Prior to their implementation, all modifications to an ongoing study must be submitted to the HSRO and approved by the IRB pursuant to regulations and these policies. Examples of study modifications include those related to the protocol or informed consent documents or process, staffing, advertisements, number of subjects to be enrolled, questionnaires, etc.
The only case where a change can be made to an approved study without prior IRB approval is when the change is necessary to eliminate apparent immediate hazards to human subjects [45 CFR 46.103(b)(4)(iii), 21 CFR 56.108(a)(3) and (4)]. In this case, the Principal Investigator must notify the IRB of such changes in writing within ten (10) working days of the occurrence. This notification should be on the amendment forms supplied by the HSRO.
To obtain IRB approval for study amendments, the Principal Investigator must submit to an amendment application via eProst describing all proposed modifications. Upon receipt of this form, an HSRO staff member will recommend into which category the amendment fits (c.f. Section 11.2) and forward the amendment for further review pursuant to that category. Any significant new findings that arise from the review process and that might decrease participants' willingness to continue participation must be provided to participants through the re-consenting or other process as determined by the IRB. All members of the IRB will be informed of amendments that are approved using the expedited review process.
Amendments will only be approved for studies with active IRB approval. Approval of a study amendment shall not extend the length of study approval or the expiration date of that approval.
Upon final approval of amendments, modified consent/assent materials or recruitment/advertising materials will receive a stamp/watermark of approval and correspondence will be sent to the Principal investigator indicating what modified documents were approved.