Essential Checklist for IRB Expedited Review

Core Components of an Expedited IRB Submission

1

Application Form

Signed application.

  1. A list of personnel involved
  2. A synopsis of the project
  3. Participant population
  4. How human participants will be engaged in the research,
  5. How you will minimize risks to the participants, including their data.
2

Study Protocol

Detailed description of the background, objectives, study design, recruitment methods, and step-by-step procedures.

3

Risk Assessment

Confirmation that the probability and magnitude of harm are not greater than those ordinarily encountered in daily life.

4

Exempt Categories Verification

Identification of which federal exemption category applies (e.g., normal educational practices, anonymous surveys/interviews, or benign behavioral interventions).

5

Informed Consent / Assent Documents

Consent forms, information sheets, or waiver requests matching federal requirements.

6

Principal Investigator & Team Credentials

Proof of completed human research protection training (such as CITI certification & HIPAA if applicable) for all study personnel.

Note that the Basic Course for Social Behavioral or Biomedical Researchers is required. The Refresher Course cannot be accepted unless the investigator has previously completed the Basic Course and is using the Refresher Course to renew training credentials.
7

Supporting Materials

Recruitment flyers, advertisements, phone scripts, survey instruments, interview questions, or debriefing sheets.

8

External Approvals/Site Permissions

Letters of cooperation or support if research takes place at external or community sites.

Nursing Students need to include the following:

  • Quality Improvement (QI) Determination Checklist is a tool used by nurses, nurse leaders, and nursing students (such as DNP candidates) to evaluate whether a clinical project requires standard IRB oversight, an expedited review, or is classified as non-research.
  • Quality Improvement (QI) worksheet (often structured as a PDSA Plan-Do-Study-Act cycle worksheet) helps clinical and nursing teams systematically plan, implement, and track a process change.

Do a final check to make sure protocol details are correct and consistent across forms and attachments, then submit to the IRB.

Your IRB administrator will likely conduct a preliminary review of the submission and contact you with any questions or additional requirements. They may also assign a review method (full board, expedited, exempt) depending on the study, and time to approval can vary based on the review method.

Once your study is approved, it is imperative that you follow the protocol, use approved documents, report issues to the IRB, and track your protocol expiration to ensure you remain compliant with your approval.