When is it necessary to inform subjects of changes in the study and/or re-consent subjects?
Informed consent is a process, not only a piece of paper. To that end, those subjects who are presently enrolled and actively participating in the study should be informed of any changes if the changes might relate to the subjects’ willingness to continue their participation in the study. Changes must receive HSC2 review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects. Re-consenting of subjects is not required for those subjects who have completed their active participation in the study, or for those subjects who are still actively participating when the change will not affect their participation (e.g., when the change will be implemented only for subsequently enrolled subjects).
