Using Musculoskeletal Models to Assess FES Rowing for Skeletal Health After SCI
Phase: NA
Conditions: Spinal Cord Injury
Sponsor: VA Office of Research and Development

COVER PAGE 
 
 
Clinicaltrials Title: FES Rowing for Skeletal Health After SCI 
Official VA Project Title: Using Musculoskeletal Models to Assess FES Rowing for 
Skeletal Health After SCI 
IRB Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
NCT #: NCT02008149 
Date: 09/02/2015 
 

Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015
Modification
1. Summarize your proposed changes.
1) Change the status of Dr. Rebecca Lambach to take the role of the Admin Contact, with authority to edit the
IRB protocol and associated documents.
2) Modification to the inclusion criteria to allow for the recruitment of subjects over the age of 50 years, and
to allow for the recruitment of subjects for the control group who have C5, C6, C7, or C8 injuries in addition
to T1 to T12 injuries. The injury levels in the rowing groups remain as T1 to T12.
2. Indicate Level of Risk
No Change
3. Update the Conflict of Interest (COI) section if any changes in COI have been made since the last
protocol submission.
N
Is there a change in the conflicting interest status for any existing personnel on this protocol?
Protocol Director
Name
Gary Scott Beaupre
Degree (Program/year if
student)
PhD
Position, e.g. Assistant Professor,
Resident, etc.
Professor - Consulting
Department
Mechanical
Engineering -
Biomechanical
Engineering
Mail Code
4038
Phone
650-493-5000
x64272
Fax
650-493-4919
E-mail
Gary.Beaupre@va.gov
CITI Training current
Y
Admin Contact
Name
Rebecca Lambach
Degree (Program/year if
student)
PhD
Position, e.g. Assistant Professor,
Resident, etc.
Biomedical Engineer
Department
Vice Provost and Dean
of Research - Research
Compliance
Mail Code
Phone
650-493-5000
x69411
Fax
650-493-4919
E-mail
rebecca.lambach@va.gov
CITI Training current
Y
Investigator
Name
Beatrice Jenny Kiratli
Degree (Program/year if
student)
PhD
Position, e.g. Assistant Professor,
Resident, etc.
Clinical Associate Professor
(Affiliated)
Department
Orthopaedic Surgery
Mail Code
Phone
650-493-5000
x65095
Fax
E-mail
Jenny.Kiratli@va.gov
CITI Training current
Y
eProtocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 1 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University

Other Contact
Name
Graham Harold Creasey
Degree (Program/year if
student)
MD
Position, e.g. Assistant Professor,
Resident, etc.
Professor-Med Ctr Line
Department
Neurosurgery
Mail Code
5327
Phone
650-704-2394
Fax
E-mail
gcreasey@stanford.edu
CITI Training current
Y
Academic Sponsor
Name
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Department
Mail Code
Phone
Fax
E-mail
CITI Training current
Other Personnel
Participant Population(s) Checklist
Yes/No
• Children (under 18)
N
• Pregnant Women and Fetuses
N
• Neonates (0 - 28 days)
N
• Abortuses
N
• Impaired Decision Making Capacity
N
• Cancer Subjects
N
• Laboratory Personnel
N
• Healthy Volunteers
N
• Students
N
• Employees
N
• Prisoners
N
• Other (i.e., any population that is not specified above)
Y
Study Location(s) Checklist
Yes/No
• Stanford University
• Clinical & Translational Research Unit (CTRU)
• Stanford Hospital and Clinics
• Lucile Packard Children's Hospital (LPCH)
• VAPAHCS (Specify PI at VA)
Y
Gary Beaupre
• Other (Click ADD to specify details)
General Checklist
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 2 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

Multi-site
Yes/No
• Is this a multi-site study? A multi-site study is generally a study that involves one or more
medical or research institutions in which one site takes a lead role.(e.g., multi-site clinical
trial)
N
Collaborating Institution(s)
Yes/No
• Are there any collaborating institution(s)? A collaborating institution is generally an
institution that collaborates equally on a research endeavor with one or more institutions.
N
Cancer Institute
Yes/No
• Cancer-Related Studies (studies with cancer endpoints), Cancer Subjects (e.g., clinical
trials, behavior/prevention) or Cancer Specimens (e.g., blood, tissue, cells, body fluids with
a scientific hypothesis stated in the protocol).
N
Clinical Trials
Yes/No
• Investigational drugs, biologics, reagents, or chemicals?
N
• Commercially available drugs, reagents, or other chemicals administered to subjects (even
if they are not being studied)?
N
• Investigational Device / Commercial Device used off-label?
Y
• IDE Exempt Device (Commercial Device used according to label, Investigational In Vitro
Device or Assay, or Consumer Preference/Modifications/Combinations of Approved
Devices)
N
• Will this study be registered on# clinicaltrials.gov? ( See Stanford decision tree )
N
• Is Stanford responsible for ClinicalTrials.gov registration? (See Stanford decision tree)
NCT#
Tissues and Specimens
Yes/No
• Human blood, cells, tissues, or body fluids (tissues)?
N
• Tissues to be stored for future research projects?
N
• Tissues to be sent out of this institution as part of a research agreement? For guidelines,
please see https://sites.stanford.edu/ico/mtas
N
Biosafety (APB)
Yes/No
• Are you submitting a recombinant DNA vector or Human Gene Transfer investigation
using biological agents? If yes, please complete and attach the Gene Transfer Protocol
Application Supplemental Questions to section 16 of the eProtocol application.
N
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 3 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

• Are you submitting a Human study using biohazardous/infectious agents? If yes, refer to
the http://www.stanford.edu/dept/EHS/prod/researchlab/bio/index.html Administrative
Panel on BioSafety website prior to performing studies.
N
• Are you submitting a Human study using samples from subjects that are known or likely to
contain biohazardous/infectious agents? If yes, refer to the
http://web.stanford.edu/dept/EHS/prod/researchlab/bio/index.html Administrative Panel on
BioSafety website prior to performing studies.
N
Human Embryos or Stem Cells
Yes/No
• Human Embryos or Gametes?
N
• Human Stem Cells (including hESC, iPSC, cancer stem cells, progenitor cells)
N
Veterans Affairs (VA)
Yes/No
• The research recruits participants at the Veterans Affairs Palo Alto Health Care
System(VAPAHCS).
Y
• The research involves the use of VAPAHCS non-public information to identify or contact
human research participants or prospective subjects or to use such data for research
purposes.
Y
• The research is sponsored (i.e., funded) by VAPAHCS.
Y
• The research is conducted by or under the direction of any employee or agent of
VAPAHCS (full-time, part-time, intermittent, consultant, without compensation (WOC),
on-station fee-basis, on-station contract, or on-station sharing agreement basis) in
connection with her/his VAPAHCS responsibilities.
Y
• The research is conducted using any property or facility of VAPAHCS.
Y
Equipment
Yes/No
• Use of Patient related equipment? If Yes, equipment must meet the standards established by
Hospital Instrumentation and Electrical Safety Committee (650-725-5000)
Y
• Medical equipment used for human patients/subjects also used on animals?
N
• Radioisotopes/radiation-producing machines, even if standard of care?
http://www.stanford.edu/dept/EHS/prod/researchlab/radlaser/Human_use_guide.pdf More
Info
Y
Payment
Yes/No
• Subjects will be paid/reimbursed for participation? See payment considerations.
Y
Funding
Yes/No
• Training Grant?
N
• Program Project Grant?
N
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 4 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

