An REC (or a comparable ethical review body) should review: | |
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 –whether the consent given is sufficient for the planned use [17, 31]; | |
 –for determining when to seek re-consent [19]; | |
 –use of data on the basis of broad consent [19]; | |
 –(the justification of) a waiver of informed consent requirements [17, 19, 31, 37]; | |
 –Usage of data not anticipated in the original informed consent process [19]; | |
 –Re-use in cases where informed consent may not have been obtained previously [19]; | |
 –whether the consent procedure meets the specifications of broad informed consent [17]; | |
 –whether explicit informed consent is required [17]; | |
 –whether an informed opt-out procedure can be used [17]; | |
 –the proposed usage and/or collections, the storage protocol [17]; | |
 –if other measures need to be taken to protect the donor [31]; | |
 –the use of personal identifiers, its necessity and how confidentiality will be protected [17]; | |
 –whether individual counselling is necessary when returning genetic findings [17]. |