Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk. Once all application requirements are fulfilled, the expedited review process takes approximately 2 weeks.

All protocols approved through the Expedited Procedure must be submitted for continuing review and approval, as described in Continuing Review & Approval. A final report is also required when the study has ended.

Investigators applying for expedited review should become familiar with all sections of this guidebook and the requirements described in them.

Eligibility

Expedited review is applicable for research activities that involve no more than minimal risk to the human participants and that can be placed in one or more of the nine categories listed on the Expedited Category Review Sheet.

Categories 1 through 7 pertain to both initial and continuing review. Categories 8 and 9 pertain only to continuing review. The definition of minimal risk for the purpose of IRB application is the amount of risk encountered in daily life.

The expedited review procedure cannot be used in the following circumstances:

• When one or more participants are prisoners or become incarcerated during participation (see Prisoners under "Participant Populations" in General Information).
• Where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
• When the activity is “classified research” involving human subjects.

Decision Trees

OHRP has published decision trees that are available online to help in determining whether a research proposal fits the criteria for Expedited review.

Application Process

There are no deadlines for the submission of initial applications for expedited review. However, you will have thirty days to submit your response, or it will be withdrawn.

1. Obtain the approvals that are required of all investigators (see "Before Applying for IRB Review" in General Information).
2. Complete the ePortfolio, including any additional forms or special approvals that may be required (see Special Approvals). Each mandatory (*) item requires a response. If an additional item or form is required, that requirement may be noted during the administrative or member review. Nevertheless, the following points deserve special mention:
   1. The ePortfolio must indicate whether it is minimal or greater than minimal risk (expedited or convened review). For Expedited Review, the ePortfolio must show the appropriate expedited category (from the Expedited Category Review Sheet).
   2. When submitting the initial application, the coordinator submits on behalf of the Principal Investigator, but the PI is responsible for ensuring all things submitted are adequate.
   3. If the research receives any extramural funding, the ePortfolio must include the OSP Assigned number, and the application must include a copy of the funding application as submitted to the sponsor. Any changes or updates to the funding application must be submitted to the IRB for review regarding the research protocol.
   4. If children are involved, the following requirements apply:
   • The protocol must not involve greater than minimal risk.
   • The Special Population section of the ePortfolio must be completed and indicate that the Children's Risk Level is appropriate.
   • Unless a waiver of consent is requested, the description of the informed consent process must include plans for obtaining and documenting both permission/consent from at least one person authorized to consent for the child and assent from the child participant. (See "Participant Populations" in General Information, and Informed Consent.)
3. Develop an informed consent process and document that comply with the applicable requirements (see Informed Consent, and "Participant Populations" in General Information). The ePortfolio must indicate whether (a) informed consent will be obtained, (b) informed consent will be documented, and/or (c) the investigator requests a waiver or alteration of these requirements.
   1. If informed consent will be obtained, including a copy of any form, script, or other materials used in the process.
   2. If informed consent will be documented, including a copy of the document(s) with the revision date.
   3. If informed consent will not be obtained, will not contain all of the required elements, or will not be documented, including the applicable form(s) for waiver: Waiver of Consent, Waiver of Authorization and Informed Consent, and/or Waiver of Informed Consent Documentation.
4. Include the Protocol Oversight Review Form or IRB-approved equivalent with the appropriate original signatures (see Before Applying for IRB Review). Refer to the departmental review process in the department of the principal investigator's primary appointment.
5. Include all additional items required by the nature of the protocol, as applicable:
   1. Sponsor's protocol
   2. Funding application
   3. NIH-approved informed consent document
   4. FDA Form 1572
   5. Verification of Notification of Proposed Research for protocol-related performance sites
   6. Documentation of IRB approval from all other sites engaged in research for the protocol
   7. Documentation/verification of the sponsor's injury compensation policy
   8. Industry-sponsored Protocol Billing Information form​ for payment of $1,000 fee for expedited review, if applicable.

Forms:

• Expedited Category Review Sheet