• Federally Sponsored Project?
Y
• Industry Sponsored Clinical Trial?
N
Funding
Funding - Grants/Contracts
Funding Administered By :
VA
SPO # (if available) :
Grant # (if available) :
RX001410
Funded By (include pending) :
VA
Principal Investigator :
Gary Beaupre
Grant/Contract Title if different from Protocol Title :
Using Musculoskeletal Models to Assess FES Rowing for Skeletal Health After SCI
Y
For Federal projects, are contents of this protocol consistent with the Federal proposal?
N
Is this a Multiple Project Protocol (MPP)?
N
Is this protocol under a MPP?
Funding - Fellowships
Gift Funding
Dept. Funding
Other Funding
Resources :
a)
Qualified staff.
Please state and justify the number and qualifications of your study staff.
Gary Beaupre, PhD
Dr. Beaupre is the Principal Investigator for this project. Dr. Beaupre is a Research Career Scientist at VA
Palo Alto Health Care System (VAPAHCS) and he has overseen numerous research projects involving
human subjects, including a recent one with a recruitment total of over 265 participants. Dr. Beaupre is a
recognized expert in the field of skeletal biomechanics and the role of physical activity in maintaining
skeletal health. He will oversee all aspects of the study, including subject recruitment, consenting, data
collection, data analysis and interpretation. He will provide 20% effort on this project.
Graham Creasey, MD
Dr. Creasey will serve as a Co-Investigator. Dr. Creasey is Professor of SCI Medicine in the Department
of Neurosurgery at Stanford University and an Attending Physician in the Spinal Cord Injury Service at
VAPAHCS. Dr. Creasey's subspecialty certification is in spinal injuries and his clinical focus for more than
three decades has been on the care of individuals with SCI. His research focus during this time has been on
the use of functional electrical stimulation (FES) to restore function and improve health after spinal cord
injury and he spent 18 years in the VA Rehabilitation R&D Center on Functional Electrical Stimulation in
Cleveland. He also collaborated with the VA Rehabilitation R&D Center on the Medical Consequences of
Spinal Cord Injury in the Bronx on the molecular and cellular basis of the effects of electrical stimulation on
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 5 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

bone density after spinal cord injury. He will assist with subject recruitment, consenting, data interpretation.
and he will provide input on the use of the adapted rowing equipment for use by subjects with spinal cord
injury, and on the use of the equipment for electrical stimulation of lower limb muscles. He will also
contribute to manuscript preparation and dissemination of findings. He will provide 10% effort on this
project.
B. Jenny Kiratli, PhD
Dr. Kiratli will serve as a Co-Investigator. Dr. Kiratli is the Director of Clinical Research in the Spinal
Cord Injury Center at VAPAHCS, and has over 25 years performing research on bone loss and
musculoskeletal response following spinal cord injury and paralysis. Dr. Kiratli has a long-standing interest
in exercise physiology and evaluation of physical activity in individuals with SCI. She also is
knowledgeable in the use of FES and has co-authored a seminal article on the effect of SCI on
cardiovascular fitness and the potential benefits from FES exercise. Dr. Kiratli works closely with
physicians and therapists in planning and conducting research in the clinical setting and has established
protocols within the SCI Service for the efficient recruitment and screening of patients, coordination with
clinical personnel related to scheduling to minimize participant burden, and maintaining communication
with treating clinicians as needed in regard to potential risks and adverse events. Dr. Kiratli is a member of
the VA Central IRB and well versed in human subjects protections especially as applicable within VA. Dr.
Kiratli and Dr. Beaupre are long-time collaborators and co-authors. Dr. Kiratli will assist with human
subjects issues including the recruitment and participation of patients with SCI, consenting, managing and
promoting adherence to study protocols, and IRB submissions. She will also contribute to data
interpretation, manuscript preparation and dissemination of findings. She will provide 10% effort on this
project.
Rebecca Lambach, PhD
Dr. Lambach will serve as a Co-Investigator and will be directly supervised by Dr. Beaupre. Dr. Lambach
has practical experience in the acquisition of kinetic and kinematic data using force places and a
multi-camera motion capture system. Dr. Lambach also has prior experience working with human subjects
in research. Dr. Lambach will work closely with Dr. Creasey to learn the basic skills involved in the
handling, basic health monitoring, and general interactions with individuals with spinal cord injuries,
especially during year 1 of the project. Dr. Lambach has completed all required VA trainings.
Summary: The expertise and level of staffing have been carefully considered to provide appropriate skillsets
and sufficient levels of effort to accomplish all of the project needs.
b)
Training.
Describe the training you will provide to ensure that all persons assisting with the research are
informed about the protocol and their research-related duties and functions.
The staff will read the proposal research plan and the IRB protocol and all staff will be trained regarding
their specific duties and functions by Dr. Beaupre or his co-investigators. Staff will complete all trainings on
proper research involving human subjects and on providing subject confidentiality.
c)
Facilities.
Please describe and justify.
VA Palo Alto Biomotion Laboratory
The Biomotion Laboratory is a 600 square foot motion capture studio that is dedicated to the analysis of
human movement for biomedical applications. The lab includes a ten-camera analysis 240 Hz Qualiys
motion capture system along with two Bertec force plates mounted on a raised floor.
VA Palo Alto Bone Densitometry Facilities
Bone density measurements will be made using a Hologic QDR-1000W pencil beam DXA scanner
located in the Spinal Cord Injury Unit (Bldg 7) and a Stratec XCT3000 pQCT scanner located in the
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 6 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

