Are there special considerations in the banking and/or use of biological specimens or in data/tissue registries?
• General Issues • If the banking of biological specimens is proposed within the context of clinical care, a distinct consent form for the tissue procurement procedure should be used, separated from the consent for the clinical procedure. It must be made clear to potential subjects that their refusal to consent for the research use of biological materials will in no way affect the quality of their clinical care. • If the banking of biological specimens is proposed within the context of a larger research study, the following issues can be addressed within the main research consent form, but the actual request for consent to bank the tissue should be separated out from the request to consent for the main study. This can be achieved by adding yes/no statements right before the signature lines of the main consent: For example: Do you agree to allow use of extra blood obtained from this study/extra tumor from your surgery for use in future research, the purposes of which are unknown at this
