Brad Therrell, PhD – NNSGRC Jana Monaco – ACHDNC (parent advocate) W. Harry Hannon, PhD – NNSGRC (CDC) Don Bailey, PhD – RTI (parent advocate) Proposed ‘White’ Paper Retention and Use of Residual Dried Bloodspot Material Following Newborn Screening: Guidance from the ACHDNC May 12, 2009
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Brad Therrell, PhD – NNSGRC Jana Monaco – ACHDNC (parent advocate) W. Harry Hannon, PhD – NNSGRC (CDC) Don Bailey, PhD – RTI (parent advocate) Alaina Harris,
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Brad Therrell, PhD – NNSGRC Jana Monaco – ACHDNC (parent
Retention and Use of Residual Dried Bloodspot Material Following Newborn Screening:
Guidance from the ACHDNC
May 12, 2009
Proposed ‘White’ Paper
Retention and Use of Residual Dried Bloodspot Material Following Newborn Screening:
Guidance from the ACHDNC
May 12, 2009
• 2005 Publication:“Stability studies show that genomic DNA is stable in dried blood spots stored on filter paper at ambient tropical conditions for at least 11 years. However, DNA quality for amplification of larger DNA fragments decreased when the specimens were stored for longer than 10 years.” DNA Stability in Dried Blood Spots. Chaisomchit S, Wichajarn R, Janejai N, Chareonsiriwatana W. Southeast Asian J Trop Med Public Health. 2005 Jan;36(1):270-3.
• 2008 Publication: “Despite storage for 25 years, at times without air conditioning, all specimens yielded genotyping results. However, the climate in Washington is moderate, and our assays mainly required short amplicons— genotype might not be determinable for all subjects for assays requiring long amplicons.” Newborn Screening Archives as a Specimen Source for Epidemiologic Studies: Feasibility and Potential for Bias. Nielsen SS, Mueller BA, DeRoos AJ, Checkoway H. Ann Epidemiol 2008;18(10):58-64.
Stability of DNA in Stored DBS Specimens
• 2009 Publication:“Lightly abrasive contact between DBS resulted in DNA cross-contamination –while contamination was detected, contamination levels were not sufficient to affect most routine molecular genetic assays currently used in NBS.” Assessment of DNA Contamination from Dried Blood Spots and Determination of DNA Yield and Function using Archival Dried Blood Spots. Cordovado SK, Earley MC, Hendrix M, Driscoll-Dunn R, Glass, M, Mueller PW, Hannon WH. Clin Chim Acta 2009;402:107-113.
Stability of DNA in Stored DBS Specimens
• 1996 Publication: “Stability of other non-DNA biomarkers for NBS vary with each specific analyte and many start to degrade within a few months.”
Guidelines for the Retention, Storage, and Use of Residual Dried Blood Spot Samples after Newborn Screening Analysis: Statement of the Council of Regional Networks for Genetic Services. Therrell BL, Hannon WH, et al., Biochem Molec Med 1996;57:116-24.
• 1996 – CORN Newborn Screening Committee:“Appropriate consent is an important issue. Some legal experts have proposed that proper consent is impossible since it is not possible to adequately inform or educate parents about all potential uses….” Source: Guidelines for the Retention, Storage, and Use of Residual Dried Blood Spot Samples after Newborn Screening Analysis: Statement of the Council of Regional Networks for Genetic Services. Therrell BL, Hannon WH, et al. Biochem Molec Med. 1996; 57:116-24.
• 2000 – AAP Task Force Recommendations:“Develop model consent forms and informational materials for parental permission for retention and use of newborn screening samples.”
“Develop educational materials for parents that include information regarding the storage and use of residual samples.”Source: Serving the Family from Birth to Medical Home – Newborn Screening: a Blue Print for the Future. Pediatrics. 2000;106 (No. 2 suppl.): 382-426.
Consent - The Issue“Residual NBS dried-blood spots have taken on a new life as a result of
developments in genetics and increasing ability of bioinformatics to link DNA information with clinical data.1”
1 Storing Newborn Blood Spots: Modern Controversies. BM. J Law, Med and Ethics 2004;Winter:741-748.
• 2004 Publication: “ In light of growing use of DBSs and their potential secondary applications, proactive solutions should be envisaged to ensure proper protection of choice, consent, and the privacy and confidentiality of genetic information. Transparency, supervision, strict rules for scientific study and informed consent requirements, are rules that a properly regulated biobank should live by.” Source: Storing Newborn Blood Spots: Modern Controversies. Kharaboyan L, Avard D, Knoppers BM. J Law, Med and Ethics. 2004; Winter:741-748.1
• 2009 Newspaper Article: “Medical privacy advocates, ethicists say parents should be asked for consent before newborns’ screening samples are kept.” Source: Austin American Statesman, Sunday, February 22, 2009.
Consent - The Issue“Residual NBS dried-blood spots have taken on a new life as a result of developments in genetics and increasing ability of bioinformatics to link
DNA information with clinical data.”1
1 Storing Newborn Blood Spots: Modern Controversies. BM. J Law, Med and Ethics 2004;Winter:741-748.
Thesis: Dried-blood specimens that remain after newborn screening is completed are valuable resources that should be carefully and thoughtfully preserved and used for public health benefit.
Approach: To develop a national guidance policy for retaining and using dried blood specimens that remain after newborn screening is completed.