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Expedited Review

Category II: Expedited Review

(Link to full text: CFR §46.110)

Expedited review involves research activities (recruitment, participant population, procedures, data storage) that pose no extra risks to participants than those they would expect from their typical daily life activities (i.e., those activities posing no greater than minimal risk). The term "expedited" does not mean fast or short review. It refers to the role the Full Board plays in the review.

For a research activity to qualify for expedited review (category II), all of the following conditions must apply:

  • The frequency and magnitude of risks posed by the study and its procedures (including data storage) are expected by investigators and the IRB to reach the level of minimal risk; that is, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (considering the participant population);
  • The research must cleanly fit one of the categories for expedited review, refer to the OHRP Guidance;
  • Sometimes research including children and other special populations cannot be classified as expedited (ask the IRB for more details about the difference between expedited and full review research); and
  • The research does not involve the study of controversial or sensitive topics (as recognized by the surrounding community).

OHRP decision charts may help you decide if you should apply for exempt review. The IRB holds the final responsibility for classifying the level of review. If you would like assistance with identifying the appropriate level of review for your research, contact the IRB ([email protected]).

Expedited Application

Creating a New IRB Submission in PACS

Important Note: Prior to beginning this process, it is important to make sure you have already accessed the IRB website to utilize the latest forms and templates for drafting your Application, Informed Consent and/or Assent forms, as well as any supporting documents, such as the Investigator Assurance Form, Appendix B (if applicable), Letter of Agreement(s), survey/interview/intervention materials, recruitment materials, mental health resources, etc. All applicable documentation must be completed and uploaded in your PACS submission. Additionally, please make sure you, your Faculty Advisor (if applicable), and all members of your study team are registered in P(opens in a nPACS and have completed the required CITI Program training. (opens in a new window)

  1. Log into PACS
  2. Select the IRB tab at the top, then select the Create New Study tab below on the left side of the screen.
  3. Complete the PACS smart form, answering all questions and uploading documents in the appropriate locations. Select +Add to upload documents. Please only upload the completed Application under #8 Attach the protocol section of the smart form. Supplemental documents such as the consent forms, etc. will be uploaded under Local Site Documents. See below for details regarding where to load study documents.

Screenshot of the Basic Study Information section of the PACS smart form. The steps, numbered one through eight, are as follows: One, Title of Study, two, Short Title, three, Brief description, four, What kind of study is this? Multi-site or Collaborative, and Single-site are the options, five, Will an external IRB act as the IRB of record for this study?, six, Local principal investigator, seven, Does the local principal investigator have a financial interest related to this research?, and eight, Attach the protocol. Step three has a note that reads, "In this section, summarize the central research question, the primary objectives, and the methods used. Step eight has a note that reads, "Attach the protocol: Upload only the application from our website." The application can be found on the IRB Application webpage under the appropriate level of review. A screenshot of the Local Site Documents section of the PACS smart form. There is a not at the top that reads, "Local Site Documents appears later in the PACS submission. This is just to show you what needs to be uploaded when it appears." There are three sections to upload documents/ One, Consent Forms, Upload all consent and assent forms here if applicable. Please use the templates on the IRB Resources, Templates, and FAQS webpage. Two, Recruitment Materials, Upload all recruitment emails, letters, scripts, advertisements, social media posts, et cetera. Three, Other Attachments, Upload supplemental items such as Letter(s) of Agreement, the Investigator Assurance (signature page), survey/interview measures, images/study stimuli, et cetera.

  1. Add all study team members under Local Study Team Members and select their corresponding role in the research study. For student researchers, please make sure you add your Faculty Advisor here as well. (you will not be able to add team members unless they have registered with PACS)
    A screenshot of the Local Study Teams Members section of the PACS smart form. There are two steps in this section. Step one, Identify each additional person involved in the design, conduct, or reporting of the research. There is an Add button with a plus sign that can be used to add team members. Step 2, External team member information. There is an add button under this as well. There is a note on the screenshot that reads, "If a study team member is not populating in the search, that means they are not registered in PACS. Please share the PACS Account Request Form, linked on the SUNY Cortland IRB homepage and Application page, with your team and ask them to complete the registration in order to add them to the study submission. For External team member information you must upload the CITI completion certificates (Group 1 Biomedical Researcher of Group 2 Social and Behavioral Research) for all study team members not affiliated with SUNY Cortland.
  1. The CITI training section in the PACS smart form is informational and does not always populate the CITI training for internal study team members. The IRB will verify training for all team members, but this should be completed before submission. Please do not upload CITI certifications for internal team members.
  2. Note that on the 5th PACS page it asks for local research locations. You can leave this information blank.
  3. Once all relevant documents are uploaded, study team members have been added, and the smart form completely filled out, select Finish to save and return back to the pre-submission page.
    A screenshot of the Final Page section of the PACS smart form. There are four steps listed on this page. One, Click the "Finish" button on this page to exit the submission forms and be redirected to the workspace. Two, When you are ready to submit for IRB review, you will then need to click the "Submit" activity button. Three, Read and attest to the content of the pop-up window and click "Ok" which will execute the "Submit" activity. Four, Provided that all required information has been completed, the study wil be sent to the IRB for review. There is a red arrow in the lower right pointing to the "Finish" button. There is also a note the reads, "You can select Save at the bottom of the page and then Exit the form at any time. This will bring you back to the pre-submission page. You can select Edite Study to go back into the submission and make changes."
    1. You will be directed back to the pre-submission page where you will need to select Submit on the left side of the screen in order for your study to be submitted to the IRB for processing.
      A screenshot of the Next Steps page in PACS. There is a red arrow pointing toward the "Submit" button on the left side of the screen. A note reads, "If you do not select Submit, the study will not come through to the IRB. Please make sure this step is completed when you are ready to submit you IRB application. Additionally, you may selct Edit Study in order to go back and edit documents, add study team members, et cetera, before you submit. However, once you select Submit, you cannot edit the study unless you Withdraw the submission or the IRB administrator sends the study back to you in PACS. Finally, communication is sent from PACS to one study member. If the person submitting is not who should receive communication, you can assign a Primary Contact." This can all be done using the options in the menu on the left side of the screen.

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