Application and Review Process
Developing Your Application
Please allow adequate time for the preparation and submission of your application. Present all information clearly and concisely, keeping in mind that members of the review committee may not be familiar with your field. Avoid or explain technical terms whenever possible. Answer all questions completely, provide any requested documentation, and ensure your application is complete before submission. Your application may receive full, expedited, or exempt review; to determine which application form is appropriate for your research see IRB Application Page.
Submitting Your Application
Completed applications will be submitted to the IRB chair, Bob Kachelski, via email. For student research projects, the application must be submitted by the faculty advisor, who is also responsible for thoroughly reviewing the application prior to submission.
Approval of Your Application
Criteria for full or expedited approval are the following:
- The risks to participants are minimized and are reasonable in relation to benefits.
- The study is well designed.
- Procedures already being performed on the subject for diagnostic or treatment purposes are used whenever possible.
- Selection of participants is equitable.
- The researcher is cognizant of the special considerations of vulnerable populations, such as children, pregnant women, and the economically disadvantaged.
- Informed consent follows IRB guidelines, and is appropriately documented.
- The researchers monitor the collected data to ensure the safety of the participants.
- The privacy of participants is protected and the data is kept confidential.
- The rights of participants, including freedom from coercion, are protected.
There are three levels of committee response to an application:
- Approved without modification. The researcher may proceed upon receiving the official letter.
- Minor required modification(s)needed. Some proposals require minor modifications to the protocol or consent form but the study is essentially considered "approvable". The researcher must address the concerns identified by the committee. The researchers will submit the modifications, and can begin the research upon receiving the official letter.
- Not approved. The research must address substantial concerns identified by the committee and resubmit the proposal in order to receive approval by the IRB committee.
Receipt of an official letter of approval indicates the investigator(s) may proceed with the study.
The decision to approve an IRB application lies with the chair, expedited review team, or full committee to which it has been assigned, and is based upon application of the federal regulations cited above. Because the IRB is dedicated to maintaining the overall high quality of its peer review system and of the review of individual applications, it has established appeal procedures for investigators to address such concerns. An investigator who is concerned about the review of his or her application should first contact the IRB chairperson.