IRB Documents

08/01/2017
Laura Dunlap
c/o Victoria Albright
RTI
3040 E. Cornwallis Rd.
Durham, NC 27709
Re:

Centers for Disease Control and Prevention (CDC)
Protocol #:
N/A
PI:
Laura Dunlap
QR#:
32609/1

Dear Dunlap:
Quorum Review has reviewed and approved the following material on 08/01/17 for use
during the course of the above referenced study:










Client Focus Group Guide
Participant Form: Medication Assisted Treatment Evaluation Study (MATES)
Client Permission Form
Provider Focus Group Guide
Questionnaire: Crime and Criminal Behavior Questions
Questionnaire: Medication Assisted Treatment Evaluation Study (The MAT
Study) Check-In Questionnaire (Version 1, 06-21-2017)
Questionnaire: Medication Assisted Treatment Evaluation Study (The MAT
Study) Client Questionnaire (Version 1, 06-23-2017)
Questionnaire: Medication Assisted Treatment Evaluation Study (The MAT
Study) Screener Form
Questionnaire: Medication Assisted Treatment Evaluation Study (The MAT
Study) Site Director Questionnaire
Questionnaire: Medication Assisted Treatment Evaluation Study (The MAT
Study) Visit Form

Please note the following conditions of Quorum Review’s approval of recruitment and
participant study materials:



The above material is approved for use on the Quorum approval date noted above or
this site’s IRB approval date, whichever is later.
Any changes to the content or presentation of approved material, other than site
specific contact information modifications or spelling corrections, must be reviewed
and approved prior to use.

This document was electronically reviewed and approved by Diana Bratton on 08/01/2017 at 1:49:27 PM PT









Material listed above as “Replacement Material” has been identified as a
replacement for previously approved material. Approval documents for previous
versions of this material no longer apply.
Radio and television scripts to be recorded are approvable pending review and approval of
a final audio/video recording. The final recording must be approved by Quorum prior to
broadcast use.
Radio scripts for live broadcast use must be read exactly as approved.
The approval stamp on this material represents Quorum Review’s approval for the use of
this version of the material within the context of the above identified protocol.
This material may not be used for other studies without appropriate IRB approval,
however, this version of the material may be used without the Quorum approved stamp as
long as no other modifications are made.

Additionally, please note that recruitment activities might implicate the HIPAA Privacy
Rule (U.S.) or PIPEDA (Canada). You may need to have a specific authorization to
collect and use health information in conjunction with your recruitment activities. Please
consult your legal counsel with any questions. If your site is in the U.S. and you decide
you need a partial HIPAA waiver of authorization for your recruitment activities, you can
contact Quorum or visit our website at www.quorumreview.com.
If you have any questions, please don’t hesitate to contact the Client Support Team at
(206) 448-4082. Thank you for using Quorum Review.

CC:
RTI
Quorum Review File #

Sarah Duhart Clark
32609/1

This document was electronically reviewed and approved by Diana Bratton on 08/01/2017 at 1:49:27 PM PT

Re: Centers for Disease Control and
Prevention (CDC)
Protocol # N/A
PI: Laura Dunlap
QR#: 32609/1

Laura Dunlap
c/o Victoria Albright
RTI
3040 E. Cornwallis Rd.
Durham, NC 27709

Notice of Approval
Dear Dunlap:
Quorum Expedited Review has reviewed and approved the above-referenced research.
Enclosed please find a Notice of Approval and, if applicable, stamped consent form(s) in
support of this approval.
Quorum Review has determined this research is expeditable under the following category(ies):


5,7

Your site’s approval for this study expires on 8/1/2018. Quorum Review will remind you to
submit a Site Status Report form four weeks prior to the due date. Per FDA and other regulatory
agency regulations research activity may not continue on or after the expiration date shown on
the Notice of Approval without prior review and approval.
Please note that documents helpful to your site (including Participant Recruitment and Safety
Reporting Guidance, Safety Report Forms, the California Bill of Rights (for CA sites) etc.) can
be found on Quorum Review’s website at www.quorumreview.com.Current and historical Board
Rosters can be found on the Quorum OnQ Portal at https://onq.quorumreview.com/Library/.
If you have any questions, please don’t hesitate to contact the Client Support Team at (206)
448-4082. Thank you for using Quorum Review.
Enclosure
CC:
RTI

