Storage and use of residual dried blood spots from state newborn screening programs

Olney, Richard S.; Moore, Cynthia A.; Ojodu, Jelili; Lindegren, Mary Lou; Hannon, W. Harry

doi:10.1016/j.jpeds.2005.12.053

Cited by 68 publications

(62 citation statements)

References 13 publications

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“…A third of US states retain DBS leftover from newborn screening programs for long-term storage and potential secondary research applications (Olney et al 2006); policies for these large population "biobanks" (in effect if not in name), operated by state departments of health, vary widely (Health Resources and Services Administration 2011; Lewis et al 2011). While informed consent is an ethical cornerstone of human subjects research, biobanks present challenges for developing ethically sound, practicable consent policies, since in many cases, specific research projects are unknown, and risks and benefits cannot be clearly articulated.…”

mentioning

confidence: 99%

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Thiel

Platt

et al. 2013

J Community Genet

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Biobanks raise challenges for developing ethically sound and practicable consent policies. Biobanks comprised of dried bloodspots (DBS) left over from newborn screening, maintained for long-term storage, and potential secondary research applications are no exception. Michigan has been a leader in transforming its DBS collection, marketing its biobank of de-identified samples for health research use. The Michigan BioTrust for Health includes approximately 4 million unconsented retrospective samples collected as early as 1984 and prospective samples added since the fall of 2010 with blanket parental consent. We engaged Michigan citizens to ascertain public attitudes, knowledge, and beliefs about the BioTrust and informed consent. A convenience sampling of 393 participants from communities around the state of Michigan (oversampling for minority populations) participated in meetings addressing newborn screening, the BioTrust and informed consent, yielding quantitative and qualitative survey and discussion data. Participants affirmed the principle of voluntary informed participation in research and advocated for greater public awareness of the existence of the BioTrust. Most expressed support for the use of DBS for research and a desire for greater involvement in granting permission for research use. Opinions varied as to which specific research uses were acceptable. Participants indicated a desire for greater engagement, public awareness, and more active decision making on the part of biobank participants and parents. Diversity of opinion over which research areas were deemed acceptable problematizes the blanket consent model that currently applies to the BioTrust's prospective DBS collection and that could become the new norm for research using de-identified data under proposed changes to the Common Rule.

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mentioning

confidence: 99%

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Thiel

Platt

et al. 2013

J Community Genet

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“…3 A total of 40% of state public health laboratories have reported retaining DBS for at least 1 year. 4 DBS have a broad range of potential uses, including the evaluation of state newborn screening programs, quality improvement, and the development of new technology to improve newborn screening. They also may be used for surveillance or other public health activities, for example the detection of HIV seroprevalence rates.…”

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confidence: 99%

State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples

Lewis

Goldenberg

Anderson³

et al. 2011

Pediatrics

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BACKGROUND: After newborn screening has been completed, many states retain residual newborn screening dried blood samples for various purposes, including program evaluation, quality assurance, and biomedical research. The extent to which states possess legal authority to retain residual dried blood samples (DBS) and use them for purposes unrelated to newborn screening is unclear. OBJECTIVE: The purpose of this study was to evaluate state laws regarding the retention and use of DBS. METHODS: State statutes and regulations related to newborn screening of all 50 states plus the District of Columbia were accessed online between November 2008 and December 2009 and reviewed by 2 independent reviewers to determine the extent to which the retention and use of DBS were addressed. RESULTS: The retention or use of DBS has not been addressed in 18 states. In 4 states, DBS becomes state property. Eight states require that parents be provided information regarding the retention of DBS. Parents in 5 states may request the destruction of their child's residual sample. Parental consent is required under certain circumstances to release DBS for research in 6 states. One state prohibits DBS from being used for research purposes. CONCLUSIONS: States have wide variability in their policies regarding the retention and use of DBS. Many states have not addressed key issues, and some states that retain DBS may be acting outside the scope of their legal authority. The lack of transparency on the part of states in retaining DBS may undermine public trust in state newborn screening programs and the research enterprise.

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“…Typically parents are not aware that the NBS are being stored [60,61] and the possibility of requesting to use dried blood spots for research was not mentioned in the educational materials provided to the parents. In the past, the storage and use of newborn blood spots for research received minimal public attention [62].…”

Section: Resultsmentioning

confidence: 99%

Newborn screening programmes: Emerging biobanks?

Knoppers

Avard²,

Sénécal³

2012

Nor J Epidemiol

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Storage and use of residual dried blood spots from state newborn screening programs

Cited by 68 publications

References 13 publications

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

Community perspectives on public health biobanking: an analysis of community meetings on the Michigan BioTrust for Health

State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples

Newborn screening programmes: Emerging biobanks?

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