Attachment 16_CertificateOfApproval-August

Attachment 16: IRB CERTIFICATE OF APPROVAL
Web-based Skills Training for SBIRT (Screening, Brief Intervention, and Referral to Treatment)
August 2011

WIRB

®

Certificate
of
Approval

Western Institutional Review Board ®

(360) 252-2500
1-800-562-4789
FAX: (360) 252-2498

3535 SEVENTH AVENUE, SW, OLYMPIA, WA 98502-5010
P.O. BOX 12029, OLYMPIA, WA 98508-2029

THE FOLLOWING WERE APPROVED:

BOARD ACTION DATE: 1/26/2011
PANEL: 3
STUDY APPROVAL EXPIRES: 1/26/2012
STUDY NUM: 1122531
WIRB PRO NUM: 20102107
INVEST NUM: 69105
WO NUM: 1-646958-1
CONTINUING REVIEW: Annually
SITE STATUS REPORTING: Annually

INVESTIGATOR: Kelly Carpenter MA, Ph.D.
1121 34th Avenue
Seattle, Washington 98122

SPONSOR: National Institute on Drug Abuse (NIDA)
PROTOCOL NUM: None
AMD. PRO. NUM:
TITLE:
Web-based Skills Training for SBIRT -- SBIRT-PC: Screening, Brief Intervention and Referral to Treatment for Tobacco, Alcohol, and
Other Drugs in Primary Care

APPROVAL INCLUDES:
Investigator
Advertisement - Letter - Helping patients quit tobacco and #8524322.0 - As Submitted
Advertisement - Website - Welcome to the SBIRT in #8524326.0 - As Submitted
Core Curriculum and Basics of Motivational Counseling #8524336.0 - As Submitted
Continued on Next Page...
WIRB APPROVAL IS GRANTED SUBJECT TO:
The Board requires that all subjects must be able to consent for themselves to be enrolled in this study. This means that you cannot enroll
incapable subjects who require enrollment by consent of a legally authorized representative.
Federal Regulations do not recognize Co-Principal Investigators. Therefore, the Board has approved the two investigators for this study as
if each is THE Investigator and holds each individually responsible for the conduct of the entire study.
The Board directed that persons who are unable to read are not allowed to consent for themselves or others to participate in this study.
The Board found that this research meets the requirements for a waiver of documentation of consent under 45 CFR 46.117(c)(2)
IF YOU HAVE ANY QUESTIONS, CONTACT WIRB AT 1-800-562-4789
This is to certify that the information contained herein is true and correct as reflected in the records of the Western Institutional Review
Board (WIRB), OHRP/FDA parent organization number IORG 0000432, IRB registration number IRB00000533. WE
CERTIFY THAT WIRB IS IN FULL COMPLIANCE WITH GOOD CLINICAL PRACTICES AS DEFINED UNDER THE U.S.
FOOD AND DRUG ADMINISTRATION (FDA) REGULATIONS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
(HHS) REGULATIONS, AND THE INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) GUIDELINES.

1/29/2011
(Date)

Theodore D. Schultz, J.D., Chairman

This document electronically reviewed and approved by Ennever, John on 1/29/2011 11:22:59 AM PST. For more information call Client Services at 1-360-252-2500
Page 1 of 4
Board Action: 1/26/2011; Study: 1122531

Copyright © 2008 Western Institutional Review Board, Inc. All rights reserved.

APPROVAL INCLUDES, Continued From Previous Page:
Core Curriculum Knowledge Test #8524330.0 - As Submitted
Demographic Questions #8524329.0 - As Submitted
Eligibility Screening #8524327.0 - As Submitted
Perceived Barriers to SBIRT Questionnaire #8524334.0 - As Submitted
Protocol (12-20-2010)
Recruitment of Subjects Under the Grant N44DA-9-2216 (Web-based Skills Training for SBIRT)
Reminder Emails #8524328.0 - As Submitted
SBIRT Attitudes #8524332.0 - As Submitted
SBIRT Clinical Practices Questionnaire #8524335.0 - As Submitted
SBIRT Self-Efficacy #8524333.0 - As Submitted
Standardized Patient Case for Role-Play #8524337.0 - As Submitted
Virtual Standardized Patient Evaluations #8524331.0 - As Submitted
Consent Form [S0]
WIRB HAS APPROVED THE FOLLOWING LOCATIONS TO BE USED IN THE RESEARCH:
• Talaria, Inc., 1121 34th Avenue, Seattle, Washington 98122
If the PI has an obligation to use another IRB for any site listed above and has not submitted a written statement from the
other IRB acknowledging WIRB's review of this research, please contact WIRB's Client Services department.