Sarah Duhart Clark

Quorum Review File #

32609/1

This document was electronically reviewed and approved by Dwayne Flansburgh on 08/14/2017 at 4:51:00 PM PT

NOTICE OF APPROVAL
Approval Date: 8/1/2017
Expiration begins on: 8/1/2018

Study Title:
Medication-Assisted Treatment for Opioid Use Disorders (MAT Study)
Protocol Number:
N/A
Sponsor:
Centers for Disease Control and Prevention (CDC)
Principal Investigator: Laura Dunlap

This approval includes:
The Protocol, dated 06/28/17; Grant Requisition/Reference No.: 0HCUHFC3-201600372
The Principal Investigator
Client Informed Consent/Assent Form, Version 1, dated 08/01/17;Provider Focus Group
Participant Informed Consent, Version 1, dated 08/01/17; Client Focus Group Participant
Informed Consent/Assent Form, Version 1, dated 08/01/17
The following report is necessary:
Site Status Report due by:

6/17/2018

CC:

RTI

Sarah Duhart Clark

Quorum Review File #

32609/1

See the next page for additional conditions of this approval.

This document was electronically reviewed and approved by Dwayne Flansburgh on 08/14/2017 at 4:51:00 PM PT

Quorum Review approvals are provided to Principal Investigators contingent upon the continuing
approval of the underlying protocol and also subject to the following conditions:
Quorum Review regards the Principal Investigator as responsible for the conduct of research trials at
his/her site and all associated research facilities. Specific responsibilities of the Principal Investigator
include ensuring:
 supervision of all research activity at the site and facilities in accordance with Quorum Review
policy, applicable laws, guidelines and the ethical principles outlined in the Belmont Report
 conduct of research according to the research protocol as approved by Quorum Review and any
restrictions or conditions placed on the study by Quorum Review
 if the site is utilizing consent forms:
o use of the most recently Quorum Review-approved, stamped informed consent form
o provision of a Quorum Review-approved consent form in the participant’s first language
o subjects unable to read are enrolled only if a Quorum Review-approved consent form
contains the witness statement and signature lines and all expected safeguards are followed
o subjects requiring a legally authorized representative are enrolled only if a Quorum Review
approved consent form contains a legally authorized representative statement and signature
lines and all expected safeguards are followed
 prospective approval by Quorum Review of changes in research activity including protocol
amendments and/or consent form revisions prior to implementation, changes in Principal
Investigator, change in research site, and addition of research facilities to a previously approved
site
 prompt reporting to Quorum Review of the completion of research
 prospective approval by Quorum Review of all advertisements / recruiting materials prior to use
 prompt reporting to Quorum Review of serious adverse events, major protocol
deviations/violations, and other unanticipated problems involving risks to participants or others
 prompt reporting to Quorum Review of updated safety information and significant findings or
information during the course of research which may relate to a participant’s willingness to
continue participation in the research
 timely submission of required progress reports
 all participants are aware that the research is investigational
 maintenance of adequate records in accordance with national, federal, state, provincial and local
regulations
 maintenance of open communication with participants regarding participant requests for
additional information or concerns about the research
 compliance with all requirements specified in the Quorum Handbook
_________________________________________________________________

Quorum Review IRB is an appropriately constituted research ethics board as required by regulation. This research was reviewed
and approved by the Board in accordance with pertinent authorities, including but not limited to, the ICH Guidelines for Good Clinical
Practice, U.S. Food and Drug Administration (21 CFR Parts 50 and 56), U.S. Department of Health and Human Services (45 CFR
Part 46), the ethical principles outlined in the Belmont Report, the Canadian Food and Drug Regulations (Part C, Division 5), Part 4
of the Canadian Natural Health Products Regulations, and the Tri-Council Policy Statement (TCPS). This approval and the views of
the Board have been documented in writing and certified by the Board Chair.

This document was electronically reviewed and approved by Dwayne Flansburgh on 08/14/2017 at 4:51:00 PM PT