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 |