Musculoskeletal Research Laboratory (Bldg. 51).
Additional laboratory space exists in Bldg. 51 to accommodate the rowing machine used for the rowing
exercise sessions.
Additional office space exists in Bldg. 7 and Bldg 51 for the investigators and associated staff.
d)
Sufficient time.
Explain whether you will have sufficient time to conduct and complete the research. Include how much
time is required.
We believe staffing levels are sufficient given the total recruitment target of 10 individuals with SCI and the
tasks to be accomplished during the two-year study.
e)
Access to target population.
Explain and justify whether you will have access to a population that will allow recruitment of the
required number of participants.
We expect to enroll a total of 10 participants with SCI; five individuals in a standard-of-care control group
and five individuals in an FES-rowing group. Approximately 35 new patients with SCI are seen per year at
the VA Palo Alto Spinal Cord Injury Center. If recruitment from VA Palo Alto proves to be insufficient, we
will contact Dr. James Crew who is the Chief of Spinal Cord Injury, Department of Physical Medicine &
Rehabilitation, at the Santa Clara Valley (SCV) Medical Center In San Jose. Dr. Crew has agreed to provide
consulting assistance as needed on the recruitment of potential participants with spinal cord injuries
receiving their medical care at the SCV Medical Center. Approximately 125 new patients with SCI are seen
per year at the SCI Rehabilitation Center at SCV Medical Center. Between VAPAHCS and SCV Medical
Center, we do not anticipate difficulty in achieving our recruitment target.
f)
Access to resources if needed as a consequence of the research.
State whether you have medical or psychological resources available that participants might require as
a consequence of the research when applicable. Please describe these resources.
The VA SCI Center provides comprehensive care to patient with SCI on an in- and out-patient basis. There
are dedicated physicians, nurses, therapists, and psychologists on staff with extensive experience addressing
the medical and mental needs of this patient population. While it is unlikely that there will be
research-related events that will require significant medical follow-up, these services are readily available
within the facility.
g)
Lead Investigator or Coordinating Institution in Multi-site Study.
Please explain (i) your role in coordinating the studies, (ii) procedures for routine communication with
other sites, (iii) documentation of routine communications with other sites, (iv) planned management of
communication of adverse outcomes, unexpected problems involving risk to participants or others,
protocol modifications or interim findings.
1. Purpose
a)
In layperson's language state the purpose of the study in 3-5 sentences.
Following a complete spinal cord injury (SCI), individuals experience progressive bone loss,
especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some
point during their lifetime. Fractures following SCI are costly to treat and more than half of
patients experience a medical complication, requiring extended hospitalization, resulting
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 7 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

in a substantial impact on their quality of life. To reduce the incidence of fractures, more
effective rehabilitation strategies to prevent bone loss are needed. The goal of this
research is to determine if bone health can be preserved using an indoor rowing exercise
program in which the leg muscles are electrically stimulated using several, small surface
electrode pads that are placed on the skin on the front and back thigh muscles. An
encouraging case study has recently shown remarkable bone preservation in one individual
with SCI who participated in an electrical stimulation rowing program, however, whether
other individuals with SCI can achieve the same benefit is currently unknown.
b)
State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of
this new knowledge.
We hope to learn if participation in an 36-week exercise program consisting of Functional
Electrical Stimulation (FES) leg muscle conditioning followed by FES-rowing can
significantly attenuate bone loss in the lower limbs in individuals with acute and sub-acute
SCI. Reports in the literature of attempts to prevent bone loss following SCI, via the use of
anti-osteoporosis drugs, or with static loading in a standing frame, or with dynamic
loading from FES-cycling have produced disappointing clinical results. If we are able to
show better bone preservation than has been reported previously in a pilot group of five
individuals participating in an FES-rowing program, our study will be considered a seminal
and clinically important achievement.
c)
Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of
investigational device in individuals with specific condition; purpose of study is to examine specific
behavioral traits in humans in classroom or other environment)
The objective of this study is to determine if participation in an FES-rowing exercise
program can better preserve bone density in the lower limbs of individuals with spinal cord
injury than have others types of activities or rehabilitation strategies. Previous literature
studies using animals and computer models suggest that the repetitive mechanical
stimulation derived from regular participation in a FES-rowing program may be sufficient
to attenuate bone loss following SCI. No further animal studies or computer models can
confirm the actual benefit in humans, therefore there is no other way to obtain this
information without using human subjects.
2. Study Procedures
a)
Please SUMMARIZE the research procedures, screening through closeout, which the human subject
will undergo. Refer to sections in the protocol attached in section 16, BUT do not copy the clinical
protocol. Be clear on what is to be done for research and what is part of standard of care.
In this study we expect to enroll a total of 10 participants with SCI. Five participants will be
assigned to a Standard-of-Care (control) group and five participants will be assigned to an
FES-rowing intervention group. Group assignment will be partly based on the preference of
each potential participant and their willingness to make the necessary time commitment
required for participation in a given group, with the added goal, to the extent possible, of
matching the two groups for age, gender and time since injury. Only those individuals who
have a strong desire to participate in a regular exercise program and who express a
willingness to travel to VA Palo Alto the necessary number of times per week to perform
FES-rowing will be potential candidates for inclusion in the rowing group.
Bone density measurements for both the Standard-of-Care group and the FES-rowing
group will be performed using Dual energy X-ray Absorptiometry (DXA) and peripheral
Quantitative Computed Tomography (pQCT). The Standard-of-Care group will undergo no
other research procedures.
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 8 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

The subjects in the FES-rowing group will undergo a muscle conditioning and rowing
program developed and refined over the past decade by two of our consultants in England,
Dr. Brian Andrews and Mr. Robin Gibbons. These consultants have pioneered the use of
FES-
rowing, and they have directly facilitated the establishment of ongoing FES-rowing
programs
in multiple locations in England, the US (Harvard/Spaulding Rehab, Boston), and Canada
(University of Alberta).
The muscle conditioning program is accomplished through electrical stimulation of the
quadriceps and hamstring muscles using a 4-channel electrical stimulator that
applies stimulation using surface electrodes adhered using gel to the skin overlying the
quadriceps and hamstrings muscles. The muscle strengthening initially takes place three
times per week, sixty minutes per session, progressing up to five sessions per week, for
approximately 8 weeks. The muscle strengthening program ensures that subjects have
sufficient muscle strength and endurance before they embark on the rowing program.
Following the 8-week muscle strengthening program, subjects will begin FES-rowing, with
three sessions per week, thirty minutes per session for the following 28 weeks. In the FES-
rowing group, we will measure isometric knee extension strength at the start of week 0,
and at the end of weeks 8, 22 and 36.
For the rowing group, we will capture 3D kinetics and kinematics in our motion capture
laboratory during FES-rowing at the end of weeks 8, 22 and 36. Kinematics during rowing
will be collected from fifty passive retroreflective markers that will be placed on each
participant to capture the position and orientation of the 12 interconnected body segments
used to represent each subject.
A participant will be recruited to do a subset of the measurement procedures, as that
individual will be an experienced rower, and thus does not need to undergo a muscle
conditioning/strengthening program. The target individual is someone who is a consultant
on
the study and who has 13 years of FES-rowing experience. The procedures for this
individual
are described in a new consent in section 13.
b)
Explain how the above research procedures are the least risky that can be performed consistent with
sound research design.
The procedures we will use in this FES muscle strengthening and rowing program are
modeled exactly after established FES-rowing research procedures in current use at
Spaulding
Rehab in Boston and at several research FES-rowing facilities in England. We know of no
other
way approaches to ask and answer the main research questions in this study.
c)
State if deception will be used. If so, provide the rationale and describe debriefing procedures. Since
you will not be fully informing the participant in your consent process and form, complete an
alteration of consent (in section 13). Submit a debriefing script (in section 16).
Deception will not be used.
d)
State if audio or video recording will occur. Describe what will become of the recording after use, e.g.,
shown at scientific meetings, erased. Describe the final disposition of the recordings.
Video recordings may be made while subjects perform research-related tasks, with
possible
use at scientific meetings. Should any videos be used during a scientific presentation the
subject's face will be photographically or electronically masked to conceal their identity.
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 9 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

