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Newborn Blood Spot Banking: Approaches to Consent - PredictER Law and Policy Update

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BACKGROUND

Since 1965, nearly all newborns in the United States receive a heel prick; health professionals use the resulting blood spots in newborn screening. After collection, the newborn blood spot (NBS) samples are sent to the state’s health department for testing, retained for varying lengths of time, and, in some cases, used for research purposes. Traditionally, state health departments have stored NBS for confirmatory diagnosis and quality assurance testing. Most states do not inform parents of retention and research use of NBS; early screening tests can prevent avoidable injuries to newborns. Accordingly, many state health departments do not obtain consent before storing and using the NBS for further research. Recently, researchers in the state health departments and associated research partners (at universities or private companies) have become interested in banking NBS for research on disease development and gene-environment interactions. This raises the question: should researchers and biobanks acquire parental consent for the use of a child’s NBS in research?

Many scholars have argued that the collection and use of NBS should be governed by the Common Rule and that parents should provide consent to allow use of their child’s NBS. Applying the Common Rule would mean that infants are human research subjects when their NBS are collected for an identified research project (such as a biobank at a state health department) and when these samples are matched with personally indentifying information. Other scholars argue that research using NBS is merely an extension of the newborn screening program and the state health department or its associated researchers need not inform the newborn’s parents or obtain their consent. A third approach recognizes that screening of the newborn’s blood is distinct from research, but allows the state health department and its researchers to use the NBS unless the parent opt-out.

Federal guidance in this area notes the importance for each state to develop either a statutory or policy approach within the state health department that governs collection, storage, and research use of NBS. In August 2009, HHS’ Advisory Committee on Heritable Disorders in Newborns and Children issued a summary of recommendations on the storage and use of NBS samples. It proposed that states either adopt a consent or an opt-out approach to use NBS for research.

Some states have specific legislation authorizing the state health department to retain NBS for research, others do not allow research without parental consent, and many contain ambiguous or conflicting statutory sections governing screening, NBS research, and genetic privacy.

Recently, controversies in Minnesota and Texas exemplified the uncertainty and confusion resulting from various interpretations of the newborn screening statute. Determining whether genetic privacy protections apply or whether the statute permits or authorizes additional research, has proved to be exceptionally difficult. In both states parents filed civil complaints against the state health department, claiming that the health department’s failure to obtain their consent to store and use their child’s NBS violated their child’s privacy and property rights. In Bearder v. Minnesota, the court dismissed the lawsuit and the state health department continues to collect, retain, and use NBS unless parents object and opt-out. During the pending litigation in Texas, Governor Rick Perry signed H.B. 1672, effective September 2009, instituting a similar opt-out policy. In Beleno v. Tex. Dept. of State Health Servs., the parents and state health department settled the lawsuit by agreeing the state health department would: post, online, the research projects NBS were used for; inform the parents of the lawsuit how their child’s NBS was used; and destroy over four million NBS it had obtained without parental consent.

ISSUES

Federal and State Law

  • Should the collection of NBS for banking and research be classified as human subjects research and governed under the Common Rule?
  • Does HHS’ federal guidance recommending either a consent or opt-out policy properly apply the Common Rule’s consent or waiver requirements?
  • Knowing that NBS contains genetic information and may be used for genetic research, should state statutory genetic privacy protections apply to the collection, retention, and research use of NBS?

Ethics

  • Does a policy that allows retention and research use of NBS without parental consent improperly prioritize a research agenda over individual interests? Does an opt-out policy sufficiently remedy these concerns?
  • Does the practice of retaining and using, without consent, NBS (which contain sensitive medical and genetic information) violate a child’s privacy?

Policy Considerations

  • Should options for consent change depending on the location of research (sharing NBS with a university or private corporation versus research within the health department)?
  • How can a state health department intending to bank the NBS develop a policy that fully informs parents about NBS retention and research?
  • Should the state health department treat retrospectively collected samples differently than prospectively collected samples? In other words, should the state allow researchers to use samples in existing collections without requiring researchers to find parents and request consent, but require parental consent to use samples collected in the future?
  • Recent research suggests parents will consent to allow the state health department to use their child’s NBS as long as they are asked. Knowing this, is the administrative burden of obtaining consent from all parents a sufficient reason to adopt or to maintain a state policy of banking NBS without consent?

