Databanks and biobanks created through health research:

Should their content be anonymized?A reflection…

Emmanuelle Lévesque, LL.M., lawyerResearch Associate, Centre de recherche en droit public, Université de Montréal

STIRRHS - Seminar on Transdisciplinarity

June 1-3 2006

Distinguishing Databank and Biobank

Biobank: collection of biological material

Databank:collection of data

Distinguishing Anonymization and Coding

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

Data are separated from personal identifiers through use of a code

# 1234

# 1234

Coding

Anonymization

Various interests at play

Advancement of science

Population

Researchers

Research participants

And money...

A. Protection of confidentiality

B. Duration of conservation

C. Return of results

D. Withdrawal from participating

OutlineOutline

Coding:Values, principles,

rights promoted

Anonymization:Values, principles, rights

promoted

Anonymization:Maximum ProtectionMaximum Protection

Coding:Limited Limited ProtectionProtection

Protection Protection varies depending varies depending on the rules around access to on the rules around access to the coding keythe coding key

Promotes: PrivacyProfessional secrecyRight to confidentiality

Promotes:Protection of Health: offers a

means of prevention through recontact

Advancement of knowledge: obtains missing information and validates results

A. A. ProtectiProtecting ng ConfidentialityConfidentiality

Anonymization:Duration of conservation often Duration of conservation often longerlonger

Sometimes held for an Sometimes held for an intedeterminate duration (to intedeterminate duration (to perpetuity)perpetuity)

B. B. Duration of conservationDuration of conservation

Coding:Duration of conservation Duration of conservation often shorteroften shorter

Generally duration of Generally duration of determinate lengthdeterminate length

Promotes:Optimal use of

research resources

Promotes:Reasonable evaluation

of consequencesConfidentiality: shorter

duration minimizes risk

AnonymiAnonymizzation:ation:

Returning information is impossible

C.C. ReturningReturningResultsResults

CodCodinging::

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

AnonymiAnonymizzation:ation:Withdrawal is impossible

D. D. Withdrawal from Withdrawal from ParticipatingParticipating

CodCodinging::Withdrawal is usually possible

Withdrawal 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

ConclusionConclusion

• 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)