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Levels Of Review
Determining the level of review for individual research project proposals is generally the responsibility of the investigator in consultation with their faculty advisor or department chair, as appropriate. All investigators are strongly encouraged to take formal training pertaining to the protection of human subjects in research. This includes determination of research review classification.
There are three levels of review, and each level poses different requirements for investigators and reviewers. The review level determination is made on a number of factors, but primarily focuses on the potential risk to research subjects.
LEVEL 1 - Exempt
Exempt research determinations are issued by the Office of Research Compliance and Integrity (ORCI) and are required in order to maintain compliance with university policy. Researchers may not make this determination independently.
Important notes regarding exemptions:
- Research that is otherwise exempt from the regulations may receive upgraded review as indicated by ORCI staff or an IRB member
- Exempt studies are subject to quality assurance activities
- Exempt research conducted at Grand Valley is still subject to Ethical Research Standards
For further clarification, refer to this listing of the exempt categories.
The following amendments to exempt studies require a change in approved protocol submission in order to confirm continued exemption eligibility:
- alterations in the ratio of risk-to-benefit ratio (including increased benefit or decreased risk)
- significant increase in the scope of the project
- a change that impacts eligibility for exempt status
- addition of personnel to the research team
LEVEL 2 - Expedited Review
Expedited reviews must fit into 1 of 9 categories and must be minimal risk studies. They are reviewed by IRB members.
Expedited reviewed studies require documentation of informed consent from participants or legal guardians (including legally authorized representatives), unless a waiver or alteration is approved. Additional information regarding informed consent may be found under Planning Your Research. Additional regulatory and university criteria to protect vulnerable populations is applied to this level of research.
Serious or ongoing noncompliance of expedited studies may result in reports to the federal Office for Human Research Protections, regardless of funding.
For further clarification, check out the Decision Chart created by the Office for Human Research Protections, regarding expedited procedures.
LEVEL 3 - Full Board Review
Any covered human subjects research project that is not determined to be exempt or is not eligible under an expedited category must be reviewed by the IRB at a convened meeting. Typically, the researcher (along with any team members selected) is invited to attend the committee meeting in order to represent the study and engage in Q&A with the board.
- Full board submissions must be submitted and authorized at least 4 weeks prior to a scheduled full board meeting
- Initial feedback is provided to researchers in writing approximately 2 weeks prior to the meeting
- PI's are encouraged to return a written response in order to facilitate the meeting Q&A (appreciated 1 week prior to the scheduled meeting)
- ORCI staff will contact the Principal Investigator in order to schedule and confirm an appearance with the full board
- Parking permits may be arranged with ORCI staff