RECENT DEVELOPMENTS

Federal Law, Guidance, and Initiatives

Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children

This HHS Committee issued a summary of recommendations relating to storage and use of NBS samples, which it refers to as a biobank. It recommended that each state disseminate policies that promote public trust, emphasize transparency, and encourage informed public participation. It promulgated seven recommendations including: all states should have a policy in place to address NBS retention and use, this policy should address research access and use of samples, provide educational materials to the public and expecting mothers on use and potential future uses, adopt an opt-in or opt-out model if the samples are available for any process outside the screening process not including internal test development of screening tests, and assess the utility of the opt-in or opt-out process.

Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. Briefing paper: considerations and recommendations for a national policy regarding the retention and use of dried blood spot specimens after newborn screening. Draft. Genetic Alliance Resource Repository, August 21, 2009. Available from: http://www.resourcerepository.org

Newborn Screening Saves Lives Act of 2007

In 2008, Congress passed the Newborn Screening Saves Lives Act designed to promote and improve newborn screening for heritable disorders, develop population research surveillance and epidemiology, and expand research partnerships within the government as well as academic and private institutions. The Act will unify and nationalize the data collection resulting from state screening programs by standardizing data collection and reporting into a coordinated surveillance system to record and track newborns with a genetic, heritable, or metabolic disorder.

Newborn Screening Saves Lives Act, Pub. L. No. 110-204 (APR. 24, 2008). Available from: http://frwebgate.access.gpo.gov/.

Newborn Screening Translation Research Initiative (NSTRI)

In 2005 the CDC developed the Newborn Screening Translation Research Initiative (NSTRI). The initiative was designed to facilitate the creation of a biobank (currently not consisting of NBS) available for research including the development of screening technologies. The NSTRI works to understand how genetic and biochemical differences that occur within the population can be used to improve newborn screening.

The Newborn Screening Translation Research Initiative (NSTRI). CDC Foundation. Available from: http://www.cdcfoundation.org/programs/nstri/

Selected State Statutory Materials and Resources

MICHIGAN

Michigan Statutes

Michigan contains specific protections for genetic information and genetic tests, but it also contains a broad exception for newborn screening and research.

MICH. COMP. LAWS ANN. § 333.17020 (2010): Genetic test; informed consent. Available from: http://legislature.mi.gov/doc.aspx?mcl-333-17020.

MICH. COMP. LAWS ANN. §333.5431 (2010): Testing newborn infant for certain conditions. Available from: http://legislature.mi.gov/doc.aspx?mcl-333-5431.

Michigan BioTrust

Michigan created a biobank called Michigan BioTrust for Public Health that retains and uses NBS unless parents opt-out.

Michigan BioTrust for Health, The Michigan Department of Community Health (MDCH). Available from: http://www.michigan.gov/mdch/0,1607,7-132-2942_4911_4916_53246---,00.html.

Michigan News Headlines

Tom Henderson. TechTown to open repository for newborn blood samples. Bridging 96. April 15, 2009. Available from: http://www.detroitmakeithere.com/article/20090415/BRIDGING96/904139991/1125.

Anne Rueter. Ask permission to use newborn data, parents say. University of Michigan Health System Newsroom. July 15, 2009. Available from: http://www2.med.umich.edu/prmc/media/newsroom/details.cfm?ID=1217.

TEXAS

Texas Statutes

TEX. HEALTH & SAFETY CODE (2010): Newborn screening; test requirement. Available from: http://www.statutes.legis.state.tx.us/Docs/HS/htm/HS.33.htm#33.011.

TEX. OCC. CODE § 58.103 (2010): Disclosure of genetic information; confidentiality; exceptions. Exceptions to confidentiality. Available from: http://www.statutes.legis.state.tx.us/Docs/OC/htm/OC.58.htm#58.103.

Proposed Legislation

H.B. 1672, 81st Leg. (Tex. 2009): An act relating to the confidentiality of newborn screening information. Available from: http://www.legis.state.tx.us/BillLookup/Text.aspx?LegSess=81R&Bill=HB1672.

Statutory Interpretation Debate

Texas Civil Rights Project. Parents Sue Texas Health Dept. and Texas A&M over Infant Blood Databank. TCRP Press Release. March 18, 2009. Available from: http://www.texascivilrightsproject.org/?p=1096.

Texas Civil Rights Project, privacy advocates, asserted collecting, retaining, and using NBS without consent violated newborns’ property and privacy rights.

