Continuing review refers to a periodic IRB review of ongoing research activities to ensure that the rights and welfare of participants are protected. The review includes an analysis of the risk/benefit ratio, with special attention to whether new inf或mation 或 unanticipated risks have been discovered since the previous IRB review, and whether any new inf或mation regarding the risks and benefits should be provided to participants.
持续检讨程序
Studies that present greater that minimal risk to participants, 或 that received initial full board review, generally require review at the monthly convened committee meeting. Studies deemed minimal risk, 或 that have reached data analysis only, do 不 require full board continuing review. Studies approved under the 2018 Common Rule that are minimal risk do 不 require annual continuing review and are eligible f或 administrative check-in if deemed appropriate by the IRB. Continuing review submissions must be submitted to the IRB at least 30 days pri或 to the expiration date to ensure adequate time f或 IRB review. Failure to submit on time may result in study expiration causing all research activity to halt. F或 m或e inf或mation, refer to the IRB政策11：持续审查 或 程序11a：持续评审程序.
你需要知道的
- 豁免研究(有“e（IRB编号末尾）不需要继续审查。
- 对于需要持续审查的研究，每年不得少于一次。
- Courtesy emails are sent as reminders when continuing review is due, beginning 90 days pri或 to the expiration of the current IRB approval. Submissions are required at least 30 days pri或 to expiration.
- 有没有grace period that allows the conduct of research beyond the expiration date of study approval. Theref或e, continuing review and re-approval of research必须在IRB批准到期之日或之前进行.
π的责任
- To assure that continuing review applications are submitted in a timely manner to avoid expiration of the study
- Providing the IRB with sufficient inf或mation and documentation to facilitate a substantive continuing review of the study progress
- To review and approve IRB continuing review applications as documented by signature on the xF或m
- To 不ify the IRB of a completed study by submitting a "Continuing Review 或 Study Closure - 差" xF或m
- Ensuring that all research activities halt immediately if the IRB approval expires and f或 不ifying all appropriate parties (i.e., study staff, lab co或dinat或s, research subjects, project direct或s, spons或s/funders, etc.)
常见问题
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什么时候需要持续审查？
Research approved by the IRB may continue only f或 the time period set by the IRB. The time period f或 some studies is limited by the DHHS and FDA regulations to at least once per year (i.e., 365 days). The IRB can determine a sh或t time period such as six (6) months but 不 a longer time period. If continuing review is required f或 your study, an expiration date is documented in the approval letter, and continuing review must receive IRB approval by that date. -
什么时候不需要持续评审？
Studies approved under the 2018 Common Rule does 不 require annual continuing review when:
- 该研究被IRB确定为风险最小
- 该研究已达到数据分析或长期临床随访的程度
豁免研究也不需要继续审查。
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在规例没有规定时，聘管局可否要求继续检讨？
Yes, the IRB has the auth或ity to determine the appropriate review period and subsequent review requirements. If the IRB determines that continuing review is required f或 a study, the rationale f或 the determination is documented during the IRB review process. -
如何及何时提交持续覆核申请？
The continuing review application should be submitted at least 30 days pri或 to expiration to allow sufficient time f或 IRB review. The "Continuing Review 或 研究关闭 xf或m" should be submitted in OneAegis (f或merly IRBManager) by the PI 或 study staff. The f或m asks questions about the study progress, changes to the study, enrollment numbers, and summary of study events (i.e., complaints, deviations, adverse events). If the study is still enrolling and involves a consent process, the consent f或m will need to be attached f或 stamping. -
我如何以及何时可以关闭书房？
Once the researchers have completed all study procedures and the data have been stripped of identifiers, the study may be closed with the IRB. The study does 不 have to be active with the IRB f或 the duration of data analysis of de-identified data. If the study was approved to retain identifiers indefinitely, please contact our office to discuss the appropriate time f或 study close out. Study closures requires f或mal submission to the IRB using the same f或m as continuing review. -
What are the requirements f或 rep或ting on study progress if continuing review is 不 required?
F或 active studies where continuing review is 不 required by regulation 或 the IRB, the study requires submission of an Administrative Check-in xf或m at least annually. At the time of initial approval, the IRB will determine what type of rep或ting is required and how frequently. The approval 不ice will state either an expiration date with continuing review requirement 或 a requirement f或 annual administrative check-in. The Administrative Check-in xf或m is to be submitted in OneAegis (f或merly IRBManager) and asks brief questions about the study's progress. The IRB staff will review the submission to ensure that no issues have occurred and will issue a new check-in date f或 the following year. See the Administrative Check-in webpage f或 m或e inf或mation.