cerc/cerc survey work group presented by: maureen smith and ingrid holm for the cerc survey work...
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CERC/CERC SURVEY WORK GROUPPresented by:
Maureen Smith and Ingrid Holm
For the CERC Survey Work Group
eMERGE Steering Committee Meeting
June 29-30, 2015
Goals of the Survey• Development of a national survey to address changes in
the Advanced Notice of Proposed Rulemaking (ANPRM) including the requirement that participants consent to research use of their de-identified samples and data, obtained in a one-time, open-ended or “broad” fashion, greatly impacting biobank research.
• Survey developed regarding:• perspectives on broad consent and data sharing• perspectives on enrolling themselves, and their children <18 years
of age, in the biobank in which they were randomized
Overview• CERC Survey
• Majority of CERC work group members involved• All eMERGE sites participating
• 3 pediatric medical centers• 7 adult medical centers• 1 adult/pediatric
• Uniform printing and mailing through Scantron• Pilot: 1,500• Full Survey: 90,000- in second wave• Paper and web-based submission methods
DeliverablesDays Required Deliverable Responsible Party
Rollout 1/16/15 Mailing List Provided (Mail file 1) Sites 1/14/15 1st Pilot phase data file made available Scantron
1/15-2/2/15 Content Revised based on Pilot Results Survey Dev WG 2/2/15 Revised content submitted to IRBs Sites 3/5/15 $2 Bill Inserts Invoice for Rollout must be paid Sites 3/5/15 Proof Approval on Survey CC per sites
3/27/15 Pre-Notification Postcard Print & Distribution (Mail file 1) Scantron 4/3/15 Wave 1 Surveys Print & Distribution (Mail file 1) Scantron 4/3/15 Overnight Group Health Survey and Envelopes (all 20,000) Scantron
4/16/15 Data Collection (processing U) Scantron 4/22/15 Mailing List Update (removal of U, R & WR) (Mail file 2) Scantron/CC 5/13/15 1st Reminder Postcard Print & Distribution Scantron 6/1/15 Data Collection (processing U) Scantron 6/5/15 Mailing List Update (removal of U, R, PR & WR) (Mail file 3) Scantron/CC 6/8/15 First Data File Available Scantron 7/7/15 Wave 2 Surveys Print & Distribution (Mail file 3) Scantron 7/7/15 Mailing List Update (optional removal of R & WR) (Mail file 4) Scantron/CC
7/10/15 Second Data File Available Scantron 7/21/15 2nd Reminder Postcard Print & Distribution (Mail file 4) Scantron 8/13/15 Third Data File Available Scantron 8/29/15 Final Cutoff Date Scantron 9/4/15 Final Data File Available Scantron
*Dates are dependent on receipt of deliverables and approvals.
Full Survey Results (Wave 1)
Full Survey Results (Wave 1)
Hypothetical Biobank Scenarios
Scenario Data Sharing Type of Consent and Data Uses
A National database
You will be asked what types of medical research you will allow your health information to be used for
B National database
You will be agreeing for your health information to be used for all kinds of medical research
C Publicly accessible
online database
You will be agreeing for your health information to be used for all kinds of medical research
ManuscriptsTitle First Author Manuscript# Status
A Systematic Literature Review of Individuals’ Perspectives on Broad Consent and Data Sharing in the United States
Nanibaa´ Garrison NT125 Accepted to GIM, working on revisions
A Literature Review of US Individuals’ Perspectives on Privacy, Trust, and Perceived Risks and Benefits in Biobanking
Nanibaa´ Garrison NT144 In process
Developing a National Survey on Consent Across a National Network of Genomic Medicine Sites
Maureen Smith/Ingrid Holm
NT146 Writing, planned subm to AJE
A Review of US Individuals’ Perspectives on Governance and Consent in Biobanking
Nanibaa´ Garrison NT145 In process
Cognitive Interviews-no specific title yet
Melanie Myers NT147 Working on 1st draft
What are patients’ views on consent and data sharing in biobank research? A large multisite experimental survey in the US
