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o f f i c e 770.690.9491
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IRB
--. i 1.888.636.1062
Suite 600-351
www.sterlingirb.conn
^ax 7 7 0 . 6 9 0 . 9 4 9 2
Atlanta, G e o r g i a 3 0 3 3 9
\. [email protected]
CJ
Memo
To:
Louis O Rabinowitz
Fronn:
Site Support Team
Date:
February 10, 2014
Re:
The Impact of Driver Compensation on Commercial Motor Vehicle Safety Survey
IRB ID#:
4609-001
Attached is approval documentation for the above-referenced study.
•
Check all addresses (sites) and phone numbers for accuracy in the Approval Document and
Informed Consent. Let our office know ASAP if there are any inaccuracies.
•
Please note the due date listed on the Approval Document for the Site Continuing Review
Status Report. A Site Final Report should also be submitted once the study at your site is
completed. These reports are required by the Board and by Federal Regulations.
•
Please include the IRB ID # on all correspondence pertaining to this study.
•
Sterling IRB forms for use by the Principal Investigator/Site are available on our website,
www.sterlingirb.com.
•
Sterling IRB has developed an Investigator Handbook that outlines the responsibilities of the
Principal Investigator. The Investigator Handbook should be read by all key personnel on the
research team. It can be located on the Sterling website, www.sterlingirb.com.
•
Sterling IRB requires Principal Investigators to promptiv report all events that may constitute
unanticipated problems involving risk to subjects or others and new or updated safety
information relating to the study or study product. Please refer to Chapters 7 ('Reportable
Events') and 10 ('Research Conflicts and Noncompliance') of the Investigator Handbook
(located on our website at www.sterlingirb.com) for additional information regarding reporting
guidelines.
If you have any questions please call our office at 888-636-1062.
Initial Approval PI Cover Memo APP246 Effective Date: 4/20/12 Version: 4.1
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6 3 0 0 Powers Ferry Road
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Suite 600-351
_ www.sterlingirb.com
fax 770.690.9492
Atlanta, Georgia 30339
:
[email protected]
CJ
February 10, 2014
Study
Expiration Date: February 6, 2015
Site Continuing
Review Status
Report Due:
Principal
Investigator:
Sites(s):
January 6, 2015 (form available at www.sterlingirb.com)
Louis O Rabinowitz
Street Legal Industries, Inc Corporate Headquarters
102 Jefferson Court
Oak Ridge, TN 37830
Protocol:
The Impact of Driver Compensation on Commercial Motor Vehicle Safety Survey
IRB ID:
4609-001
Sponsor:
US Department of Transportation, Federal Motor Carrier Safety Administration
TYPE OF REVIEW: Expedited Review - Study Approval - Initial
•
•
•
•
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Protocol (Date and Version ofthe Protocol: January 20, 2013, Version 1)
Survey Introductory Letter (Version Date: 22 January 2014)
Waiver of Documentation of Informed Consent under 45 C F R 46.117(c)
See Attachment A for Additional Approved Materials, including Recruitment Materials if applicable
Investigator's Qualifications
A P P R O V E D WITHOUT MODIFICATION
This study was reviewed and approved on February 7, 2014.
Sterling IRB has determined that this study represents the following category(ies) of research eligible for expedited review:
research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral
history, focus group, program evaluation, human factors evaluation or quality assurance methodologies
Sterling IRB has approved this Principal Investigator to conduct this study at the above-listed site(s). Approval will expire on the study
expiration date listed above, and if the study is to continue the Principal Investigator must receive Sterling IRB approval for study
continuation prior to the expiration date. The Principal Investigator should submit the Site Continuing Review Status Report not less
than one month prior to the last Sterling IRB meeting preceding the expiration date. If approval for study continuation is not obtained
prior to the expiration date, the study will be considered to be in noncompliance with Federal Regulations and IRB requirements, may
be suspended, and may be subject to termination.
A Site Final Report will be due at the conclusion of the study (form available at www.sterlingirb.com).
Any changes to the research must be submitted in writing to Sterling IRB for review and approval prior to implementation. Sterling IRB
should be informed immediately of any serious adverse reaction or should any unanticipated problems involving risks to the subject or
others occur or should the Sponsor provide safety information. Local prejudices or negative attitudes in the community toward the
conduct of research projects must be reported immediately. State laws pertaining to PatientA/olunteer Bill of Rights and specific state
laws concerning research which affect the conduct of clinical research must be enforced. Non-English speaking subjects enrolled in this
study must be provided with an informed consent written in their fluent language, which must be approved by Sterling IRB before use.