All
videos will be erased or destroyed after they are no longer required for use at scientific
meetings. When not in use, all videos will be stored in a locked filing cabinet, in lockable
office, in VA Bldg 51, which a secured building at VA Palo Alto HCS.
e)
Describe alternative procedures or courses of treatment, if any, that might be advantageous to the
participant. Describe potential risks and benefits associated with these. Any standard treatment that is
being withheld must be disclosed in the consent process and form. (i.e. standard-of-care drug, different
interventional procedure, no procedure or treatment, palliative care, other research studies).
N/A
f)
Will it be possible to continue the more (most) appropriate therapy for the participant(s) after the
conclusion of the study?
It would only be possible to continue FES-rowing using research equipment at VA Palo Alto if
a follow-on research study is conducted and if a given subject continues to qualify for
participation at the time of a subsequently approved study.
g)
Study Endpoint. What are the guidelines or end points by which you can evaluate the different
treatments (i.e. study drug, device, procedure) during the study? If one proves to be clearly more
effective than another (or others) during the course of a study, will the study be terminated before the
projected total participant population has been enrolled? When will the study end if no important
differences are detected?
The goal of this pilot study is to obtain preliminary data for five subjects participating in a
36-week FES-rowing group. Because of the small number of subjects, it is important to
acquire data for all subjects and for all time points in order to determine the best estimates
for key descriptive statistics including the mean, standard deviation and range of bone
density changes. The study will not end until five subjects have completed the 36-week
FES-rowing program.
3. Background
a)
Describe past experimental and/or clinical findings leading to the formulation of the study.
In 1993, Wheeler and colleagues at the University of Alberta, Canada, introduced the first
functional electrical stimulation-assisted rowing system. In 1997 and in 2002, Garry
Wheeler,
Brian Andrews, and colleagues reported refinements to the FES-rowing system and
demonstrated clinically important health benefits, such as improvements in cardiovascular
function. Throughout the past decade, Brian Andrews and Robin Gibbons in the United
Kingdom have continued to make design improvements to the rower and optimize training
protocols for FES-rowing. In addition, they have been steadfast advocates for the
establishment of FES-rowing programs targeting community participation and they have
promoted FES-rowing competitions at international venues. Due to their efforts, FES-
rowing
programs now exist at four locations in the greater London area (Brunel and Coventry
Universities, Aspire National Training Centre, and the London Regatta Centre). The Aspire
group recently announced plans for creating additional FES-rowing facilities around the
UK.
Between 2007 and 2009, Andrews and Gibbons facilitated the creation of two FES-rowing
stations for installation at Spaulding Rehabilitation Hospital in Boston, MA. This effort was
accomplished in collaboration with Dr. Andrew Taylor, Director of the Cardiovascular
Research
Laboratory at Harvard Medical School and Spaulding Rehab. Taylor and his team have since
established the Exercise for Persons with Disabilities (ExPD) program at Spaulding and
Protocol # 28434 ( Modification )
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PD: Gary Scott Beaupre
APPLICATION FORM
Page 10 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

ExPD
has in turn recently partnered with Community Rowing Inc. to offer FES-assisted rowing
systems at several locations in the Boston metropolitan area. Community Rowing also
offers
free rowing programs (including adapted rowing and FES-assisted rowing) to any US
military
service member or veteran. A similar FES-rowing program exists at the Steadward Centre
for
Personal & Physical Achievement at the University of Alberta. The Alberta group reports
that
interest in their FES-rowing program far exceeds capacity, with wait-list times of 1.5 to 3
years. These rowing programs in the UK, Alberta, and Boston have attracted many
individuals
with SCI who are interested in promoting health benefits via exercise and recreation, and
for
competition in events such as the British Indoor Rowing Championship (FES-rowing first
included in 2004) and the World Indoor Rowing Championship (FES-rowing first included
in
2006).
As might be expected with any sufficiently strenuous whole-body exercise regimen, FES-
rowing has been reported to result in improvements in cardiovascular fitness, glucose
control, and body composition. In a presentation at the 16th Annual International FES
Society Conference in 2011, Gibbons et al. reported the only results known to date on the
benefits to bone from FES-rowing, but only for a single subject. The remarkable benefit to
skeletal health reported for that single individual were in large part the motivation for the
present study. However, before FES-rowing can be advocated as a clinical counter-measure
for bone loss following SCI we must determine if the results reported by Gibbons and
colleagues for a single individual can be repeated in a larger pilot study. That is the goal of
our study.
b)
Describe any animal experimentation and findings leading to the formulation of the study.
While there are numerous studies that indicate that exercise can elicit an osteogenic
response
in animals, such as mice and rats, the ultimate translation of those findings must be
demonstrated in humans.
4. Radioisotopes or Radiation Machines
a)
List all standard of care procedures using ionizing radiation (radiation dose received by a subject that
is considered part of their normal medical care). List all research procedures using ionizing radiation
(procedures performed due to participation in this study that is not considered part of their normal
medical care). List each potential procedure in the sequence that it would normally occur during the
entire study. More Info
Identify Week/Month of study
Name of Exam
Identify if SOC or Research
Start of week 0, end of weeks 8,
22 and 36
DXA and pQCT bone density
measurements
Research
b)
For research radioisotope projects, provide the following radiation-related information:
Identify the radionuclide(s) and chemical form(s).
N/A
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 11 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