Saskia Sanderson NT167 Finalizing CC
Manuscripts cont’dTitle First Author Manuscript # Status
A targeted sampling scheme utilizing both EHR and census information
Nate Mercaldo Finalizing CC
Multi-site IRB review – experience of the eMERGE Network
Jen McCormick Finalizing CC
Methodologic approaches to analyzing survey data
Nate Mercaldo/Jonathan Schildcrout
Finalizing CC
…..and more
Presentations• Abstract submitted to ASHG (early August notification)
• “A Large Scale Survey Conducted by the eMERGE Network of Patient Perspectives on Broad Consent and Data Sharing in Biospecimen Research”
• Poster presented at ACMG (2015): • “The Electronic Medical Records and Genomics (eMERGE) Network – A
Population Survey of Perspectives toward Proposed Rule on Broad Consent and Data Sharing in Biomedical Research”
• Submitted session to ASHG (2015) – not accepted• “The eMERGE Network Survey of Patient Perspectives on Broad Consent and
Data Sharing in Biospecimen Research”
• Poster presented at NHGRI Symposium (2014)• “The Electronic Medical Records and Genomics (eMERGE) Network – A
Population Survey of Perspectives toward Proposed Rule on Broad Consent and Data Sharing in Biomedical Research”
• CSER IC & G Work Group (2013)• “Patient Perspectives on Broad Consent in Biobank Research in the eMERGE
Network”
Survey-Next Steps• Receive data from Scantron after second wave complete• Analysis• Manuscripts• Analysis extends beyond end of grant period
• No-cost extensions to February 2016 at all sites
Acknowledgements• Subcommittee leads
• Nanibaa’ Garrison and Ellen Wright Clayton (Literature Review)• Saskia Sanderson (Survey Development)• Jen McCormick and Sharon Aufox (IRB)• Melanie Myers (Cognitive Interviews)• Jonathan Schildcrout and Nate Mercaldo (Sampling Strategies and
Survey Analysis)• Kyle Brothers (Data Management)
• All members of CERC Survey work group• Coordinating Center
The patients at the eMERGE sites who completed the pilot survey
OTHER CERC WORK GROUP ACTIVITIES
MyResults.org – New Section
EHRI Infobutton Compatibility
For Health Professionals• Three CDS-linking modules already built
• Azathioprine (w 6-mercaptopurine/thioguanine) • Clopidogrel• Warfarin
• Several more planned for Phase 3 (pending)• Omeprazole• Morphine• Montelukast• Simvastatin
Google Analytics, Overview: • ~1600 visits/month• Mean session duration: 2:47 minutes• Mean page views 5.43• ~61% of traffic from the United States• 73% of visitors are new to the site
Google Analytics
Phase 3• Continued Content Development
• More drug-gene pairs • Disease-specific resources• Review/update of existing content
• Enhanced For Professionals Options • More CDS-linking modules• Infobutton support (Luke/Casey)
• RoR resources (Iftikhar)
CERC Work Group Collaborations• EHRI WG
• OpenInfoButton Project: Contributed educational content• Knowledge of educational needs through initial focus group and advisory committee discussions
• A. Hartzler et al. Stakeholder engagement: a key component of integrating genomic information into electronic health records. Genetics in medicine : official journal of the American College of Medical Genetics. 2013 Oct;15(10):792-801.
• ROR WG• Holding joint calls regularly due to overlap in projects and interests• GP Jarvik et al, Return of genomic results to research participants: the floor, the ceiling, and the
choices in between. AJHG, 2014 Jun 5;94(6):818-26.• IJ Kullo et al, Return of results in the genomic medicine projects of the eMERGE network. Frontiers in
genetics. 2014;5:50.
• Pediatric WG• KB Brothers et al, Practical Guidance on Informed Consent for Pediatric Participants in a Biorepository.
May Clinic Proceedings (2014) 89, 1471–1480• KB Brothers et al, When Participants in Genomic Research Grow Up: Contact and Consent at the Age
of Majority. Undergoing revisions for J of Pediatrics.
• CSER/ROR/GC WG• Attending F2F meetings/conference calls• Presentations of our ongoing projects