Procedures & Criteria for Approval
The principal investigator may be asked to meet with the IRB should it be apparent that clarification or modification of statements in the application are required. No individual involved in the conduct and/or supervision of the research project shall participate in its review, except to provide information to the IRB. The IRB may approve the project as is or may approve it with certain modifications required to meet federal standards. In the latter instance, the investigator will be informed by letter. The IRB approval letter will be sent upon written receipt of the modification. The faculty advisor will be copied on any correspondence sent to student investigators.
If the IRB action is to disapprove the application, reasons for this negative decision will be provided in writing to the principal investigator or project director. If the researcher decides to modify the proposed research in such a way as to meet the objections of the IRB, the investigator may resubmit the modifications of the proposal for consideration of the IRB. If desired, the investigator may request a personal hearing with the IRB Committee.
Continuing Review and Submission of Annual Update
Complex and potentially dangerous projects will be reviewed at a frequency commensurate with the related risks. When initial approval of such a protocol is given, the IRB may indicate the need for re-evaluation of the project after a specified interval so that continued acceptance of the protocol is assured. Projects that are determined to be exempt will not require additional review. Non-exempt proposals are approved for a maximum period of one year only. For projects which continue beyond one year, it is the responsibility of the principal investigator to submit to the IRB an annual update. The first annual update is due twelve months following the date the proposal was approved and released. Upon receipt of the annual update the IRB will review and approve, if appropriate, continuation of the project for the next twelve month period. Investigators will receive one notification regarding the due date of an annual update. Failure to submit an update within 30 days following the due date will result in termination of IRB approval. Projects can be updated annually for a maximum approval period of five years. Continuation of projects beyond five years requires resubmission.
If the IRB determines that a project requires review more often than annually, the investigator will be so notified. The IRB has the authority to directly observe ongoing research projects and the consent process as well as audit research records.
When a project that has required continuing review is terminated/completed, the investigator must immediately notify the IRB in writing.
Ongoing projects modified to include humans or animals as subjects also must be submitted to the IRB for review and approval prior to the use of such subjects. In the case of an externally funded project, the granting agency would be notified of the IRB action prior to the appropriation cycle for a budget period during which human and/or animal subject involvement is proposed.
Reporting Proposed Changes in a Research Protocol
Any proposed change in a protocol which affects the human or animal subjects must be reviewed and approved by the IRB prior to the implementation except where an immediate change is necessary to eliminate a hazard to the subjects. Investigators should submit a Request for Change in Protocol and a revised consent form as required. Minor changes during the period for which approval is in force will be reviewed by an expedited review procedure.
If a change in protocol is relatively minor (e.g., change in investigator, change in the sequence of follow-up visits) it is not necessary to have the subject sign a revised consent form or an addendum to the consent form. If, however, the change is not minor (e.g., addition of an intervention not addressed in the original consent form, disclosure of a previously unidentified risk) the investigator should have all new subjects sign a revised consent form and all currently enrolled subjects who are actively participating in the protocol sign an addendum to the consent form. If the change is considered significant (e.g., disclosure of a serious risk) the use of a witness is required.
Submission of a Report of Injury
If a subject suffers an injury, the investigator must submit a Report of Injury to the IRB within 48 hours.
Reporting Non-Compliance with IRB Guidelines
Any incident of non-compliance with IRB Guidelines should be reported immediately to the IRB. Non-compliance with IRB requirements is a violation of federal regulations for the protection of human and/or animal subjects.