EXAMPLE: Completed Full Review Application
Belmont University Institutional Review Board
Full Review Application
Title of Project: The effects of backpack carrying method on gait kinetics
Date proposal submitted to the IRB__12/01/04___________
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: Amy Student
Address: 1234 Student Housing Road
Nashville, TN
Phone Number: 223-4545
e-mail: studenta@pop.belmont.edu
School or Department Represented: graduate student in Occupational Therapy
2.) List all Associate Investigators (Please type full name of each investigator)
Associate Investigator: George Student_______________________
Associate Investigator: _Casey Student________________________
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: Susan Faculty Member
Phone Number: 460-3231
email: Members@mail.belmont.edu
FUNDING
1.
Expected cost of the research: Please itemize your research expenses. Please attach
a separate list if needed. Photocopying and paper $100.00
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EXAMPLE: Completed Full Review Application
2.
3.
Two identical backpacks $80.00
Total = 180.00
Please identify all sources of funding
Governmental Agency or Agencies:
Foundation(s):
Corporation(s):
Organization(s):
Belmont University Departmental funds:
Individual(s):
Other: Total cost will be split between the three investigators
Is this proposal part of a grant?
Yes_______ No____X____
If this proposal is part of a grant, please answer the following questions.
a. Name of grant:
b. Agency or institution providing the grant
c. Principal Investigator listed on the grant
LOCATION OF RESEARCH
1. Where will the research physically be conducted? Best Intermediate School in Small
Town, TN
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 REQUIRED (describe): Coordination is required with the school
principal for use of space in the school for data collection and for permission to
advertise for participation from students and parents. Please see letter of
agreement for details.
NAME (of responsible individual): Ms. Mary School-Principal
COORDINATION WITH OTHER INSTITUTIONAL REVIEW BOARDS
(Or other agencies involved with ethical review)
1. Subjects from other institutions:
Will subjects be from other institutions, such as other hospitals, high schools, or
other universities?
Yes____X____ No________
Name of involved institution/school: Best Intermediate School. Letter of
Agreement attached.
2.
Has this proposal been or will it be submitted to other Human Subjects Review Boards,
departmental committees or community agencies for review and approval?
Yes_________ No___X____
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EXAMPLE: Completed Full Review Application
.
SUBJECTS
1. Number of Subjects and Controls:
a. Proposed Number of subjects 40 healthy middle school students, males and
females, who will serve as their own controls (this study uses a repeated
measures design). Forty subjects will be recruited for this study based on a
pilot study power analysis.
b. Proposed number of controls (If appropriate) See above.
2.
Types of Subjects and Controls:
a. Age range of subjects: 7th and 8th graders (ages 11-15 years).
b. Population from which subjects were derived: Healthy male and female
students attending Best Intermediate School in Small Town Tennessee.
c. Inclusion Criteria for subjects and controls: Subjects will be healthy middle
School children.
d. Exclusion Criteria for subjects and controls (Include any age, sex, physical,
mental and health restrictions.): Students will not be able to participate if
they have any of the following: history of a heart and/or lung condition, any
current musculoskeltal disorder, and any injury to the arms, legs, or spine
within the last three months that would cause difficulty with walking or
carrying a backpack.
3.
Subject Screening Procedures
a. 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. Parents will be asked to sign an informed consent form
(see appendices) and complete a health history form (see appendices) and
return them to school. Youth participants will also be asked to sign a
pediatric consent form (see appendices).
b. Specifically explain how the results of your screening procedures will be used
to identify subjects who are eligible to participate in your study and identify
persons who are ineligible to participate in your study.
The health history forms completed by parents will be used to identify
students who are eligible for participation in the study and to identify
students who should not participate in the study. Students will not be able
to participate if they have any of the following: history of a heart and/or
lung condition, any current musculoskeletal disorder, and any injury to the
arms, legs, or spine within the last three months that would cause difficulty
with walking or carrying a backpack.
