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
An IRB designate will determine whether a research protocol qualifies for exemption from coverage under 45CFR46.101 or 21CFR56.104. 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. 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.
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 and will make one of the following determinations:
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.
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 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:
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 the IRB with any questions or concerns