As Principal Investigator you are responsible for following all policies of Sterling IRB as described in the Investigator's Compliance Agreement
which you signed with study submission. It is your responsibility to ensure this research is conducted in accordance with applicable regulations
(local, state and federal) as well as any requirements established by the IRB at the time of the approval. Refer to the Investigator Handbook at
www.sterlingirb.com for details ofthese responsibilities.
Attachments (if applicable):
Attachment A, Sterliffg IRB Membership List, Approved Informed Consent / Approved Recruitment Material(s)
APP232 Approval.Ini.Site Effective Date: 8.14.13 Version: 8.3
©Sterlin
Achieve
Date Issued:
More.
o f f i c e 770.690.9491
^oll f r e e 1.888.636.1062
6300 Powers Ferry R o a d
IRB
Suite 600-351
fax 7 7 0 . 6 9 0 . 9 4 9 2
Atlanta, Georgia 30339
www.sterlingirb.com
[email protected]
February 10, 2014
Study
Expiration Date: February 6, 2015
Site Continuing
Review Status
Report Due:
January 6, 2015 (form available at www.sterlingirb.com)
Principal
Investigator:
Louis O Rabinowitz
Protocol:
The Impact of Driver Compensation on Commercial Motor Vehicle Safety Survey
IRB ID:
4609-001
Sponsor:
US Department of Transportation, Federal Motor Carrier Safety Administration
ATTACHMENT
A:
ADDITIONALAPPROVED
MATERIALS
study Materials:
•
•
Email Thank You Message to C M V Carriers Who Participated in the Impact of Driver Compensation on Commercial Motor
Vehicle Safety Survey
Online questionnaire item set and process logic
Recruitment Materials:
•
•
Email Message Inviting C M V Carriers to Participate in the Impact of Driver Compensation on Commercial Motor Vehicle
Safety Sun/ey
Email Follow-Up Message Encouraging C M V Carriers to Participate in the Impact of Driver Compensation on Commercial
Motor Vehicle Safety Survey
For these approved materials, you may insert or change site-specific information without resubmitting to the IRB.
The following may apply dependent upon approved item:
Federal Regulations require that Sterling IRB be supplied with an actual copy ofthe advertisement (MPS, CD, DVD, tear sheet, cassette,
VHS, etc.), when applicable, for review and approval prior to use. Approved print advertisements are authorized for internet use without
being resubmitted to the IRB provided that they remain true to scale and are in no way modified.
If the above-referenced recruitment and/or study material(s) contain(s) a reference or link to a website, Sterling IRB assumes that the
link(s) provided do/does not contain any information which would violate either Sterling IRB requirements or applicable regulations. It is
your responsibility to submit any research-related content, including any information which pertains to a study under the review of
Sterling IRB, for review and approval prior to use.
APP232Approval.lni.Site Effective Date: 8.14.13 Version: 8.3
office 770.690.9491 toll free 1.888.636.1062 fax 770.690.9492
6300 Powers Ferry Road
Suite 600-351
Atlanta, Georgia 30339
www.sterlingirb.com e-mail [email protected]
Sterling IRB Membership Roster
Term: July 25, 2012 – July 24, 2014
IRB Registration Number: 00001790
Primary Members
Area of Expertise / Representative Capacity
Steven L. Saltzman, M.D., F.A.C.O.G., Chairman
Scientific
Obstetrics and Gynecology / College Educator
Pregnant Women / Prisoners / General Participant
Perspective
Maziar Rezvani, M.D., F.A.A.A.A.I., Vice-Chairman
Scientific
Allergy and Immunology
Children / General Participant Perspective
Melody Palmore, M.D., Medical Director
Scientific
Infectious Diseases / College Educator
Pregnant Women / Cognitively Impaired Persons /
Prisoners / General Participant Perspective
George A. Kramer, M.D., MPH
Scientific
Cardiology
Cognitively Impaired Persons / General Participant
Perspective
Robert L. Stahl, M.D., F.A.A.H.P.M.
Scientific
Hematology/Oncology
Cognitively Impaired Persons
Jennifer R. McGaughey, RN, BSN, CIP
Scientific
Human Research Protection / Nursing
Children / General Participant Perspective
Arin Neely, BS, CIP
Scientific
Human Research Protection / Biology
Children / General Participant Perspective
Lisa K. Kuklinski, BBA, CPMSM, CPCS, CAP
Non-Scientific
Credentialing / Medical Staff Management
General Participant Perspective
Rev. Dcn. Georgia A. Newman, PhD
Non-Scientific
Pastoral Care and Education
Pregnant Women / Cognitively Impaired Persons /
Prisoners / General Participant Perspective
Alternate Members
Area of Expertise / Representative Capacity
Mark Cavitt, M.D.
