Transcript PopGen Ethical Considerations

Consultation and Consent:
Ethical Issues in
Human Population
Genetic Research
Dennis H. O’Rourke
Department of Anthropology
University of Utah
Salt Lake City UT
2 November 2006
Populations Defined

Geographic


Sardinia, Iceland, Pacific Islands, Mountain
Valleys, Arctic
Cultural/Social

Religious Isolates
 [e.g., Amish, Hutterites, Ashkenazi Jews]

Historic/Political/Ethnic

Utah Mormons, Native American, AfricanAmerican
ELSI

Research Access

Consent Process

Group vs. Individual

Risk/Benefit Assessment

Reporting Constraints

Continuing Communication
Ethical Goals

Justice
Benefits and Burdens of research fairly distributed

Beneficence
Benefits maximized; Risks minimized

Respect
Voluntary & Informed Consent
Initial Study Design

Initiate Community Dialogue Early


How are Decisions Made?




Involve Community in Study Design
Collectively or Individually?
In family or lineage groups?
Public or Private discussions?
Culturally appropriate locus for
decision making
Community Negotiation

Permission to Collect Data


Options for Population Identification


Name community, [ethnic] group/affiliation,
geographic location/region, anonymity
Fate of analyzed samples


Scope of Project
Archival samples, future research,
immortalization of cell lines, extraction of stem
cells?
Intellectual Property Issues
BIOPIRACY
BIOWEAPONS

Genuine fear of [continuing?]
Genocide

Often based on historical precedent
e.g., Tuskegee Study

Fueled by popular press -

“Gene Research is Leading to
Biological Weapons that Target
Specific Ethnic Groups”
[SLC Tribune headline - 2002]
Informed Consent

What are consent boundaries?

e.g., Anonymity, Voluntary withdrawal,
Financial risk

How to inform participants re genetic
research if basic knowledge of scientific
method is limited?

Risks


Personal, Cultural, Ethnic Identities,
Individual Informed Consent

Not entirely adequate in contexts of collective
decision making
Informed Consent

What are consent boundaries?

e.g., Anonymity, Voluntary withdrawal,
Financial risk

How to inform participants re genetic
research if basic knowledge of
scientific method is limited?

Risks


Personal, Cultural, Ethnic Identities,
Individual Informed Consent

Not entirely adequate in contexts of collective
decision making
KNOW LOCAL KNOWLEDGE
Norwegian Survey
• Q: What is a gene?
• A: What Americans put in
tomatoes.
[Courtesy of Andrew Luca]
Informed Consent

What are consent boundaries?

e.g., Anonymity, Voluntary withdrawal,
Financial risk

How to inform participants re genetic research if
basic knowledge of scientific method is limited?

Risks
•
Personal, Cultural, Ethnic Identities,
Thomas Jefferson/Sally Hemmings case;
African-American heritage example

Individual Informed Consent

Not entirely adequate in contexts of collective decision
Informed Consent

What are consent boundaries?

e.g., Anonymity, Voluntary withdrawal

How to inform participants re genetic
research if basic knowledge of scientific
method is limited?

Risks


Personal, Cultural, Ethnic Identities,
Financial considerations
Individual Informed Consent

Not entirely, or completely, adequate in contexts
of collective decision making
Group Consent

Who speaks for the group?




Who identifies group spokespersons?


Potential to change community power structure,
and affect sampling strategy
What is relation between group consent and
‘informed’ or ‘voluntary’ individual consent?


Community/political leaders?
Cultural Leaders/Elders?
Religious leaders?
Group consent includes non-participants
Anonymity
Anonymity
 Why Anonymize?
Assure Privacy
Maintain Confidentiality
 Anonymity can work effectively
to protect individuals, but may
not be effective for groups - the
base of population based
research strategies
Anonymity & Consent Boundaries

When is anonymity guaranteed?

What is anonymized?

Individual ID? Group ID?

How does anonymity relate to group
consent? To privacy? To
confidentiality?

Anonymity can compromise
‘voluntary’ withdrawal
Consultation & Consent

Multiple successful models

Context, population specific

ONE SIZE DOES NOT FIT
ALL
Summary

Patience is not a virtue - It is a
necessity

If group consent is appropriate, add
50% to project design time - then
double it

Don’t oversell
Finis
 The problem is that no ethical system has
ever achieved consensus. Ethical systems
are completely unlike mathematics or
science. This is a source of concern.
Daniel Dennett
 By nature's kindly disposition most
questions which it is beyond a man's power
to answer do not occur to him at all.
George Santayana
Finis
The fact that an opinion has been
widely
held is no evidence whatever that it is
not
utterly absurd.
Bertrand Russell
Acknowledgments
Permissions for Destructive Analysis
Aleut Corporation
Chaluka Corporation
Aleutian and Pribilof Islands Association
Inuit Heritage Trust
Kivalliq Inuit Association
Coral Harbour & Chesterfield Inlet
communities
Samples
Canadian Museum of Civilization
Smithsonian Institution
Western Aleutian Archaeological and
Paleobiology Project
Funding
• Office of Polar Programs, National
Science Foundation
• Wenner Gren Foundation for
Anthropological Research
• Natural Sciences and Engineering
Research Council of Canada
• University of Utah
Colleagues & Collaborators
• Shawn Carlyle, Hank Greely, Henry
Harpending, Eric Juengst, Allen McCartney,
James O’Connell, Doug Veltre, Dixie West
• Special appreciation to the Norton Sound
Health Corporation Scientific Advisory
Board