Form IRB-1: Protocol Application for the Involvement of Human Participants in Research: for Expedited or Full Board Review. Expedited and Full Board studies require the same level of review, so the same form is used for both types of review. See the next section to determine which level of review is required.
Form IRB-5: Request for Exemption from Continuing IRB Review. The IRB makes exemption determinations. This category requires initial IRB review, but the study is then exempt from continuing review. See the next section to determine which level of review is required.
Form IRB-7: Protocol Application for Research Methods Courses (RMC). Course Instructors must submit an application for IRB approval of the types of research projects to be conducted by students in the class. The IRB-7 protocol will receive expedited review.
Form IRB-9: Protocol Application for Ethnographic/Naturalistic Research. Ethnographic/naturalistic research activities may require expedited or full board review. The same form is used for both types of review. See the next section to determine which level of review is required.
Investigators make an initial determination for which type of review is appropriate for their study (full board, expedited, or exempt) and submit the required number of copies of the protocol and supporting documentation. Upon receipt, the IRB staff, in consultation with the Chair or an IRB member, screens the protocol to verify the investigator’s initial determination. The protocol is then placed into the appropriate queue for review. The Chair, or his/her designee, makes the final determination of the type of review required and the appropriate expedited or exempt category.
For more information on each type of review, please see:
- Exempt Procedures (New Protocol Submissions)
- Initial Review by Expedited Procedures
- Initial Review by the Full Board
Several factors affect the amount of time a review will take. These factors include how many other applications were received ahead of yours, whether all investigators on the application have completed the CITI training program, and whether the application is complete or if there is missing information required. The IRB reviews application in the order in which they were received. When a new application is received, the IRB Cover Page is stamped, and an IRB protocol number is assigned. The IRB Cover Page is returned to the Principal Investigator (or Correspondent) to verify receipt. From the date of receipt, the amount of time a review takes is as follows:
- Exempt reviews generally take one to two weeks.
- Expedited reviews generally take two to three weeks, depending on the time of year. The heaviest submission period is at the beginning of the semester.
- Full Board reviews are dictated by the Meeting Dates/Deadlines. IRB determination letters are sent to investigators within one week of the meeting. If a protocol determination is deferred, the study must be revised and be returned to the full board for review. If the IRB approves the protocol contingent upon minor modifications being made, the study can be approved as soon as the modifications are made and approved by the IRB Chair or his/her designee.
The consent discussion that takes place between an investigator and participant must be captured in a document called an “informed consent form”, or “consent form.” Ordinarily, all research participants must indicate in writing their willingness to participate in research by signing the consent form. However, signed consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research, or in research where the participants are to remain anonymous. In these cases, the IRB gives an investigator permission to alter the consent process (waiver of signed consent), and the investigator should prepare an information sheet appropriate for the study. Federal regulations identify certain specific elements required for informed consent. Depending on the nature of the research, the IRB may require additional elements.
For more information, see Standard Consent and Documentation section of the IRB Policies and Procedures documentation.