For the typical subject, provide the total number of times the radioisotope and activity will be
administered (mCi) and the route of administration.
N/A
If not FDA approved provide dosimetry information and reference the source documents (package
insert, MIRD calculation, peer reviewed literature).
N/A
c)
For research radiation machine projects, provide the following diagnostic procedures:
For well-established radiographic procedures describe the exam.
Bone density measurements for both the Standard-of-Care group and the FES-rowing group will be
performed using Dual energy X-ray Absorptiometry (DXA) and peripheral Quantitative Computed
Tomography (pQCT). These scans will take place at VA Palo Alto. Scans will be performed at four time
points: baseline (time 0, i.e., at the start of week 1), and at the end of weeks 8, 22 and 36 following baseline.
The DXA scans will include a proximal femur scan and a scan starting immediately proximal to the patella
and extending proximally 23 cm, ending just distal to the femoral mid-shaft. Those scans will be
randomized to one side only. A standard AP spine DXA scan will also be done. The pQCT scans (same
side as DXA scans) will entail two image slices in the distal femur (4% and 20% up from the distal limit of
the lateral femoral condyle) and three image slices in the tibia (4% and 34% down from the proximal end of
the medial tibial plateau and 4% up from the distal end of the tibia, referenced from the distal limit of the
tibial subchondral bone at the center of the tibiotalar joint).
For the typical subject, identify the total number of times each will be performed on a single
research subject.
Each subject in each group will be scanned using DXA and pQCT on 4 occasions, at 0, 8, 22 and 36 weeks
after enrollment in the study.
For each radiographic procedure, provide the setup and technique sufficient to permit research
subject dose modeling. The chief technologist can usually provide this information.
Both scanners are well-established and substantial information for both exists in the literature to estimate
effective dose levels.
Lewis et al. (Osteoporosis Int, 4:11-15,1994) determined effective dose (ED) levels for a hip and AP spine
scans using the QDR-1000 DXA scanner. The ED for one hip scan was 0.1 microSv in males, and 1.4
microSv in females because of additional dose to the ovaries. The ED for an AP spine scan is 0.5 microSv.
These dose levels were subsequently incorporated into the "Technical White Paper: Bone Densitometry"
developed by the Conference of Radiation Control Program Directors' Task Force on Bone Densitometry
(2006). We estimate the DXA dose for the mid-shaft/distal femur scan to be 0.1 microSv, since that scan
mimic the hip scan, but with no dose to the ovaries. The total dose for the three DXA scans would be 1.4 +
0.5 + 0.1 = 2.0 microSv. Accounting for four scan sessions throughout the study (start of week 0, end of
weeks 8, 22 and 36), the total cumulative effective dose from the DXA scans would be 4 x 2.0 = 8 microSv.
The effective dose for the pQCT scans, based on data reported by Gordon et al. (J Bone Min Res, vol. 18,
Suppl 2, p. S314, 2003), is 1.0 microSv for a single scout view plus one CT slice, with 60% of the ED, or
0.6 microSv, due to the scout view and 0.4 microSv due to the CT slice. In our protocol, we will perform 2
scout views (one at the knee; one at the ankle) and 4 CT slices (2 distal femur; 1 proximal tibia; 1 distal
tibia). The total ED per scan session will be (2 x 0.6) + (4 x 0.4) = 2.8 microSv. Accounting for four scan
sessions throughout the study, the total cumulative effective dose from the pQCT scans will be 4 x 2.8 =
11.2 microSv.
The combined total effective dose from all DXA scans and all pQCT scans will be 19.2 microSv, which is
slightly more than 2 days of background radiation based on an average background radiation dose of 3,000
mircoSv per year in the US (Report in Brief, June 2005, BEIR VII: Health Risks from Exposure to Low
Levels of Ionizing Radiation, National Research Council).
For radiographic procedures not well-established, provide FDA status of the machine, and
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 12 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

information sufficient to permit research subject dose modeling.
Both radiographic procedures (DXA, pQCT) are well-established and both scanners are FDA approved.
d)
For research radiation machine projects, provide the following therapeutic procedures:
For a well-established therapeutic procedure, identify the area treated, dose per fraction and
number of fractions. State whether the therapeutic procedure is being performed as a normal part of
clinical management for the research participants's medical condition or whether it is being
performed because the research participant is participating in this project.
N/A
For a therapeutic procedure that is not well-established, provide FDA status of the machine, basis
for dosimetry, area treated, dose per fraction and number of fractions.
N/A
5. Devices
a) Please list in the table below all Investigational Devices (including Commercial Devices used off-label) to
be used on participants.
5. 1
Device Name :
Odstock 4 Channel Stimulator, model # O4CHS
Describe the device to be used.
In this study we will use a 4-channel muscle
stimulator. This device is made by Odstock
Medical Limited, The National Clinical FES Centre,
Salisbury District Hospital, Salisbury, Wiltshire, SP2-
8BJ, UK. This device is currently used in research
facilities in England, Canada and United States in
programs that offer FES-rowing exercise to
individuals with spinal cord injuries.
The device is described on the website:
http://www.odstockmedical.com/products/odstock-
4-channel-stimulator-kit
Manufacturer :
Odstock Medical Ltd.
Risk :
Non-significant
Y
I confirm the above are true.
Rationale for the device being non-significant risk:
The manufacturer of the O4CHS stimulator, Odstock Medical Limited, was
formed in 2005 in response to demand by researchers and clinicians for
neuromuscular stimulators with features that are not available with other
commercial stimulator devices, such as the use of manual trigger. Odstock
Medical, has obtained CE mark for all of their stimulation devices for sale and
use within the European Union.
The Odstock 4-channel muscle stimulator (model O4CHS) has been
used for many years in FES-rowing research studies in England, Canada and the
United States. Our research consultants in England who are pioneers of FES-
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 13 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

rowing programs, and who have helped establish FES-rowing programs around
the world, have used this exact 4-channel stimulator with approximately 30
subjects with SCI and have never had a serious adverse event related to the use
of the O4CHS stimulator. Researchers at Spaulding Rehab in Boston also have never
experienced a serious adverse event related to the use of the 04CHS stimulator.
Given the long history of safe use of the O4CHS stimulator in other FES-rowing
program we believe this device qualifies as a non-significant risk.
Sponsor of Project
Indicate who is responsible for submitting safety reports to the FDA:
Y
The sponsor is a non-STANFORD investigator or group.
Ordering, Storage and Control
To prevent the device being used by a person other than the investigator, and in someone other than a
research participant: Confirm that the device will be handled according to the SHC/LPCH policy for
Investigational New Devices or as appropriate. If no, please provide an explanation. :
Y
Confirm?
b) Please list in the table below all IDE Exempt Devices (Commercial Device used according to label,
Investigational In Vitro Device or Assay, or Consumer Preference/Modifications/Combinations of
Approved Devices) to be used on participants.
6. Drugs, Reagents, or Chemicals
a) Please list in the table below all investigational drugs, reagents or chemicals to be administered to
participants.
b) Please list in the table below all commercial drugs, reagents or chemicals to be administered to
participants.
7. Medical Equipment for Human Subjects and Laboratory Animals
If medical equipment used for human patients/participants is also used on animals, describe such
equipment and disinfection procedures.
N/A
8. Participant Population
a)
State the following: (i) the number of participants expected to be enrolled at Stanford-affiliated site(s);
(ii)the total number of participants expected to enroll at all sites; (iii) the type of participants (i.e.
students, patients with certain cancer, patients with certain cardiac condition) and the reasons for
using such participants.
(i) 10
(ii) 10
(III) Subjects with SCI will be enrolled. Subjects with SCI will be used because these subjects exhibit
substantial musculoskeletal atrophy in the lower limbs, the prevention of which is the focus of our research.
b)
State the age range, gender, and ethnic background of the participant population being recruited.
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 14 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

