The policy describes the IRB actions that must be communicated to the investigator and the importance of open communication among IRB, investigators, ORA staff, and officials.
It is important that staff, subjects, and other interested parties have a means of communicating information about the conduct of a research project directly to the appropriate institutional officials. It is vital that IRB members, department heads, and other officials with responsibility for oversight of research have open and ready access to the highest levels of authority within the institution. The researcher and his/her research staff interact with subjects; therefore, it is vital that open and frequent communication with the investigative team be maintained.
3. Specific policies
3.1 Investigator notifications
Initial full-board submission
The investigator will be notified by e-mail of the IRB decision as soon as possible after the meeting. If the approval is withheld or deferred pending receipt and review of requested materials or responses from the investigator or sponsor, the IRB must receive the response within 180 days of the date of notification.
Exempt and expedited
The investigator will be notified by e-mail of the decision as soon as possible after review of the project. If the approval is pending upon receipt and review of requested materials or responses from the investigator, the IRB must receive the response within 60 days of the date of notification. Studies received after 180 days will be reviewed as a new initial review.
Renewals and revisions
Investigators will be notified by e-mail as soon as possible as to the action taken by the IRB for any continuing reviews or revisions.
Notification of final approval
Investigators will be notified by e-mail of the final approval. The IRB-approved consent form will be stamped with the approval and expiration date and submitted to the investigator with the final approval letter.
Correspondence will provide the reason(s) for disapproval and instructions to the investigator for appeal of this decision.
Correspondence will provide reason(s) for tabling and instructions to the investigator to respond to this decision.
If a project expires and the investigator does not respond to continuation notices, a letter of expiration will be sent to the investigator and appropriate institutional and regulatory officials. If the investigator does not respond in five (5) business days, the IRB will not accept future research proposals from the investigator or from students for whom he/she serves as advisor until all submitted research is current.
3.2 Investigator appeal of IRB action
An investigator may appeal the revisions required by the IRB in the protocol and/or informed consent form. This appeal must be in writing, signed by the investigator, and submitted to the IRB.
Investigators may also appeal an IRB decision to disapprove a study. Any such appeal must be in writing, signed by the investigator, and must be reviewed by the full IRB at a convened meeting. The investigator may request or be asked to attend the convened IRB meeting.
In response to an appeal, the IRB may reverse its decision, table consideration in order to obtain more information, or affirm its original decision.
If the appeal is denied, the investigator’s institution cannot override the IRB’s decision. A declined appeal is final.
3.3 Investigator and IRB communications
The investigator and his/her staff can call or e-mail the IRB office at any time with questions, concerns, or suggestions. The phone call or e-mail will be triaged to the appropriate personnel. All attempts will be made to respond to messages or e-mails within 48 hours.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|ORA director||Ensure that all communications follow established procedures and format.
Review and sign IRB decision communications.
Ensure that documentation, either electronic or paper, of any communication of determinations, requirements, or actions of the IRB or representatives of the IRB, when acting in a regulated capacity, are maintained, according to procedures in section 305: Documentation and Document Management.
|IRB coordinator||Ensure that the determinations and requirements of the IRB are communicated to the investigator as soon as possible. File documents electronically according to established filing procedures.
Triage questions, concerns, and/or suggestions as appropriate. Distribute correspondence as directed.