Change Requests / Protocol Amendments
Changes in approved research, during the period for which CPHS approval has already been given, may not be initiated without CPHS review and approval except when necessary to eliminate apparent immediate hazards to the subject. The Principal Investigator must submit and receive approval from the CPHS before initiating any changes to a research study.
Submission - The Principal Investigator must submit the change request / protocol amendment via iRIS. The submission should include adequate information of the change / amendment including, but not limited to:
a. Description of Change/Amendment- A detailed explanation of changes proposed and rationale for the request,
b. Amended documents e.g. informed consent document, protocol, questionnaire, survey form,
c. Any other documentation that CPHS may specifically request,
d. Research Conflict of Interest forms and human subjects education documentation for any key study personnel being added to the protocol,
e. Any other relevant documentation that is outlined in this policy and procedure to be given to subjects when, in the judgment of the CPHS, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects.
Assigning for Review - The ORSC Staff will screen the change request to assess if the information submitted is adequate. If the information is not adequate, ORSC staff will request additional information from the Principal Investigator.
Once adequate information is obtained, ORSC Staff will determine if the change request may be reviewed and approved by ORSC Staff, expedited review or Full Board review.
Administrative Change Request/Amendment: Administrative changes that may be reviewed by the ORSC Staff, include but are not limited to:
a. Editorial changes within protocol or consent document like change in telephone numbers, clarification of language
b. Addition/Deletion of co-investigators or key study personnel after ensuring no conflicts of interest have been indicated
c. Title changes
e. Administrative clarifications within the protocol received from the sponsor
f. HIPAA documents
g. Study handouts, cards and logs.
Expedited Change Request/Amendment: The ORSC Staff will determine if the proposed changes affect the risk/benefit assessment. Proposed changes that do not significantly affect the risks to the subjects and/or new procedures added that fit within the categories 1 – 7 for expedited review as listed in policy and procedure Expedited Review may be reviewed by Expedited Review. For proposals that were initially reviewed by expedited review, the ORSC staff will assign the change request/amendment to the same Reviewer that initially reviewed the proposal, if possible. If the Reviewer determines that the change request/amendment does not qualify for expedited review, the ORSC Staff will assign the submission for Full Board review. The Reviewer must declare any conflict of interest. If there is a conflict of interest, the ORSC staff will re-assign the change request/amendment to another Reviewer.
Full Board Change Request/Amendment: Change requests/Amendments that do not qualify for administrative or expedited review are reviewed by the Full Board. ORSC staff will assign the change request / amendment to the IRB Panel that conducted the Initial Review.
Change requests/amendments to research involving prisoners do not qualify for expedited review and will be assigned for Full Board Review. When the CPHS reviews a modification request that involves prisoners, at least one voting member must be present at the CPHS meeting who is a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity as described in policy and procedures – Research Involving Prisoners.
The ORSC Staff will schedule the change request / amendment for the next available Full Board meeting. The ORSC Staff shall assign it to the Chairperson of the subcommittee that initially reviewed the research. If the Chairperson is not available, ORSC Staff will assign it to one of the other subcommittee members or another CPHS member. The Reviewer must declare any conflict of interest. If there is a conflict of interest, the ORSC staff will re-assign the change request/amendment to another Reviewer.
Review Process: All CPHS members including the reviewer have access to the submission for change request and protocol amendment as well as all study materials regarding the research protocol in iRIS. The Reviewer is expected to conduct an in-depth review of modified documents and all members are expected to review the change request and protocol amendment submission form. The Reviewer will determine if the criteria for approval are met as outlined in policy and procedure – Initial Review. If key study personnel are being added to the study with a stated conflict, then the conflict management plan will be discussed during the review.
In addition to the criteria for approval, the Reviewer will determine if the proposed changes to the study may impact:
a. the current subject's willingness to continue participation in the research. If applicable, CPHS will ensure that this information is provided to the subject through an updated consent process.
b. subjects who have completed research involvement. If applicable, CPHS will ensure that the Principal Investigator re-contact these subjects and provide them with additional information.
Changes made to a protocol in order to address an immediate hazard to study participants must be reported to CPHS in a timely manner and reviewed by CPHS to determine whether the change was consistent with ensuring the subject’s continuing welfare.
Possible Outcome of Review – The CPHS may decide to approve, approve pending, defer, disapprove or table the change request / protocol amendment as per policy and procedure Initial Review. For change requests / protocol amendments approved by the Full Board, the approval date is the date of the meeting. For change requests / protocol amendments approved by expedited review, the date of approval is the date of review. The expiration date for research study does not change through the approval process of a change request. During review of change requests / protocol amendments, CPHS may decide to decrease the approval period or change the approval cycle to review after certain number of subjects are enrolled as described in the policy and procedure for Initial Review, Item 8.
Communication of Outcome: The ORSC Staff will notify the Principal Investigator of the outcome of review via iRIS in a timely manner. The ORSC staff will include a list of change requests/amendments approved by expedited review in the agenda for the next Full Board meeting.
1. 45 CFR 46.110
2. 21 CFR 56.110
3. 45 CFR 46.110(b)(2)
4. 21 CFR 50.110(b)(2)
5. 63 FR 60364-60367; 63 FR60353 – 60356 DHHS-FDA list published in Federal Register November 9, 1998
6. FDA Information Sheets: Continuing Review After Study Approval
REFERENCE TO OTHER POLICIES
1. Initial Review
2. Expedited Review
1. Change Request / Protocol Amendment Form
2. Change Request – Approval Letter
3. Change Request – Approval Pending Letter
4. Change Request – Disapproval Letter
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Change Requests and Protocol Amendments
1 Aug 2008
1 Jan 2009
1 Aug 2011