B. Review Decisions
Researchers/Investigators shall be notified in writing of IRB decisions affecting research activity (i.e. approve: disapprove; suspend; modify).
45 CFR 46.109(d)
1.ApprovalApproval MAY be granted to authorized principal investigators when the IRB is satisfied that:
- Required checklist procedures have been completed,
- Requirements of 21 CFR 56.111 and 45 CFR 46.111 have been met,
- Principles set forth in the Belmont Report and the World Medical Association are satisfied, and
- Consent form is readable, understandable and complete.
Despite IRB approval, a study may be disapproved by other NGHS entities such as by other committees (i.e. Radiation Safety; Infection Control) or by other administrative offices (i.e. Risk Management). Those decisions will be separate and independent of the IRB decision. Any NGHS entity disapproving of an IRB approved study should notify the IRB in writing of the disapproval.
Approval Contingent: This common action indicates that the IRB agrees that no serious problems remain in the study and that it can be approved, but the IRB requires some minor changes be made before the research is implemented (e.g. revisions to ICDs for clarity). The study’s approval date is the date of the convened IRB meeting at which the IRB reviewed and approved the protocol.
The contingency can be removed without an additional meeting IF THE RESPONSE IS RECEIVED WITHIN 45 DAYS. The full IRB will be notified of the contingency removal in the ‘Standing Report’ presented at the next IRB meeting.
- Approval With Condition Or Suggestion: This very rare action is granted on the condition that: a stated requirement must be met; or, includes some suggestions to improve the study further. The investigator need not respond to the point(s) raised as it is automatically integrated with the protocol as approved.
2.Return For Clarification
Should some aspect of a proposed study (i.e. application; protocol; consent) be so unclear that no decision is possible without making assumptions and /or prior to a decision for ‘Disapproval’, the Board may vote to return the application with a written summary of questions/comments needing clarification. Extensive revisions may be needed. Attendance by the investigator or his/her designee to a regularly scheduled meeting of the IRB, to provide clarification to question/comments, is expected. The PI should be prepared to attend the meeting to discuss the study if so requested by the Board. It is the responsibility of the PI or his/her designee to contact the IRB Office to make arrangements for IRB meeting attendance. Applications for which no response has been received within 60 days will be rescinded without prejudice. This would require a complete new application package to be submitted for consideration by the Board at a future meeting.
45 CFR 46.109(d)
3.DisapprovalPrior to a final decision to disapprove, the IRB will put all concerns relevant to the final decision in writing to the investigator and seek and consider the investigator's response.
Disapproval will be issued only after it is found that sufficient improvements cannot be made in the study to render it eligible for approval. The written notification of this decision will include a statement of the reason(s) for disapproval. IRB disapproval cannot be overturned by any other institutional entity..
45 CFR 46.112
Following the final decision, if the investigator remains unhappy with the decision, he or she may make a presentation to the Director of Performance Improvement and/or NGHS Administration for the sole purpose of informing them of the perceived problem.
4.Suspension Or Termination Of ApprovalThe IRB has the authority to suspend or terminate research that: a.Is not being performed in accordance with the approved protocol, or b.Has been associated with unexpected serious harm to subjects, or c.Evidences serious or continuing non-compliance, or d.From new information or allegations, has the potential for serious harm.
Any member may request that Board members be polled or that an emergency meeting be called if there are any issues associated with the research that could result in a decision to suspend or terminate the study.In an emergency, the chair is empowered to take unilateral action if it is deemed necessary for the protection of subjects.
21 CFR 56.113
Action taken under this section will be reported to the Director of Performance Improvement who may be required to report the action to the funding or regulatory agency. Suspension or termination of a study regulated by FDA must be reported to the FDA.
21 CFR 56.113