Ethical and Social Issues in SocialBehavioral Science Research

1
Ethical and Social Issues inSocial/Behavioral
Science Research

• Dennis H. ORourke
• Co-Chair, University of Utah IRB
• 3 August
  2007

2
Isolation, Identity and Community

• 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

3
ELSI

• Research Access
• Consent Process
• Group vs. Individual
• Risk/Benefit Assessment
• Reporting Constraints
• Continuing Communication

4
Initial Study Design

• How are Decisions Made?
• Collectively or Individually?
• In family or lineage groups?
• Public or Private discussions?
• What is culturally appropriate locus for decision
  making?
• Is this relevant to IRB review?

5
Study Design

• Myriad of social science research approaches
• qualitative, quantitative,
  questionnaire, interview (oral history),
• participant/observation (ethnography),
  experimental, deception, etc.
• More heterogeneous than medical/clinical model
• Multiple decision making and consent contexts
• Review risk/benefit regs, or quality of science?

6
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 data/samples
• Archival data, future research, data sharing,
  collaborations
• Intellectual Property Issues

7
BIOPIRACY
8
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

9
Informed Consent

• What are consent boundaries?
• e.g., Anonymity, Voluntary withdrawal
• How to inform participants (e.g., genetic
  research) if basic knowledge of scientific method
  is limited?
• Risks
• Personal, Cultural, Ethnic Identities,
  Financial considerations
• Individual Informed Consent
• Not entirely adequate in contexts of collective
  decision making

10
Informed Consent

• What are consent boundaries?
• e.g., Anonymity, Voluntary withdrawal
• How to inform participants (e.g., genetic
  research) if basic knowledge of scientific method
  is limited?
• Risks
• Personal, Cultural, Ethnic Identities,
  Financial considerations
• Individual Informed Consent
• Not entirely adequate in contexts of collective
  decision making

11
KNOW LOCAL KNOWLEDGE
12
Norwegian Survey

• Q What is a gene?
• Courtesy of Andrew Luca

13
Norwegian Survey

• Q What is a gene?
• A What Americans put in tomatoes.
• Courtesy of Andrew Luca

14
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 adequate in contexts of collective
  decision making

15
Risk to Cultural/Ethnic Identity

• Two Case Studies
• Aleut Origins
• African-American Ethnic Identity

16
Personal ID Risk

• Population Genetics of Garifuna
• Multidisciplinary biomedical and cultural
  research project.
• Very high participation rate, but large numbers
  declined to sign consent form or permit
  collection of dermatoglyphics

17
Why?

• 10-25 of adult men, and some women, in any
  given community occasionally, or routinely, lived
  and worked illegally in the New York City garment
  industry to support their families.
• Legitimate concern with confidentiality and
  personal identification -
• fingerprints and personal signature

18
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

19
Group Consent

• Who speaks for the group?
• Community/political 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

20
Anonymity

• When is anonymity guaranteed?
• What is anonymized?
• Individual ID? Group ID?
• How does anonymity relate to group consent?
• Anonymity can compromise voluntary withdrawal

21
Consultation Consent

• Multiple successful models
• Context, population/community, specific
• ONE SIZE DOES NOT FIT ALL

22
Take Home Message

• Research (including consent) is a process, not a
  signature.
• PI is usually most knowledgeable about how that
  process will work in specific contexts.
• Risk is not a simple, uniform construct. It is
  perceived differently in different places.
• For minimal risk studies, focus on risk/benefit
  ratio and consent process rather than scientific
  merit.
• Be thorough, thoughtful, and flexible

23
GOCADAN

• Collaboration between Norton Sound Health
  Corporation MedStar Research Institute
• NSHC and local community input in design stage
• NSHC and Alaska Native representation on initial
  IRB evaluation (continuing RERB)
• Local decision making style is community consensus

24
GOCADAN - cont.

• Continued local involvement in data collection
• Local repository for collected samples
• Regular, personal report of individual results to
  participants
• Participation rate for 8 communities gt80

25
Nuvuk - Pt. Barrow, AK

• 1 yr. discussion with local tribal and corp.
  authorities to rescue at risk cemetery
• 6 mo. discussion prior to permission for aDNA
  analyses, 12 mo. for modern population genetic
  analysis
• Written permissions for research obtained from
• Ukpeagvik Inupiat Corp.
• Barrow Senior Advisory (Elders) Council
• Native Village of Barrow
• (Inupiat Traditional Govt.)

Reconstruct long-term population history and
community origins