EXAMPLE: Completed Exempted Review Application
Belmont University Institutional Review Board
Exempt Verification Application
Title of Project: Assessment of Teacher’s Knowledge of Backpack Safety: A Survey
Date proposal submitted to the IRB___12/01/03_________
Type of Proposal or Activity:
( X ) New proposal ( ) Renewal ( ) Modification
If renewal or modification, what was the date of last IRB approval? _________________
If this proposal is a renewal or modification, Please attach most recent IRB approval
letter and a copy of your previously approved IRB application.
Investigator information
1.) Name of Principal Investigator:
Sarah Student
Address: 106 Student Housing Place
Small Town, TN
Phone Number: 615-460-1234
e-mail: Students@pop.belmont.edu
School or Department You represent: Graduate student in Physical Therapy
2.) List all Associate Investigators (Please type full name of each investigator)
Associate Investigator: Sam Student
___________________
Associate Investigator: _____________________________________
Associate Investigator: _____________________________________
Associate Investigator: _____________________________________
Associate Investigator: _____________________________________
If more Associate Investigators are involved with this project, electronically insert
their names or include on an attached sheet.
3.) Faculty Sponsor(s)– A faculty sponsor is required for all student research projects
NAME: Savanna Faculty-Sponsor
Phone Number: 460-5678
email: Sponsors@belmont.edu
FUNDING
1.
Expected cost of the research: Please itemize your research expenses. Please attach
a separate list if needed. $50.00 Duplicating surveys
$75.00 Travel costs to schools to collect data (gasoline)
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EXAMPLE: Completed Exempted Review Application
2.
Please identify all sources of funding
Governmental Agency or Agencies:
Foundation(s):
Corporation(s):
Organization(s): Benevolent Graduate Foundation
Belmont University Departmental funds:
Individual(s):
Other:
3.
Is this proposal part of a grant?
Yes___X____ No________
If this proposal is part of a grant, please answer the following questions.
a. Name of grant: Starving Student Grant for health sciences students
involved in research
b. Agency or institution providing the grant Benevolent Graduate
Foundation
c. Principal Investigator listed on the grant Sarah Student
LOCATION OF RESEARCH
1. Where will the research physically be conducted?
At 10 middle and intermediate Schools throughout Tennessee.
2.
Coordination for use of facilities or for medical supervision - if coordination is required
for a laboratory, clinical space, supervision, or medical assistance, provide the name and
signature of the individual who has the authority to provide the needed assistance or
clearance. A Letter of Agreement must be attached to the application in all cases where
outside coordination is required to perform the requested research.
Coordination is required with the principal at each school to enable the
investigators to come to faculty meetings to explain the study and to
administer the surveys. Each principal has completed and signed a Letter of
Agreement. All 10 letters of agreement contain the names and addresses of
the schools and principals have been signed (See appendices).
SUBJECTS
1.
Number of Subjects: 500 (50 teacher per school at 10 different schools.)
2.
Types of Subjects:
a. Age range of subjects: Adults older than 18 years.
b. Population from which subjects were derived: Middle school teachers, men
and women.
c. Inclusion and exclusion criteria for subjects: All study participants will be
middle and intermediate schoolteachers aged older than 18 years.
3.
Subject Screening Procedures
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EXAMPLE: Completed Exempted Review Application
Describe the screening procedures you will use to determine if subjects are able to
participate in your study. Please also attach any questionnaires or screening forms
you will use. No screening procedures will be used other than the
selection of these teachers from 10 schools.
4.
Describe your procedures for subject recruitment. Please also attach any subject
recruitment flyers, emails, or telephone scripts.
Investigators will visit the middle and intermediate schools in which
principals have agreed to participate during a faculty meeting and will
describe the purpose and procedures of the study.
5.
Will your subjects receive compensation in any form for participating in this study?
Yes______ No___X____
If yes, please explain how and when subjects will be compensated.
STUDY DURATION
1.
Probable duration of the entire study: One year.
2.
Total average time commitment of each subject involved with this project: Ten to
15 minutes on one day.
DESCRIPTION OF THE RESEARCH PLAN.
Please be sure to address all of the following questions using lay language. Please write in
complete sentences.
1. Provide a brief (no more than one paragraph) review of the pertinent literature and
identify the need for the study.
There has been growing public concern about the effects of heavy school
backpacks on children. Actual backpack weights carried by children and
students’ perceptions of backpack weight have been studied; however, to date
no study has examined teachers’ knowledge of student backpack safety.
The purpose of this study is to
examine teachers’ knowledge and perceptions of backpack safety.
2. Clearly state the purpose(s) of your project:
3. Describe your study design. If applicable also identify your variables and hypotheses.
This is a descriptive study using survey methodology.
4. Explain your instrumentation and methods. (Please explain your proposed methodology
step by step.)
This study is a descriptive study. A survey will be used to obtain
information about the knowledge and perceptions of middle school teachers
about backpack safety and use among middle school students. The survey
was developed using information from the literature. The survey was
reviewed by four teachers, four physical therapists, and two experts in
survey writing to establish face validity and appropriate content. (See survey
in appendices.)
