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.
- 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 the generalizable knowledge.
If you are unsure if your project involving human subjects requires review, contact
[email protected] for assistance. Additional guidance resources available below:
- Review our Guidance on Student Research, Capstone Projects, and Theses
- Research Compliance Zoom: Is it Research? Do I need IRB Review
- Research Determination Guide
- 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 prior to submitting an application for approval. Modules are categorized
based on type of research being conducted. Investigators receiving external funding
may be required to complete additional modules.
- Submit an application for approval through our online portal - Cayuse IRB - via MyFSU
The IRB Office communicates with the Principal Investigator after submission to verify that the application has been received. During the review process the IRB may request additional information or modifications in areas of the protocol via email.
For projects involving multi-site/collaborative research, please review our multi-site/collaborative research guidance.
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.
Investigators with projects that may require Full Committee Review should anticipate their application will be reviewed and discussed at multiple meetings; therefore, adequate time should be built in to account for the review process of projects meeting elevated risks. Note, the Full Board does not meet during the summer months; projects wishing to begin at the start of the Fall Semester should be submitted no later than early Spring Semester to allow the Committee adequate time to review and provide comments as necessary.
- Exempt and Expedited Projects: minimum of 14 working days
- Full Committee Projects: reviewed at monthly meetings; committee meets during the academic year (September -May)
Review Category Description: Exempt, Expedited and Full Review
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
- The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice” (45 CFR 46.107, see also FSU-IRB SOP 2. “IRB Composition)
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 closure form for completed projects or a request for extension for continuing projects via Cayuse IRB.
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 application will need to be submitted via Cayuse IRB before any changes may be implemented.
To submit a closure/revision/extension request via Cayuse IRB:
- Open the Project within Cayuse
- Select the blue, ‘new submission’ button
- From the drop down select the appropriate application (closure/revision/extension)
- Complete the form, certify & submit to the IRB for review
For projects in which you would like to request both a revision and an extension, you will need to complete two separate forms. Submit the revision request first; once it has been approved you may then submit the extension request. The system does not allow dual submissions.
- Withdrawals should be completed for projects you will no longer submit to the IRB for review.
- Revision requests should be submitted if your project has any major revisions that the IRB should be made aware of in advance of implementing those changes. (ie, PI changes, subject recruitment changes, recruitment location changes, etc). Minor revisions (ie, survey word changes)need not be submitted. Should you have questions regarding changes-please contact our office.
- Extensions should be requested at least one month prior to a project's expiration date to request for extended time.
- Closures should be submitted to the IRB once your project is finished. If all research-related interventions or interactions with participants have been completed and collection and analysis of identifiable private data (as described in the IRB approved protocol) are finished, the study should be closed with the IRB.
- Unanticipated Events should be submitted within a week from the day an unanticipated event which may cause risk to subjects/others occurs. An unanticipated event is defined as "any problem or event that is determined by the principal investigator to be unanticipated, causing new or increased risk to the subjects and is possibly related to the research procedures".
Email [email protected] with any questions.