IRB-HSR: Approval Comment Form for Protocol Continuations
IRB-HSR Protocol #:
Expedited Review
Full Board Review
Modification
Meeting Date:
If protocol involves Gene Transfer- approval may be only be granted for 6 months.
OK? Review Criteria:
Comments
If full board, create a folder for this studies review documents or verify this is not necessary because study is expedited.
MAIN PAGE REVIEW
STATUS : Review the Current Status checked on Status Form
No change
Status Change This change will be considered a Receipt)
Approval form comments: Protocol status changed from
Update database as necessary. Add approval comment and update
__________________to _____________ per Status Form OR
Regulatory page as necessary with expedited criteria #8 choices
per Protocol Status Change Form on file with this continuation.
Open to Enrollment
Closed, subjects being treated
Database Closed
Database Open
Temporarily Closed to Enrollment
Closed, Follow-up only
Closed to enrollment, no subjects enrolled
Data Analysis Only
RE-OPEN with this continuation:
FB Continuation Receipt comment: This Protocol was previously
Separate reopening event is required:
closed/expired on (insert). The PI is requesting that, with the approval
Event type = Approval Protocol reopening
of this continuation the study be reopened with a status of (insert).
Review Type = same as Continuation Review
Continuation Approval form comments: This Protocol was
Agenda = None
If 5 year update due and not completed, reopen to status of: Closed to previously closed/expired on (insert). With the approval of this
continuation, the protocol is now re-opened with the status of (insert).
Enrollment Pending 5 Year Update
Reopening Approval form comments: Protocol reopened with the
Continuation approved on (insert date)
Verify is 5 year update is due. If due, be sure it has been processed before the continuation is placed on the agenda for approval

If the team only has a few more subjects to enroll OR there are other extenuating circumstances, you may grant an extension of 1 year.
ENROLLMENT
Approval Form Comment if there was over enrollment:
1. Review how many subjects have enrolled and update Subjects
With this submission the minor violation of over-enrollment was noted.
Studied field in database as necessary.
Study was approved to enroll x and Y were enrolled.
2. Update the Enrollment table at the bottom of the main page with
yearly and cumulative information.
3. If over-enrollment has occurred add Comment and if open to
enrollment, request a modification to enrollment numbers.
Verify any Comment on Main page of the database is resolved or confirm this is NA. Add receipt comments to the approval comment.
Verify if PAM occurred during review period, reports, letters, or response to audits have been submitted. Include all as part of Full Board agenda
file (even if submitted previously). Receipt comment for all studies if submitted with continuation.
EVENTS: Print Events/AE reports for all continuations. IF Full Board review is required, create e-files for these documents and place in review
folder for agenda files.
REGULATORY PAGE CHECK:
DSMB/C REVIEW: Verify DSMB reports are on file. Do not place on the agenda for review until issues with the DSMB are resolved.
NA
For Cancer Center DSMC: The CCDSMC meets every month but only produces a report if there are issues. If a PAM review has occurred, there
should be a DSMC letter for each PAM review. The DSMC does not review studies with no enrollment OR those in Follow Up
CERTIFICATE OF CONFIDENTIATLIY: Verify C of C approval letter is on file and is not expired
If received with continuation, include in receipt comment and update Regulatory page as necessary – type of C of C and expiration
NA

If it is expired /request C of C extension application or C of C approval from the study team.

