Ethical Issues in Collecting and Using Biospecimens in Population Research

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Ethical Issues in Collecting and Using
Biospecimens in Population Research

• Nancy M. P. King, JD
• Professor of Social Medicine
• School of Medicine
• University of North Carolina

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Biospecimens in Research Issues to Address

• Genetic vs. non-genetic specimen/biomarker
  research
• Informed consent
• Storage future research sharing data and
  specimens recontact (for new research or with
  results)
• Confidentiality
• Potential benefits/risks of harm?
• Vulnerable populations, sensitive issues

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Biospecimens in Research Design Considerations

• Design of Research
• The value of the research question
• The reason for collecting biospecimens
• Methodology and validity of data obtained
• Linking biospecimens to other information
• Survey research information
• Medical records
• Other records (education, employment, criminal)
• Other people (relatives, unrelated neighbors)

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Biospecimens in Research Consent Issues

• Informed Consent
• Information and process
• Explaining research purpose and data use
• Sensitive questions
• Individual or group implications?
• What to disclose and how
• Community advice/Cultural humility
• Specimen storage
• Future uses and data sharing
• Scope of consent
• Recontact required?
• Consent is necessary, but not sufficient!

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Biospecimens in Research Data Dissemination

• What does biospecimen data measure?
• How do the results help address the problem
  identified?
• Investigator responsibility
• Public explanation
• Information for subjects
• Unexpected findings
• Stigma or discrimination?
• Ongoing relationship
• Recontact about results
• Clinical significance?

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Genetic Biospecimen Research

• Multigenic disorders and conditions
• Exploratory research, probabilistic findings
• Public health implications? (heart disease,
  cancer, diabetes, mental illness)
• Population genetics
• Fishing expeditions?
• Interpreting risk factors
• Behavioral genetics
• Soft findings, uncertain meaning
• Stigma? (alcoholism, violence, criminality,
  risk-seeking behavior, homosexuality)
• Gene-environment interactions
• Predisposition and risk reduction
• Prevention or blame?

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Genetic Research Ubiquitous Ethical Issues

• Genetic essentialism vs. uncertainty
• Genetic determinism vs. personal responsibility
• Genetic discrimination risks employers, insurers
• Genetic information is also information about
  others choosing to know or not to know
• Genetic privacy vs. public health/family
  interests
• Race and risk
• Problematic categories, varying measures
• Biology vs. society
• Stigma and discrimination

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A Distinction Without A Difference?

• Whats different about genes?
• Linking specimens with other information
• Medical records (current, or also future?)
• Nonmedical records (school, work, DMV, criminal?)
• Other studies
• Environmental data
• Design disclosure (what, why, how?)
• Sharing and selling of information
• Disclosed to subjects?
• Controlled by subjects?
• Saving, perpetuating, and pooling specimens
• Genes may be different, but most issues arent!

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Biospecimen Repositories Ethical/Policy
Considerations

• Informed consent/waiver of consent
• Secondary/future uses of specimens, data
• Privacy vs. confidentiality
• Data/specimen security
• Data/specimen sharing
• Ownership and financial gain 
• Data disclosure
• Oversight of repositories

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Secondary and Future UsesScope of Consent

• Repository/researcher states plan
• Consent form describes plan for secondary/future
  use
• Subject agrees/declines to participate under
  stated conditions
• Research subject selects preferences
• Consent form provides options
• Repository/researcher must monitor choices
• Tailored consent forms
• To reflect level of identifiability
• To describe system delinking specimen and
  information
• Simple consent where no recontact possible
• Separate consent forms for recontact
• IRB decides when reconsent is required

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Waiver of ConsentExisting Specimens, New
UsesAgreement/Near Agreement

• Study must be minimal risk
• Mechanism exists to protect privacy and
  confidentiality
• No disclosure of research information
• No conflict with original consent form

• Sound mechanism to unlink identity
• Waiver does not conflict w/state, federal laws,
  customs
• Waiver does not harm others--family, individuals
  of similar social, ethnic group or community

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HONEST BROKER MODEL (Dressler, 2004)
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A Case Example

• Havasupai Tribe Case
• Diabetes is the problem is genetic research the
  solution?
• Genetic/nongenetic uses of biospecimens other
  data
• Researchers duty to explain design?
• From diabetes to schizophrenia to migration
  patterns monitoring? reconsent?
• Ownership and sharing researchers vs. donors
• Linkage with other data consent needed?
• Group vs. individual harms
• The crazy tribe
• Challenging creation stories
• Duties fair subject selection, nonexploitation
• Duties respect, transparency, humility
• Duties education, shared goals, reciprocity