4. Describe your procedures for subject recruitment. Please also attach any subject
recruitment flyers, emails, or telephone scripts. The investigators will visit the
school and talk with all of the students about the study during an assembly. The
investigators will also meet with the teachers during a teachers’ meeting to
explain the study. A letter explaining the study along with parental consent
forms, youth consent forms, and a health history will be sent home with each
child at Best Intermediate School. In the letter, parents will be asked to return
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EXAMPLE: Completed Full Review Application
all of the forms completed to school if they are willing to allow their children to
participate in the study. See appendices for copies of the letter of explanation,
the youth consent form, and the parent consent for, and the health history
form.
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: One
hour on one day either immediately before school or immediately after school at the
convenience of the child and his or her family.
If this protocol is approved, the approval process is for a period of time not to exceed one
year from the date of the approval. A report requesting an extension is required for all
research that exceeds one year. Additionally, the Principal Investigator is responsible for
providing the IRB with findings and/or notification of the status of the research at the
completion of the project.
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 to three paragraphs) review of the pertinent literature
and identify the need for the study
The increasing incidence of back pain in adolescents has sparked an interest in
backpack safety within the medical and education communities. While no definitive link has
been established between backpack use and back pain, the relationship between the two is
of interest due to long-term implications of back pain in children. Research indicates a history
of back pain as a child may be a predictor of future back pain as an adult. Spinal pain is one of
the most costly and debilitating problems of adults in industrialized countries.
Consequences of wearing backpacks include: poor postural alignment, muscle
fatigue, impaired shock absorption, and nerve compression in the shoulder. Based on the
results of several studies, the American Physical Therapy Association (APTA) has developed
the following recommendations for backpack use: 1) backpacks should contain no more than
15% of the carrier’s body weight and 2) backpacks should be worn high in the mid-thoracic
area, with straps over both shoulders. While it is generally agreed upon that backpacks
should weigh no more than 15% of the carrier’s bodyweight, it is not known if the manner in
which the backpack is carried affects the carriers’ posture and manner of walking. It is
common practice for middle and high school students to carry their backpacks over one
shoulder or slung very low on their backs as opposed to wearing them high and over both
shoulders as recommended. The purpose of this study is to compare the effects of three
different methods of wearing a backpack, loaded with 15% of body weight, on gait
characteristics (stride length, cadence, velocity, base of support, and single stance time).
The methods of carrying a backpack that will be compared include: 1) wearing the backpack
in the mid-thoracic area with straps over both shoulders as recommended 2) wearing the
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EXAMPLE: Completed Full Review Application
backpack in the low lumbar area with straps over both shoulders 3) wearing the backpack in
the low lumbar area with a strap over one shoulder and 4) a control condition in which no
backpack is worn during walking. If it is determined that the manner in which a backpack is
worn affects gait kinetics, then educating children, teachers, and parents on proper
backpack wearing techniques may help avoid future back pain and other medical problems.
2. Clearly state the purpose(s) of your project
The purpose of this study is to determine the effects of three different backpack carrying
methods on the gait kinetics (step length, cadence, velocity, single stance time, and base of
support) of healthy seventh and eighth graders.
3. Describe your study design. If applicable also identify your variables and hypotheses.
This study is a repeated measures design in which each child will be asked to walk while
carrying a backpack under 4 different conditions (independent variables): 1) wearing the
backpack in the mid-thoracic area with straps over both shoulders as recommended 2)
wearing the backpack in the low lumbar area with straps over both shoulders 3) wearing the
backpack in the low lumbar area with a strap over one shoulder and 4) a control condition in
which no backpack is worn during walking
This study will use the GAITRite system to measure the dependent variables of:
Stride length (cm)
Step length (cm)
Single limb stance time (sec)
Double limb stance (sec)
Cadence
Velocity
Base of support (cm)
4. Explain your instrumentation and methods. (Please explain your proposed methodology
step by step.)
Instrumentation
This study will use the GAITRite system to measure the dependent variables of:
Stride length (cm)
Step length (cm)
Single limb stance time (sec)
Double limb stance (sec)
Cadence
Velocity
Base of support (cm)
The GAITRite consists of an electronic walkway containing six sensor pads imbedded
within the 24in X 144in active area of the mat. Within the sensor pads, there is a grid
style layout of 48 X 288 sensors (0.5 inches on center). The sensors record the
subjects’ footfalls and the computer calculates the parameters listed above. An IBM
compatible computer will be used in order to process each subject’s footfall patterns
as they walk across the mat under each of the four research conditions described in
the procedures. From the footfall information, the program will calculate each of the
dependent variables.
