title: Conducting a large, multi-site survey about patients' views on broad consent: challenges and solutions.
abstract: As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic.
  
  
  
  A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results.
  
  
  
  Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers.
  
  
  
  Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.
authors.affiliation: Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, 645 N. Michigan Avenue, Chicago, IL, 60611, USA. m-smith6@northwestern.edu.
authors.forename: Maureen E
authors.initials: ME
authors.lastname: Smith
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA.|University College London, London, UK.
authors.forename: Saskia C
authors.initials: SC
authors.lastname: Sanderson
authors.affiliation: University of Louisville School of Medicine, Louisville, KY, USA.
authors.forename: Kyle B
authors.initials: KB
authors.lastname: Brothers
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Melanie F
authors.initials: MF
authors.lastname: Myers
authors.affiliation: Penn State College of Medicine, Hershey, PA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: McCormick
authors.affiliation: Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University, 645 N. Michigan Avenue, Chicago, IL, 60611, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Aufox
authors.affiliation: Vanderbilt University Medical Center and Vanderbilt University, Nashville, TN, USA.
authors.forename: Martha J
authors.initials: MJ
authors.lastname: Shrubsole
authors.affiliation: Seattle Children's Research Institute, Seattle, WA, USA.
authors.forename: Nanibaá A
authors.initials: NA
authors.lastname: Garrison
authors.affiliation: Vanderbilt University Medical Center and Vanderbilt University, Nashville, TN, USA.
authors.forename: Nathaniel D
authors.initials: ND
authors.lastname: Mercaldo
authors.affiliation: Vanderbilt University Medical Center and Vanderbilt University, Nashville, TN, USA.
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Schildcrout
authors.affiliation: Vanderbilt University Medical Center and Vanderbilt University, Nashville, TN, USA.
authors.forename: Ellen Wright
authors.initials: EW
authors.lastname: Clayton
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Armand H Matheny
authors.initials: AH
authors.lastname: Antommaria
authors.affiliation: Vanderbilt University Medical Center and Vanderbilt University, Nashville, TN, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Basford
authors.affiliation: Marshfield Clinic Research Foundation, Marshfield, WI, USA.
authors.forename: Murray
authors.initials: M
authors.lastname: Brilliant
authors.affiliation: The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
authors.forename: John J
authors.initials: JJ
authors.lastname: Connolly
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Fullerton
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Carol R
authors.initials: CR
authors.lastname: Horowitz
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: Gail P
authors.initials: GP
authors.lastname: Jarvik
authors.affiliation: National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Dave
authors.initials: D
authors.lastname: Kaufman
authors.affiliation: Marshfield Clinic Research Foundation, Marshfield, WI, USA.
authors.forename: Terri
authors.initials: T
authors.lastname: Kitchner
authors.affiliation: National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Rongling
authors.initials: R
authors.lastname: Li
authors.affiliation: Group Health Research Institute, Seattle, WA, USA.
authors.forename: Evette J
authors.initials: EJ
authors.lastname: Ludman
authors.affiliation: Essentia Institute of Rural Health, Duluth, MN, USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: McCarty
authors.affiliation: Marshfield Clinic Research Foundation, Marshfield, WI, USA.
authors.forename: Valerie
authors.initials: V
authors.lastname: McManus
authors.affiliation: Vanderbilt University Medical Center and Vanderbilt University, Nashville, TN, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Stallings
authors.affiliation: Geisinger Health System, Danville, PA, USA.
authors.forename: Janet L
authors.initials: JL
authors.lastname: Williams
authors.affiliation: Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Ingrid A
authors.initials: IA
authors.lastname: Holm
mesh_terms: D003219:Confidentiality; D057286:Electronic Health Records / Q000706:statistics & numerical data*; D055106:Genome-Wide Association Study / Q000706:statistics & numerical data*; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D007258:Informed Consent; D054560:National Human Genome Research Institute (U.S.); D010358:Patient Participation; D028701:Patient Rights; D011795:Surveys and Questionnaires; D014481:United States
keywords: Cognitive interviews; Consent; Genomics; Institutional Review Board; Multi-site; Pilot; Survey