Exempt Amendments
Exempt research is also exempt from the requirement that every change to the research be prereviewed by the IRB. As a general guide, any change that might call into question the original exempt determination should be submitted for review. Also, changes that might necessitate additional privacy board review under HIPAA (e.g., reconsideration of waivers of authorization), should be submitted for review.
Submit an amendment for:
Do not submit an amendment for:
- Changing the PI
- Adding investigators
- Changing the Primary Contact
- Adding a new aim
- Adding a new cohort
- Adding a new survey
- Changing the consent process
- Adding a new recruitment method
- Expanding a data set subject to HIPAA (e.g., accessing additional PHI or health records)
- Removing investigators
- Adding staff
- Making minor editorial changes to study documents
- Making modest changes to an approved survey without collecting new sensitive information
- Enrolling a small number of additional subjects
Quality Improvement, Program Evaluation and Public Health Surveillance
Quality improvement (QI), program evaluation (PE), and public health surveillance projects do not require COMIRB review. If COMIRB reviewed such a project and issued a Not Human Subjects determination letter, do not submit amendments. If you are converting such a project into a research study, submit a brand new application for review.
Questions
If you have questions about whether you need to submit an amendment for your exempt research, please contact us at COMIRB@ucdenver.edu or drop into Office Hours.