Biobank & Bio-PIN. Dr. J.J. Nietfeld
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1 Biobank & Bio-PIN Anonymous material and data, 2-way communication Dr. J.J. Nietfeld INTRESCO 1
2 2011 Apr; 11(4): Published online 17 March The Bio-PIN: a concept to improve biobanking J.J. Nietfeld 1, Jeremy Sugarman 2, Jan-Eric Litton 3 1 UMC Utrecht, Department of Pathology 2 Johns Hopkins Univ., Berman Inst. of Bioethics 3 Karolinska Inst., Dept. Med. Epidem. & Biostat. 2
3 28 Apr 2011 Bio-PIN could cut biobanking risks J.J. Nietfeld 1 & Jan-Eric Litton 2 1 UMC Utrecht, Department of Pathology 2 Karolinska Inst., Dept. Med. Epidem. & Biostat. 3
4 Content 1. Introduction 2. Biobanking problems + Bio-PIN solutions 3. Bio-PIN technology + procedures 4. Alternative? 5. Advantages + Disadvantages 6. Conclusions + Applications 4
5 About advantages of the Bio-PIN for: Participants (patients / donors) Biobankers Researchers A new PET Privacy Enhancing Technology 5
6 About potential effects of the Bio-PIN on: 1. Registering / Managing samples & data 2. Laws / regulations & Ethics 3. Informed consent procedures 4. Privacy protection 5. Public trust / engagement 6. International harmonization / exchange 6
7 What is a Biobank? A facility for: storage and release of biomaterial - material to retrieve data - material to use in therapy storage and release of data related to the material - data retrieved from the material: > diagnostic, prognostic data > research data (e.g. for pharma) - data from the donor of the material: > medical history, lifestyle, environment, demographics, genealogy 7
8 Types of samples / data in a biobank Not-anonymous Identified Stored with identity data Samples / Data Coded Stored with code identity data Anonymous Stored without identity data 8
9 Biobanking problems 1 Building a statistically significant collection. Especially for diseases with low prevalence and incidence. Especially for multi-factorial diseases. Building a local collection can take decades. International collaboration is necessary! 9
10 Biobanking problems 2 In many countries for identified or coded samples & data each new use requires a new signed consent. For identified or coded samples & data special security measures have to be taken. Laws / regulations differ between countries. Differences in definitions between US and EU. 10
11 Laws & Regulations For use of anonymous samples & data in most countries lighter regulations apply. No privacy to be protected! Should samples & data be anonymous? 11
12 Anonymity has disadvantages No messages from biobank to patient / donor. No new research proposal No request for more data / material No unexpected finds No messages from patient / donor to biobank. No objection to new research No reply to requests No requests for results / deletion (opt out) 12
13 Choices & Problems Identified / coded samples Privacy risks Regulatory burdens International differences or Anonymous samples No privacy risks No communication Less valuable collection 13
14 Solution? Can one build an anonymous system without the disadvantages? Yes! Replace identity data with the Bio-PIN. Samples & data become anonymous. Features of non-anonymous system remain. A person s name has no biomedical meaning. In research it is not needed. 14
15 Biological PIN code The Bio-PIN is based on a distinguishing biological characteristic (e.g. a set of SNPs). Biobanking card Biobanking card Bio-PIN system Bio-PIN system Security code chip 15
16 Bio-PIN linking prevented SNPs lab Bio-PIN facility Individual SNPs set Bio-PIN Bar code 16
17 Set of SNPs Does not contain identity data: Name, birth date, birth place, address. Does not contain gene data: Eye / hair / skin color etc. Does not contain medical data: Diagnostic / prognostic etc. 17
18 Can a linkable sample be anonymous? Yes, it can! 18
19 Bio-PIN properties The Bio-PIN can not be linked back to the SNPs. The Bio-PIN is not linkable to an individual. The Bio-PIN can not be linked to a name. The Bio-PIN gives maximum privacy protection. 19
20 Biobanking with the Bio-PIN Hospital Donor / patient A A & & A Bio-PIN facility +DBC* Biobank Website DBC* laboratory Research laboratory A A A Other biobanks Data users A = Anonymous = Sample = A number & = Exchange = Data = Bio-PIN * = Distinguishing Biological Characteristic 20
21 Is a random number an alternative? Dangers: Patient / donor loses number. Biobank loses number. Mistakes / fraud (no proof). Impossibilities: No combination of different samples. No combination of different data sets. 21
22 Sample / data labeling with the bio-pin locked Bio-PIN < < < < < Biobanking card Bio-PIN system + Biobank Card reader Locked Bio-PIN Security code e.g sample data. Bio-PIN Hospital computer Bio-PIN label 22
23 Bio-PIN advantages for biobanks + Maximum privacy protection + No privacy costs, no regulatory burden + Ambiguity in identity data is not an issue + Enhanced donor trust and engagement + If lost, the Bio-PIN can be re-determined + Flexible biobanking system + Combination of samples / data of one person + Easier international sample / data sharing 23
24 Bio-PIN advantages for biobanks + All advantages of anonymous samples / data (like less regulatory burden and costs, plus enhanced security and data protection). + All possibilities of a system with identified samples / data can be utilized, except knowing the identity. 24
25 Bio-PIN disadvantages for biobanks Identity of participants is not know Biobank has to wait for participants Differences in speed of participation Potential (temporary) bias in data The disadvantages are not worse than for systems with participants approached via letters and/or telephone, part of whom will not respond. 25
26 Bio-PIN advantages for participants + Maximum privacy protection + Safety (unalienable) & Sustainability (once) + All rights protected: The rights to be informed / not to know The rights to object / opt out The rights to request / correct / add data No necessity to give broad / blanket consent + Strengthened autonomy + Electronic personal health record possible 26
27 Bio-PIN disadvantage for participants Losing the Bio-PIN leads to costs 27
28 Electronic Personal Health Record: a contact stimulus for participants Biobanking card Bio-PIN system Biobank slogan: Use your biobank account to invest in Health! Biobank Research Results Amplifying loop 28
29 Conclusions The Bio-PIN system offers: Maximum protection of patient / donor rights. Maximum possibilities for biobanks / researchers. The Bio-PIN system is superior to systems with a code that is a random number. The Bio-PIN system leads to a whole new way of biobanking, involving ethical, legal and societal aspects. 29
30 2011 Apr; 11(4): Published online 17 March Referee: The proposal offered by the authors seems to be extremely elegant and feasible and deserves to be seriously taken into consideration. 30
The Bio-PIN: J.J. Nietfeld, PhD UMC Utrecht. Prof. J.-E. Litton, PhD. A tool that can solve biobanking problems INTRESCO. J.J.
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