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Table 6 Items subject to ethical review

From: Responsible data sharing in international health research: a systematic review of principles and norms

An REC (or a comparable ethical review body) should review:
 –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].