MinerAlert
MinerAlert
Effective January 21, 2019, the Revised Common Rule removes the requirement to conduct continuing review of ongoing research for minimal risk studies approved via the expedited review process and for full board research that is in long-term follow-up or data analysis only, unless the research is FDA regulated or sponsored/funded by the Department of Justice. Most minimal risk studies approved via the expedited review process on or after January 21, 2019, will not automatically undergo continuing review by the IRB.
The IRB may require continuing review for special circumstances, to be determined on a case-by-case basis and documented as part of the review. The research team will be notified at the time of initial approval whether a continuing review will be required.
When a continuing review is required, study approval end dates will be on the determination letter. Investigators will receive automatic reminders from the electronic protocol system when a continuing review is required.
Research approved via convened IRB review will be subject to continuing review unless the study intervention(s) has been completed, and the remaining research activities consist of data analysis and/or involve only observational follow-up in conjunction with standard clinical care.
Additionally, all non-exempt research regulated by the FDA or sponsored/funded by the Department of Justice will be subject to continuing review. Time intervals for such reviews shall be made at the discretion of the IRB based on the anticipated risks to subjects but shall occur no less than once per year. The PI must seek approval of continuation unless all the following are true:
As a courtesy, the IRB office will send reminders to PIs approximately two months, one month, and fifteen days before the study expires. However, it is ultimately the PI’s responsibility to complete and submit the IRB Continuing Review Application in time for IRB review prior to the study’s expiration of approval.
Generally, if a protocol was approved at a full board meeting of the IRB at initial review, it must be reviewed at a full board meeting of the IRB for its continuing review. However, if the research initially did not qualify for expedited review the IRB may designate the protocol as minimal risk and determine that the protocol may undergo an expedited review process under Category 9. This determination can be made at the time of initial review or at a subsequent continuing review.
No research protocol may continue after approval has expired until final approval for continuation is granted.
Continuing reviews must be submitted through the electronic protocol system. Full board and expedited reviews requiring continuing review require project status information.
The IRB will review initial and continuing full board review projects during a scheduled convened IRB meeting.
Each protocol is assigned to a primary and secondary reviewer to review the protocol in depth. Primary and secondary reviewers are assigned based on how closely the protocol content matches their expertise. Primary and secondary reviewers may contact the PI, Co-PI, other IRB Members, or outside sources to ensure a thorough evaluation of risks and balances are made. Members with a COI will recuse themselves from a review assignment.
The IRB may not have the appropriate expertise to review a study for scientific or scholarly validity. In such cases, the IRB Chair will consider who in the University or community has that expertise and ask them to serve as an expert consultant. Consultants will disclose any COI prior to performing the review.
All submitted study materials will be accessible to members in the electronic protocol system not less than one week prior to the scheduled meeting. Assigned reviewer(s) are expected to review materials as appropriate.
Protocols undergoing continuing full board review at a full board meeting are presented individually to the IRB by the primary and secondary reviewers. PIs are often invited to attend to provide clarification or answer IRB questions. Members with appropriate scientific expertise, local knowledge, or other expertise specific to the protocols should also be present. If research involving vulnerable participants is reviewed, at least one member should be knowledgeable about or experienced in working with that population. If a member with the appropriate expertise cannot be present, the IRB staff will notify the IRB Chair to defer the review to the next regular meeting or have a consultant provide a written report of their evaluation of the protocol.
A quorum of members, including a non-scientist, must be present for the entire presentation, discussion and deliberation. A prisoner representative must be present if research involving prisoners is discussed. IRB staff will determine if a quorum of members is present and will inform the Chair when the quorum is met, then document the quorum in the meeting minutes. Members who are not present for a substantial part of the discussion and deliberation should abstain from voting. The following are discussed in detail for protocols in initial review:
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 interval for the continuing review is determined based on the participant risk level. Continuing review intervals may be three (3) months, six (6) months, or twelve (12) months. The review period may be discussed during full board continuing review discussions, if determined by the IRB reviewer and full board that a change in the review period is appropriate.
The following conditions may require shorter approval periods:
The PI remains responsible for submitting any modifications or unanticipated problems for review and a closure report when the project meets criteria for closure. The UTEP IRB is authorized to administratively close research protocols that have had no research activity for a period of three years or more. This may include those without subject enrollment, funding, and/or in data analysis phase.
The IRB has the authority to observe or appoint a third-party to observe research conduct, including consent procedures. It may also consider whether a study requires independent verification from sources other than the PI to ensure that no material changes have occurred since the last IRB approval. The IRB will require verification of the information provided for continuing review when:
If the findings of such investigations during the continuing review process warrant corrective actions, the IRB may suspend or terminate a research project to ensure the quality of research and protection of research subjects.
Continuing review is required for approved expedited research if the research is regulated by the FDA or sponsored/funded by the Department of Justice. Additionally, the IRB may require continuing review in certain situations as appropriate. PIs must also continue to report unanticipated problems and non-compliance as directed in this manual. Approved expedited research that does not require continuing review must still submit modifications and reportable events (e.g., unanticipated problems, non-compliance) as they occur throughout the life of the study so the IRB can provide ongoing review and oversight to research that does not require continuing review.
Continuing reviews for expedited studies are reviewed by IRB staff for completeness and congruence with the currently approved protocol. In addition, the IRB staff determine how the continuing review of studies previously reviewed at a full board meeting qualified for expedited review. Any of the following may apply:
The research falls into one or more of the categories of expedited review and meets applicability criteria for expedited review:
The designated reviewer will make one of the following determinations:
Approved: Made when all criteria for approval are met. Approved 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.
Referred to Full Board: The project does not meet requirements for expedited review or additional input from the board is appropriate prior to approval.
The continuing review approval period is determined based on the original review period. Continuing review intervals may be three (3) months, six (6) months, or twelve (12) months. The review period may be discussed during full board continuing review discussions, if determined by the IRB reviewer and full board that a change in the review period is appropriate.
A list of protocols approved for continuation through the expedited review process is provided to IRB members at each meeting.
Exempt and Limited Review does not require continuing review.
After the IRB meeting at which the protocol was reviewed for continuation, or after expedited review by an IRB Chair or designated reviewer, the PI will be notified of the IRB determination for their protocol.
Approved: Made when all criteria for approval are met. Approved 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.
There is no grace period beyond the expiration date of IRB approval. Extensions of approval beyond the expiration date cannot be granted. Failure to submit the required documents and receive IRB continuing approval for the protocol before the end of the approval period will result in a status of “Lapsed.” This will occur even if the PI has provided the required documents, but IRB review and approval is not completed before the expiration date. If a protocol is placed in this status, the PI will be notified that they must cease all research activities (recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection and analysis of private identifiable information) until the required documents are submitted, reviewed, and approved by the IRB. However, subjects who are currently enrolled and for which continuation would be in the best interest of their health or well-being, may continue to participate if the PI requests and justifies, in writing, the need for continuation. The request will be considered by the IRB Chair. Research procedures may not continue after the expiration date of the protocol until final approval for continuation is granted.