 |
All changes in protocols and consent forms require approval by the IRB prior to their implementation by submitting a Protocol Amendment Form to the IRB. Minor changes are reviewed and approved by expedited review by the IRB chair. Minor changes to previously approved research are eligible for expedited review under 45 CFR 46.110. Minor changes include, but are not limited to: 1. Administrative changes 2. Additions or deletions of investigators or study coordinators 3. Corrections of grammatical or typographical errors 4. Changes leading to clarification of a protocol 5. Changes leading to enhanced safety of study participants 6. Minimum changes in numbers of enrolled participants 7. Changes recommended by members of the Institutional Review Board at an adjourned meeting during which the Chair or the IRB has been designated to approve the changes by the expedited mechanism 8. Changes secondary to drug dispensation, software upgrades 9. Changes in the consent form to include Adverse Events noted during the course of the study 10. Changes in the consent form to incorporate Health Insurance Portability and Accountability Act (HIPAA) language Significant changes undergo full IRB review and voting at a convened meeting. For full and expedited review, submit original plus 11 copies of Protocol Amendment Form and supporting documentation. The changes must be highlighted in one set of the supporting documentation.
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
