SAMPLE INFORMATION LETTER for Biomechanics Research
(Department/School logo, name, address)
Date
Title of Project: (Insert Title)
Principal Investigator: (Insert Name of Principal Investigators)
University of Waterloo, Department of (Insert Dept Name)
519-884-4567 Ext. (Insert extension)
Student Investigator: (Insert Name of Student Researcher, if applicable)
University of Waterloo, Department of (Insert Dept Name)
519-884-4567 Ext. (Insert extension)
Purpose of this Study
Lift assists are devices that support the weight of a load and are designed to
make work tasks easier. Previous research has found that lift assist use
decreases the strength required to perform a job. This not only decreases the
risk of injury but also increases the number of people capable of performing that
job. However, it is not known how long it takes someone to become a skilled
operator, nor have reductions in maximum or total muscular loading been
documented in a laboratory setting.
Training operators in the use of lift-assists is one possible solution to reducing
fatigue and inefficiency among novice lift-assist operators. However, there are
currently no scales available for determining when an individual has become a
skilled lift-assist operator. In addition to this, the decrease in total and maximum
loading while performing production tasks manually versus using a lift-assist is
not yet known. By collecting electromyographical data on several muscles, it
would become possible to determine the loads experienced by workers
performing production operation tasks. Scales could be developed as to how
long an operator must train before the loading has become significantly less than
when the job is being performed manually. Also, this information would help
document that lift assists decrease the maximum and total loading felt by the
muscles.
The purpose of the research in which you have been invited to participate is
twofold. First, the study will enable us to develop scales to determine when an
individual has become an accomplished manual material-handling device user
(i.e. using a lift-assist). Second, the study will look at the effect of performing
production operations manually (i.e. lifting by hand). This will be compared to the
effect when the task is performed using a lift-assist by comparing the maximum
and total muscular effort of workers' low backs, necks, shoulders and forearms.
Procedures Involved in this Study
The project consists of a thirty-minute orientation session and a two-hour testing
session simulating a production operation. In the orientation session, you will
have the opportunity to practice moving the part using the lift assist and lifting,
carrying, and lowering the part manually.
In the first task you will be asked to transport a part using a lift assist, from a
parts stand to a production table, wait for 15s and then return the part to the parts
stand. The part is made of sheet metal, has a mass of 18 kg and is 1.4m X 0.4 X
0.4m. The task will be repeated at a rate of one part every thirty seconds for a
total duration of forty minutes (i.e. a total of 80 parts).
The second task will be identical to condition one except this time you will
complete the task by handling the part manually. Prior to lifting the part manually,
five material handling principles that have been incorporated in the back injury
prevention program developed by the University of Waterloo Ergonomic and
Safety Consulting Service, will be reviewed with you. The following five principles
are designed to minimize the risk of injury:
1. Minimize the moment of force (e.g. keeping the load close to your navel)
2. Maintain the normal curve in your lower back (e.g. keeping your head up)
3. Avoid twisting to extremes (e.g. pivot your feet)
4. Lightly tense your musculature prior to load handling
5. Avoid lifting after prolonged periods of immobility.
While performing the task, the following procedures will occur:
1) You will complete a diagram at the start, mid point, and end of the study,
which asks you to identify locations of discomfort.
2) You will be videotaped and/or photographed. Typically, this will be of your
whole body. These images are used for analysis of the data by trained observers
and/or computer models. These materials are stored in a locked office. Names of
participants will be removed.
3) To assess the demands of the job, we must compare them with the force you
can voluntarily produce with your muscles. These efforts are similar to those you
might produce during exercise or while moving something at home. They involve
holding a moderate weight (about 10 kg) in your hands while bending at the
waist, squeezing a hand grip as hard as you can, and shrugging your shoulders
as hard as possible against a shoulder strap. Electrical activity from your muscles
will be measured by taping small electrodes to the skin over the muscles on your
back, neck, right shoulder and arm. The small electrical signal produced by your
muscles goes from these muscles to a small recording device strapped around
your waist. Note to facilitate placement of the electrodes, we ask that you not
wear excessively tight clothing.
4) How you lift, carry, and lower the part will be observed by the researcher and
suggestions will be made as to how you may improve your "load handling"
technique.
Risks to Participation and Associated Safeguards
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There is always a risk of muscle, joint or other injury in any physical work.
However, the risks in this study are not anticipated to be greater than
those required to move personal belongings from one apartment to
another or those encountered in an exercise program or recreational
activity that requires brief maximum muscular efforts.
During either of the two conditions, you may experience muscular fatigue,
and/or soreness, and/or lower back fatigue or soreness during the manual
operation task. The stiffness and/or soreness may develop or persists for
two or three days following the study if you are unaccustomed to this type
of work. This soreness/stiffness is normal and usually disappears in a few
days. If it does not go away within a few days, you should contact the
researcher.
