July 2, 2018
This release contains small improvements and resolves the following issues in the Human Subjects Application.
For All Roles
- Amendments Section 2, Related PAF/UFA data is now updated for in-progress Amendments
- Section 10 - Informed Consent Waivers, Corrected question 10-3.2 text to: "Check below to affirm that this study meets each of the criteria for waiver or alteration of informed consent and explain how."
- Application routing to Section 10-4 - Informed Consent Documentation Waiver, was changed based on answers to
- 10.1 - Informed Consent Adults
- 10.2 - Informed Consent Children
For IRB Staff and Reviewers
- A new approval letter (Editable_Continuing Report_Approve_Administratively No CR Reqd) is available for Amendments where No Continuing Review is required.
- In the No CR Required notification letter (Editable_Amendment_Approve_Full Committee CR Required), below the benefits and risk section, "Continuing Review Required: No" was changed to "Continuing Review Required: Yes".