Page 2 of 4
Board Action: 1/26/2011; Study: 1122531

Copyright © 2008 Western Institutional Review Board, Inc. All rights reserved.

ALL WIRB APPROVED INVESTIGATORS MUST COMPLY WITH THE FOLLOWING:
1. Conduct the research in accordance with the protocol, applicable laws and regulations, and the principles of research ethics as set
forth in the Belmont Report.
2.

Although a participant is not obliged to give his or her reasons for withdrawing prematurely from the clinical trial, the investigator
should make a reasonable effort to ascertain the reason, while fully respecting the participant’s rights.

3.

Unless consent has been waived, conduct the informed consent process without coercion or undue influence, and provide the
potential subject sufficient opportunity to consider whether or not to participate. (Due to the unique circumstances of research
conducted at international sites outside the United States and Canada where WIRB approved materials are translated into the local
language, the following requirements regarding consent forms bearing the WIRB approval stamp and regarding certification of
translations are not applicable.)
a.

Use only the most current consent form bearing the WIRB "APPROVED" stamp.

b.

Provide non-English speaking subjects with a certified translation of the approved consent form in the subject's first language.
The translation must be approved by WIRB.

c.

Obtain pre-approval from WIRB for use of recruitment materials and other materials provided to subjects.

4.

Obtain pre-approval from WIRB for changes in research.

5.

Obtain pre-approval from WIRB for planned deviations and changes in research activity as follows:
•

If this research is federally funded or conducted under an FWA, obtain pre-approval from WIRB for all planned deviations and
changes in research activity, except where necessary to eliminate apparent immediate hazards to the human subjects. OHRP
considers all planned protocol deviations to be changes in research that need prior IRB review and approval.

•

If this research is not federally funded and not conducted under an FWA, obtain pre-approval from WIRB for any planned
deviations that could adversely affect the rights, safety or welfare of subjects, or the integrity of the research data and any
changes in the research activity, except where necessary to eliminate apparent immediate hazards to the human subjects. FDA
has not adopted the policy that all planned protocol deviations are changes in research that need prior IRB review and approval.

Deviations necessary to eliminate apparent immediate hazards to the human subjects should be reported within 10 days.
6.

Promptly report to WIRB all unanticipated problems (adverse events, protocol deviations and violations and other problems) that
meet all of the following criteria:
a.

Unexpected (in terms of nature, severity or frequency);

b.

Related or possibly related to participation in the research; and

c.

Suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.

Please go to www.wirb.com for complete definitions and forms for reporting.
7.

Provide reports to WIRB concerning the progress of the research, when requested.

8.

Ensure that prior to performing study-related duties, each member of the research study team has had training in the protection of
human subjects appropriate to the processes required in the approved protocol.

Federal regulations require that WIRB conduct continuing review of approved research. You will receive Continuing
Review Report forms from WIRB. These reports must be returned even though your study may not have started.

Page 3 of 4
Board Action: 1/26/2011; Study: 1122531

Copyright © 2008 Western Institutional Review Board, Inc. All rights reserved.

DISTRIBUTION OF COPIES:
Contact
Kelly Carpenter MA, Ph.D.
Tasha Mikko
Susan Stoner Ph.D.

Company Name
Talaria, Inc.
Talaria, Inc.
Talaria, Inc.

Page 4 of 4
Board Action: 1/26/2011; Study: 1122531

Copyright © 2008 Western Institutional Review Board, Inc. All rights reserved.