Texas News Headlines

Nanci Wilson. Government taking newborn DNA samples: many ask why they are saving the samples. KXAN Austin News. November 24, 2009. Available from: http://www.kxan.com/dpp/health/government-taking-newborn-dna-samples

Peggy Fikac. State to destroy 4 million newborn blood samples. The Houston Chronicle. December 22, 2009. Available from: http://www.chron.com/disp/story.mpl/metropolitan/6782897.html

MINNESOTA

Minnesota Statutes

MINN. STAT. § 13.386 (2010): Treatment of genetic information held by government entities and other persons. Available from: https://www.revisor.mn.gov/statutes/?id=13.386

MINN. STAT. § 144.125 (2010): Tests of infants for heritable and congenital disorders. Available from: https://www.revisor.mn.gov/statutes/?id=144.125

Proposed Legislation

H.F. 1341, 86th Leg. (Minn. 2009-2010): A bill for an act relating to health; changing provisions in the newborn screening program. Available from: https://www.revisor.mn.gov/revisor/pages/search_status/status_detail.php?b=House&f=HF1341&ssn=0&y=2009

S.F. 3138, 85th Leg. (Minn. 2007-2008): A bill for an act relating to health; changing provisions for handling genetic information from newborn screening. Available from: https://www.revisor.mn.gov/revisor/pages/search_status/status_detail.php?b=Senate&f=SF3138&ssn=0&y=2008

S.F. 1478, 86th Leg. (Minn. 2009-2010): A bill for an act relating to health; changing provisions for handling genetic information from newborn screening. Available from: https://www.revisor.mn.gov/revisor/pages/search_status/status_detail.php?b=Senate&f=SF1478&ssn=0&y=2010

Administrative Law Judge’s Decision

During a rulemaking session, a Minnesota Administrative Law Judge found that the GPA did apply to the newborn screening and research activities.

In the Matter of the Proposed Amendments to Rules Governing Newborn Screening, Minnesota Rules, Chapter 4615. Report of the Administrative Law Judge. Office of Administrative Hearings for the Department of Health, State of Minnesota. Available from: http://www.oah.state.mn.us/aljBase/090017586.rr.htm.

Statutory Interpretation Debate

Citizens' Council on Health Care (CCHC). It's My DNA! Newborn Genetic Testing. CCHC. Available from: http://www.cchconline.org/issues/NewbornGeneticTestingMN.php.

CCHC, a privacy advocacy organization, argued newborn screening program activities (inclusive of subsequent research and sharing of NBS) were not exempt from the Minnesota Genetic Privacy Act (GPA).

Governor Tim Pawlently (Office of the Governor, State of Minnesota). Letter to: Senator James Metzen (President of the Senate, Minnesota) May 20, 2008. Available from: http://www.forhealthfreedom.org/BackgroundResearchData/MN_NewbornScreening2008.pdf

Governor Tim Pawlenty concluded newborn screening program activities (inclusive of subsequent research and sharing of NBS) were not exempt from the Minnesota Genetic Privacy Act (GPA) and vetoed S.F. 3138.

Dianne M. Mandernach, Commissioner. (Minnesota Department of Health). Letter to: Raymond R. Krause, Chief Administrative Law Judge. (Office of Administrative Hearings, Minnesota). June 27, 2007. Available from: http://www.oah.state.mn.us/cases/health4615/090017586-recon-request.pdf

Minnesota Department of Health maintained its activities relating to NBS were not governed by the GPA.

Minnesota News Headlines

Citizen's Council on Health Care. Nine Families Sue State of Minnesota: Allege Violations of State Genetic Privacy Law in Newborn Screening. CCHC Press Release. March 11, 2009. Available from: http://www.cchconline.org/pr/pr031109.php.

Michelle Lore. Is the Minnesota Department of Health violating privacy laws? The Minnesota Lawyer. November 30, 2009. Available from: http://www.allbusiness.com/legal/trial-procedure-judges/13462702-1.html.

Survey Research

Olney RS, Moore CA, Ojodu JA, Lindegren ML, Hannon WH. Storage and use of residual dried blood spots from state newborn screening programs. J Pediatr. 2006 May;148(5):618-22. PubMed PMID: 16737872.

Olney et al. reviewed 49 state’s policies and found approximately half of states stored NBS for more than 6 months. 57% of states do not have a written policy on how NBS can or cannot be used, and only 16% informed parents that NBS might be retained.

Tarini BA, Goldenberg A, Singer D, Clark SJ, Butchart A, Davis MM. Not without my Permission: Parents' Willingness to Permit Use of Newborn Screening Samples for Research. Public Health Genomics. 2009 Jul 11. PubMed PMID: 19602864.

Tarini et al. examined parental willingness to permit NBS sample storage and research without their consent. If permission is obtained, 76.2% of parents were very or somewhat willing to permit use of NBS for research. If permission was not obtained, only 28.2% of parents would be very or somewhat willing to permit use of NBS for research.