Scientific
Psychiatry / Pediatric Psychiatry
Children / Cognitively Impaired Persons
Harvey DuBiner, M.D.
Scientific
Ophthalmology
Paula S. Hickman, MHA, CPMSM, CPCS
Non-Scientific
Health Information Systems & Technology /
Credentialing
General Participant Perspective
Arthur J. Powell, PhD
Non-Scientific
Ethics
Lauren S. Surden, MSW
Scientific
Clinical Research / Social Work
General Participant Perspective
Sterling IRB – APP035 IRB Roster – July 25, 2012 – July 24, 2014 – Published
Effective Date: 10.09.13 Version: 28.3
Page 1 of 1
STUDY: The Impact of Driver Compensation on Commercial Motor Vehicle Safety Survey
STERLING IRB ID: 4609-001
DATE OF IRB REVIEW: 02/07/14
[OFFICIAL LETTERHEAD]
CMV Carrier Company Name
Attn: Contact Name or Generic Title
Contact Address 1
Contact Address 2
Contact City, State, Zip
Dear [Contact Name or Generic Title]:
The primary mission of the Federal Motor Carrier Safety Administration (FMCSA) of the US Department
of Transportation is to reduce crashes, injuries and fatalities involving large trucks and buses. Recent
reports show declines in both truck and bus crashes over a ten-year period. While these findings are
encouraging, much work needs to be done to prevent commercial motor vehicle-related fatalities and
injuries. An important group FMCSA works with to improve highway safety is the motor carrier industry.
FMCSA works with companies like yours to advance our mutual goal of maximizing the well-being of
your drivers and others who share the nation’s highways.
FMCSA has contracted with Street Legal Industries, Inc. (Street Legal), to conduct a research study to
determine if there is a correlation between safety and the way drivers are paid and we are asking that
you consider participating. Street Legal is conducting a two-part survey as part of the study. FMCSA will
use study findings to develop guidelines commercial motor vehicle carriers can use in determining best
practices for compensating drivers and to provide information that will be useful to FMCSA as policy
issues are considered. The study report will be made available to the public on the FMCSA website.
About 2,500 commercial carrier companies will participate in this study.
Your participation in the study is voluntary. You may refuse to participate or withdraw from the study, at
any time, without penalty or loss of benefits to which you are otherwise entitled. There is no alternative
to study participation. There is minimal risk expected with participation in the study. You will be
informed in a timely manner if new information that may influence your willingness to continue
participation in the study becomes available. You will not personally benefit from your participation in
the study, but information may be learned that could benefit others in the future.
Data collected by Street Legal will be coded and your answers will be kept in strict confidence. The
resulting report and dataset provided to FMCSA will be reported only in the aggregate. Personally
identifiable information and information identifiable by participating company will not be provided to
FMCSA.
The method for collecting data will be a two-part survey. The first round will consist of a short phone
interview to determine how your company pays drivers. Depending on your response to that item, you
may be asked additional questions. The total time anticipated for completing the first interview is
anticipated to be less than ten minutes.
Page 1 of 2 – Survey Introductory Letter
Version Date: 22 January 2014
STUDY: The Impact of Driver Compensation on Commercial Motor Vehicle Safety Survey
STERLING IRB ID: 4609-001
DATE OF IRB REVIEW: 02/07/14
You may be asked to participate in a second round of data collection. Should you be selected to
participate in the second round, you may be required to pull information from drivers’ records.
Depending on your recordkeeping system, it may take up to an hour complete the collection of driver
information. You will have the option of receiving a second phone call to respond to interview questions
or to complete an online, web-based form to complete a short questionnaire. It is anticipated that the
interview or completing the online questionnaire will take no longer than fifteen minutes.
Your participation may be stopped without your consent by the study investigator for any reason. For
example, your participation may be stopped:
if it is deemed to be in the best interest of your health and welfare.
if you fail to follow instructions.
There is no cost to participate in the study. You will not be compensated to participate in the study.
You do not waive any of your legal rights by participating in the study.
Should you have questions about the research study described in this letter, please contact the FMCSA
contracting officer for the project:
US Department of Transportation
Federal Motor Carrier Safety Administration
Office of Acquisition Management
ATTN: Ms. Theresa Hallquist
1200 New Jersey Avenue, SE
W66 – 6th Floor
Washington, DC 20590-0001
If you have questions regarding your rights as a research participant, or if you have questions, concerns,
complaints about the research, would like information, or would like to offer input, you may contact the
Sterling Institutional Review Board Regulatory Department, 6300 Powers Ferry Road, Suite 600-351,
Atlanta, Georgia 30339 (mailing address) at telephone number 1-888-636-1062 (toll free).
