Abstract
BackgroundThe ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Although informed consent often does not anticipate such cross-domain sharing, it is important to examine its plausibility. The purpose of this study was to explore the feasibility of bridging consent between disease-specific and population-based research. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted.DiscussionEthical and legal frameworks governing consent dissuade cross-domain data sharing. Paradoxically, analysis of consent models for disease-specific and population-based research reveals such a high degree of similarity that bridging consent could be possible if additional information regarding bridging was incorporated into consent forms. We submit that bridging of consent could be supported if current trends endorsing a new interpretation of consent are adopted. To illustrate this we sketch potential bridging consent scenarios.SummaryA bridging consent, respectful of the spirit of initial consent, is feasible and would require only small changes to the content of consents currently being used. Under a bridging consent approach, the initial data and samples collection can serve an identified research project as well as contribute to the creation of a resource for a range of other projects.
Highlights
The ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation
For the purpose of this study, we identified three separate domains of research across which data sharing would be valuable: 1) Disease Specific Biobank Research (DSBR) refers to research typically conducted by large research consortia outside of a clinical setting using a collection of human biological material and associated information stored for research on a pre-determined set of diseases; 2) Disease Specific Clinical Research (DSCR) refers to clinically-based research conducted in association with a biobank to evaluate the effectiveness and safety of medications or medical devices; 3) Population Biobank Research (PBR) refers to research conducted on populations unselected with respect to a particular disease using human biological material and associated information stored for future unspecified research
In order to respect the choices expressed in the initial consent, it could be assumed that a research participant would agree to allow his/her samples, associated data, and results to be accessed for other research in different research domains, provided that the new research focuses on the same diseases or a more restrictive set of diseases than the initial research
Summary
The ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted. The ability to share and combine data from disease-specific and population-based research has become increasingly important for translational medicine. Such study designs will entail extensive cross-domain data sharing between disease-specific and population-based research. We conduct two sets of comparative analyses that focus on: 1) current ethical and legal frameworks governing consent with regards to potential hindrances and opportunities for cross-domain sharing, and 2) current consent models found in disease-specific and population-based research. The purpose of this work is to identify potential hindrances and opportunities to bridge consent and to propose practical solutions to bridging consent that dovetail with the new interpretation of consent as envisioned by the Human Genome Organization’s Ethics Committee
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