Validity and Reliability:
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EXAMPLE: Completed Full Review Application
The validity and reliability of the GAITRite gait analysis system have been found to be
good. The GAITRite gait analysis system has been compared to the paper and pencil
method and the video-based method of analyzing gait, both validated “gold
standards,” using intra-class correlation coefficients (ICC). When GAITRite was
compared to the paper and pencil method, ICCs for spatial parameters were
excellent (right step length = 0.97; left step length = 0.99), while ICCs for temporal
parameters were fair (right step time = 0.67; left step left step time = 0.61). When
GAITRite was compared to video-based method, ICCs for temporal parameters were
excellent (right step time = 0.97; left step time = 0.95), while ICCs for spatial
parameters were weaker (right step length = 0.44; left step length = 0.85).
Examination of reliability between GAITRite and paper and pencil method revealed
no significant differences between spatial parameters. Examination of reliability
between GAITRite and video-based method revealed no significant differences
between temporal parameters. The authors of the validity and reliability study
concluded that GAITRite was a valid and reliable tool for assessing spatial and
temporal aspects of gait. A calibrated scale will be used for weight measurements,
and a calculator will be used for calculating 15 percent body weight.
Procedures:
Both the subjects and their legal guardians will be informed of the purpose,
procedures, and alternatives to participation. Students and parents will then be invited to
sign an informed consent form.
Consent forms for the 7th and 8th grade students, parental consent forms, and
health forms will be sent home with students along with a letter of invitation from the USN
principal. (See Appendices ) Parents will be asked to sign the consent form and complete
the health form and return them to school with their children. Seventh and eighth grade
student participants will also be asked to sign consent forms. Students’ legal guardians will
also be asked to fill out a medical history form to insure that no subjects have a medical
condition or history of trauma that would contraindicate participation (See appendices).
Children will be excluded from participating in the study if they have any of the following:
history of heart condition, lung condition, any current musculoskeletal disorder, or any
injury to the lower extremities, upper extremities or spine within the last three months that
would cause difficulty with walking or prevent carrying a backpack.
Subjects will be asked to wear athletic shoes and comfortable clothing for
participation in the study. Subjects will also be asked to bring their school backpack with
them to the study.
Upon arrival to the study area, each subject will be weighed with and without their
own back pack. The weight of the subject with the backpack is descriptive information to
determine the typical load these students are carrying at a given time. The weight of the
student without the backpack will be used to determine 15% of the subject’s body weight.
This is the recommended maximum backpack weight by APTA. As each subject is weighed,
he or she will be asked a series of questions about how they typically carry their backpack.
These questions are also for descriptive purposes.(See appendices)
Each subject will be asked to walk across the GAITRite mat three times under each of
the conditions listed below.
a. Walk across the GAITRite mat three times with no backpack (Control)
b. Walk across the GAITRite mat three times with the standardized backpack worn over
both shoulders and placed in the mid-thoracic area as recommended by the APTA.
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EXAMPLE: Completed Full Review Application
c. Walk across the GAITRite mat three times with the standardized backpack in the
strung low position (defined below)
d. Walk across the GAITRite mat three times with the standardized backpack across one
shoulder with the straps remaining in the strung low position (defined below)
Defining Carrying Methods:
---Correct carrying position: top of backpack level with the spine of the scapula
---Strung low carrying position: top of backpack level with the inferior angle of the
scapula
---One shoulder strung low position: backpack carried on one shoulder (subject’s
preference) with straps extended to the same length as in the normal strung low
position.
Conditions will be presented in random order as determined by drawing numbered
cards out of a box. A standardized backpack will be used that contains 15% of the subject’s
body weight for all trials with the exception of the three control trials. A starting and
stopping point eight feet from the mat will also be designated to account for the effects of
acceleration and deceleration. A two-minute rest period will be allowed between each
pass to prevent fatigue.
