Continuation Review and Amendment Proposals: Instructions and Forms
Continuation Review for Approved Projects
All approved ongoing Non-Exempt projects are subject to a potential annual review.
Principal Investigators (PIs) receive notices at least 30 days prior to the month in which their project’s approval is due to expire. That notice reminds them of the pending expiration date and includes a list of the criteria used to evaluate if a continuation review is required.
The criteria are:
- subject data collection is ongoing; or,
- contact with subjects is ongoing after initial data collection; or,
- analysis of data by which subjects are directly identifiable is ongoing; or,
- analysis of coded data (by which subjects can still be identified via a master coded listing) is ongoing.
When a project meets any one of these criteria, a continuation proposal for further project review and approval must be submitted well before the expiration date of the current approval for the project. Timely submission is vital to avoid a lapse in the project’s approved status. (If a lapse occurs, the research must be suspended until approved status is reinstated.)
Submission of a continuing review proposal generally is not required in any other than the above-cited circumstances. However, if a PI is uncertain about how to proceed, he/she should contact the Chair of the HSIRB or the Chair of IRB #1, as appropriate, to discuss the particulars of the study.
If a PI believes that no continuation review is required, PI is expected to reply to the reminder notice, citing the reason(s) why that’s the case, so the Board can annotate the project records accordingly.
Both the HSIRB and IRB #1 will continue to apply historical continuation review procedures and forms to Non-Exempt projects that were approved prior to January 21, 2019 and, therefore, are subject to the “Old” Common Rule regulations.
- HSIRB Continuation Review:
- IRB #1 Continuation Review:
Proposed Amendment to Approved Projects
Changes to on-going projects generally require approval by the appropriate Board prior to implementation, regardless of whether the approved proposal falls under Exempt or Non-Exempt criteria. PIs are encouraged to consult with the Board Chair to determine the form and content of any proposed amendment.
A proposed amendment to the original project should be submitted in a timely manner.
Usually an amendment takes the form of a memo in which the PI details the nature of and rationale for the proposed changes to the contents of the originally approved project. Particular attention ought to be paid to any change in risks to subjects, especially to any shift in level of risk or potential new risks. The memo must cite the Board approved project number, the date of the original approval, and the title of the project.
- Very modest proposed changes frequently are managed as an “administrative” amendment. These amendments normally are adjudicated quickly.
- More substantive amendments may require a more detailed memo and a fuller level of HSIRB or IRB #1 review. PIs ought to consider how the possible lengthier review process might affect implementation of their project plan.
- Additionally, PIs of approved Exempt projects should be sensitive to any proposed changes that might eliminate the project’s Exempt status and, thus, require submission of a new Non-Exempt proposal for review. This situation might be particularly likely if there are changes regarding risk to subjects.
Proposed amendment memos are to be submitted either to HSIRB@touro.edu or to IRB#1@touro.edu.
