MinerAlert
MinerAlert
Modifications to consent forms or process, protocols, or procedures/study-related activity must be reviewed and approved by the IRB prior to making any changes in study procedures except when necessary to eliminate apparent immediate hazards to subjects. If modifications are made prior to IRB approval to remove immediate hazards to subjects, the modification must be promptly (within 5 days of learning of the event) reported to the IRB and the modification(s) will be reviewed by the IRB to determine whether the change was consistent with ensuring participants’ continued welfare. If there are questions regarding IRB modification submissions, the IRB staff will provide written notice to the investigator specifying the additional information needed.
All modifications to research must be submitted in the electronic protocol system. An Amendment request form, and all relevant revised study materials are required for review and approval.
The amendment may be referred to the convened IRB at the reviewer’s discretion. Study amendments considered to be greater than minor must be reviewed at the next convened IRB meeting.
Minor Study Amendments in previously approved research that do not change the risk level will be processed as expedited, as permitted per 45 CFR 46.110. IRB Staff will verify whether the amendment changes the potential risk in the project. All required documents will be verified at screening by the IRB administrative staff. Minor changes such as personnel changes to the project will be administratively acknowledged. All other study amendments to the project will be reviewed by the Chair or designated reviewer. All study amendments reviewed through the expedited process are reported to the IRB at the next full board meeting.
Because Not Human Subject Research does not fall within the IRB purview, Study amendments are not required when changes are made within the project. If personnel changes are required, for administrative purposes, an amendment form must be submitted, and processed by IRB staff.
The IRB Chair, a designated reviewer, or the IRB committee will make one of the following determinations:
Acknowledged: Administrative determination used in study amendments or continuing status reports when there are very minor, or no changes to the project.
Approved: Made when all criteria for approval are met. Approved by the IRB as written with no explicit conditions.
Approved With Conditions: Criteria for approval are met but corrections are required. These are identified to the PI and must be completed and documented prior to beginning the research. Minor or prescriptive changes or requirements will be reviewed for approval by the IRB chair or a designated IRB member, typically the IRB staff person assigned to the study.
Modifications or Information Required: Substantive changes or requirements, requests for more information for IRB consideration, and other issues related to the criteria for approval are required so the project can be reviewed and approved by the convened IRB.
The IRB will provide ethical and scientific scholarly review of all human subject research to ensure that all requirements of 45 CFR 46.111 are satisfied.
Study amendments do not change the approval period of the protocol. Therefore, the expiration date will remain the same as was determined for the protocol at the time of initial or continuing review as appropriate.
A determination letter generated in the electronic protocol system for all submissions requesting a protocol modification.