Review Process for New Submissions

Any research that involves human subjects and is authorized and conducted under the jurisdiction of Drake University is subject to review by the Drake University IRB. No new research project or changes to previously approved research projects may be initiated until approved by the IRB.

Review Process for Exempt Submissions
Review Process for Expedited Submissions
Review Process for Full Board Submissions
IRB Action

Review Process for Exempt Submissions

An IRB designate will determine whether a research protocol qualifies for exemption from coverage under 45CFR46.104.  Under certain conditions, the IRB may also conduct a limited review of the protocol to ensure compliance with federal regulations. After you have submitted your application, your submission will be reviewed and you will be notified in writing of the official determination within approximately fourteen (14) days; incomplete submissions may take longer.  If it is determined that your project does not qualify for exempt status, you will be asked to submit your protocol for either expedited or full board review, as appropriate.

Review Process for Expedited Submissions

After you have submitted your application for expedited review, your submission will be reviewed by the IRB Chair and/or one or more experienced IRB members designated by the Chair. The reviewer(s) may exercise all of the authorities of the IRB except that the reviewer(s) may not disapprove the research. The reviewer(s) will complete the review within 2-3 weeks (incomplete submissions may take longer) and will make one of the following determinations:

• Approved
• Approved pending modifications
• Requires full board review

You will be notified in writing of the determination. If you are asked to make changes, allow one week for the IRB to respond once you have submitted the requested changes.

Activities approved through the expedited review process are recorded in the IRB meeting minutes, which are distributed to the full IRB prior to the next regularly scheduled IRB meeting. At a convened IRB meeting, any member may request that an activity that has been approved under the expedited review procedure be reviewed by the full IRB in accordance with full board review procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue. Full IRB decision shall supersede any expedited review decisions.

Review Process for Full Board Submissions

If your project requires full-board review, you will need to submit your materials one week prior to the scheduled full-board meeting at which you wish to have your proposal considered. You should also contact the IRB Chair if you wish to personally present your proposal at that meeting. In some cases, the Chair might contact a Principal Investigator to arrange for the PI to attend the meeting in order to address questions or concerns about a proposal. IRB meetings only occur monthly, so it is important to make submissions on time.

The Principal Investigator or co-investigator may be asked to explain the purpose for, risks of, and alternatives to the proposed research, including subject selection and exclusion criteria at the IRB meeting IRB members are then encouraged to ask clarifying questions concerning the protocol and consent process. The investigator is dismissed from the inquiry and any IRB members who have a conflict of interest with the project are excused from the meeting.

IRB Action

IRB members will make determinations regarding the category of risk, risk and benefit issues and whether informed consent procedures are adequate. The IRB takes one of the following actions:

• Approval: The IRB informs the Principal Investigator of its approval along with a copy of the approved informed consent document with the IRB date noted on each page. The Principal Investigator may begin the research project upon receipt of IRB written approval.
• Approval Subject to Modification: The IRB shall provide written notice to the Principal Investigator of its approval subject to modification, identifying specific areas of modification required. The Principal Investigator must provide the IRB with a revised protocol and/or informed consent document incorporating the modifications. The IRB Chair or designated member of the IRB shall review the revised protocol and/or consent document within one week of receipt of the revised documents. The IRB reviewer will then provide written notice to the Principal Investigator granting final approval of the protocol if the required modifications have been made. The notice of final approval will include a copy of the approved informed consent document with the IRB date noted on each page, if appropriate. The Principal Investigator may begin the research project upon receipt of IRB written approval.
• Tabled: If the IRB requires additional information and has a concern regarding the proposed research project, the Principal Investigator will be notified of the IRB decision and will be allowed to address the issue at the next regularly scheduled IRB meeting.
• Disapproval: If the IRB disapproves a research protocol, the IRB shall provide to the Principal Investigator, in writing, the reasons for the IRB decision and an opportunity for the Principal Investigator to appeal the decision. 

APPEAL PROCESS The appeal process consists of resubmission of the project to the IRB, with or without modification, accompanied by a letter from the Principal Investigator indicating why he or she feels the project should be again considered by the IRB.

Please contact IRB staff with any questions or concerns
515-271-2850
irb@drake.edu