Some individuals may experience mild skin irritation from the tape used to
attach the electrodes to your skin or the gel used to moisten the electrode.
This is similar to the irritation that may be caused by a bandage and
typically fades within 2 to 3 days.
If you are allergic to rubbing alcohol, you should not participate in this
study.
The portable part of the electrical recording system is battery operated
and isolates you from the main electrical lines. There is no risk of electrical
shock.
Whenever you are handling the part, either manually or with the lift assist,
you will be required to wear the protective equipment provided to you
(safety glasses, hearing protection, foot protection, gloves, long sleeves
and pants).
Prior to participation, you will be given a 30 minute session to learn how to
operate the lift-assist. You will be observed while performing all lifting
tasks, and verbal corrections will be given regarding your lifting, carrying,
and lowering technique.
You will be instructed to monitor your level of discomfort and to record this
at the start of the study, mid point, and end of the study. In addition, you
will be advised to terminate the testing session if you experience severe
discomfort or at any time you feel that you can no longer continue.
Time Commitment
Participation in this study will require approximately 2½ hours of your time
because you will attend a 30-minute orientation session and a two-hour testing
session.
Changing Your Mind about Participation
You may withdraw from this study at any time without penalty. To do so, indicate
this to the researcher or one of the research assistants by saying, "I no longer
wish to participate in this study".
Personal Benefits of Participation
By participating in this study, you will benefit by gaining experience in the
operation and utilization of lift-assists which may be useful in future work
experience. You also will further your knowledge and understanding of
experimental procedures commonly used in biomechanics/ergonomics research.
There are no other expected benefits to you.
Confidentiality
To ensure the confidentiality of individuals’ data, each participant will be identified
by a participant identification code known only to the principle investigator and
his research assistants. Videotapes and/or photographs will be stored indefinitely
in a secure area. A separate consent will be requested in order to use the
videotapes and/or photographs for teaching, for scientific presentations, or in
publications of this work.
Participant Feedback
After the study is completed, you will be provided with a feedback sheet that will
include summary graphs of your performance. You will also be provided with a
copy of any scientific articles prepared for presentation and/or publication based
on this study.
Health Status Screening Form and Suitability for Participation
This questionnaire asks some questions about your health status. This
information is used to guide us with your entry into the study. This study will not
include anyone who has sustained previous injuries, or has sustained a lower
back, upper limb, or lower limb injury in the past six months, or suffers from
chronic pain.
Concerns about Your Participation
I would like to assure you that this study has been reviewed and received ethics
clearance a University of Waterloo Research Ethics Committee. However, the
final decision about participation is yours. If you have any comments or concerns
resulting from your participation in this study, you may contact Dr. Maureen
Nummelin, the Director, Office of Research Ethics, at 1-519-888-4567, Ext.
36005 or maureen.nummelin@uwaterloo.ca.
Questions About the Study
If you have additional questions later or want any other information regarding this
study, please contact (insert principal investigator and co-investigator's name(s))
at 519-888-4567 ext. xxxx.
CONSENT TO PARTICIPATE
By signing this consent form, you are not waiving your legal rights or releasing
the investigator(s) or involved institution(s) from their legal and professional
responsibilities.
______________________________________________________________________
I agree to take part in a research study being conducted by Dr. (Insert researcher
name) and (Insert student researcher name) of the Department of (Insert Dept
Name), University of Waterloo.
I have made this decision based on the information I have read in the Information
letter. All the procedures, any risks and benefits have been explained to me. I
have had the opportunity to ask any questions and to receive any additional
details I wanted about the study. If I have questions later about the study, I can
ask one of the researchers (list names, departments, telephone numbers of
investigators).
I understand that I may withdraw from the study at any time without penalty by
telling the researcher.
This project has been reviewed by, and received ethics clearance through a
University of Waterloo Research Ethics Committee. I may contact this office at
519-888-4567, ext. 36005, if I have any concerns or questions resulting from my
involvement in this study.
_____________________________
Printed Name of Participant
__________________________
Signature of Participant
_____________________________
Dated at Waterloo, Ontario
___________________________
Witnessed
Consent To Use Video and/or Photographs
Sometimes a certain photograph and/or part of a video-tape clearly shows a
particular feature or detail that would be helpful in teaching or when presenting
the study results in a scientific presentation or publication. If you grant permission
for photographs or videotapes in which you appear to be used in this manner,
please complete the following section.
I agree to allow video and/or photographs to be used in teaching or scientific
presentations, or published in scientific journals or professional publications of
this work without identifying me by name.
_____________________________
Printed Name of Participant
__________________________
Signature of Participant
_____________________________
Dated at Waterloo, Ontario
___________________________
Witnessed