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 |