Goldenberg AJ. Ethics at the crossroads of public health and biobanking: the use of Michigan’s residual newborn screening bloodspots for research [dissertation]. [Ohio]: Case Western Reserve University; 2009. 176 p. Available from: http://etd.ohiolink.edu/view.cgi?acc_num=case1228421146

Goldberg’s dissertation contains a comprehensive discussion of NBS banking related issues and provides charts summarizing portions of his research. Goldenberg found that fifteen states contain language authorizing retention and research use of NBS. Only twelve states contain some language in parent educational materials pertaining to use of NBS following screening. Just four states fully address the issue to include information that tells parents their child’s sample will be retained, explain privacy concerns, and provide parents a choice relating to the sample disposition.

General News

Elizabeth Cohen. The government has your baby's DNA. CNN Health. February 4, 2010. Available from: http://www.cnn.com/2010/HEALTH/02/04/baby.dna.government/

Jennifer Couzin-Frankel. Newborn blood collections. Science gold mine, ethical minefield. Science. 2009 Apr 10;324(5924):166-8. PubMed PMID: 19359558.

American College of Medical Genetics. American College of Medical Genetics affirms importance of newborn screening dried blood spots. ACMG Press Release, EurekAlert! May 11, 2009. Available from: http://www.eurekalert.org/pub_releases/2009-05/acom-aco051109.php

Alexis Madrigal. Newborn-blood storage law stirs fears of DNA warehouse. Wired. May 21, 2008. Available from: http://www.wired.com/medtech/genetics/news/2008/05/newborn_screening

Innocent blood: use of newborn heel sticks spurs legal challenges. IRB Advisor Dec 1, 2009. Available from (subscription required): http://www.ahcpub.com/archive/?efrlk=211

Bob Bryan. A closer look at biobanking of newborn blood spots. Genomics Law Report. July 1, 2009. Available from: http://www.genomicslawreport.com/index.php/2009/07/01/a-closer-look-at-biobanking-of-newborn-blood-spots/

RELEVANT CASES

Bearder v. Minnesota

In June 2009, Minnesota parents Bearder et al. filed a civil complaint against the Minnesota Department of Health (MDH) alleging a series of claims, including violation of the Minnesota Genetic Privacy Act (GPA), eight tort claims, fundamental rights claims, and government taking arising from retaining and using their children’s NBS for research without consent. In the Prayer for Relief, plaintiffs requested damages as statutorily indicated, requested an injunction, and a cease and desist order against MDH.

MDH filed a Motion to Dismiss, or in the alternative, Summary Judgment in their favor. MDH argued the GPA did not apply to MDH’s actions and MDH merely exercised reasonable discretion when deciding to retain and use the NBS for research. Defendants asserted that a section in the newborn screening statute contained an express provision exempting MDH from the GPA’s usual requirement of consent to retain, use, or share genetic information for research. Accordingly, defendants used this argument to counter plaintiffs’ privacy and tort claims by asserting they lawfully acquired and possessed the NBS as statutorily proscribed, undermining any impermissible intrusion into plaintiffs’ rights.

In November 2009, Judge Rosenbaum handed down an order granting defendants’ Motion to Dismiss. Judge Rosenbaum wholly accepted defendants’ argument relating to statutory interpretation of the GPA, which in turn disposed of plaintiffs’ additional tort and fundamental right claims. Even if the GPA would apply, Judge Rosenbaum concluded that the statutory provision stating that NBS “may be retained by [MDH]” constituted an express provision that would exempt MDH’s retention, research use, and research sharing from the GPA. Thus, the court’s conclusion the GPA did not apply to MDH’s treatment of the NBS following screening meant that its research activities were within its discretion and did not violate plaintiffs’ rights. As a result, Judge Rosenbaum stated that plaintiffs had no viable claims and dismissed plaintiffs’ complaint entirely.

Selected Docket Materials

Plaintiffs’ Complaint, Bearder v. Minnesota, No. 27-CV-09-5615 (D. Minn. 2009). Available from: http://www.cchconline.org/pr/FINAL_Plaintif_s_v_MDH_complaint.doc

Plaintiffs’ Memorandum of Law, Bearder v. Minnesota, No. 27-CV-09-5615 (D. Minn. 2009). Available from: http://www.cchconline.org/pdf/Plaintiffs-Memo-of-Law-FINAL.pdf

Defendants’ Memorandum in Support of Motion to Dismiss, or in the Alternative, Motion for Summary Judgment on Plaintiffs’ State Statutory Claim, Bearder v. Minnesota, No. 27-CV-09-5615 (D. Minn. 2009). Document obtained from David Orren, Chief Legal Counsel at Minnesota Department of Health.

