Re-consent Requirements

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National Jewish will comply with federal regulations regarding re-consent requirements.

PROCEDURES

1. All changes, alterations and amendments in an IRB approved study must be approved by the IRB before implementation unless the change is necessary to eliminate an apparent hazard to the subject.
2. Those subjects presently enrolled and actively participating in the study should be informed of the change and re-consented if the change might relate to the their willingness to continue participation.
3. Re-consent is not required of subjects that have completed active participation in the study.
4. Re-consent is not required for subjects still actively participating when the change will not affect their participation, for example, when the change will be implemented only for subsequently enrolled subjects.