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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1 The Bio-PIN: A tool that can solve biobanking problems J.J. Nietfeld, PhD UMC Utrecht INTRESCO Prof. J.-E. Litton, PhD J.J.Nietfeld 1
2 Content 1. Introduction 2. Biobanking problems + Bio-PIN solutions 3. Bio-PIN technology + procedures 4. Alternative? 5. Advantages + Disadvantages 6. Conclusions + Applications J.J.Nietfeld 2
3 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 J.J.Nietfeld 3
4 Laws & Regulations 1 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. J.J.Nietfeld 4
5 Laws & Regulations 2 For use of anonymous samples & data in most countries lighter regulations apply. No privacy to be protected! Should samples & data be anonymous? J.J.Nietfeld 5
6 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) J.J.Nietfeld 6
7 Open / broad consent? Some state: privacy does not exist anymore! Open / broad consent should be given. Some want: patient data owned by society. Everyone benefits, thus everyone should contribute. However, participants main worry is privacy. Many cases of data loss (in other area s). Without trust, no participation / engagement. J.J.Nietfeld 7
8 Choices & Problems Identified / coded samples Privacy risks Regulatory burdens International differences or Anonymous samples No privacy risks No communication Less valuable collection J.J.Nietfeld 8
9 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. J.J.Nietfeld 9
10 Biological PIN code The Bio-PIN is based on a Distinguishing Biological Characteristic (DBC). The DBC can be: a SNP panel, or an STR profile (=DNA fingerprint), or another set of biochemical parameters. J.J.Nietfeld 10
11 What about identical twins? Identical twins have the same DNA. Their DBC* (based on DNA) would be identical Their Bio-PIN would be identical That could cause ethical problems Solution: Their birth order number is added to the DBC* A different DBC* results in a different Bio-PIN For other people, the birth order number is 1 * = Distinguishing Biological Characteristic J.J.Nietfeld 11
12 Bio-PIN production DBC* lab Bio-PIN facility Bio-PIN Individual DNA DBC * 2 x 52 SNPs XLS file > 99 kb 2D bar code < 55 bytes * = Distinguishing Biological Characteristic J.J.Nietfeld 12
13 International Data Protection Convention Protection of personal data against destruction, loss, access, alteration and dissemination. Personal data means any information relating to an identified or identifiable individual. The Bio-PIN does not constitute personal data. Anonymous data + Bio-PIN remain anonymous. Privacy protection is not an issue. The Bio-PIN is PET (privacy enhancing technology). J.J.Nietfeld 13
14 DBC* based on SNP s: Does not contain identity data: Name, birth date, birth place, address. Does not contain genetic data: Eye / hair / skin color etc. Does not contain medical data: Diagnostic / prognostic etc. * = Distinguishing Biological Characteristic J.J.Nietfeld 14
15 Can a linkable sample be anonymous? Yes, it can! J.J.Nietfeld 15
16 DBC* and Bio-PIN compared The DBC* might be linkable to an individual. If linkable and if the identity of the individual is known, the DBC* is personal data. The Bio-PIN can not be linked back to the DBC*. The Bio-PIN is not linkable to an individual. The Bio-PIN does not constitute personal data. Privacy maximally protected. Differences in privacy laws do not matter. * = Distinguishing Biological Characteristic J.J.Nietfeld 16
17 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 J.J.Nietfeld 17
18 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. J.J.Nietfeld 18
19 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 J.J.Nietfeld 19
20 Biobanking card check 1 UMC Utrecht Bio-PIN holder Central Biobank Type security code J.J.Nietfeld Hospital computer screen 20
21 Biobanking card check 2 UMC Utrecht Bio-PIN holder Central Biobank Type security code - J.J.Nietfeld Hospital computer screen 21
22 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 J.J.Nietfeld 22
23 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. J.J.Nietfeld 23
24 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. J.J.Nietfeld 24
25 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 J.J.Nietfeld 25
26 Bio-PIN disadvantage for participants Losing the Bio-PIN leads to costs J.J.Nietfeld 26
27 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 J.J.Nietfeld 27
28 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. J.J.Nietfeld 28
29 International Bio-PIN registry (IBR) Biobank1 Biobank2 Biobank3 IBR Lab-A Lab-B Bio-PIN facility = Samples* = Data* = DBC** = Bio-PIN * = Anonymous J.J.Nietfeld ** = Distinguishing Biological Characteristic 29
30 Apr; (4): Apr; 11(4): The Bio-PIN: a concept to improve biobanking Reviewer: The proposal offered by the authors seems to be extremely elegant and feasible and deserves to be seriously taken into consideration. J.J.Nietfeld 30
Biobank & Bio-PIN. Dr. J.J. Nietfeld
Biobank & Bio-PIN Anonymous material and data, 2-way communication Dr. J.J. Nietfeld INTRESCO 1 2011 Apr; 11(4): 303-308. Published online 17 March 2011. The Bio-PIN: a concept to improve biobanking J.J.
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