The GAITRite system (see description above) will be used to measure the dependent
variables of: Stride length (cm), Step length (cm), Single limb stance time (sec), Double
limb stance (sec), Cadence, Velocity, base of support (cm)
At the conclusion of data collection the investigators will instruct each subject in the
proper method of carrying a backpack as recommended by the APTA. Each student will
also receive a handout with this information. (See appendix)
5. Describe your plan for data analysis and statistics
Forty subjects will be used as determined by pilot study findings. A two way repeated
measures ANOVA will be used to analyze this data. A paired t-test with a Bonferoni
correction post hoc will be used. This will allow researchers to determine if there is a
significant difference in the kinetic aspects of gait identified above based on backpack
carrying method
ASSESSMENT OF RISKS AND BENEFITS:
1. List and describe any possible risks.
Be sure to include potential physical, psychological, and social risks.
For each risk listed also describe risk frequency, severity and reversibility.
Risks involved in this study include the possibility of muscle soreness from lifting and
carrying the weighted backpack; however participants in this study are middle school youth,
who routinely carry backpacks containing significantly more weight than will be used in this
study. There is also the slight possibility of tripping and falling while carrying the weighted
backpack, which could result in injury.
2.
Describe procedures and precautions to be taken to avoid or minimize each risk listed
above to the extent possible. In order to reduce both the possibility of muscle
soreness and falls, subjects will be asked to only carry 15% of their body weight. This is
the maximum weight for backpack safety recommended by the APTA. A maximum
backpack weight of 30 pounds will be the limit, regardless of the subject’s body
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EXAMPLE: Completed Full Review Application
weight, in order to further prevent any injury or soreness. A clear path around the
mat will be enforced to prevent tripping. Subjects will also be asked if they are
feeling any discomfort several times during data acquisition, and if they report
discomfort the backpack will be repositioned. If at any time the subject feels
uncomfortable, he or she can choose to stop.
3. List and describe any benefits. Each student will be instructed in the proper method
of carrying a backpack at the end of the data collection session, and each student
will be given a handout to take home (see appendices for a copy of the handout).
4. If appropriate, describe any withholding of normal treatment and alternative treatments.
N/A
5. Based on the information you provided above, identify the risk:benefit ratio for the
subjects.
Although there is a slight chance of muscle soreness and/or tripping while carrying
the backpack during the study, the participants will be learning how to carrying a
backpack correctly at the conclusion of data collection which may help to reduce the
potential for injury in the future.
6. Explain the conditions under which an individual subjects’ participation in the study
would be discontinued.
The researchers will withdraw subjects if they complain of back pain, neck pain, or
if they become ill.
7. Explain the conditions under which the entire study would be discontinued if hazards
materialize.
The study will be discontinued or the weight placed in backpacks reduced if the
investigator find that students routinely complain of muscle soreness or if tripping is
routinely observed during data collection. If the weight placed in the backpacks is
reduced a change of protocol will be requested from the IRB.
8. Does this study involve deception?
Yes________ No____X_____
If yes, how and when will you provide debriefing?
Please attach a copy of your debriefing script.
REPORTING OF SERIOUS AND UNEXPECTED ADVERSE EVENTS
1. Explain the emergency procedures for your study and how you will handle adverse
events. Data will be collected at Best Intermediate School. School administrators
and the School Nurse will be on site during data collection. In case of emergency
the School Nurse will be consulted and the child’s parents will be called.
2.
In addition to the emergency procedures described you described above, in the case of an adverse
event you must also do the following:
a.) Immediately report the event by telephone to the Chair of the IRB or to University Counsel
b.) Submit a written of the event to the chair of the IRB and University Counsel within three
working days.
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EXAMPLE: Completed Full Review Application
c.) In some circumstances you may be required to any adverse events to the sponsoring agency
and the appropriate state and federal agencies. Please see more information about reporting
serious events in research.
d.) The IRB requires that any research project must be terminated if there has been unexpected
serious harm to subjects.
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 privacy and confidentiality
prior to, during, and after data collection? During data collection, children will be
tested individually in a private room. No photographs or videorecordings will be
taken of the participants. Data will be de-identified (see below).
2. Data Confidentiality
Will any identifying information (name, date of birth, etc.) or health information be
collected from subjects or their records?
