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The Impact of Obtaining Documented Informed Consent on MS/MS Screening

The Impact of Obtaining Documented Informed Consent on MS/MS Screening. L.A. Faulkner 1 , L.B. Feuchtbaum 2 , M. Hanlon 1 , F.W. Lorey 2 , K. Velazquez 2 , and G.C. Cunningham 2. Funded by Health Resources and Services Administration grant #5 H46 MC00199-03.

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The Impact of Obtaining Documented Informed Consent on MS/MS Screening

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  1. The Impact of Obtaining Documented Informed Consent on MS/MS Screening L.A. Faulkner1, L.B. Feuchtbaum2, M. Hanlon1, F.W. Lorey2, K. Velazquez2, and G.C. Cunningham2 Funded by Health Resources and Services Administration grant #5 H46 MC00199-03 1 Public Health Institute, 2 Genetic Disease Branch (GDB), California Department of Health Services

  2. Purpose of Research To assess the impact of obtaining documented informed consent on participation & informed decision-making during population-based newborn screening for inborn errors of metabolism (IEM) using tandem mass spectrometry (MS/MS)

  3. Introduction to Newborn Screening in California • Mandatory newborn screening (NBS) program allows refusal for religious reasons only • 18 month supplemental screening research project required written informed consent to ensure voluntary MS/MS screening

  4. Informed Consent Process

  5. Consent Form

  6. Overview of Methods • Tracked uptake of MS/MS screening in prospective cohort by hospital • Surveyed prenatal care providers by mail • Conducted 5 focus groups with 31 pregnant women

  7. Summary of MS/MS Screening *Excludes PKU

  8. Hospital MS/MS Participation

  9. Prenatal Care Provider Survey • Mailed 12 question survey to 6200 providers • Questions asked about knowledge & experience • 700 surveys returned for 11% response rate as shown

  10. How Providers Learned GDB Offered MS/MS Screening

  11. How Providers Handed Out Educational Materials to Patients

  12. Focus Group Questions • What information is most important? • What would influence you to not have test? • How else would you like to receive this info? • Importance of choosing to participate? • What should the State address before making it mandatory? • Introductions? • How many received IIP booklet? • What do you think of it? • Advantages/Concerns? • Feelings about making the decision? • What information do you think should be in the IIP booklet?

  13. What Participants Told Us • Benefits and risks not understood • Importance of testing not conveyed • Purpose of research not obvious • Didn’t hear from prenatal provider but want to • Choice is important, but not to all • Don’t overwhelm with dense or confusing text • Provide more information in their words

  14. Burdens of Informed Consent • Increased time and effort for Genetic Disease Branch, State IRB, and hospitals • Reduced population screened • 354,000 for MS/MS vs. 756,000 mandatory NBS • <1% refusal in mandatory NBS vs. 10 – 50% non-acceptance in MS/MS • 52 diagnosed disorders in screened population vs. 12 (59 expected) in non-screened population • Didn’t meet parents’ needs

  15. Recommendations for Population-based Research • Obtain waiver of informed consent, if possible, by demonstrating: • Minimal risk to participants • Participant rights not adversely affected • Informed consent is impractical • Educational materials still provided • Improve educational materials, especially by using parents’ words • Reduce barriers for prenatal care providers (e.g. combine prenatal and newborn screening materials)

  16. More Details About Evaluation Study Available Visit our web-site www.CaliforniaMsMs.org Special thanks to all staff at the Genetic Disease Branch, California providers, patients and contract staff.

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