Practice variation across consent templates for biobank research Daniel Strech, Hannes Kn端ppel, Irene Hirschberg
LAST-JD Research Workshop Tilburg, 7.11.2013
Agenda Background/Objectives Methods (three parts) Synthesis of international guidelines Sampling of biobank consent forms Assessment of biobank consent forms
Results Discussion & Conclusion
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Background: Biobanks Biobank = Collection of human samples + personal clinical and sociodemografic data
+ Important resource for health research (biomarker, disease development, prevention) Ethical, legal and social issues (ELSI), e.g. Privacy issues, incidental findings, public involvement, consent
Need of modified/new models for consent from donors of biomaterials Asslaber and Zatloukal 2007, Budimir et al. 2011 / Gottweis and Kaye 2012
Biobanks and consent Precondition for biomedical / biobank research
Protect donor´s autonomy and maintain public trust
Scope and content
Scope: Future research projects? (broad vs. specific consent) Particular consent issues: e.g. data protection / sharing
Procedures
Who/When/How? Dynamic/renewed consent necessary? Waiver, e.g. for “old” sample collections?
Formal aspects, language, Harmonization essential for data/sample-sharing and cooperation on inter/national level Cambon-Thomsen et al. 2007, Budimir et al. 2011, Brehault et al 2012…
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Rationale and Objectives Evidence for the need of improvements regarding content, comprehensibility and practicability of consent in biobank research * Several guidances describe consent criteria relevant for biomedical research (WMA 2008, CIOMS 2002), few mention specific aspects for biobanks (OECD 2009) No broadly accepted “best practiceâ€? model for consent forms in biobank research Objective: Status quo analysis in Germany through a content analysis of biobank specific consent forms ** * Padhy et al 2011, Brehault et al 2012, Mandava et al 2012 ** Hirschberg I, KnĂźppel H, Strech D (2013) Frontiers in Genetics
Methods: Guideline synthesis
Matrix
No specific and comprehensive guidance available that describes biobank specific consent issues Development of an assessment matrix on potential consent issues for biobank research Synthesis of 10 national/international guidances for biomedical / biobank research
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Methods: Guidances considered U.S. DoH 2009: Code of Federal Regulations 45 CFR 46 (Common Rule) CIOMS 2002: International Ethical Guidelines for Biomedical Research Involving Human Subjects WMA (2008): Declaration of Helsinki 2008. Ethical Principles for Medical Research Involving Human Subjects EM(E)A 2002, CPMP/ICH/135/95: Guideline for good clinical practice, ICH Topic E 6 (R1) European Parliament + Council of Europe: Directive 2001/20/EC on … good clinical practice in the conduct of clinical trials on medicinal products for human use Council of Europe 1997: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine 2005: Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research 2006: Recommendation … on research on biological materials of human origin OECD 2009: Guidelines on Human Biobanks and Genetic Research Databanks TMF 2006: Checkliste und Leitfaden zur Patienteneinwilligung
Methods: Guideline synthesis
Matrix
1.
Search for text passages with explicit or implicit relevance to the content of consent forms
2.
Relevance test I
context Biobank
Exclusion of “random assignment” (EMA), “treatment free of charge” (CIOMS), “alternative procedures or courses of treatment” (U.S. DOH)
3.
Relevance test II Exclusion of formal aspects “title of the document” or “date/signature” (TMF)
4.