Yes____X____ No_________
a. If yes, please explain your deidentification and coding system to ensure
that your subjects’ data remains confidential
All subject’s information will be kept confidential and secure by locking
forms in a file box. All subject information and data will be identified by
a code number. The list of code numbers with the subject names will
be kept in a separate lock box in a different location. All data entered
into computers will be password protected. Data will be stored in the
faculty advisor’s office.
b. If no, please explain how you will ensure that your subjects’ data is not
identifiable. Data key will be kept separate from data.
Will you be using audio or video recordings of your subjects?
Yes________ No____X__
a. If yes, please explain why this is necessary
b. Please explain how you will protect the identities of subjects’ who have
had audio or video recordings. The usual procedure is to transcribe
recordings and then destroy the original audio or video recordings.
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)
3 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)
Office of faculty sponsor in a locked file and on password protected
computer files.
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EXAMPLE: Completed Full Review Application
c.) Please explain who will have access to the data and under what
circumstances
Only the two investigators and the faculty sponsor will have access to
the data.
d.) How will you protect the data from unauthorized access? Data will be
stored in locked files and in password protected computer 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
Please attach a copy of your Informed Consent form and/or Letter of Invitation
1. Who will obtain voluntary and informed consent from study participants?
The student researchers have developed and duplicated the consent forms. The
schoolteachers will send home the forms with the students to the parents. The
teachers will collect the completed consent forms and send them to the investigators
via the school principal.
2. How will consent be obtained? Each parent will be sent the following via their student:
a letter explaining the study, a parental consent form, a youth consent form, and a
heath history form. If parents and children agree to participation, they will sign the
consent forms and the parent will complete the health form and send all forms back
to school.
3. When will consent be obtained? Consent from both the parents and the students will
be obtained prior to entrance into the study.
4. How often will consent be obtained (applies to longitudinal studies)? One time prior to
entrance into the study.
5. How will you verify that the subject fully understands the consent? The investigators
will ask the students questions about the study to determine their understanding
prior to data collection. Students will also be encouraged to ask questions
throughout the study. Parents will be given a contact phone number and email if
they wish to contact the investigators with questions.
6. Will you be requesting a Waiver of Informed Consent? (This will be a very rare
occurrence)
No__X______ Yes______
If yes, justify this request.
Please explain how you will ensure subjects understand the study and will provide
consent in absence of written informed consent.
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EXAMPLE: Completed Full Review Application
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, investigator, consent or recruiting of participants to the IRB and receive IRB approval
before implementing any changes. I will prepare an Annual Progress Report for studies lasting
longer than one year and a Final Report at the conclusion of this study. I will report any adverse
reactions or subject complaints will be reported within 48 hours to the Office of University
Counsel and to the Chair of the IRB. I will maintain all records of this research as required by the
Belmont University Institutional Review Board.
All investigators and faculty advisors (for student projects) must sign below:
Principal investigator signature__Amy Student___________ Date___12/01/04___
Associate investigator signature__George Student____________ Date___12/01/04___
Associate investigator signature__Casey Student___________Date___12/01/04__
_
Associate investigator signature_______________________ Date____________
Associate investigator signature_______________________ Date____________
Faculty Advisor signature
_ Susan Faculty Member _______ Date___12/01/04___
Faculty Advisor signature
_______________________ Date____________
Faculty Advisor’s Statement (for student projects only)
I, _SUSAN FACULTY MEMBER, am the faculty advisor for ___AMY STUDENT____. My
signature below indicates that I have read the attached protocol and have checked the contents
with IRB guidelines.
Faculty Sponsor Signature___Susan Faculty Member________ Date___12/01/04___
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EXAMPLE: Completed Full Review Application
APPENDICES
The following is a list of required appendices for this study. These items were with
the application for full IRB review
1)
2)
3)
4)
5)
6)
7)
Signed Letter of Agreement from the school principal
Letter to the parents explaining the study (recruitment letter)
Health History form to be completed by parent
Parental consent form*
Youth consent form*
List of questions that participants will be asked during data collection
Handout given to students about the correct method of carrying a backpack
*The consent forms for this study can be seen in the examples of consent forms at
http://www.belmont.edu/irb/forms-instructions.html
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