Change Requests / Protocol Amendments


POLICY

Changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. The Principal Investigator must submit and receive approval from the IRB before initiating any changes to a research study. 


PROCEDURE

Submission - The Principal Investigator must submit change requests via iRIS. The submission should include adequate information of the change including, but not limited to:

  1. Description of change - A detailed explanation of changes proposed and rationale for the request,
  2. Amended documents e.g. informed consent document, protocol, questionnaire, survey form,
  3. Any other documentation that the IRB may request,
  4. Research conflict of interest forms for co-investigators and human subjects education documentation for any key study personnel being added to the protocol,
  5. Any other relevant documentation that is outlined in this policy and procedure to be given to subjects when, in the judgment of the IRB, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects.

Assigning for Review - IRB staff will screen the change request to assess if the information submitted is adequate. If the information is not adequate, IRB staff will request additional information from the Principal Investigator.

Once adequate information is obtained, IRB staff will determine if the change request may be reviewed and approved by IRB staff, expedited review or full board review.  

Administrative Change Request: Administrative changes that may be reviewed by the IRB staff, include but are not limited to:

  1. Editorial changes within protocol, consent, or other document like change in telephone numbers, clarification of language
  2. Addition/deletion of co-investigators or key study personnel after ensuring no conflicts of interest have been indicated
  3. Title changes
  4. Flyers/recruitment materials
  5. Administrative clarifications within the protocol received from the sponsor
  6. HIPAA documents
  7. Study handouts, cards and logs.

Expedited Change Request: The IRB 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 expedited review categories may be reviewed by the expedited procedure. For proposals that were initially reviewed by expedited review, the IRB staff will assign the change request to the same reviewer that initially reviewed the proposal, if possible. If the reviewer determines that the change request does not qualify for expedited review, the IRB 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 IRB staff will re-assign the change request to another Reviewer.

Full board change request: Change requests that do not qualify for administrative or expedited review are reviewed by the convened IRB. IRB staff will assign the change request to the IRB Panel that conducted the Initial Review.

Change requests to research involving prisoners do not qualify for expedited review and will be assigned for Full Board Review. When the IRB reviews a modification request that involves prisoners, at least one voting member must be present at the IRB 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 IRB staff will schedule the change request for the next available Full Board meeting. The IRB staff shall assign it to the chair of the subcommittee that initially reviewed the research. If the chair is not available, IRB staff will assign it to one of the other subcommittee members or another IRB member. If a reviewer declares any conflict of interest related to the research, IRB staff will re-assign the change request to another reviewer.

Review Process: All IRB members including the reviewer have access to the submission for change request 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 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 subject's willingness to continue participation in the research. For active subjects, the new information should be provided to the subject through an updated consent process. For subjects who have completed research involvement, the IRB may require 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 the IRB in a timely manner and reviewed by the IRB to determine whether the change was consistent with ensuring the subject’s continuing welfare.

Possible Outcome of Review – The IRB may decide to approve, approve pending, defer, disapprove or table the change request as per policy and procedure Initial Review. The expiration date for research study does not change through the approval process of a change request.

Communication of Outcome: The IRB staff will notify the Principal Investigator of the outcome of review via iRIS in a timely manner. The IRB staff will include a list of change requests approved by expedited review in the agenda for the next Full Board meeting.

APPLICABLE REGULATIONS

  1. 45 CFR 46 Protection of Human Subjects
  2. 21 CFR 50 Protection of Human Subjects
  3. 21 CFR 56 Institutional Review Board
  4. OHRP Expedited Review Category
  5. FDA - Categories of Research that may be Reviewed through an Expedited Procedure
  6. FDA Information Sheet: Continuing Review After Study Approval

REFERENCE TO OTHER POLICIES

  1. Initial Review
  2. Expedited Review

ATTACHMENTS

  1. Change Request / Protocol Amendment Form
  2. Change Request – Approval Letter
  3. Change Request – Approval Pending Letter
  4. Change Request – Disapproval Letter

If you find errors in this document, contact cphs@uth.tmc.edu

Document Number:

101-C06

Document Name:

Change Requests and Protocol Amendments

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021

 




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