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