Age range: 18-50 years
Gender: both
Ethnic background: subjects of all ethnicities are eligible
c)
State the number and rationale for involvement of potentially vulnerable subjects in the study
(including children, pregnant women, economically and educationally disadvantaged, decisionally
impaired, homeless people, employees and students). Specify the measures being taken to minimize the
risks and the chance of harm to the potentially vulnerable subjects and the additional safeguards that
have been included in the protocol to protect their rights and welfare.
No potentially vulnerable subjects will be enrolled.
d)
If women, minorities, or children are not included, a clear compelling rationale must be provided (e.g.,
disease does not occur in children, drug or device would interfere with normal growth and
development, etc.).
Our inclusion criteria specifically allows for the inclusion of women and minorities. Children will not be
included since the study is funded by the Department of Veterans Affairs, which does not conduct research
using children.
e)
State the number, if any, of participants who are laboratory personnel, employees, and/or students.
They should render the same written informed consent. If payment is allowed, they should also receive
it. Please see Stanford University policy.
We do not plan to recruit participants who are VA or Stanford laboratory personnel, VA or Stanford
employees, or Stanford students.
f)
State the number, if any, of participants who are healthy volunteers. Provide rationale for the
inclusion of healthy volunteers in this study. Specify any risks to which participants may possibly be
exposed. Specify the measures being taken to minimize the risks and the chance of harm to the
volunteers and the additional safeguards that have been included in the protocol to protect their rights
and welfare.
The study will not include healthy volunteers.
g)
How will you identify participants for recruitment? (E.g., by: chart review; referral from treating
physician; response to ad). Attach recruitment materials in Section #16 (Attachments). All Final or
revised recruitment materials, flyers, etc. must be submitted to the IRB for review and approval before
use. You may not contact potential participants prior to IRB approval. See Advertisements:
Appropriate Language for Recruitment Material.
The identification of potential participants from VA Palo Alto will be facilitated by Dr. Graham Creasey,
who is an Attending Physician in the Spinal Cord Injury Service at VA Palo Alto, and by Dr. Jenny Kiratli,
who is the Director of Clinical Research in the VA Palo Alto Spinal Cord Injury Center. In the course of
performing their standard clinical responsibilities, both Dr. Creasey and Dr. Kiratli are in regular contact
with inpatients and outpatients in the VA SCI Center. Clinical colleagues of Drs. Creasey and Kiratli whom
we will tell about out planned study, will also assist in identifying potential subjects during the course of
their standard clinical interactions with patients. A similar situation exists for Dr. James Crew who is the
Chief of Spinal Cord Injury at the Santa Clara Valley Medical Center in San Jose. Any patients who appear
to be possible candidates for the study will be told briefly about the study by Drs. Creasey and Kiratli, or by
their clinical colleagues, and if a patient expresses an interest in the study, they will be given contact
information for Dr. Beaupre. Interested patients will be able to ask any additional questions by contacting
Dr. Beaupre.
h)
Inclusion and Exclusion Criteria.
Identify inclusion criteria.
Subjects in the rowing groups:
· male and female SCI outpatients or inpatients
· have a T1 to T12, ASIA-A or ASIA-B, spinal cord injury
· be at least 18 year old
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 15 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

· have their physician's clearance to exercise
· between 3 and 12 months post spinal cord injury
· minimum passive hip flexion range of motion (ROM) from 20 to 100 deg
· minimum passive knee flexion ROM from 20 to 100 deg
· minimum passive ankle ROM from +10 deg (dorsi-flexion) to -15 deg (plantar-flexion)
· currently use a manual wheelchair
· be able to perform independent and safe transfers to and from their wheelchair
Subjects in the control group:
· male and female SCI outpatients or inpatients
· have a C5 to T12, ASIA-A or ASIA-B, spinal cord injury
· be at least 18 year old
· between 3 and 12 months post spinal cord injury
· be able to perform safe transfers to and from their wheelchair, either independently or with assistance
Identify exclusion criteria.
Exclusion Criteria
• pregnant women
• women of childbearing potential not practicing a reliable method of contraception
• women who are post-menopausal
• have mechanical instability of the spine
• resting blood pressure higher than 140/90
• a grade 1 or greater, sacral, gluteal or ischial pressure ulcer
• history of low trauma, lower limb fracture since SCI
• renal disease
• current osteomyelitis
• current thrombosis/hemorrhage
• cancer
• other neurological disease (i.e. stroke, peripheral neuropathy, myopathy)
• any implanted electronic device
• active treatment for epilepsy
• regular use of tobacco
• known coronary artery disease
• family history of sudden cardiac death
• current use of cardioactive medications, e.g., for treatment of congestive heart failure or arrhythmia
• current use of medications that can affect bone density and fracture risk including:
bisphosphonates
parathyroid hormone (PTH) and PTH analogs
androgenic steroids
estrogenic steroids
glucocorticoids
anti-epileptics
We will also exclude patients with cognitive impairments that will limit understanding of the nature of the
project or understanding of the informed consent process.
i)
Describe your screening procedures, including how qualifying laboratory values will be obtained. If
you are collecting personal health information prior to enrollment (e.g., telephone screening), please
request a waiver of authorization for recruitment (in section 15).
Subjects initially identified as potential candidates by Drs. Creasey and Kiratli or their clinical colleagues at
VA Palo Alto or Santa Clara Valley Medical Center, will be given contact information for Dr. Beaupre.
Interested patients will be told to contact Dr. Beaupre to find out about the study and ask any additional
questions.
j)
Describe how you will be cognizant of other protocols in which participants might be enrolled. Please
explain if participants will be enrolled in more than one study.
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 16 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

