All investigators involved in a research project must complete online CITI Training prior to submitting an application for approval.
Investigators may NOT conduct human subjects research activities until they have obtained IRB approval.
Who Approves Research Projects?
Ferris State University's Institutional Review Board (IRB) approves all research projects involving human subjects. The IRB's responsibilities include overseeing the protection of the rights and welfare of human subjects. Committee members are composed of Ferris faculty and community members with various backgrounds and research interests. For more information on committee members, visit the committee webpage.
- Determine if your project is research, according to the federal definition. In order for projects to be considered human
subjects' research it must develop or intend to contribute to generalizable knowledge.
If you are unsure if your project involving human subjects requires review, contact IRB@ferris.edu for assistance.
- Complete CITI Training with a score of 80% or better before submitting the application to the IRB. All investigators
(employees and students) involved in a research project must complete appropriate
training. Modules are categorized based on type of research being conducted. See CITI training instructions for more details. Additionally, investigators receiving external funding are required
to complete the training for Responsible Conduct of Research and Conflict of Interest.
- Submit an application for approval to IRB@ferris.edu at least one month before the intended starting date.
The IRB Office communicates with the Principal Investigator after submission to verify that the application has been received, typically within one to two business days.
During the review process the IRB may request additional information or modifications in areas of the protocol via email.
- Notification of approval will be given via email with a letter outlining project terms, including the expiration date. Projects may not continue past the expiration date. Approval is granted only for the application submitted to and reviewed by the IRB; any changes to project design and/or procedures made must be reviewed by the IRB before implementation.
Time Frame for Application Review
Estimated time span for the review and approval process is determined by type of review, as well as accuracy and completeness of applications submitted. A delay in review may be expected between semesters, during final examination periods and university closures.
- Exempt and Expedited Projects: minimum of 14 working days
- Full Committee Projects: reviewed at monthly meetings
Review Category Description: Exempt, Expedited and Full Review
Investigators are encouraged to select the level of review for their proposal among the federal review categories; however, determination of review is made by the IRB. Protocols that are classified as Exempt and Expedited are not reviewed by the Full IRB Committee, but must still be reviewed and approved by at least one IRB member in accordance with institutional policy and federal regulations.
Exempt Reviews are those projects that involve no more than minimal risk and human subject data can not be identified, directly or through identifiers linked to subjects. This means, investigators must not be able to distinguish who participates in the research. Consent waivers may be applied to exempt reviews in order to maintain anonymity of subjects. Approval is granted for up to three years, with requirements to update the IRB annually on the status of the project (ongoing or completed).
Expedited Reviews are those projects that involve no more than minimal risk, but human subject data can be identified, directly or through identifiers linked to subjects. Protocols classified for expedited review are reviewed by at least one IRB member and/or a subject matter expert. Approval is granted in one year increments.
Full Reviews are projects that do not meet either the exempt or expedited categories provided by the government and are reviewed and voted on by the full IRB committee.
The IRB determines approval of a project based on the following criteria:
- Research design and procedures do not unnecessarily cause risk to subjects
- Risks to subjects are determined to be reasonable in relation to any anticipated benefits
- Selection of subjects is unbiased, and extra protections are in place for vulnerable populations
- Informed consent will be obtained and documented in writing by each prospective subject or the subject's legal guardian, unless a consent waiver has been granted (see Consent Instructions for more details)
- When appropriate, adequate provisions are in place to monitor data privacy and confidentiality
Application Expiration and Reports
Per the Code of Federal Regulations (CFR Title 45) for using human subjects in research, annual follow-up reports for all approved research protocols, exempt, expedited and full, are required.
Investigators must submit either a final report for completed projects or a request for extension for continuing projects. Requests for extension need to be submitted 30 days before the project's expiration date.
If the research project is ongoing, but changes need to be made to the approved protocol that would substantially alter the methods and procedures initially reviewed and approved by the IRB, a summary of the changes is required for IRB review; a request for revisions form will need to be submitted before any changes may be implemented.