Staking the Public Trust on Newborn Dried Blood Spot Retention: How the Beleno and Bearder Decisions May Impact Canadian Newborn Metabolic Screening Processes
Bibliographic record
Abstract
Introduction Public trust is fickle. Hard to obtain, even harder to maintain, it can be lost in an instant. From the 1960s onward, the medical community in North America has advocated and implemented a series of tests for newborns to help target, treat and possibly eliminate certain genetic diseases. Newborn metabolic screening (NMS) takes blood drops from a heel poke of an infant, collected on filter paper, which is then sealed when dry. Samples are sent to centralized laboratories where they undergo a battery of tests including mass spectrometry and DNA microarray technology. Such advanced testing is said to help identify dozens of potentially dangerous genetic abnormalities that could affect the future health of a child. (1) What has placed NMS practices in many countries at odds with public perception, however, is what health authorities do with the dried blood spots (DBS) after the screening is completed. Samples are routinely stored for at least one year after testing to ensure there is a specimen available for re-testing if necessary and for on-going quality assurance/quality control of the tests being performed (2). Members of the public and privacy advocates have expressed concern about the longer term non-consensual retention of DBS for secondary uses such as (3) The collection and storage of DBS gives rise to tissue repositories or biobanks. Such collections raise numerous ethical questions, including issues related to access, informed consent and privacy. Canadian jurisdictions have yet to legislate on the practice of DBS retention and secondary use of stored DBS. The first legal challenge to DBS retention in Canada was initiated in British Columbia in May 2010 (4) and this case will provide an opportunity to address unsettled issues. This paper provides an overview of the NMS programs and DBS storage practices in Canada. This summary provides a foundation for a discussion of the legal and ethical dilemmas raised by the creation of DBS biobanks. Recent American cases of Beleno v. Texas Department of State Health Services (5) and Bearder v. Minnesota (6) groundbreaking precedents concerning the collection of DBS, are incorporated into a larger discussion related to the probable outcome of similar legal arguments in Canadian jurisprudence. Up until a decade ago, little was known of the retention and storage practices for DBS. With the exponential growth of genetic research worldwide, however, the demand for tissue samples, including DBS, has risen. (7) Biobanks and the millions of infant DNA samples contained within them are said to represent an enormous potential resource for scientific study. In a 2002 workshop, the US Centers for Disease Control and Prevention commented on the importance of access to DBS: leftover DBS specimens are a unique, valuable population-based source for important public health surveillance and potential epidemiologic research. (8) However, privacy advocates and concerned citizens have seized upon the fact that there is a noted absence of regulatory policy or legal instrument in Canada that controls the retention and dissemination of stored DBS. (9) Such concerns have been distilled into constitutional and legal challenges, discussed in more detail below. (10) Newborn Screening Programs In Canada, where NMS is an integral part of the public health program, there is currently no legislation that directly regulates the collection, retention and secondary use of DBS. NMS programs in North America have been implemented by governments as public health initiatives and have progressed over 50 years to become a part of routine, preventive medicine. As such, NMS programs are not required to obtain explicit consent from the parents of newborns for the collection and retention of DBS. (11) The justification for NMS programs is evidenced through the early detection of life threatening genetic conditions in newborns which, in turn, provides a direct benefit to newborns while posing minimal risk of harm. …
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.042 | 0.120 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.047 | 0.026 |
| Scholarly communication | 0.030 | 0.011 |
| Open science | 0.008 | 0.014 |
| Research integrity | 0.018 | 0.022 |
| Insufficient payload (model declined to judge) | 0.022 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".