Patients will be asked during recruitment if they are participating in any other studies. Participants will not
be eligible for our study if they are already participating in another research study that uses drugs or
exercise to maintain skeletal health.
k)
Payment/reimbursement. Explain the amount and schedule of payment or reimbursement, if any, that
will be paid for participation in the study. Substantiate that proposed payments are reasonable and
commensurate with the expected contributions of participants and that they do not constitute undue
pressure on participants to volunteer for the research study. Include provisions for prorating payment.
See payment considerations
Subjects in the Standard-of-Care group will receive $50 after each DXA assessment.
Subjects in the FES-rowing group will receive $150 after each of three participation milestones as
appreciation for their participation, distributed as follows:
• After 8-weeks of participation: $150
• After 22-weeks of participation: $150
• After 36-weeks of participation: $150
We do not consider these payments to be inducements to continue or to influence a subject's desire to
withdraw at any point in time. The payments are meant to acknowledge our appreciation for a given subject
having achieved key study milestones.
l)
Costs. Please explain any costs that will be charged to the participant.
No costs will be charged to the participants.
m)
Estimate the probable duration of the entire study. Also estimate the total time per participant for: (i)
screening of participant; (ii) active participation in study; (iii) analysis of participant data.
The duration is the study is expected to be two years. Screening and consenting of each participant is
expected to take 1 hour.
Active participation for each subject in the Standard-of-Care group is expected to total 10 hours, associated
with four, 2.5-hour visits to VA Palo Alto for DXA and pQCT scans, occurring over a span of 36 weeks.
Active participation in the FES-rowing group is expected to be 10 hours for bone density scans, plus 116
hours for regular sessions of muscle conditioning and FES-rowing, plus 12 hours for motion capture and
muscle strength testing. The total time for active participation for the FES-rowing group is expected to be
138 hours, or 17.25 days, occurring over a span of 36 weeks.
9. Risks
a) For the following categories include a scientific estimate of the frequency, severity, and reversibility of potential
risks. Wherever possible, include statistical incidence of complications and the mortality rate of proposed
procedures. Where there has been insufficient time to accumulate significant data on risk, a statement to this
effect should be included. (In describing these risks in the consent form to the participant it is helpful to use
comparisons which are meaningful to persons unfamiliar with medical terminology.)
The risks of the Investigational devices.
This study will use an Odstock 4-channel muscle stimulator (model O4CHS) that has been used for many
years in FES-rowing research studies in England, Canada and the United States. This device is powered by a
standard, 9-volt battery identical to those used to power a transistor radio or smoke alarm. Our research
consultants in England who are pioneers of FES-rowing programs, and who have helped establish
FES-rowing programs in several other research laboratories around the world, have used this exact
4-channel stimulator with approximately 30 subjects with SCI and have never had an adverse event related
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 17 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

to its use. Researchers at Spaulding Rehab in Boston also have never experienced an adverse event related
to the use of the 04CHS device. Given the long history of safe use of the O4CHS device in other
FES-rowing programs we believe this device qualifies as a non-significant risk.
The Odstock 4-channel muscle stimulator is used during FES muscle conditioning, FES muscle strength
testing, and FES rowing.
The risks of the Investigational drugs. Information about risks can often be found in the Investigator's
brochure.
None.
The risks of the Commercially available drugs, reagents or chemicals. Information about risks can
often be found in the package insert.
None.
The risks of the Procedures to be performed. Include all investigational, non-investigational and
non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
Other than the bone density scans for which the risk is described later, there are no other procedures to be
performed on the Standard-of-Care (control) group.
For the FES-rowing group, participants will undergo an 8-week, Functional Electrical Stimulation (FES)
muscle conditioning program to strengthen the quadriceps and hamstring muscles, followed by a 28-week
FES-rowing program. At four time points (0, 8, 22, 36 weeks), participants will perform FES muscle
strength testing of the quadriceps and hamstrings.
We have assessed potential risks of these procedures by consulting with other research groups with
extensive FES-rowing experience and ongoing FES-rowing programs. Potential risks include the following:
1) Soft tissue reaction during FES training
2) Muscle strain during muscle conditioning, strength testing or FES-assisted rowing
3) Fall during transfer to or from rowing machine
4) Serious autonomic dysreflexia during FES training
5) Lower limb fracture during muscle conditioning, strength testing or FES-assisted rowing
6) Increase in neuropathic pain to an unacceptable level
7) Increase in spasticity to an unmanageable level
Based on the experience of other researchers with ongoing FES-rowing programs, only two of the above
seven issues have ever occurred. These are: 1) a soft tissue reaction during FES training and rowing; and 2)
a muscle strain during FES-rowing. Since those are the only issues experienced in previous FES-rowing
projects we will discuss them first.
1) A soft tissue reaction to FES training can be associated with several causes. The first is a local reddening
of the skin under the electrodes. This reddening is thought to be due to an increase in blood flow beneath the
electrode caused by the electrical stimulation. This reddening typically lasts for less than one hour after
stimulation is stopped. This reddening is expected to occur to some degree with all participants in the
FES-rowing group.
Reddening may also potentially occur as a result of an allergic reaction to the gel used to adhere the surface
electrode to the skin. If reddening of the skin persists for much longer than one hour after removal of the
electrode, then an allergic reaction is a possible cause. Our consultants in England who have trained
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 18 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

approximately 30 individuals to become FES-rowers have never seen a case of an individual who was
allergic to the electrode gel, although this remains a potential risk.
The third and final potential skin reaction is reddening suggestive of the initiation of soft tissue breakdown
(e.g., a "pressure sore") due to excessive pressure or shear stress. In individuals with SCI, the areas most
prone to excessive stress are the sacral, gluteal or ischial regions. This potential for skin breakdown exists
for all individuals who utilize a wheelchair or who are bed-bound for prolonged periods. Our consultants in
England have never had any participants experience skin breakdown caused by their participation in
FES-rowing, although this remains a potential risk.
2) Muscle strain during muscle conditioning, strength testing or FES-assisted rowing: As with participating
in any exercise program, there is a risk of experiencing a muscle strain. Based on the experience of other
researchers with FES-rowing programs, only two out of thirty FES-rowing participants have ever
experienced a muscle strain. Muscle strains have never been observed in the lower limbs. For both
participants with muscle strains, the strain occurred in the torso, between innervated and paralyzed muscle.
These strains were treated by ceasing FES training for 48 to 72 hours and by the use of ice and
over-the-counter analgesics. Neither participant has had a repeat incidence of a muscle strain.
3) Risk of a fall during transfer to or from rowing machine: There is a possibility that a participant may fall
while transferring to or from the rowing machine or to or from the table they will lie on while having their
bone density scans. The risk of falling can be minimized to a very low level by using safe transfer
techniques.
4) Serious autonomic dysreflexia during FES training: Autonomic dysreflexia (AD) is a condition which
can occur in people who have sustained a spinal cord injury. Autonomic dysreflexia is more common in
individuals with tetraplegia (quadriplegia), but it can also occur in individuals with paraplegia. Autonomic
dysreflexia can be brought on by a variety of stimuli, including a full bladder or bowel, a pressure sore or
infection, exercise, or by Functional Electrical Stimulation. Possible symptoms of an AD reaction include:
• Severe headache
• Flushing or blotching of the skin above the level of the spinal cord injury
• Profuse sweating, particularly above the level of the spinal cord injury
• Increased blood pressure
• Decreased heart rate
Generally, an AD reaction will quickly diminish once the initiating stimulus that caused the reaction is
removed. To reduce the risk of an AD response, all participants will be encouraged to completely empty
their bladder prior to each muscle conditioning or rowing session. The risk of an AD response should also
decrease as training progresses and a participant's muscles become conditioned from the electrical
stimulation. Thus, the risk of AD is highest during the initial muscle conditioning session. During a
participant's first muscle conditioning session we will assess the ability of their muscles to respond to the
electrical stimulation and we will pay particular attention to any signs of an AD response. It is possible that
an AD response that is greater than mild might be identified at a participant's initial session and that could
mean that they are not an acceptable candidate for continuation in the study.
It should also be noted that an individual's likelihood of having an AD episode in response to exercising part
of the body below the level of a spinal cord injury will be heightened if an individual already has an
underlying condition that is perceived by their body as a noxious stimulus. For example, an individual with
a bladder infection might be more prone to an AD episode from an additional stimulus, such as Functional
Electrical Stimulation of the legs, compared to an individual without a bladder infection. Therefore, it is
important that any underlying noxious stimulus that might predispose an individual to an AD response is
identified as early as possible and addressed before commencing or continuing with the rowing exercise.
We should note that FES-rowing research groups in England and Boston have never had a participant in
their FES-rowing programs experience a severe case of AD, and those participants who have experienced
Protocol # 28434 ( Modification )
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PD: Gary Scott Beaupre
APPLICATION FORM
Page 19 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

