How to Submit Electronic IRB (e-IRB) Applications for Review
Overview
Federal regulations divide human subjects research into three categories (based upon risk to subjects), each of which has a corresponding requirement for institutional approval or registration. For an explanation of each, visit Levels of Review. Once the level of review has been determined, investigators need to submit an application for exempt registration or IRB review. No human research may begin until an IRB registration or approval letter is provided.
Exempt Registration Confirmation
Exempt research involves virtually no risk to subjects. Investigators cannot "self-exempt" research protocols that meet the criteria for exempt registration. Rather, investigators must apply for Exempt registration by completing an IRB Application and protocol narrative for IRB review and registration. The IRB will require a complete description of the research to determine whether the project falls within the 6 exempt categories of review.
- Visit our Application and Forms page to complete the electronic Application for IRB Review.
- Be sure to submit the Protocol Narrative and all other attachments with the electronic IRB Application (e.g., a data collection instrument, survey or questionnaire).
- All prerequisite human research tutorials must be completed by every study team member before the protocol can be submitted or reviewed.
- There are no submission deadlines for Exempt registration protocols; they are reviewed on a rolling basis, usually within 2-3 weeks.
- If the human research study does not qualify under any of the six exempt categories, the application will require expedited or full committee review.
To apply for Exempt Review, investigators submit the following to the IRB:
- Submit the electronic IRB Application and the Protocol Narrative with all applicable attachments
- After the Lead Researcher has electronically submitted the e-IRBAPP, the following hard copy documentation must be submitted:
- 1 copy of e-IRB Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with original signatures of Lead Researcher and Department Chair or Organized Research Unit Director, and Faculty Sponsor, if required.
- For studies where some required documentation (e.g., survey packets, interview schedules, and permission letters) was not uploaded and submitted during the e-IRBAPP process, 4 copies of these materials.
Applications are placed in the queue for IRB review once the application has been submitted electronically and the hard copy with required signatures has been received by the Human Research Protection (HRP) staff in the ORA.
Expedited Review
Human research that is no more than minimal risk to subjects qualifies for expedited review if it falls within the 7 expedited categories of review. All expedited applications must be reviewed and approved by the IRB. The IRB will require a complete description of the research to adequately assess risks and benefits, and to determine whether the project falls within the 7 expedited categories of review.
- Visit our Application and Forms page to complete the electronic Application for IRB Review.
- Be sure to include the Protocol Narrative and all other attachments with the electronic IRB application (e.g., informed consent documents, data collection instrument, survey or questionnaire, recruitment materials).
- Some expedited research qualifies for a waiver of written (signed) informed consent or a waiver of consent all together. See Informed Consent Preparation for more information.
- All prerequisite human research tutorials must be completed by every study team member before the protocol can be submitted or reviewed.
- There are no submission deadlines for Expedited Review; they are reviewed on a rolling basis, usually within 3 weeks.
- Print out the Protocol Preparation Checklist and refer to it when preparing your protocol.
- " If the human research study does not qualify under any of the seven expedited criteria for review, the protocol will require full committee review.
To apply for Expedited Review, investigators submit the following to the IRB:
- Submit the electronic IRB Application and the Protocol Narrative with all applicable attachments
- After the Lead Researcher has electronically submitted the e-IRBAPP, the following hard copy documentation must be submitted:
- 1 copy of e-IRB Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with original signatures of Lead Researcher and Department Chair or Organized Research Unit Director, and Faculty Sponsor, if required.
- For studies where some required documentation (e.g., survey packets, interview schedules, and permission letters) was not uploaded and submitted during the e-IRBAPP process, 4 copies of these materials.
- Applications are placed in the queue for IRB review once the application has been submitted electronically and the hard copy with required signatures has been received by the HRP staff in the ORA.
Full Committee Review
Human research that does not qualify for exempt or expedited review involves more than minimal risk to subjects and must be reviewed by the full IRB at a convened meeting. The IRB will require a complete description of the research to adequately assess risks and benefits and to assure appropriate protections for subjects.
- Visit our Application and Forms page to complete the electronic Application for IRB Review. Be sure to include the Protocol Narrative and all other attachments with the electronic IRB application (e.g., Sponsor's master protocol, informed consent document(s), data collection instrument, survey or questionnaire, recruitment materials).
- Virtually all full committee protocols require written informed consent. See Informed Consent Preparation for more information.
- All prerequisite human research tutorials must be completed by every study team member before the protocol can be submitted or reviewed.
- There are submission deadlines for Full Committee Review and protocols must be received by 5 pm on the deadline day to be considered for the IRB meeting agenda.
- Print out the Protocol Preparation Checklist and refer to it when preparing your protocol.
To apply for full committee review, investigators submit the following to the IRB:
- Submit the electronic IRB Application and the Protocol Narrative with all applicable attachments
- After the Lead Researcher has electronically submitted the e-IRBAPP, the following hard copy documentation must be submitted:
- 1 copy of e-IRB Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with original signatures of Lead Researcher and Department Chair or Organized Research Unit Director, and Faculty Sponsor, if required.
- For clinical investigations, 4 copies of the Sponsor/Master Protocol and the Investigator's Brochure
- For studies where some required documentation (e.g., survey packets, interview schedules, and permission letters) was not uploaded and submitted during the e-IRBAPP process, 4 copies of these materials.
- Applications are placed in the queue for IRB review once the application has been submitted electronically and the hard copy with required signatures has been received by the HRP staff in the ORA.
