Institutional Review Board (IRB) > Part Two

Approval Process
Once an activity has been determined to require IRB oversight, it is submitted to ORC via a Project Outline Form. Staff of the ORC will then review the proposal and determine what review level is required. In determining the review level, the risk to the participants must be assessed using the following definition:

Minimal Risk - the probability and magnitude of harm or discomfort anticipated in the resear ch are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

TIP: The Project Outline Form can be found at: http://www.ohiou.edu/research/compliance/ irb_forms2002.html#forms

There are three review levels:

Exempt - For studies that are determined to be minimal risk and meet one of six defined categories in the federal regulations. Some general examples of exempt studies are: studies that examine the effectiveness of an instructional technique, anonymous surveys with adults (over the age of 18), or observation of public behavior. Exempt proposals are not s ent to the IRB, but are processed in the Office of Research Compliance. Investigators may not declare their own project exempt. To obtain a letter of exemption, prior to beginning, investigators should submit a project outline form. The average turnaround is 1 – 2 weeks.

Expedited - For studies that are determined to be minimal risk and meet one of nine defined categories in the federal regulations. Expedited proposals ar e sent to a subcommittee of the IRB. The average turnaround for review is 2 – 3 weeks. For a complete list of exempt and expedited categories, consult the “Guidelines for Review of Research Involving Human Subjects” on the IRB forms website.

Full Committee - For studies that are determined to be greater than minimal risk or do not meet one or more of the categories for exempt or expedited studies. Full committee proposals must be reviewed in a convened meeting of the IRB. The IRB typically meets once per month. Meeting schedule and submission deadlines are posted on the Research Compliance website. The average turnaround is 3 – 4 weeks.

The use of certain classes of participants (prisoners, pregnant, women, children) require additional safeguards. Researchers proposing to conduct non-exempt research must complete training in the protection of human subje cts. The training is a web-based module available on the Compliance website: http://www.ohiou.edu/research/compliance.

Regardless of review level, a signed approval letter will be sent to all investigators of a research project. If the proposal was determined to be exempt, there i s no expiration date, and no need to “renew” the approval. For non-exempt proposals, approval is good for a maximum period of twelve months. The expiration date is listed on the approval form. It is important to request a periodic review several weeks prior to expiration of the previous approval. Once a proposal approval has expired, all research related procedures must halt, except when doing so would jeopardize the welfare of human subjects. The approval remains in effect provided the study is conducted exactly as described in the application for review. Any additions or modifications to the project must be approved by the IRB (as an amendment) prior to implementation. Adverse or unanticipated events must be reported to the IRB promptly, within 5 working days of the occurrence.

Forms
All Compliance forms are available on the ORC website, www.ohiou.edu/research/compliance.

Project Outline Form - This form is used to describe a research project. It is used for new submissions, regardless of review level.
Amendment Form - This form is used to request a modification to a previously approved proposal.
Periodic Review Form - This form is used to request a ‘renewal’ of a previously approved study.
Adverse Event Reporting Form - This form is used to report any undesirable or unintended injury or physical or emotional consequence to a human subject. Such report is required as soon as possible, and within 5 working days of the occurrence. < br>
Assurances
The Office of Human Research Protections (OHRP), within the US Department of Health and Human Services, is the agency charged with overseeing human subjects research. OHIO has an OHRP-approved federal wide assurance of compliance with the HHS regulations (45 CFR 46) for the protection of human subjects. The assurance number is FWA00000095.

TIP: The human subjects assurance identification for OHIO is FWA00000095.

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