By Federal regulations (45 CFR 46) and Clark University policy, all human subjects research by Clark faculty, research personnel, students and staff must be reviewed and approved by the Institutional Review Board for Research Involving Human Subjects (IRB).
IRB Proposal Application Review and Approval
All IRB applications and amendment requests must be submitted through the Mentor IRB website. This website provides instructions and forms for all types of IRB applications and requests.
IRB approval (or a formal indication that research is exempt) must be obtained before research activities may begin. To obtain approval or exemption, an application with the IRB must be filed. The IRB conducts different levels of review, depending on the type of research activities and subjects that are involved. Expedited reviews may be conducted for certain types of minimal risk research, as permitted by federal guidelines (45 CFR part 46). Other reviews must be conducted by the convened IRB at a regular meeting. The IRB will determine what type of review is applicable to each submitted protocol.
If you wish to alter your research methods for an already-approved protocol, you must submit an amendment request to the IRB. These requests will be subject to either expedited or full-board review.
Some types of work with human subjects may not be considered “research” according to federal guidelines and may not require IRB review. If you have questions regarding whether your research requires review, please contact humansubjects@clarku.edu. If in doubt, please assume the IRB review is required.
The Anonymous Survey Application can only be used for anonymous surveys. Data are anonymous if no one, including the researcher, can connect the data to the individual who provided it. All other research types require the standard IRB Proposal Application.
IRB Proposal Procedures
- If a project meets the definitions of human subjects research described above, it must be submitted to the IRB using the Mentor IRB system for review following standard IRB Proposal Procedures.
- If a project involves human subjects and/or human subjects data but the investigator believes that it might not meet the definition of human subjects research, the IRB must determine if it qualifies as “human subjects research” and thereby requires IRB review. Investigators collecting human subjects data for research purposes cannot “self-exempt” (declare their own project as “Not Human Subject Research”). If there is any possibility that a project might be human subjects research, the IRB must be consulted to determine if the project requires review.
- To receive an official determination of whether a project is human subjects research, investigators should complete a protocol application using the Mentor IRB system. Mentor includes a set of path-dependent questions that allow the IRB to determine whether a project involves human subjects research and what type of review is required.
- Protocol submissions for “not human subjects research” determinations follow the same general procedures as other submissions in Mentor. However, responses to the full set of possible protocol application questions are not required for projects that do not meet the criteria for human subjects research. In such cases, Mentor only asks a limited set of path-dependent questions necessary for the IRB to make this determination. In addition, CITI training is not required prior to submitting a determination application of this type. If the project is determined to involve human subjects research, CITI training must be completed before the project is reviewed by the IRB.
- Upon receipt of the protocol submission in Mentor, the IRB Coordinator assigns the protocol to the IRB Chair for categorization, following IRB Proposal Procedures. As part of the initial categorization review, the Chair determines whether the project includes human subjects research.
- If the project is determined not to include human subjects research, a determination of “not human subjects research” will be made within Mentor. The IRB Coordinator then sends a formal notification of this determination to the investigator through Mentor. No further IRB review or approval is required.
- If the project is determined to include human subjects research, it is categorized by the Chair for further review and approval (or exemption) by the IRB, following standard IRB Proposal Procedures. Prior to this review, the investigator will be asked to complete any additional protocol sections in Mentor necessary to complete the IRB review, as a protocol revision request.
- Informal inquiries into whether IRB review and approval may be needed do not require submission of a protocol within Mentor. Informal inquiries may be directed to the IRB Office or Chair, who will provide guidance on whether a Mentor protocol submission is required. The IRB will retain records of these informal inquiries and their disposition.