STERLING IRB ID: 4609-001
This document has 2 pages.
Thank you in advance for your participation in this important research.
Sincerely yours,
[NAME OF APPROPRIATE DOT OFFICIAL]
[TITLE OF DOT OFFICIAL]
Page 2 of 2 – Survey Introductory Letter
Version Date: 22 January 2014
Approved by Sterling IRB
IRB ID 4609
Attachment K
Survey Introductory Letter, Questionnaire Email Invitation, Follow-up remind for non-response or
incomplete questionnaire, Thank you email, Online Questionnaire and Process Logic Flow
Email Message Inviting CMV Carriers to Participate in the Impact of
Driver Compensation on Commercial Motor Vehicle Safety Survey
Dear CMV Carrier Representative:
The Federal Motor Carrier Safety Administration (FMCSA) recently sent you an email message to tell you
about a study that Street Legal Industries (SL) is administering for FMCSA. As you may recall from that
message, the study is being conducted to determine the ways in which CMV carrier companies pay their
drivers and whether pay methods correlate to driver safety.
We would like to invite you to participate in this important study by completing an online survey
questionnaire. Should you participate, your information will be kept in strictest confidence. Data
obtained from the survey will be coded and reported in the aggregate. Individuals completing survey
questionnaires will not be identified and no individual company’s data will be reported.
The survey questionnaire and instructions for completing the questionnaire can be accessed at
. The survey is presented in two parts. Every survey participant will fill out the
Part 1 questionnaire. Part 1 of the questionnaire should take no longer than thirty (30) minutes to
complete.
Depending on your response to certain items on Part 1 of the questionnaire, you may be asked to
complete Part 2. Filling in Part 2 will also take less than thirty (30) minutes, but you will be asked to
provide demographic information about your company’s drivers such as average age and the numbers
of drivers who are paid using various methods. The amount of time it will take for you to research
information required for Part 2 will depend on your accessibility of your company’s driver information.
Note that you will be able to complete part of the questionnaire, save it, and return to the survey
website to complete the survey at a later time. There is an email link at the survey website to send
questions about questionnaire items to the research team. You will also have the option of sending
questions to the FMCSA about the study to Ms. Terri Hallquist, FMCSA through another the email link available at the survey website.
We certainly hope that you’ll participate in this important study. Thank you for your consideration.
< SIGNATURE HERE>
FMCSA Project Manager
Approved by Sterling IRB
IRB ID 4609
Attachment K
Survey Introductory Letter, Questionnaire Email Invitation, Follow-up remind for non-response or
incomplete questionnaire, Thank you email, Online Questionnaire and Process Logic Flow
Email Follow-Up Message Encouraging CMV Carriers to Participate in
the Impact of Driver Compensation on Commercial Motor Vehicle
Safety Survey
Dear CMV Carrier Representative:
We recently transmitted an email message to you containing an invitation to participate in a study that
Street Legal Industries (SL) is administering for the Federal Motor Carrier Safety Administration (FMCSA).
The study is being conducted to determine the ways in which CMV carrier companies pay their drivers
and whether pay methods correlate to driver safety.
We urge you to participate in this important study by completing an online survey questionnaire. Should
you participate, your information will be kept in strictest confidence. Data obtained from the survey will
be coded and reported in the aggregate. Individuals completing survey questionnaires will not be
identified and no individual company’s data will be reported.
A few reminders about the survey:
The survey questionnaire and instructions for completing the questionnaire can be accessed at
. The survey is presented in two parts. Every survey participant will fill
out the Part 1 questionnaire. Part 1 of the questionnaire should take no longer than thirty (30)
minutes to complete.
• Depending on your response to certain items on Part 1 of the questionnaire, you may be asked
to complete Part 2. Filling in Part 2 will also take less than thirty (30) minutes, but you will be
asked to provide demographic information about your company’s drivers such as average age
and the numbers of drivers who are paid using various methods. The amount of time it will take
for you to research information required for Part 2 will depend on your accessibility of your
company’s driver information.
• You will be able to complete part of the questionnaire, save it, and return to the survey website
to complete the survey at a later time. There is an email link at the survey website to send
questions about questionnaire items to the research team. You will also have the option of
sending questions to the FMCSA about the study to Ms. Terri Hallquist, FMCSA through another the email link available at the survey website.
We certainly hope that you’ll participate in this important study. Thank you for your consideration.
•
FMCSA Project Manager
| File Type | application/pdf |
| File Modified | 2015-02-06 |
| File Created | 2014-02-10 |