Wording & Synthesis Adaption to biobank context: “duration of participation in trial/study” to “duration of participation or storage” Synthesis: “money or material goods” (CIOMS), “payment” and “expenses” (EMA), “additional costs” (U.S.), “allowance” (TMF) “payment/allowance and additional costs”
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Origin of assessment items for consent in biobank research
Items (Biobank)
WMA (2008): Declaration of Helsinki
13
CIOMS (2002): Guidelines for Biomedical Research
32
U.S. DOH (2009) “Common Rule” (45 CFR 46)
14
EMA (2002): ICH-Guideline for GCP
15
OECD (2009): Guidelines on HBGRD
34
CoE (2005): Add Protocol on Biomedical Research…
18
CoE (2006): Recommendation… biological materials
22
CoE + Eur Parl (2001): GCP conduct of clinical trials…
8
CoE (1997): “Convention of Biomedicine”
7
TMF / Harnischmacher (2006): Checkliste Einwilligung
39
Total number of items
41
Assessment matrix: 41 items under 4 headings A) “General information” e.g. Explanation of type of research and its purpose Ownership rights B) “Conditions of participation” e.g. Voluntary participation and Right to withdraw C) “Consequences of participation” e.g. Feedback on findings / incidental findings D) “Dealing with data and biomaterial” e.g. Data protection / privacy measures Cooperation with other researchers and third parties
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Sample 108
German National Biobank Register
(adjusted 102)
(July 2012); www.biobanken.de/
Consent forms available on website
9 / 102
Chairs of biobank asked via email
90 (100%) (excluded 3)
(3 excluded for incorrect mailing address)
Answers
44 / 90 (49%)
Consent forms for analysis (incl. shared forms)
30 *
*Consent forms of 33 biobanks, 33/102 (32%) of all registered biobanks
Results 30 consent forms (participant information and consent form) from 33 German biobanks different types of biobank with varying characteristics disease-specific / population-wide, number of participants…
different „types“ of consent forms length, target group, scope, complexity…
Coverage of 41 items very variable: 0-97% 97%: “Right to withdraw or alter consent / without disadvantage” 0% “Dealing with data and material after participants die or become incapacitated”
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Results Consent issues for biobank research Assessment items
Origin: Guidelines (n=10)
Coverage: biobank consent forms (n=30)
n
%
n
%
Research explanation and purpose
10
100%
28
93%
Future development and changes
5
50%
9
30%
A) General information
Biobank design and structure
5
50%
21
70%
Funding and (conflict of) interests
6
60%
6
20%
Duration of participation or storage
7
70%
15
50%
Biomaterial: types and quantity of specimen
3
30%
27
90%
Description of collection procedures and additional tests
8
80%
26
87%
Rights/Ownership of samples and data and their transfer
2
20%
17
57%
Opinion or approval of Research Ethics Committee
5
50%
16
53%
Results “Uncontroversial” items often covered “Research explanation and purpose” (93%) “Free and voluntary participation” (80%) “Privacy rights and procedures/safeguards, data processing, and identifiability of data and samples” (90%).
“Controversial” items less often covered “Future development and changes” (30%) “International Cooperation / trans-border use” (23%) “Right of access to personal data” (17%) “Policy on use / disclosure to third parties for non-research purpose” (23%)
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Results Consent issues in biobank research
Coverage in 30 German biobank consent forms
Range
N
%
33-41 (approx. 80-100%)
3
10 %
25-32 (approx 60-80%)
14
47 %
17-24 (approx 40-60%)
6
20 %
9-16 (approx 20-40%)
7
23 %
0-8 (approx 0-20%)
0
0%
High variation across forms: min 9 (22%), max 36 (88%)
Discussion German consent forms for biobank research differ widely in range of covered issues Consider
heterogeneity of biobanks not all items equally applicable more items not per se better less items need justification*
Why low coverage? Lack of awareness, new developments?
* First steps: Beskow et al. (2010): Developing a simplified consent form for biobanking. PLoS One 5, e13302.
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Conclusion Need for improvement and harmonization to better support an informed choice by potential donors to maintain public trust in biobank research * to facilitate research cooperation and data sharing
Further steps for a “best practice” model of a consent template public involvement and empirical testing Guidance synthesis: More often needed to inform new law/guideline development?
* Gottweis and Kaye, 2012
Thank you very much for your attention! Daniel Strech, Hannes Knüppel, Irene Hirschberg
LAST-JD Research Workshop Tilburg, 7.11.2013
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