If not received, the IRB approval will be allowed to expire (if in process with FDA, request documentation from study team)
PROTOCOLS APPROVED TO ENROLL PRISONERS:
FB Continuation Receipt comment:
Research Involving Prisoners Checklist must be completed
Full Board review: include checklist in agenda documents. Prisoner
Approval Form Comment:
NA
Representative must attend meeting when protocol enrolling prisoners is
all studies: A majority of the IRB (exclusive of the prisoner
being reviewed. Scientific reviewer may complete the checklist
representative) has no association with the prison(s) involved and a
UNLESS research is being conducted inside the Bureau of Prisons.
qualified prisoner representative was involved in the review
Expedited review: Prisoner Representative must complete checklist for
if full board review add: and voted on the continuation.
expedited review when subjects have been enrolled under written
all studies: The Prisoner Representative concurred with the
consent.
permission for prisoners to enroll as subjects in the research.
Prisoner Checklist is NOT required if the study does not involve an
interaction/ intervention (e.g. chart review under waiver of consent) or
the study has had no enrollment (approved under Category #8b)
NA
See AG 3-34 for additional info.
PROTOCOLS APPROVED TO ENROLL MINORS
Enrollment requiring 2 parent signatures: verify if wards of the state were enrolled
If wards were enrolled without permission, request protocol deviation
Version Date 05-08-17
IRB-HSR: Approval Comment Form for Protocol Continuations
If minors reach age of majority (18 yrs in VA) confirm Age of Majority Cover Letter + Consent Addendum or Waiver is present.
If not present, process Age of Majority modification with continuation following Age of Majority instructions
PEOPLE/PERSONNEL: Verify if any personnel changes are required
Approval Form Comment: Modification expedited: Minimal
and update database and/or Status Form as necessary.
risk/Minor change: The following personnel changes were made per
the Status Form/Personnel Change Form on file with this
submission:
Verify training is current for all study personnel. Remove those with
Approval Form Comment: Modification expedited: Minimal
expired training Print Certificate
risk/Minor change: (insert names) were administratively removed
from this protocol due to expired Human Subject Protection
Training.
QUESTIONS: Review all answers. All questions should be addressed and the responses should be consistent with information in the database.
Update/clarify as necessary
1. Brief summary is present and consistent with remaining information. If attachments are noted, be sure they are attached and listed as
received.
2. YES/NO response is required
3. Plans for the coming year are consistent with remaining info
4. Yes/No response is required. If YES, verify a mod has been approved to change funding source.
5. Verify response is consistent with page 1 and Reg Page. IF DSMB report is required it is either submitted previously, attached or there is a
comment such that there was not enough enrollment OR a board meeting is schedule in x timeframe.
6. Adverse events: IF NO AEs are submitted for the year per the AE report, the response should = NA. If AEs are present then the response
should =YES. Review AE report to see if these appear to be reported correctly. ( if no sponsor, then no external AEs should be present etc.)
Questions # 7-13 – Yes /NO response required
SIGNATURE: Verify the form is signed by the PI or typed in and have accompanying email from PI on file.
VERSIONS: Use the database to verify correct version dates.

Verify current consents are submitted. Print and stamp consents or verify this is not necessary. IF Full Board, move current consents and
protocols to the review folder.

IF full board, verify current protocol and application are also submitted and moved into agenda file folder.
RECEIPTS: List in the approval comments documents received. No
Approval Form Comment:
need to stamp these as received.
On file with this submission are the following documents: (List)
EXPEDITED STUDIES ONLY
1. Make sure Expedited Categories are listed on Regulatory Page and on the Meeting Page as well. Use the Regulatory Insert feature to insert
expedited categories, copy and paste into comments on Meeting page.
2. Insert PLEASE REMEMBER text section of the regulatory insert information into the approval comment
EXPEDITED CATEGORIES : Continuation Review ONLY
Category 1-7
PER REGULATORY PAGE
Category # 8a
Follow up ONLY
Category # 8c
Data Analysis Only
Category # 8b
No Enrollment
Category # 9
Humanitarian Device Exemption
other:
Place on the agenda by using the Meeting Continuation view and changing responses to Y/N. Change event to EXPEDITED and enter the
expedited date. Then enter the expedited categories on this page.
FULL BOARD STUDIES ONLY
Scan (separately) Status Form, any attachments referred to in the report, and any DSMB reports
Move e versions of all documents and scans to agenda files
Place on the agenda by using the Meeting Continuation view and changing responses to Y/N. From the EVENT, change the AGENDA TYPE to
ADDENDUM
MODIFICATION WITH CONTINUATION Only modifications related to Age of Majority consent may be processed with the continuation. All
other modifications to the protocol or consents must be submitted separately by the study team to [email protected] . Status updates
and Personnel Changes (non-PI) may be processed with the continuation
FB Continuation Receipt comment: This protocol includes continued
Age of Majority Consent Addendum
New Version Date:
interaction with subjects who will reach Age of Majority. The use of the
Issue cover letter and stamped consent addendum
Age of Majority Cover Letter and Consent Addendum are being
requested with the approval of this continuation.
Age of Majority waiver of consent
Update regulatory page to include #11 – Waiver of Consent/HIPAA
Authorization – Age of Majority
Include only #11 language in approval comment
Initials of Administrative Staff who completed this form:
Version Date 05-08-17
Approval Form Comment: Modification expedited: Minimal
risk/Minor change: Approved use of Age of Majority Cover Letter
Template and IRB approved Age of Majority Consent Addendum
Approval Form Comment: Modification expedited: Minimal
risk/Minor change: Granted Waiver of Consent and Waiver of HIPAA
Authorization to allow the study team to continue to use data/specimens
for any subject who has reached/will reach Age of Majority