The completed survey will be administered to approximately 500 fifth
through eighth grade teachers in middle and intermediate schools
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EXAMPLE: Completed Exempted Review Application
throughout Tennessee. At each school the investigators will attend faculty
meetings at a time agreed upon with the principle. The investigators will
explain the purpose and procedures of the study to the teachers. The
teachers will then be given the opportunity to complete the survey. It will be
emphasized to the teachers that participation is voluntary The investigators
will step out of the room while the teachers complete the survey, and the
teachers will put the completed survey in a large envelope to ensure
confidentiality during data collection. No identifying information will be
obtained on the surveys. After all teachers who wish to participate have
completed the survey the investigators will reenter the room and pick up the
envelope with the completed surveys.
Upon completion of data collection and data analysis, the investigators
will return to each school and provide results of the study to the teachers. At
this time the teachers will also be instructed in backpack safety (i.e. proper
carrying position, maximal safe weight, etc.)
5. Describe your plan for data analysis and statistics
Data will be analyzed using descriptive statistics.
RISKS AND PRECAUTIONS:
1. List and describe any possible risks – (physical, psychological, and social.)
Please note that there are risks involved with any study; “None” is an unacceptable response
There are no physical risks associated with this study; however there are minor
risks of emotional discomfort or inconvenience when completing the surveys.
There is also a minor risk of loss of confidentiality or anonymity.
3. Describe procedures and precautions to be taken to avoid or minimize these risks.
It will be emphasized to the teachers that participation is completely
voluntary. Teachers will be asked not to put names or other identifiers on
the surveys.
4. Does this study involve deception?
Yes________ No_____X____
If this study involves deception or if any aspect of the protocol would be perceived by subjects as
embarrassing or threatening, then a full review is indicated and you will need to complete an
application for full IRB review.
CONFIDENTIALITY AND DATA MANAGEMENT
1. Subject Confidentiality:
When the results of your study are presented in publications and presentations, no
information may be provided that would reveal the identities of your subjects.
What additional measures are you taking to assure subject confidentiality prior to, during,
and after data collection?
The investigators will step out of the room while teachers are completing
the surveys, and the surveys for each school will be collected in one large
envelope. Teachers will be asked not to put names or other identifiers on the
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EXAMPLE: Completed Exempted Review Application
surveys. Additionally, prior to data one investigator will inspect all of the
surveys and remove any identifying information.
2. Data Confidentiality
Will any identifying information (name, date of birth, etc.) or health information be
collected from subjects or their records?
Yes_________ No_____X___
a. If yes, you will need to complete an Application for Expedited Review
form
b. If no, please explain how you will ensure that your subjects’ data is not
identifiable.
Will you be audio or video recordings of your subjects?
Yes________ No__X____
3. Data Storage
a.) How long do you plan to store your data?
(You must store data a minimum of three years per federal regulations)
Three years.
How will you dispose of your data at the end of your data storage time?
Shred paper data, and erase computer files.
b.)
Where will you store your data (Be specific)
Faculty sponsor’s office.
c.) Please explain who will have access to the data and under what
circumstances
Only the student investigators and the faculty sponsor will
have access to the data.
d.) How will you protect the data from unauthorized access? Paper data
will be stored in locked files and computer files will be stored in
password protected files.
**Compliance with HIPAA Privacy Regulations**
It is expected that all studies approved by the Belmont University IRB comply with other
federal regulations including HIPAA. In accordance with the provisions of the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), investigators shall
respect the confidential nature of all information that they may have access to, including
but not limited to the subjects’ personal health information provided to them orally or
contained in medical records in written or electronic form.
INFORMED CONSENT
1.
How will obtain voluntary and informed consent from study participants?
The investigators will explain the purpose and procedures of the study verbally
during faculty meetings. Additionally each potential participant will receive a
written letter of invitation. Implied consent will be used in which completing and
submitting the survey implies consent to participate – this will be described to
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EXAMPLE: Completed Exempted Review Application
potential subjects both verbally and in the letter of invitation. Please see letter of
invitation in the appendices.
2. When will consent be obtained? Immediately prior to data collection (surveys)
during faculty meetings.
3. How will you verify that the subject fully understands the consent? All potential
participants will be given the opportunity to ask questions.
CERTIFICATION:
My signature below indicates that I will operate in accordance with all federal and Belmont
University regulations governing research involving human subjects as stated in the IRB
guidelines for the protection of human subjects.
I certify I will follow the study protocol and the method of obtaining informed consent as
approved by the IRB during the period of the research project. I will submit any changes of
protocol to the IRB and receive IRB approval before implementing any changes. I will report any
adverse reactions or subject complaints within 48 hours to the Office of University Counsel and
to the Chair of the IRB.
All investigators and faculty advisors (for student projects) must sign below:
Principal investigator signature___Sarah Student __________ Date_December 1, 2003_
Associate investigator signature__Sam Student___ ______ Date_December 1, 2003_
Associate investigator signature_______________________ Date____________
Associate investigator signature_______________________ Date____________
Faculty Advisor signature
_ Savanna Faculty-Sponsor
Faculty Advisor signature
_______________________ Date____________
Date_12/03/03___
Faculty Advisor’s Statement (for student projects only)
I, _Savanna Faculty-Sponsor_____, am the faculty advisor for _Sarah Student and Sam Student. .
My signature below indicates that I have read the attached protocol and have checked the
contents with IRB guidelines.
Faculty Sponsor Signature__ Savanna Faculty-Sponsor
Date_12/03/03___
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EXAMPLE: Completed Exempted Review Application
APPENDICES:
The following is a list of appendices that should be included with this study.
1.) Ten signed Letters of Agreement (one from each participating school.)
2.) Letter of Invitation
3.) A copy of the survey
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