Assessing Public and Biobank Participant Attitudes toward Collecting and Sharing Genetic Research Da

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Assessing Public and Biobank Participant
Attitudes toward Collecting and Sharing Genetic
Research Data A Community Consultation Approach

• Amy A. Lemke, MS, PhD
• CERC Seminar
• Northwestern University
• March 25, 2009

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Overview

• Background
• Community consultation
• Study objectives
• Methods
• Results
• Discussion

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Background Implications of New Genomic
Technologies

• Emergence of Genome
• Wide Association Studies
• (GWAS)
• Development of
• biorepositories

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Background National Data Sharing

• Database of Genotypes and Phenotypes (dbGAP)
  -available to approved researchers to access
  datasets from GWAS
• NIH Data Sharing Policy- outlines expectations
  including data access and sharing procedures as
  well as methods to protect research participants

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Background Ethical, Legal and Social Issues
(ELSI)

• Confidentiality/privacy
• Identifiability
• Stigma/fear of genetic discrimination
• Non-research uses of data
• Adequate informed consent
• Clear data sharing mechanisms

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Community Consultation
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Community Consultation Efforts

• Iceland, Estonia, UK, Quebec
• US National Childrens Study
• BC Biobank Deliberation
• US Genetic and Public Policy Center
• Lack of data on views toward data sharing from
  participant perspective

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• National consortium - to develop, disseminate
  and apply approaches to research that combine DNA
  repositories with EMR systems for large-scale
  highthroughput genetic research
• 5 network institutions
• Includes community consultation efforts to
  address ethical, legal and social issues

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• Northwestern Medical Centers biorepository
• Longitudinal medical information from
  participating patients at NU affiliated hospitals
  outpatient clinics
• Participants biospecimens combined with
  questionnaire data and updates from EMR
• Voluntary participation, broad consent
• Resource facilitating genetic research
• Community Advisory Groups
• Community Advisory Committee
• Governance Committee
• Northwestern Internal Advisory Committee

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Community Consultation Approach

• Multiple Stakeholders

Phase 1 Public and NUgene Participants Focus
Groups
Phase 2 IRB Professionals Survey
Phase 3 Professional and Consumer
Stakeholders Consensus Meetings
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Study Objectives

• To obtain in participants own words their
  attitudes toward collecting, analyzing and
  sharing genetic research data
• To compare attitudes toward collecting, analyzing
  and sharing genetic research data between
  biorepository participants and the public
• To offer recommendations for the consent process
  and sharing of genetic research data

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Methods Recruitment and Setting

• Eligibility criteria
• Recruitment strategy
• NUgene participants - telephone recruitment
• Public participants - community partners,
  on-site distribution of flyers
• Incentives, information sent
• Sites
• NUgene participants - Northwestern University
  Chicago campus
• Public participants - Homan Square Community Ctr,
  Humboldt Park Library, Gill Park Community Ctr

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Methods Data Collection

• Participant information form
• 8 background questions
• 2 questions about medical information and
  research
• Focus groups
• 3 NUgene participant 3 general public groups
• 6-10 participants each
• 1-2 hours each
• 8 question pretested focus group guide

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Focus Group Guide

• 1. What comes to mind when you think of genetic
  research data?
• 2. What might be some reasons that a person
  would participate in genetic research?
• 3. What might be some reasons that a person
  would not participate in genetic research?
• 4. How do you feel about participating in a
  genetic research study?
• 5. What kinds of information would you need to
  know before participating in a study to store and
  share your genetic research information?

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Focus Group Guide (cont)

• 6. If you agreed to participate in a study in
  which your genetic research information was
  stored in a database, what are your thoughts
  about sharing this data with other investigators?
• 7. How well do you think the privacy of
  individual genetic research data is protected?
• 8. What do you think the role of institutions
  and the government should be in protecting the
  privacy of those who participate in genetic
  research?

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Methods Data Analysis

• Transcripts - independent checks for verbatim
  transcription and accuracy
• Six primary documents - uploaded in Atlas.ti
• Codebook developed
• Intercoder reliability check conducted
• Standard coding, notation, memoing, and content
  analysis used
• Microsoft Excel - for descriptive data from
  participant information form

Miles and Huberman, 1994
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Results Participant Characteristics(n49)
1 missing data value for all categories except
gender and age
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Results Participant Attitudes
 Level of Trust in Medical Research
Range of 1-2 missing data values per participant
group
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Results Participant Attitudes
 Level of Concern about Confidentiality and
Privacy of Medical Information
Range of 1-2 missing data values per participant
group
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Focus Group Results Five Major Themes

• A Diverse Spectrum of Understanding of Genetic
  Research
• Weighing Pros and Cons of Participation in
  Genetic Research
• The Role of Oversight Body Influences
  Participation Credibility, Trust and Research
  Integrity Matter
• Questions and Concerns about Genetic Research
  Data Sharing and the NIH GWAS Policy
• Desire for more Information and Education about
  Genetic Research

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Theme A Diverse Spectrum of Understanding of
Genetic Research

• Many related genetic research to diseases, and
  others related it to non-human genetic
  manipulation (Labradoodles) and science fiction
  (Brave New World, Big Brother)
• Misunderstanding/misinformation about genetic
  research (take the sickness out before they give
  you the transfusion)
• Some expressed concern about past experience with
  eugenics (I think about back in the Hitler
  dayskind of spooky.)

