In accordance with CFR 46.107
Applications will be treated as exempt or non-exempt. Non-exempt protocols can be either expedited or Full Board Review.
IRB Actions
A majority of the IRB members must participate in all decisions and actions of the board. Final approval of all actions shall require a majority of the members present or participating in the action.
The IRB may take one of five actions in regard to proposed human subject research:
- Exempt from full review
- Approve
- Approve contingent on requested changes
- Disapprove and/or make recommendations of required changes for resubmission
- Suspend or terminate
The IRB will have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
The IRB may sanction the Principle Investigator as the board deems necessary to ensure continued human subject protection. All such actions will be reported to the Office for Human Research Protections.
Review Interval
- The review interval will be determined by the IRB at the time of approval.
- The maximum interval for IRB review is one year.
- A request for continuation must be submitted at least two months prior to the expiration date.
- Even when subject activities are complete, but data is still being analyzed or any other aspect of the study is ongoing, the study must have IRB approval to continue.
Types of Review
Exempt Review
- A research protocol can be submitted for an exempt review if the Chair deems the project qualified under CFR 46.104.
- If a majority of members have doubts of the project’s qualification as exempt, the Chair may call for full board review of the proposal.
- The term “exempt” refers to the requirement for continuing IRB review, but not the general requirements for informed consent and protection of subjects. Thus, even if the project is exempt, the PI must inform potential subjects of the proposed procedures and of their rights as subjects.
- Exempted approvals expire one year after board review. The PI must seek review annually for projects that last longer than a year. Additionally, the PI must ensure that progress reports and/or review applications are submitted more frequently if mandated by the IRB.
Non-Exempt: Expedited Review
- A research protocol may be considered for expedited review if
- the research has been reviewed and approved by another IRB;
- it is a continuation review of research previously approved by the convened IRB, where:
- the research is permanently closed to the enrollment of new subjects;
- all subjects have completed all research- related interventions, or
- the research remains active only for long- term follow-up of subjects, or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- An expedited review will be conducted by two board members selected by the Chair. Both reviewers must approve the proposal.
Non-Exempt: Full Board Review
- All proposed human subject research that does not meet the criteria for exemption or an expedited review must be reviewed by a majority of the IRB members at a convened meeting referred to as a Full Board Review.
- Protocols that involve more than minimal risk must go to Full Board Review.
- Prior to the review meeting, the Full Board Review application is previewed by the Chair or designee to determine if further documentation is needed.
- Once all materials are collected, the application is submitted to the full board for review requiring a majority of members to review proposal.
- A majority of board members reviewing the proposal must agree on the board’s determination.
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