• See HRP-308 Pre-Review Worksheet.
• Generally, up to two rounds of pre-review comments are sent to study teams. There are situations, however, when additional rounds of pre-review comments will be sent.
• Consider whether the study falls under the revised Common Rule, or the pre-2018 rule, as the rules have differing requirements. See applicable worksheets and checklists for pre-2018 exceptions.  

Expedited Changes

For Expedited Changes, if the change requires revision to HRP-401, such as adding a waiver of documentation of consent, update HRP-401 and re-finalize prior to executing HRP-402.

Full Changes

Complete HRP-401 for all full changes. If 401 has already been completed with a previous submission and requires no other updates as a result of the full change, the Notes field may be the only section that needs to be completed.

HRP-401 Notes for Full Changes of Protocol Regardless of whether any other updates are necessary to 401, prior to scheduling, complete the Notes section of 401 to include a summary of the change. Any Supplemental Checklists completed as a result of the change should be referenced in 401 notes, but avoid redundancies in content. The summary should generally be 10 sentences or less using the following as a guide:

• It is strongly recommended to include a summary of the purpose of the study (especially for HS) and to include key information on the subject population or procedures that may be relevant to review of the change.
• If changes can easily be summarized in a sentence or two then go ahead and do that. If the changes are too varied and extensive to summarize, refer IRBMs to the change form. Significant changes (e.g. those that require specific regulatory determinations or that staff want to be sure reviewers comment on) should be noted and may include:
  • Significant changes to or addition of any vulnerable subjects and applicable decisions that would need to be made. If none, skip this. E.g.:
    • The study is adding children, aged 7 12. The board will need to determine if this can be approved under 45 CFR 46.404 as minimal risk research (or other). See the childrens checklist in the application. Note that the PI has a similar study (2021-XXX) enrolling children aged 13 17 that was found to be minimal risk.
    • Subjects lacking decision-making capacity are being added. Specific justification for including this vulnerable subject population is included in the Adults with Impaired Decision-Making Capacity checklist.
  • Significant changes to or addition of new drugs/devices and comment on their FDA status. If none, skip this. E.g.:
    • The study is adding the use of an investigational agent, Irbabulumab, which will be conducted under an investigator-held IND.
    • The board will need to determine if the study drug meets the IND exemption criteria listed on HRP-306, section 5.
    • The study is adding the use of investigational software, for which the study team is requesting an NSR determination. See the Non-Significant Risk Device checklist.
  • Changes to consent or HIPAA waivers/alterations. Comment on whether reconsent is required and why/why not. Refer to HRP-441 if a HIPAA waiver/alteration is necessary. If the recruitment/consent plan isnt consistent with institutional policy, point that out to the board. Otherwise skip discussion of this. E.g.:
    • The investigators are requesting a waiver of consent as well as a waiver of HIPAA authorization to collect and use medical record data from retrospective controls. The board must determine if the study meets criteria identified in the checklist included with the application. See HRP-441 for HIPAA waiver criteria.
    • The board will need to determine if a waiver of consent documentation can be approved for study activities which occur before written consent is obtained. See the Waiver checklist included in the application.
    • The investigator has proposed that the initial, in person contact in the ER be made by a study team member who is not involved in the prospective subjects clinical care team. The board should consider whether this is approvable.
  • Changes to regulatory determinations or additional major concerns (e.g. proposed plans/procedures differ from institutional policy) not addressed above (e.g., DOD, DHS). If none, skip.
  • Changes to risk level determination and applicable implications for the risk level determination. If the study team has requested a specific determination, state that here. Note any previous determinations that are relevant. E.g.:
    • If the board determines the study now presents greater than minimal risk to subjects, due to the increased risks to subjects, additional injury compensation language should be added to the consent document. Additionally, the board should consider if the data and safety monitoring plan is adequate to protect subjects from risk.
  • Whether there is any change to continuing review determination.

Notes should be deleted prior to finalizing the checklist post-meeting.

When reviewing a change of protocol on a study that was initially approved prior to implementation of Toolkit, analyst should back-fill HRP-401 if it has not already been done. This step should be completed for all changes of protocol.

Complete other checklists as necessary based on the nature of the change (e.g. HRP-411 when approving a waiver of documentation of consent). Open text fields (e.g. justifying criteria for a waiver of consent) should include what change the text pertains to. These notes are not deleted. If a previously completed supplemental checklist needs to be updated/added to, leave the current text and add to it with a note such as CP001 adds a waiver of signed consent for a 12 hour fast prior to the first in person visit. Most recent notes should be at the top of the text box (newest to oldest):

IRB analysts acting as the designated reviewer (i.e. listed on the roster as an IRB member) for an expedited change will complete HRP-402 to document approval. Enter any commentary about the change (e.g. specifying a designated reviewer) in the Additional Information text box, specifying what change it pertains to (e.g. CP001: The prisoner representative served as the designated reviewer). These notes are not deleted.

All permanent changes of PI must be submitted as a full change of protocol, as the expedited change of protocol form in ARROW does not include the change in PI page which collects required information, such as conflict of interest status. Given the level of responsibility they assume, permanent changes of PI are generally reviewed by the convened IRB. However, in the following cases, PI changes may be reviewed under expedited procedures:

• The study is permanently closed to enrollment and open only for long-term follow-up.
• Study activities are limited to data and/or biospecimen analysis. This includes SDAC applications.
• The study was initiallyreviewed under expedited procedures and continues to meet criteria for review under expedited procedures.
• The study was determined to be excused from continuing review.
• The sole purpose of the IRB application is to document approval of a grant.

Expedited changes to not require review by VA R&D. Full changes are routed for endorsement by R&D once pre-review is complete and the change is ready to schedule. Post-meeting, changes are approved with an Administrative Hold and then sent to the VA for final approval. Do not finalize consent documents until final VA approval has been submitted and the administrative hold is lifted.

See HRP-313 Expedited Review Worksheet

What qualifies for expedited review: Expedited Change of Protocol Guidance

Changes of protocol that are submitted for convened IRB review, but appear to qualify for expedited review can be re-assigned to a designated expedited reviewer in accordance with HRP-313. Likewise, expedited changes that do not meet criteria for expedited review as per HRP-313 should be scheduled for convened board review. In these cases, staff analysts should use best judgment in determining whether the application type needs to be changed from expedited to full. This is not always necessary if there is enough information in the expedited application for the board to conduct their review. If the application type is not updated, Expedited changes are not automatically routed for ancillary review, so if an expedited change requires full review, the staff analyst should consider whether the change will require any ancillary reviews; if so, the staff analyst will need to execute the Send to Ancillary Committee prior to scheduling.