Databanks and biobanks created through health research:

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• Databanks and biobanks created through health
  research
• Should their content be anonymized?
• A reflection

STIRRHS - Seminar on Transdisciplinarity June 1-3
2006
Emmanuelle Lévesque, LL.M., lawyer Research
Associate, Centre de recherche en droit public,
Université de Montréal
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Distinguishing Databank and Biobank
Databank collection of data

• Biobank collection of biological material

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Distinguishing Anonymization and Coding
Coding
1234
Data are separated from personal identifiers
through use of a code
1234
Anonymization

• link between data/sample and the identity of the
  subject is deleted

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Various interests at play
And money...
Researchers
Advancement of science
Research participants
Population
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Outline

1. Protection of confidentiality
2. Duration of conservation
3. Return of results
4. Withdrawal from participating

• Coding
• Values, principles, rights promoted

• Anonymization
• Values, principles, rights promoted

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A. Protecting Confidentiality

• Anonymization
• Maximum Protection

• Promotes
• Privacy
• Professional secrecy
• Right to confidentiality

Coding Limited Protection Protection varies
depending on the rules around access to the
coding key

• Promotes
• Protection of Health offers a means of
  prevention through recontact
• Advancement of knowledge obtains missing
  information and validates results

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B. Duration of conservation

• Anonymization
• Duration of conservation often longer
• Sometimes held for an intedeterminate duration
  (to perpetuity)

• Promotes
• Optimal use of research resources

Coding Duration of conservation often
shorter Generally duration of determinate length

• Promotes
• Reasonable evaluation of consequences
• Confidentiality shorter duration minimizes risk

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1. ReturningResults

• Anonymization
• Returning information is impossible

Coding Returning information is possible

• Promotes
• Privacy, confidentiality, professionnel secrecy
• Protects against discrimination
  (insurance/employment)

• Promotes
• Protection of health (prevention)
• Informed reproductive choices
• Family health
• Autonomy

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D. Withdrawal from Participating

• Anonymization
• Withdrawal is impossible

Coding Withdrawal is usually possible Withdrawa
l process can be more or less complex

• Promotes
• Privacy, confidentiality, professionnal secrecy
• Advancement of knowledge stability of the sample
  size

• Promotes
• Participant autonomy
• Control of a detached body part
• Right to withdraw consent

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Conclusion

• Contradicting rights, values, interests
• No universal solution the solution must be
  adapted to the issues at play

The protection of the rights of people whose
samples and data are in the biobanks, with
respect to autonomy, confidentiality and
protection of privacy, needs to be assured at the
same time as allowing and encouraging research.
(CE-European experts group, 2004)