Consultation and Consent:

Ethical Issues inHuman Population

Genetic Research

Dennis H. O’RourkeDepartment 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, African-American

ELSI

Research Access

Consent Process Group vs. Individual

Risk/Benefit Assessment

Reporting Constraints

Continuing Communication

Ethical Goals

JusticeBenefits and Burdens of research fairly distributed

BeneficenceBenefits maximized; Risks minimized

RespectVoluntary & Informed Consent

Initial Study Design

Initiate Community Dialogue Early Involve Community in Study Design

How are Decisions Made? Collectively or Individually? In family or lineage groups? Public or Private discussions?

Culturally appropriate locus for decision making

Community Negotiation

Permission to Collect Data Scope of Project

Options for Population Identification Name community, [ethnic] group/affiliation, geographic location/region, anonymity

Fate of analyzed samples 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 making

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? Community/political leaders? Cultural Leaders/Elders? Religious leaders?

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? Group consent includes non-participants

Anonymity

Anonymity

Why Anonymize?Assure PrivacyMaintain 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 AnalysisAleut Corporation

Chaluka Corporation

Aleutian and Pribilof Islands Association

Inuit Heritage Trust

Kivalliq Inuit Association

Coral Harbour & Chesterfield Inlet communities

SamplesCanadian 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