Table 2

Proposed Modifications that Enable Bridging Consent

Disease Specific Biobank Research and Disease Specific Clinical Research


Element 1

Invitation, presentation of the study and voluntary participation


Scientific relevance of biobanks


Importance for research


Data and samples use for other related conditions or in other research settings (such as disease specific biobanks)


Element 2

Research protocols


No additional elements required


Element 3

Risks


No additional risks, except related to expansion of scope of research


Element 4

Benefits


Expected benefits related to the use of data and samples for other related conditions or other research settings (such as disease specific biobanks)


Element 5

Financial compensation, indemnification and costs


No additional elements required


Element 6

Confidentiality


No additional confidentiality issues, except related to expansion of scope of research (data storage/retention)


Element 7

Data Access and data sharing


Access procedures to data, samples and results by other research settings


Return of new data, samples and results from the other research settings to the original research setting


The participant's right to agree/disagree to access to their data and samples for other related conditions or other research settings (such as disease specific biobanks)


Element 8

Storage


Rules related to the use, retention, storage and destruction of data and samples for other related conditions or other research settings (such as disease specific biobanks)


Element 9

Return of results


Return of results for research performed in other related conditions or other research settings (such as disease specific biobanks); (return to the original research setting, general vs. individual, return to the participant (or not), etc.)


Element 10

Commercialization


Potential commercialization and possible patenting of study related tests, drugs, devices, etc. in other research or settings


Element 11

Right to withdraw


Creation of a uniform process for withdrawal


Element 12

Re-contact


Re-contact for use of samples, data and results in other research settings (such as disease specific research projects or other disease specific biobanks or population biobanks)


Creation of a uniform process to ensure that the re-contact procedure is respected in every research setting


Element 13

Contact information


Contact information for principal investigator, co-investigators, sponsoring institutions (when applicable) and the Institutional Review Board in other research settings


Element 14

Ethics oversight


Information about the extent of ethics oversight and approval mechanisms for the use of the data, samples and results of this study in other research settings


Element 15

Additional choices and signatures


Disease Specific Biobank Research

Add:

I agree that the samples and data collected during [name of the study], be used in other research settings, for research on [name of the disease] and related conditions or included in [name of disease specific biobank]. YES/NO


Disease Specific Clinical Research

Add:

I agree that the samples and data collected during [name of the study], be used for research on [name of the disease] and related conditions or included in [name of disease specific biobank]. YES/NO


No additional elements are required for Population Biobank Research.

Budin-Ljøsne et al. BMC Medical Genomics 2011 4:69   doi:10.1186/1755-8794-4-69

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