Information for IRB Reviewers (Departmental and Board)
Thank you for serving the MSSU campus as an IRB Reviewer. There are two types of reviewers on the MSSU campus: (1) Departmental Reviewers and (2) MSSU Institutional Review Board (IRB) Members. These types of reviewers may also overlap, as MSSU IRB Members can also serve as departmental reviewers. This page is designed to provide MSSU Reviewers with helpful information about the process of IRB Review.
All MSSU Reviewers must have up-to-date training credentials. Training credentials are valid for three years from the time of completion. MSSU Reviewers must complete their training through the Collaborative Institutional Training Initiative (CITI). The CITI training can be found at: https://www.citiprogram.org/. New users will need to complete the registration process before signing into the training system.
Reviewers must complete all the required modules within the Social & Behavioral Research - Basic/Refresher Course.
For MSSU Reviewers, the certificate provided at the completion of the training must be uploaded to the member's IRBNet profile. It will be maintained with the reviewer’s qualifications for the IRB. Training must be completed before reviewing IRB applications, and renewed every three years.
Application Review Timeline
MSSU's IRB Policy state that, "Reviewers are urged to facilitate the review process by completing their review within two working days." If a reviewer has not submitted their decision on an application after two working days, the IRB Administrator will send a reminder to the reviewer's email address. At this time, if a reviewer does not believe they will be able to complete the review within 7 working days from the time the application was originally sent, they should notify the IRB Administrator who will pass the application on to another reviewer. After, 7 working days, if the original reviewer has not submitted their decision, the application will automatically be passed on to another reviewer.
We understand that reviewers' time is valuable and we appreciate this important service to the university community. The process is designed to make sure that applications are turned around quickly to efficiently facilitate research on campus.
The Structure of the Decision Letter
The structure and content of a reviewer's decision letter is very important to the process. When MSSU’s IRB Ad Hoc Policy committee convened from 2014-2016, the committee decided that feedback on the principal investigator’s methodology could potentially be a part of an IRB review. If the research design is poor, then participants may be taking voluntary risks (although in many cases minimal) for results that do not yield usable findings. However, the committee determined that these must be suggestions and not requirements.
The primary role of an IRB reviewer is to protect human participants (subject welfare). We need to make sure that campus research is abiding by the principles set out in the Federal Guidelines and MSSU’s Human Subject’s research policies. Any Reviewer comments on changes that facilitate the protection of human participants are required and the principal investigator will have to alter their project to bring it in-line with protections of human subjects.
Any other reviewer comments, not pertaining to the primary charge of protecting human participants, must be suggested not required. Comments regarding errors on the application form that do not impact human subject protection, are suggestions not requirements. Any comments on the research design or methodology that does not pertain to human participants’ protection are suggestions.
The MSSU IRB requests that all reviewer comments clearly delineate requirements as separate from suggestions in their comments, by using section headings or labels. Reviewers should label their first section of the comments Requirements and then, if a reviewer has any additional suggestions, they should place those under the section heading of Suggestions. In this way, when revising the application, the researcher (and IRB Administration) will know exactly what must be changed to get the application approved and which comments are helpful suggestions for the research design (or any other suggestion that pertain to the project).
Reviewer Decision/Recommendation Levels
There are several Decision/Recommendation Levels in IRBNet that a reviewer can choose when making their decision on an application in IRBNet. However, there are only a select few from the IRBNet drop-down menu that an MSSU reviewer should choose from. The MSSU relevant levels, and their definitions, are as follows:
Approve: This decision level is used when a reviewer approves of the application in its current form and does not require further information or changes.
Approve with Conditions: This decision level is used when a reviewer approves of the application, but requires very minor changes. When a reviewer selects this decision level, the changes will be relayed to the researcher, and the IRB Administration will check the revised application to make sure that all changes have been made. The revised application will not be sent back to the reviewer. This decision level is suggested when minor changes are requested.
Exempt: This decision level is used when a reviewer determines that the application should be Exempt rather than expedited. Choosing this decision level will change the Assessment of the Research level and the IRB Administration will alter the application as neccessary. When this decision level is chosen, the IRB Administrator may seek the advice of additional reviewers and the Chair of MSSU's IRB before changing the official assessment of research level.
Information Required: This decision level is used when a reviewer determines that they do not have enough information to make a decision, or needs additional information on specific elements of the application. The researcher will be prompted to provide the additional information and, once submitted, the reviewer will make a subsequent decision (approve, approve with conditions, modifications required, etc.) based on the new information.
Modifications Required: This decision level is used when a reviewer has determined that a specific set of modifications are required before the application can be approved. If this decision level is chosen, the reviewer will make the required modifications, and the IRB Administrator will then send these changes back to the reviewer. The reviewer will then make a subsequent decision (approve, approve with conditions, modifications required, etc.) based on the changes to the application.
Refer to Full Board: This decision level is used when the reviewer determines that the application and the research project needs to be reviewed by the Full MSSU IRB. When this decision level is chosen, the IRB Administrator may seek the advice of additional reviewers and the Chair of MSSU's IRB. If it is determined that the application should go to the full board, the IRB Administrator will add the application to the next full IRB meeting agenda.
Disapprove: This decision level is reserved for when a reviewer decides that the application and the research project, even with modifications, cannot be conducted in a way that protects human participants in accordance with MSSU's policies and the Federal Guidelines. This decision level should not be used if the reviewer determines that modifications to the project would bring the application in-line with MSSU policies and Federal Guidelines.
Note: When choosing a recomendation/decision level on IRBNet, reviewers must check the box next to " Mark my personal review as complete." If this box is not selected, the IRB Administrator will not be notified that the review is complete and the reviewer will receive reminder emails, even though they have completed the review.
IRB Walkthrough for Reviews
Download this helpful guide for the IRB process.