Consent Structure Working Group
The Consent Structure Limited Duration Team compiled an example Informed Consent Document text about biospecimens collected for loosely specified future biomarker or genomic research. Selected commonly encountered topics were addressed:
- The nature and scope of the research.
- Additional ethical approvals.
- Withdrawal of consent.
- Storage and timing of biospecimen use.
- Return of results and Sharing.
- While IPWG member companies are not required to use the text, it is hoped that adoption of these exemplary passages will lead to greater commonality in the industry and contribute to success in obtaining ethical approvals of biospecimen-related sections of ICDs.