1. The application is processed by the IRB Committee.
During the academic year, applications are processed on the Thursday after submission at 5:00 p.m.
When a student is the researcher, the application must be reviewed by a Research Advisor (comps advisor, directed-reading supervisor, etc.) before it can be processed by the IRB.
When an application is turned in, the chair asks a member of the board to be Primary Reviewer. This reviewer reads the application and the supporting materials. Then, he/she prepares an analysis and a recommendation for distribution to other IRB members.
If they agree with the recommendation, the application can be approved with one of three findings:
If they agree with the recommendation, the application can be approved with one of four findings:
- Many applications are found to “Exempt” from IRB review because they either make use of existing records, involve standard educational/psychological tests, or for other reasons listed in the federal regulations. However, only the IRB – not the researcher – can determine whether a project is exempt.
- Some applications are ruled “Exempt with limited review.” This category is appropriate for projects in which the only risk to subjects comes from the possibility that sensitive, identifiable information may be made public. Such projects are reviewed only to ensure that sensitive, identifiable information is adequately secured.
- Most other applications can be dealt with on the basis of an “Expedited” review because the research poses no more than minimal risk to human subjects and because the research falls into one of several categories of relatively innocuous research listed in the federal regulations.
- An occasional application will require a Full Review. This can entail a delay of several weeks because the IRB must convene to consider the application in person. Projects that will misinform or mislead the human subjects so as not to taint the subjects’ responses will always trigger a Full Review.
Most applications are dealt with in a week or ten days. A researcher should not wait until last minute to submit an application. Delays may result from unusual circumstances or academic-calendar issues such as breaks or final exams, but most delays are due to inadequate or missing Consent Forms. (In some cases, the IRB may determine that your research is Exempt, in which case you are not required to submit a Consent Form. However, it is in your interest to submit a Consent Form regardless in order to avoid any unnecessary delays.) Doing research that involves human subjects is a privilege, not a right. The IRB has dealt with numerous applications and will work with applicants on meeting the federal requirements. However, the IRB cannot approve projects submitted after the fact (prior review is necessary to insure compliance with federally defined criteria for ethical treatment of human subjects, particularly when the intent is to contribute to generalizable knowledge: U.S. Department of Health and Human Services. Thus research done without IRB approval MUST NOT BE USED IN ANY PRESENTATION OR PUBLICATION. In fact, increasing restrictions are being placed on publication in professional journals of research conducted without IRB approval. Thus, we urge you to plan ahead and consider possible future uses of the data to be collected (e.g. class projects that do not require IRB approval would require IRB approval if used for comps and/or publication); and obtain necessary approval in advance. If you have collected data without IRB approval for a class project or other non-research purpose and later decide to pursue research that might build on or potentially use this data (for example, in a comps project), you must contact the Chair of the IRB to discuss restrictions and possible ramifications. By teaching students about the ethical treatment of human subjects, working with them on the applications, and treating this matter as an opportunity for ethical reflection rather than an irksome requirement, faculty are helping to prepare students to understand obligations they may be expected to shoulder as adults.
2. The reviewer sends an email message to the applicant confirming the approval of the application.
3. Research may begin.
Once you receive e-mail notification of approval from the IRB, you may begin your research immediately. You do not have to wait for the formal letter of notification.
4. The formal approval letter is sent.
A few days after receiving the e-mail notification of approval, the IRB Chair will send a letter through Carleton email or campus mail finalizing the process. This letter should be kept in your project records!