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Changes to the Common Rule
NEW: For studies approved after the Final Rule goes into effect in July, 2018, continuing review will not be required under the federal guidelines for the following types of research:
- Research reviewed by expedited review (unless the reviewer explicitly justifies that it would enhance protection of subjects).
- Research reviewed by limited IRB review.
- Research that has progressed to the point that it involves only one or both of the
- Data analysis, including analysis of identifiable private information, or
- Accessing follow-up clinical data from procedures that subjects would undergo as part of regular clinical care. (Does not include other types of interactions.)
- Research approved by a convened IRB the above does not apply.
Current Guidelines for Continuing Review
Continuing Review beyond the initial approval period (up to 12 months):
The IRB is required to re-evaluate research projects at intervals appropriate to the degree of risk, but not less than once a year. The approval letter from the IRB will indicate the approval and expiration or review dates.
One month prior to the expiration or review date, the IRB office should send the investigator a courtesy reminder notice. However, it is the investigator’s responsibilities to complete the continuation form, attach the appropriate information, and return the package to the IRB Compliance Officer. Please note that if for some reason you do not receive the reminder notice, it is your responsibility to contact the IRB office in advance of your project’s expiration date if you wish to continue your research.
NEW: Student projects now have a review date of 4 months. This means that the IRB will check in with any student PIs approximately 4 months after their study approval date. At that point, student PIs must submit a continuation form (Form K) to keep working on their studies or a close-out form (Form L) that serves as a final report for the IRB.
Under The College at Brockport guidelines, a maximum of two consecutive continuations can be granted. After two continuations, the project must be resubmitted to the IRB as a new protocol for review and approval.
Change in rules: Proposals in all categories of research (exempt, expedited and full board) need to be continued using Form K.
If your project was originally reviewed via full board review, your continuation and/or modifications will not require full board review if they meet one of the following guidelines:
- Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified;or
- where the remaining research activities are limited to data analysis of identifiable data.
- Continuing review of research where the convened IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified
The Continuation/Modification Form (Form K) is available in the Forms section of the IRB website.