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Practice variation across consent templates for biobank research

Daniel Strech, Hannes Knüppel, 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 biomaterialsAsslaber 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 practice” 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, Knüppel H, Strech D (2013) Frontiers in Genetics

Methods: Guideline synthesis Æ 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 guidancesfor 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 Æ Matrix

1. Search for text passages with explicit or implicit relevance to the content of consent forms

2. Relevance test I Æ 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”

Æ to “duration of participation or storage”� Synthesis: “money or material goods” (CIOMS), “payment” and

“expenses” (EMA), “additional costs” (U.S.), “allowance” (TMF) Æ“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 13CIOMS (2002): Guidelines for Biomedical Research 32U.S. DOH (2009) “Common Rule” (45 CFR 46) 14EMA (2002): ICH-Guideline for GCP 15

OECD (2009): Guidelines on HBGRD 34CoE (2005): Add Protocol on Biomedical Research… 18

CoE (2006): Recommendation… biological materials 22

CoE + Eur Parl (2001): GCP conduct of clinical trials… 8CoE (1997): “Convention of Biomedicine” 7TMF / Harnischmacher (2006): Checkliste Einwilligung 39Total 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

German National Biobank Register(July 2012); www.biobanken.de/

Consent forms available on website

Chairs of biobank asked via email(3 excluded for incorrect mailing address)

Answers

Consent forms for analysis(incl. shared forms)

108(adjusted 102)

9 / 102

44 / 90 (49%)

30 *

*Consent forms of 33 biobanks, 33/102 (32%) of all registered biobanks

90 (100%)(excluded 3)

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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ResultsConsent issues for biobank research Origin:

Guidelines (n=10)Coverage: biobank

consent forms (n=30)

Assessment items n % n %A) General information

Research explanation and purpose 10 100% 28 93%Future development and changes 5 50% 9 30%

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 biobankresearch

Coverage in 30 German biobankconsent 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 Æ not all items equally

applicable� more items not per se better Æ 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 Æ 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