a technique of last resort in only the most serious cases. The police should not be allowed to collect these samples to simply build up a database. The right, if it is to be given should be restricted to the most serious of offences;
c. Not result in the addition of the DNA or derived data to any other database;
d. Require informed consent in all but the most unusual cases;
e. In all cases require a court order made after public proceedings about which reasonable notice should be given to relevant parties to put appropriate submissions to the court.[4] and
f. The scheme should ensure that relevant parties such as medical researchers, leading research ethics committees and the Privacy Commissioner receive due notice and have standing to be heard.
We believe this approach is not only consistent with the right to privacy it would assist to maintain the integrity of the research program as people may not participate if they think the data can be used for extraneous purposes especially by the police and other state agencies.
Material on pages 25 to 27 not addressed elsewhere
We agree that if a condition is identified through screening parents should be informed and the card retained long term with their consent.
Certainly we agree that the cards should be stored to prevent unauthorised use, access, loss or other misuse.
A record should be maintained of all requests to access screening cards and the reason for that request recorded.
We would accept that it is implicit in the program that residual screening cards may be used for audit, training and development of laboratory method purposes and that the cards may be used for a reanalysis to confirm initial test results or to perform an additional analysis for the screening process for the benefit of the child and their families. Although once again we would expect that the parents would be told in the ordinary course prior to consenting that this could occur.
We also accept that identified samples may be used for further testing with the consent of the family.
We look forward to hearing the result of your deliberations.
Yours faithfully
Michael Cope
President
For and on behalf of
THE QUEENSLAND COUNCIL FOR CIVIL LIBERTIES
[1] Submission by the Victorian Privacy Commissioner to the Forensic Procedures Review Committee on its review of Part 1D of the Crimes Act dated 5/9/02 at para 87
[2] Submission to the Joint Inquiry of the Australian Law Reform Commission and the Australian Health Ethics Committee into the protection of genetic information pages 27- 28
[3] op cit at para 89
[4] We presume that in Queensland the legislation would provide for the Public Interest Monitor to be involved in the process of obtaining court approval.