Return of Results from Research Using Newborn Screening Dried Blood Samples

Linabery A. M. , “Feasibility of Neonatal Dried Blood Spot Retrieval Amid Evolving State Policies (2009–2012): A Children's Oncology Group Study,” Paediatric and Perinatal Epidemiology 25, no. 6 (2011): 549–558.

Lewis M. H. , “Research Results: Preserving Newborn Blood Samples,” Science Translational Medicine 4, no. 159 (2012): 159cm12.

Institute of Medicine, Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research (Washington, D.C.: National Academies Press, 2010).

Centers for Disease Control and Prevention (CDC), “CDC Grand Rounds: Newborn Screening and Improved Outcomes,” Morbidity and Mortality Weekly Report 61, no. 21 (2012): 390–393.

Chan K. Puck J. M. , “Development of Population-Based Newborn Screening for Severe Combined Immunodeficiency,” Journal of Allergy and Clinical Immunology 114, no. 2 (2005): 391–398.

Baker M. W. , “Improving Newborn Screening for Cystic Fibrosis Using Next Generation Sequencing Technology: A Feasibility Study,” Genetics in Medicine (2015), available at <http://www.nature.com/gim/journal/vaop/ncurrent/full/gim2014209a.html> (last visited August 18, 2015).

Burse V. W. , “Preliminary Investigation of the Use of Dried-Blood Spots for the Assessment of In Utero Exposure to Environmental Pollutants,” Biochemistry and Molecular Medicine 61, no. 2 (1997): 236–239.

Morak M. , “Clone-Specific Secondary Aberrations Are Not Detected in Neonatal Blood Spots of Children with ETV6-RUNX1-Positive Leukemia,” Haemotologica 98, no. 9 (2013): e108–e110.

Yau V. M. , “Prenatal and Neonatal Peripheral Blood Mercury Levels and Autism Spectrum Disorders,” Environmental Research 133 (August 2014): 294–303.

Barbi M. Caroppo S. , “Diagnosis of Congenital CMV Infection Via Dried Blood Spots,” Reviews in Medical Virology 16, no. 6 (2006): 385–392.

McCann P. , Minnesota Department of Health, “Mercury Levels in Blood from Newborns in the Lake Superior Basin, Final Report to the EPA,” November 30, 2011, GLNPO ID 2007–942, available at <http://www.health.state.mn.us/divs/eh/hazardous/topics/studies/glnpo.pdf> (last visited August 18, 2015).

Centers for Disease Control and Prevention (CDC), Behavioral Risk Factor Surveillance System, available at <www.cdc.gov/brfss/> (last visited August 18, 2015).

Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH Program Explores the Use of Genomic Sequencing in Newborn Health Care, Press Release, September 4, 2013, available at <www.nichd.nih.gov/news/releases/Pages/090413-newborn-sequencing.aspx> (last visited August 18, 2015).

American College of Medical Genetics and Genomics, ACMG Is Awarded Five Year, $12.5 Million Dollar Contract Renewal to Continue Important Efforts in Newborn Screening, Press Release, October 17, 2014, available at <https://www.acmg.net/docs/NBSTRN_Final.pdf> (last visited August 18, 2015).

Newborn Screening Translational Research Network, available at <https://www.nbstrn.org/research-tools/virtual-repository-of-dried-blood-spots> (last visited August 18, 2015).

Cohen E. , “The Government Has Your Baby's DNA!” CNN.com, February 4, 2010, available at <www.cnn.com/2010/HEALTH/02/04/baby.dna.government/index.html> (last visited August 18, 2015).

Segall B. , “Your Child's DNA: Who Has It?” WTHR Indianapolis, July 7, 2014, available at <http://www.wthr.com/story/25954821/2014/07/07/your-childs-dna-who-has-it> (last visited August 18, 2015).

Complaint, Beleno v. Texas Dept. of State Health Serv., No. 5:2009cv00188 (U.S. District Court for the Western District of Texas in San Antonio March 3, 2009).

Bearder v. State, 806 N.W.2d 706 (Minn. 2011).

Complaint Doe v. VanNess, No. 49D011409CT031 (Marion County Superior Court September 25, 2014).

Editorial, “There Will Be Blood,” Nature 475 (2011): 139.

45 C.F.R. § 46 (2009).

P.L. 113–240 (2014).

Mich. Comp. Laws § 333.5431 (2003).

Michigan Department of Community Health, Michigan Biotrust for Health, available at <www.michigan.gov/mdch/0,1607,7-132-2492_4911_4916–209738–,00.html> (last visited August 18, 2015).

New England Newborn Screening Program, available at <nensp.umassmed.edu> (last visited August 18, 2015).

See Michigan Department of Community Health, supra note 25.

Botkin J. , “Public Attitudes Regarding the Use of Residual Newborn Screening Specimens for Research,” Pediatrics 129, no. 2 (2012): 231–238.

105 Mass. Code Regs. 270.004 (2008).

105 Mass. Code Regs. 270.006(B) (2008).

See New England Newborn Screening Program, supra note 26.

S.C. Code Ann. Regs. 61–80 (2014).

Ande v. Fost, 647 N.W.2d 265 (Wisc. Ct. App. 2002).

Dinkins v. Hutzel Hospital, Inc. , 76 F.3d 378 (6th Cir.1996).

Lewis M. H. , “State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples,” Pediatrics 127, no. 4 (2011): 703–708.

Fabsitz R. R. , “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working Group,” Circulation: Cardiovascular Genetics 3, no. 6 (2010): 574–580.

Jarvik G. P. , “Return of Genomic Results to Research Participants: The Floor, the Ceiling, and the Choices in Between,” American Journal of Human Genetics 94, no. 6 2014): 818–826.

Wolf S. M. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data,” Genetics in Medicine 14, no. 4 (2012): 361–384.

Clayton E. W. , “Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children,” American Journal of Bioethics 14, no. 3 (2014): 3–9.

Anderson J. A. , “Predictive Genetic Testing for Adult-Onset Disorders in Minors: A Critical Analysis of the Arguments For and Against the 2013 ACMG Guidelines,” Clinical Genetics 187, no. 4 (2014): 301–310.

See Clayton , supra note 43.

Wilfond B. S. Carpenter K. J. , “Incidental Findings in Pediatric Research,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 332–340.

Watson M. S. , “Newborn Screening: Toward a Uniform Screening Panel and System-Executive Summary,” Pediatrics 117, no. 5 (2006): S296–S241.

Holm I. A. , “Clinical Management of Pediatric Genomic Testing,” Current Genetic Medicine Reports 2, no. 4 (2014): 212–215.

ACMG Act Sheets, American College of Medical Genetics and Genomics, available at <http://www.acmg.net/ACMG/Publications/ACT_Sheets_and_Confirmatory_Algorithms/About_NBS_ACT_Sheets_and_Algorithms/ACMG/Publications/ACT_Sheets_and_Confirmatory_Algorithms/About_NBS_ACT_Sheets_and_Algorithms_2.aspx?hkey=2a6a26bc-5728-44ea-a5fc-4d7932ce4281> (last visited August 18, 2015).