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Mendy M, Caboux E, Lawlor RT, et al. Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research. Lyon (FR): International Agency for Research on Cancer; 2017. (IARC Technical Report, No. 44.)
Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research.
Show detailsThese guidelines are made up of the following three sections: design decisions; guidance for broad consent participant information sheets and consent forms; and links to biobank-specific templates for participant information sheets and consent forms.
A2.1. Design decisions
This section contains useful points to consider when designing participant information sheets and consent forms for biobanks.
A2.1.1. Where do I start?
The templates for participant information sheets and consent forms listed in Section A2.3 are a good place to start to get an idea of the general contents of participant information sheets and consent forms.
A2.1.2. Will I provide the participant information sheet and the consent form as separate documents?
It is common practice to provide these documents separately, and this may be the most practical solution for biobanks in terms of the storage and distribution of these documents. However, in clinical trials that involve biobanking, the two documents are often combined, which ensures that the participant information sheet and the consent form used are stored together.
A2.1.3. Will I require that the participants initial or tick the boxes on the consent form?
It is recommended that biobanks follow best practice in clinical trials, which requires that participants initial the boxes on the consent form. It is worth making this requirement clear on the consent form itself.
A2.1.4. Will I provide opt-in/opt-out statements on the consent form?
The most critical thing to consider before providing opt-in/opt-out statements is whether the biobank can support this. For example, allowing the participant to opt out of research that involves animals but not being able to enforce this when distributing samples will cause problems for the biobank. The most common problem is that the biobank database does not record the participant’s decisions, resulting in a time-consuming search for the consent form each time a sample is distributed. If opt-in/opt-out statements are provided, add two boxes, marked with “yes” and “no”, to the consent form so that it is clear that these statements are optional. See the information on dynamic consent in Table A2.2 for examples of possible opt-in/opt-out statements.
Table A2.2
Items for consideration on a biobank consent form, including options that may be provided as consent statements and possible opt-in/opt-out statements.
A2.1.5. Should I consider what might happen to the samples in the future?
It is very important that when the participant information sheets and consent forms are being developed, the biobank should carefully consider the possible future use of the samples and data, so that the biobank can inform the participant at the outset and will not need to re-contact them for further permissions. Some examples of areas to consider are: issues that are potentially ethically or legally challenging, such as transfer of samples or data across national borders or use of samples and data by commercial researchers (see the recommendations in Section 3.1.2.3); return of results and incidental findings (see Section 3.1.4); access to and sharing of samples and data (see Section 3.1.5); when participants might need to be re-contacted; and whether the participants need to receive information or give consent via an interpreter. If an interpreter is needed, lines may need to be added to the consent form to allow the interpreter to sign the form.
A2.2. Guidance for broad consent participant information sheets and consent forms
Table A2.1 provides information on the headings that would be expected on a biobank participant information sheet aiming for a broad consent approach. The optional sections apply only to specific types of biobanks or specific types of research being conducted.
Table A2.1
Sections for inclusion on a biobank participant information sheet, indicating whether these are optional or mandatory; the initial statements or questions can be used as titles in the participant information sheet.
Table A2.2 provides information on the consent statements that might be expected on a biobank consent form aiming for a broad consent approach. Some of these consent options may be required by the legal system in a particular country, for example the need to gain specific consent to access medical records. In addition, legal requirements may mean that consent is needed to transfer samples or data across national borders if this may occur in the biobank. Opt-in/opt-out statements should be included only when these are recordable, actionable by the biobank, and practicable.
A2.3. Links to biobank-specific templates for participant information sheets and consent forms
The documents and links listed below can be used as reference materials to produce biobank participant information sheets and consent forms.
- 1.
World Health Organization (WHO):
- •
WHO Informed Consent Form Templates: http://www
.who.int/rpc /research_ethics/informed_consent/en/ - •
WHO Informed Consent Form Template for Consent for Storage and Future Use of Unused Samples: http://www
.who.int/entity /rpc/research_ethics /Informed%20consent %20for%20sample%20storage.doc?ua=1
- 2.
Public Population Project in Genomics and Society (P3G):
- •
P3G-IPAC Generic Clauses/Agreements Database, to assist researchers in building documents: http://www
.p3g.org/resources/ipac - •
P3G Generic Information Pamphlet and Consent Form (2014): http://www
.p3g.org/system /files/biobank_toolkit_documents /P3G %20Generic%20Info%20Pamphlet %20and%20Consent %20Form%20for%20Biobanks_0.pdf
- 3.
Global Alliance for Genomics and Health (GA4GH):
- •
Consent tools in relation to international data sharing: http://www
.p3g.org/sites /default/files/site /default/files/GA4GH-Consent %20Tools-FINAL%20%281%29.pdf
- 4.
Human Heredity and Health in Africa (H3Africa):
- •
H3Africa Guidelines for Informed Consent (2013), guidance for designing consent materials for genomic research in African contexts: http://h3africa
.org/images /FinalPoliciesDocuments /H3A%20WG%20Guidelines %20Informed %20Consent_FINAL_01082013.pdf
- 5.
Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP (2010). Developing a simplified consent form for biobanking. PLoS One. 5(10):e13302: http://dx
.doi.org/10 .1371/journal.pone.0013302 - 6.
Strategic Tissue Repository Alliances Through Unified Methods (STRATUM) project:
- •
Consent Models Work Package tools, including a two-page combined participant information sheet and consent form template and an in-depth biobank participant information sheet template: http:
//stratumbiobanking .org/consent.html
- 7.
UK Biobank:
- 8.
Children’s Cancer and Leukaemia Group (CCLG):
- •
Information sheets for involving children in biobank research: http://www
.cclg.org.uk /tissue-bank/information-for-patients
- ANNEX 2. Guidelines for informed consent - Common Minimum Technical Standards an...ANNEX 2. Guidelines for informed consent - Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research
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