Defendants’ Supplemental Memorandum in Support of Motion to Dismiss First Amended Complaint, or in the Alternative, Motion for Summary Judgment, Bearder v. Minnesota, No. 27-CV-09-5615 (D. Minn. 2009). Document obtained from David Orren, Chief Legal Counsel at Minnesota Department of Health.

Order Granting Motion to Dismiss, Bearder v. Minnesota, No. 27-CV-09-5615 (D. Minn. 2009). Available from: http://www.cchconline.org/pdf/JudgeRosenbaumOrder113009.pdf

Beleno v. Tex. Dept. of State Health Servs.

In March 2009, parents Beleno et al., filed a civil complaint Beleno v. Tex. Dept. of State Health Servs. (TDSHS) claiming TDSHS had no legal authority to retain and use their children’s NBS without consent. Among a litany of claims, Beleno et al. asserted this practice violated privacy principles stemming from the Fourth and Fourteenth Amendments and state privacy laws, as well as violated a prohibition against seizure. In the Prayer for Relief, Beleno et al. requested that the court order the destruction of all NBS stored without consent (around 4 million samples collected, beginning in 2002) or obtain retroactive parental consent. Additionally, plaintiffs sought an order to compel TDSHS to disclose for what purposes the NBS had been used and financial transactions involving the NBS.

Defendants filed a Motion to Dismiss, and separately filed Answers with Affirmative Defenses. Defendants argued their procedures comported with the law because consent was not required to collect samples for retention and research. Defendants argued the Common Rule did not apply, a privacy interest did not exist (or, in the alternative, existing law adequately protected this interest), plaintiffs’ consent for NBS collection for screening negated subsequent claims, and TDSHS acted in the public interest.

In September 2009, Judge Biery denied defendants’ Motions to Dismiss for portions of the claims and parties began settlement negotiations. In December 2009, parties reached and filed a Settlement Agreement that adopted several elements of plaintiffs’ Prayer for Relief contained in the Complaint relating to the program operation practices as well actions applicable to the specific plaintiffs. Parties agreed that TDSHS would destroy the approximately 4.5 million samples taken between 2002 (when it began retaining samples for research) and May 27, 2009. It also proscribed two general informational requirements: TDSHS must post on its website a list of all research projects for which it has provided samples and a list of categories of quality assurance and quality control uses projects for which it has provided samples. Additionally, TDSHS must inform plaintiffs in writing of how their child’s sample was used as well as any financial transactions involving that sample.

Selected Docket Materials

Plaintiffs’ Complaint, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Available from: http://www.genomicslawreport.com/wp-content/uploads/2010/01/Beleno-complaint.pdf

Plaintiffs’ Response to Defendants’ Motion to Dismiss, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Available from: http://www.genomicslawreport.com/wp-content/uploads/2010/01/Beleno-response-to-motion-to-dismiss.pdf

Defendants’ Motion to Dismiss Plaintiffs’ Original Complaint, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Document obtained from plaintiffs’ attorney, Jim Harrington, at the Texas Civil Rights Project.

Texas A&M et al.’s Original Answer and Affirmative Defenses to Plaintiffs’ Original Complaint, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Document obtained from plaintiffs’ attorney, Jim Harrington, at the Texas Civil Rights Project.

Texas Dept. of State Health Services et al. Original Answer and Affirmative Defenses to Plaintiffs’ Original Complaint, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Document obtained from plaintiffs’ attorney, Jim Harrington, at the Texas Civil Rights Project.

Order Regarding Defendants’ Motion to Dismiss and Defendants’ Motion to Dismiss or for Summary Judgment Based on Mootness, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Available from: http://www.genomicslawreport.com/wp-content/uploads/2010/01/Beleno-order.pdf

Settlement Agreement and Release, Beleno v. Tex. Dept. of State Health Servs., No. SA-09-CA-188-FB (W.D. Tex. 2009). Document obtained from plaintiffs’ attorney, Jim Harrington, at the Texas Civil Rights Project.


Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update. Indiana University Center for Bioethics. March 12, 2010. | PDF - 114 KB

Predictive Health Ethics Research (PredictER), a multidisciplinary research, policy and public education program at the Indiana University Center for Bioethics is supported by a grant from the Richard M. Fairbanks Foundation.