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Genetic Privacy and Research Genetic Privacy and Research in Oregon:in Oregon:

A Forum for Institutional Review A Forum for Institutional Review Boards and ResearchersBoards 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: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: Genetic Privacy in Oregon: Historical BackgroundHistorical Background

• Early-1990s – concern about genetic privacy and

potential discrimination

• 1995 – Genetic Privacy Act: genetic

information as “personal property”

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Historical BackgroundHistorical Background

• 1999 – Genetic Research Advisory

Committee reviews “property” clause

• 2001– Advisory Committee’s consensus bill

passed

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Senate Bill 114 (2001)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)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: Current Law: Key ComponentsKey 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 ConceptsKey Concepts

• Obtaining Collecting sample, getting test result

• Retaining Storing sample, recording results in a record

• DisclosingSharing results with a third party

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Overview of Law--Relationship to Overview of Law--Relationship to Federal RulesFederal 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: Comparison of Oregon and Federal Law: The Common RuleThe Common Rule

Common Rule Oregon Genetic Privacy Law

Protects all interests of subject Protects only genetic privacy

Protects DNA samples Protects DNA samples

Applies only to federally funded research

Applies to all persons

Requires IRB review Requires IRB review

Institutional Obligations Individual Rights

National Oregon only

Effective 1991 Effective 1995

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Comparison of Oregon and Federal Law: Comparison of Oregon and Federal Law: HIPAA (Federal Privacy Rule)HIPAA (Federal Privacy Rule)

Federal Privacy Rule Oregon Genetic Privacy Law

Protects health information, including genetic information

Protects only genetic information

Applies only to information Protects DNA samples

Applies to “covered entities” Applies to all persons

Implemented administratively Requires IRB review

Institutional Obligations Individual Rights

National Oregon only

Effective 2003 Effective 1995

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Advisory Committee on Genetic Advisory Committee on Genetic Privacy and ReseachPrivacy 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 ChargeAdvisory 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 Advisory Committee Guiding PrinciplesGuiding 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 Issues Advisory Committee ConsidersConsiders

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

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

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What’s Special About Genetic What’s Special About Genetic Research in Oregon?Research in Oregon?

• Informed consent

• Anonymous research

• Coded research

• Recontact of research subjects

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Informed ConsentInformed Consent(ORS 192.535 & 192.547)(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 DefinitionsConsent 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 RequirementsConsent Requirements

CONSENT EFFECTIVE DATE

Anonymous Notification & opt-out

June 12, 2003

Coded Specific consent

June 12, 2003

Identified Specific consent

June 25, 2001

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Anonymous ResearchAnonymous Research(ORS 192.537 & OAR 333-025-0120)(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 ResearchCoded Research(ORS 192.547(5))(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 Recontact (ORS 192.537(8) & OAR 333-025-0130)(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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DISCUSSIONDISCUSSION

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Institutional Review BoardsInstitutional Review Boards

• IRB Registry

• IRB review of all genetic research studies

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

• Medical records reviews

• Studies of individuals with genetic diagnoses

• Health services

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How Do Researchers and IRBs How Do Researchers and IRBs Handle Special Situations?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 Situations:Special Situations:Tissue Banks/Stored Samples?Tissue 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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IssuesIssues

• 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 InformationContact Information

Ted Falk, J.D., Ph.D.tedfalk@teleport.com(503) 939-5365

Astrid M. Newell, M.D.Medical Consultant & State

Genetics Program ManagerOregon Dept of Human

Services,Office of Family Healthastrid.marie.newell@state.or.us(503) 872-6757 or (503) 731-

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