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Views Toward Genetic Research

• Excitement Hope Uncertainty
  Skepticism Fear

• Progress
• Human evolution
• To advance science

• To cure disease
• To help family member

• Designer babies
• Concern about genetic manipulation

• Not sure
• Never hear results
• Forensic science

• Big Brother
• Control
• Discrimi-nation

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Theme Weighing Pros and Cons of Participation in
Genetic Research

• Reasons to participate desire to help, improve
  society, and cure disease (for the greater
  good, to do my good deed, family history)
• Reasons not to participate lack of
  understanding, fear of needles, fear of disease
  risk, and concern over loss of privacy and risk
  for genetic discrimination
• Overall interest in participation despite
  potential barriers and risks

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Theme The Role of Oversight Body Influences
Participation

• Reputation and trust in the organization were
  important influences to participation
• Participants expressed distrust of the government
  as an oversight body for genetic research data
• Some participants suggested an independent
  oversight body, but were unsure who this should
  be (maybe a NGO with a volunteer board of
  directors.)

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Theme Concerns about Genetic Research Data
Sharing and NIH Policy

• Varying views on whether or not genetic research
  data should be shared with other investigators
• Some requirements for data sharing similar study
  purpose, adequate security and privacy checks,
  and participant to be recontacted
• All groups - a need for more information
• Questions What are the consequences for breach
  of protection? What is approved research?
  NIH-Whats that set up for? What is the make-up
  of the NIH?

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Theme Desire for more Information and Education
about Genetic Research

• Reasons why participants felt having more
  information would be helpful to reduce fears,
  build trust, become more comfortable with the
  information, and to provide what they have a
  right to know
• Suggested methods of providing public education
  target perceived disengaged groups, young people,
  schools, neighborhoods, disease support groups
  conduct more focus groups
• Different approaches for varied communities

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Key Findings

• A wide range of understanding of genetic research
• Overall interest in participating in genetic
  research despite barriers/risks
• Trust in research organization as key influence
  to participation in genetic research
• Lack of trust in governmental oversight of
  genetic research data
• A need for public education on genetic research
  tailored to specific communities

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Key Findings

• A need for additional information in the
  national data sharing policy
• 1) identification of specific names and roles of
  oversight persons in the NIH
• 2) greater detail describing how data will be
  shared and under what specific circumstances
• 3) clearer explanations of circumstances
  constituting Breach of Confidentiality and
• 4) more information on specific penalties
  imposed on researchers who misuse data sharing.

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Study Limitations

• Lack of generalizability and inability to discern
  the prevalence of emerging themes across a
  general population
• Participants who agree to participate in a focus
  group may be significantly different from the
  general population
• Responses might reflect most vocal participants
• The views of less educated may not have been
  represented

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Discussion

• To address perceived gaps in the NIH data sharing
  policy, consider the development of
  policies/programs that foster public input and
  review of educational materials preparation
• To build more trust in genetic research oversight
  bodies, consider more consumer involvement in the
  oversight process and dissemination of
  information to the general public
• To increase public awareness and understanding of
  genetic research, identify and/or develop
  educational strategies (with public input) for
  particular communities

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Next Steps

• Disseminate findings
• NUgene newsletter article
• NUgene advisory groups
• Three community sites
• Identify public education strategies/partners
• Participate in community lecture series
• Explore funding opportunities
• Exchange dialogue on policy recommendations
• Compare with other research in this area

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References/Resources

• Christenson K, Murray JC What genome-wide
  association studies can do for medicine. N Engl J
  Med 20073561094-1097.
• Caulfield T, McGuire AL, et.al. Research ethics
  recommendations for whole-genome research
  Consensus statement. PLoS Biology
  20086(3)430-435.
• NIH. Policy for sharing of data obtained in NIH
  supported or conducted genome-wide association
  studies . http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-07-088.html
• NUgene. https//www.nugene.org/
• Points to consider when planning a genetic study
  that involves members of named populations.
  http//bioethics.od.nih.gov/named_populations.html
  

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Acknowledgements
Sharon Aufox Rex Chisholm Bob Geraghty Noah
Goss Jeni Hebert-Beirne Gail Henderson Laura
Lode Maribeth Miceli Matthew Newsted
NUgene and public participants Deepa Rao Merideth
Sanders Maureen Smith Kelli Swan Andrea
Telli Susan Young Wendy Wolf
Funding for this study is provided by a grant
from the NHGRI U01-HG-004609