The Review Process
Wabash College Principal Investigators (PI) who are planning research projects involving human subjects are responsible for initiating the review process by submitting their research proposals and all necessary forms to the appropriate individuals designated below. Non-Wabash Principal Investigators (individuals not directly affiliated with Wabash College) who propose research projects involving human subjects from the Wabash College population are required to partner with a Wabash College faculty or staff investigator who will initiate the review process.
| Glossary of Terms |
Training Requirements. 皇冠足球比分_澳门皇冠体育-在线|平台@ are now using the CITI certification service. Contact the Interim Chair of the IRB (Dr. Karen L. Gunther, guntherk@wabash.edu) for instructions.
Submission of Documents. Application materials must include the following: 1) the Research Review Declaration, stating the requested review category (required only of students), 2) a certificate of completion of the online CITI IRB training program, and 3) an application form appropriate to the category of review (Expedited, Full) along with all materials specified by that application form. An overview of the review categories can be found below; a fuller description is available at Categories of Review.
To expedite the management of human subjects research proposals, all materials must be submitted for IRB review in electronic form. Each investigator should prepare a single, paginated Word file containing all IRB documents. Please do NOT send multiple individual files.
Directing Proposals for Initial Review
- Faculty member - Submit proposal directly to the chair of the IRB.
- Staff member - Submit proposal directly to the chair of the IRB.
- Student - Submit proposal to the faculty advisor or sponsor, who will in turn submit it to the chair of the IRB.
- Non-Wabash investigator – Submit proposal to the Wabash College partner, who will in turn submit it to the chair of the IRB.
All research proposals are evaluated by the chair of the IRB or the full IRB with regard to the degree of “risk,” if any, to human subjects. Risk is conceived broadly to include the probability of harm or injury of any sort (physical, psychological, social or economic). The degree of risk can vary from “minimal” to “significant.” The concept of “minimal risk” is very important in risk assessment and is the only category of risk defined in federal regulations (Code of Federal Regulations: 45CFR46):
Minimal Risk -- A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Once the IRB chair has completed a preliminary assessment of risk, s/he will assign the proposal to one of the categories of IRB review listed below. (As part of the required package of information, if the principle investigator is a student, he must also include the Research Review Declaration, stating his opinion as to the project’s category of IRB review, and confirmed by his faculty sponsor.)
Expedited Review - If the proposal involves only minimal risk, an "expedited review" will be conducted by the chair or at least one other member of the IRB designated by the chair
Full IRB Review - For proposals judged to involve greater than minimal risk, the chair of the IRB will schedule a "full IRB review."
For additional details on the criteria for each type of review, please see Categories of Review.
Approved – A protocol that has been approved by the IRB requires no further action from the investigator prior to initiating the study. If the study required full review, and if the study should extend beyond 12 months, the investigator should send a letter to the IRB chair, informing her/him of the current status of the project, any changes in the protocol, and whether any adverse events have occurred. Expedited IRB reviews no longer (as of January, 2019) require annual review.
Conditionally Approved – A protocol that has been approved on condition may begin as soon as the condition(s) for approval have been met. These conditions typically require only simple concurrence by the PI, who must submit appropriate documentation to the chair of the IRB before the project is initiated. No additional meeting of the full IRB is required unless the chair is not completely satisfied that the required conditions have been fully met by the investigator. In that event, the chair will refer the protocol to the full IRB for review.
Deferred – A deferred protocol typically requires substantive clarifications or modifications. A revised application must be submitted to the IRB clarifying the issues involved or providing the requested documentation. The IRB will review the revised application at its next meeting.
Denied – Projects may be denied approval only by action of the full IRB, which will provide in writing the reasons for denial. An investigator is prohibited from conducting any project that has been denied approval; however, s/he may request a reconsideration of the decision by the IRB.
Research approved through the Full IRB review process must be reviewed at least once a year by the IRB. Shorter periods of review may be required by the IRB for research that has a high degree of risk.
An e-mail message describing the decision of the IRB will be sent to the investigator. If the e-mail signifies approval, it will specify the one-year time period during which the approval remains valid. If the IRB requires revisions or denies approval of the proposed research, the PI may request that the IRB reconsider its decision at the next regularly scheduled meeting.