Genetic Privacy and Research in Oregon: A Forum for Institutional Review Boards and Researchers

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Genetic Privacy and Research in Oregon A Forum
for Institutional Review Boards and Researchers

• August 15, 2003
• Oregon Health Science University,
• Oregon Dept of Human Services,
• Advisory Committee on Genetic Privacy and
  Research (ACGPR)

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Presented by

• ACGPR Co-Chairs
• Ted Falk, JD, PhD
• Astrid Newell, MD (DHS)
• ACGPR Members/Participants
• Kara Manning, PhD (OHSU)
• Emily Harris, PhD (Kaiser)
• Kerry Silvey, MA, CGC (OHSU-CDRC)

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Genetic Privacy in Oregon Historical Background

• Early-1990s
• concern about genetic privacy and potential
  discrimination
  
• 1995
• Genetic Privacy Act genetic information as
  personal property

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Historical Background

• 1999
• Genetic Research Advisory Committee reviews
  property clause
  
• 2001
• Advisory Committees consensus bill passed

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Senate Bill 114 (2001)

• Removed property clause
• Set civil and criminal penalties
• Provision for anonymous genetic research
• Established ACGPR

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Senate Bill 618 (2003)

• Delays effective date of some 2001 provisions
• Anonymous research
• Adds
• Provisions for coded research
• Transition clause
• Language to conform to HIPAA
• Sets ACGPR agenda for 03-05

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Current Law Key Components

• Defines individual rights regarding personal
  genetic material
  
• Regulates obtaining, retaining and disclosing
  genetic information
  
• Pertains to research, insurance, employment and
  clinical care settings
  

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Key Concepts

• Obtaining ?Collecting sample, getting test
  result
  
• Retaining? Storing sample, recording results in a
  record
  
• Disclosing?Sharing results with a third party

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Overview of Law--Relationship to Federal Rules

• HIPAA Federal Privacy Rule
• Common Rule Federal Rules to Protect Human
  Subjects of Research
  
• State laws may add more protection (i.e.,
  Oregon)
  
• States may not reduce federal protections
• Attempt to reconcile Oregon law with federal laws
  
  
• Questions remain open

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Comparison of Oregon and Federal Law The Common
Rule
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Comparison of Oregon and Federal Law HIPAA
(Federal Privacy Rule)
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Advisory Committee on Genetic Privacy and Reseach

• 14 member committee
• Appointed by
• Assistant Director of DHS-HS
• Senate President/House Speaker
• Multi-disciplinary expertise

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Advisory Committee Charge

• Rules to implement genetic privacy act
• Provide expertise on genetic policy issues
• Address specific issues and report back to
  legislature

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Advisory Committee Guiding Principles

• Protect individual and family privacy
• Prevent misuse of personal genetic information
• Keep legal environment in Oregon friendly to
  genetic research

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Issues Advisory Committee Considers

• On our agenda
• Privacy
• Research
• Discrimination
• Consent

• Not on our agenda
• Cloning
• Stem cell research
• Law enforcement

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Whats Special About Genetic Research in Oregon?

• Informed consent
• Anonymous research
• Coded research
• Recontact of research subjects

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Informed Consent(ORS 192.535 192.547)

• Need for consent and type of consent depends on
• Identifiability of research subject
• Date that sample was collected

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Consent Definitions

• Blanket consent ?sample may be used for
  research
  
• Specific consent ? sample may be used for
  genetic research
  
• Includes genetic research generally (or)
  particular genetic research project

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Consent Requirements
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Anonymous Research(ORS 192.537 OAR
333-025-0120)

• Notification and Opt-Out Provision
• Notify that sample may be used for anonymous
  genetic research, give opportunity to opt-out,
  document
  
• New effective date ?June 12, 2003
• Researcher responsible for assuring
• notification has been done
• NOT EXEMPT FROM IRB REVIEW!

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Coded Research(ORS 192.547(5))

• De-identification
• Similar to HIPAA for limited
• data set
• Consent Requirements
• Samples obtained on or before
• June 12, 2003 ? consent not required
• Samples after June 12, 2003 ?
• specific informed consent is required
• IRB Approval

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Recontact (ORS 192.537(8) OAR 333-025-0130)

• No disclosure of genetic research results to
  subjects allowed unless
  
• Subject was informed prior to study (OR)
• Researcher and IRB determine compelling reason
  for recontact/disclosure (AND)
  
• Subject wishes to have information disclosed at
  time of recontact
  
• Requires IRB approval

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DISCUSSION
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Institutional Review Boards

• IRB Registry
• IRB review of all genetic research studies

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How Do Researchers and IRBs Determine if a Study
is Genetic Research?

• Definitions
• Genetic information derived from a genetic test
  (e.g., DNA, RNA, proteins, chromosomes)
  
• Genetic research research involving genetic
  materials or genetic information

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Is It Genetic Research?

• Medical records reviews
• Studies of individuals with genetic diagnoses
• Health services

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How Do Researchers and IRBs Handle Special
Situations?

• Deceased subjects
• Consent for genetic
• research not waived
• Next of kin may consent
• Minor subjects
• Not covered specifically in law
• Oregon consent rules for teens
• Potential harm from predictive testing

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Special SituationsTissue Banks/Stored Samples?

• New provisions allow coded or anonymous research
  on unconsented samples obtained prior to June 12,
  2003 (with IRB approval)
  
• What needs to be included on consent forms for
  new samples?
  
• Future undefined research
• Coded vs. identified research

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Issues

• Are there other problematic components of the
  law/rules?
  
• Need for additional information/ resources?
• Ideas for future IRB/
• researcher input into policy development?

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Contact Information
Ted Falk, J.D., Ph.D. tedfalk_at_teleport.com (503)
939-5365

• Astrid M. Newell, M.D.
• Medical Consultant State Genetics Program
  Manager
  
• Oregon Dept of Human Services,
• Office of Family Health
• astrid.marie.newell_at_state.or.us
• [phone] or [phone]