- Welcome to the Department for Human Research Protections
- DHRP Contacts
- Does Your Research Require IRB Approval
- Which IRB Will Review My Research
- Before You Begin Your Research
- Guidance for Research Involving Children
- Training and Education
- Biomedical IRB Submission Forms
- Biomedical IRB Fee Schedule
- SBE IRB Submission Forms
- IRB Meeting Schedules & Member Information
- Compliance Information
- Institutional Policies
- News and Announcements
- Federal Information and Industry Links
Director of Operations
Roland Skeel, MD
Biomedical IRB coordinator
Social, Behavioral and Educational IRB
Barbara Chesney, PhD
|In order to determine whether an activity is research that requires review by the IRB the following questions should be answered:|
|A. Does the research meet the federal definition for involvement of human subjects?|
B. Does the research meets the Federal Definition for "research"?
Ifthe answer to any of the questions posed in A is "Yes" and either of the questions in B is "Yes",
the projects is subject to review by the IRB and the investigator must submit the
project on either a Protocol
Application or Claim of Exempt Application as determined by the level of risk.
|A project may be considered “instructional” and not require IRB review if it satisfies
the criterion listed
Ifthe answer is 'Yes', the project does not meet the definition of human subjects research and does not require review by the IRB.
All qualifying research projects involving human subjects not falling in the "instructional" category must be reviewed by the IRB Chair, Chair Designee or the full IRB in order to comply with federal regulations and University policies concerning the use of human subjects in research. An investigator should allow sufficient lead time for the review of any project submitted to the IRB as the committee meets on a monthly basis.
Categories for review by the IRB are: full Convened, Expedited and Exempt. Following submission of the protocol application, projects will be pre-reviewed and assigned to either the convened or expedited category. Expedited applications will not require the review of the entire committee but will be evaluated in detail by the Chair or Chair Designee to determine compliance with human subject research guidelines, 45 CFR 46 and the University's Federalwide Assurance. Exempt applications will also be reviewed in the same manner. Convened items will be reviewed by the entire board at the monthly meeting. Please see IRB Meeting Schedules & Member Information for submission dates.