79
Views
3
CrossRef citations to date
0
Altmetric
Original Research

Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US

, &
Pages 1-8 | Published online: 19 Jan 2017

References

  • Code of Federal Regulations. 45 CFR 46.116—General Requirements for Informed Consent Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/Accessed January 4, 2017
  • YawnBPYawnRAGeierGRXiaZJacobsenSJThe impact of requiring patient authorization for use of data in medical records researchJ Fam Pract19984753613659834771
  • JacobsenSJXiaZCampionMEPotential effect of authorization bias on medical record researchMayo Clin Proc199974433033810221460
  • WoolfSHRothemichSFJohnsonREMarslandDWSelection bias from requiring patients to give consent to examine data for health services researchArch Fam Med20009101111111811115216
  • TuJVWillisonDJSilverFLInvestigators in the Registry of the Canadian Stroke NetworkImpracticability of informed consent in the Registry of the Canadian Stroke NetworkN Engl J Med2004350141414142115070791
  • BuckleyBMurphyAWByrneMGlynnLSelection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart diseaseHeart20079391116112017502325
  • SACHRPJanuary 10, 2013 SACHRP Letter to the HHS Secretary; Attachment D: Informed Consent and Waiver of ConsentSACHRP2013 Available from: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2013-january-10-letter/index.htmlAccessed January 4, 2017
  • JunghansCFederGHemingwayHTimmisAJonesMRecruiting patients to medical research: double blind randomised trial of “opt-in” versus “opt-out” strategiesBMJ2005331752294016157604
  • BerryJGRyanPGoldMSBraunack-MayerAJDuszynskiKMVaccine Assessment Using Linked Data (VALiD) Working GroupA randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkageJ Med Ethics2012381061962522518045
  • HiggersonRAOlshoLEChristieLMPALISI PICFlu Study InvestigatorsVariability in IRBs regarding parental acceptance of passive consentPediatrics20141342e496e50325002659
  • DamschroderLJPrittsJLNebloMAKalarickalRJCreswellJWHaywardRAPatients, privacy, and trust: patients’ willingness to allow researchers to access their medical recordsSoc Sci Med200764122323517045717
  • BrothersKBWestbrookMJWrightMFPatient awareness and approval for an opt-out genomic biorepositoryPer Med2013104349359
  • StevensonFLloydNHarringtonLWallacePUse of electronic patient records for research: views of patients and staff in general practiceFam Pract201330222723223132893
  • KassNENatowiczMRHullSCThe use of medical records in research: what do patients want?J Law Med Ethics200331342943314626550
  • MillerFJThe Ethical Challenges of Human Research: Selected EssaysOxfordOxford University Press2012
  • MenonKWardRCanadian Critical Care Trials GroupA study of consent for participation in a non-therapeutic study in the pediatric intensive care populationJ Med Ethics201440212312623345569
  • FisherJAKalbaughCAChallenging assumptions about minority participation in US clinical researchAm J Public Health2011101122217222222021285
  • Corbie-SmithGThomasSBSt GeorgeDMDistrust, race, and researchArch Intern Med2002162212458246312437405
  • BraunsteinJBSherberNSSchulmanSPDingELPoweNRRace, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trialsMedicine (Baltimore)20088711918204365