Special Circumstances Overview
There are a number of special circumstances that might not follow the usual application process:
- The federal Office for Human Research Protections (OHRP) provides decision charts to assist investigators and others in deciding if an activity is research involving human subjects that must be reviewed by an IRB under current federal regulations.
- Use of certain types of data may not need UCAIHS review and approval. To determine whether the data for your proposed study meets the criteria for any of these categories, see the new Checklist for determining Whether a Project Involves Human Subjects.
- There are issues that require attention when employees are used as subjects. For example, consultancy does not qualify as “research” and so does not require review and approval by UCAIHS. For details, see the UCAIHS policy on Employees as Subjects in Applied Research.
- Oral history projects that are considered research need UCAIHS approval. For details, see Clarification on Oral History.
- We have a Consent Form Generator designed to help investigators prepare a draft Consent Form for development of an Application for Review to the UCAIHS.
- Proposals that are not clear, readable, complete and consistent, will be returned to investigators unreviewed, and a complete re-submission requested. For details, see UCAIHS Policy on Review and Return of Applications.