mild cases of AD also experience mild cases during their everyday lives. Therefore, we believe the risk of
experiencing a severe case of AD from participation in this study is very low, although the possibility of
experiencing a mild case of AD is higher. At the first sign of an AD response, electrical stimulation will be
stopped. Additional medical treatment in the case of a severe AD response will be available in our testing
facilities.
5) Lower limb fracture during muscle conditioning, strength testing or FES-assisted rowing: The use of
FES to stimulate paralyzed muscles in individuals with SCI has been studied for more than 50 years. Over
that 50-year period there have been two reported cases of a fracture related to the use of functional electrical
stimulation. One individual fractured their patella and a second individual fractured their lateral femoral
condyle. Although the total number of individuals with SCI who have used functional electrical stimulation
to exercise the lower limbs is not known, we believe the risk of a fracture is very low given that there have
only been two reported fractures in 50 years of FES use. To further reduce the risk of fracture, only
participants who have never experienced a low-energy or fragility fracture will be allowed to take part in
this study. In addition, we will measure bone density for each participant at the beginning of the study and
those measurements will provide us with an initial assessment of the health of each participant's femur and
tibia. If we believe a participant's bones are too weak to safely undergo the muscle conditioning and rowing
exercise, that participant will be withdrawn from the study.
6) Increase in neuropathic pain to an unacceptable level: Some spinal cord injured individuals suffer from
neuropathic pain which can range from a mild tickling sensation to a severe burning sensation. It is not
known what effect, if any, electrical stimulation has on this condition. In addition, some individuals with
SCI who have some sensation in their thighs may find the electrical stimulation to be uncomfortable or even
intolerable. Any participant who finds the electrical stimulation to produce neuropathic pain or sensation
that is unacceptable to them will be withdrawn from the study.
7) Increase in spasticity to an unmanageable level: It is not known what effect FES has on the intensity and
frequency of spasticity. In other FES-rowing programs, a few participants have had an increase in spasticity,
while some participants have had a decrease. In general, spasticity levels should be reduced after a muscle
conditioning or rowing session, since the muscles will be fatigued. If a subject experiences increased
spasticity to a level that is unmanageable, they will be withdrawn from the study.
The risks of the Radioisotopes/radiation-producing machines (e.g., X-rays, CT scans, fluoroscopy) and
associated risks.
Both of the bone density scanners we will use involve very low exposures to X-ray radiation. The total
radiation exposure from all four visits will be 19.2 microSv. For comparison, a person can be expected to
receive 8 microSv of natural background radiation per day from the environment. For an additional
comparison, a person can be expected to receive approximately 30 microSv of radiation during an airline
flight from San Francisco to New York. Therefore, the total additional radiation from the bone density scans
is equivalent to slightly more than 2 days of natural background radiation and slightly more than half the
radiation from a coast-to-coast airline flight. There are no known hazards from radiation at such a low level.
This radiation dose is considered safe to administer to humans except during pregnancy. Although there are
no documented risks to a fetus, we will exclude any subject who might be pregnant at the time of the study.
The risks of the Physical well-being.
None other than those described above.
The risks of the Psychological well-being.
We do not anticipate that any research-related procedure will adversely affect the psychological well-being
of the participants.
The risks of the Economic well-being.
We do not anticipate that any research-related procedure will adversely affect the economic well-being of
the particpants.
The risks of the Social well-being.
We do not anticipate that any research-related procedure will adversely affect the social well-being of the
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 20 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

participants.
Overall evaluation of Risk.
Low - innocuous procedures such as phlebotomy, urine or stool collection, no therapeutic agent, or safe
therapeutic agent such as the use of an FDA approved drug or device.
b)
If you are conducting international research, describe the qualifications/preparations that enable you
to both estimate and minimize risks to participants. Also complete the International Research Form
and attach it in the Attachments section. If not applicable, enter N/A.
N/A
c)
Describe the planned procedures for protecting against and minimizing all potential risks. Include the
means for monitoring to detect hazards to the participant (and/or to a potential fetus if applicable).
Include steps to minimize risks to the confidentiality of identifiable information.
Confidentiality of the identifiable information will be carefully protected and data security measures will be
strictly enforced. Any information or data on paper, including signed consents, will be stored in locked
cabinets in locked offices in a secure VA building. All electronic data that contain identifiable subject
information will be saved on a secure VA file server behind the VA firewall. No data will be maintained on
portable electronic devices.
Protecting against and minimizing potential risks: To reiterate, the following are the potential risks to
participants in the FES-rowing group.
1) Soft tissue reaction during FES training
2) Muscle strain during muscle conditioning, strength testing or FES-assisted rowing
3) Fall during transfer to or from rowing machine
4) Serious autonomic dysreflexia (AD) during FES training
5) Lower limb fracture during muscle conditioning, strength testing or FES-assisted rowing
6) Increase in neuropathic pain to an unacceptable level
7) Increase in spasticity to an unmanageable level
The following paragraphs describe how these risks will be mitigated to reduce them to the lowest possible
levels.
1) Soft tissue reaction: Other than the typical reddening beneath the electrodes, which is to be expected, we
will be vigilant to look for other types of soft tissue reactions and we will encourage all participants to be
vigilant. To the best of our knowledge no prior FES-rowing participants have experienced a skin breakdown
or pressure sore caused by their participation in an FES-rowing program. Nevertheless, before and after
each session, we will look for any signs of bruising or swelling that might be suggestive of tissue
breakdown, paying particular attention to the shoulders, back, buttocks, upper calves and knee areas.
2) Muscle strain: We will inform all participants of the possibility of a muscle strain and encourage
participants that it is not necessary to perform at levels which push personal boundaries of performance,
especially in terms of the energy which they exert when pulling on the handle of the rowing machine with
their arms, since excessive upper body exertion is the more likely cause of muscle strain in the torso. Since
subjects with SCI can have normal arm strength it is possible that a subject might believe that intensive arm
pulling is required or encouraged. We will make it clear to participants that intensive arm pulling is not
required. We will also discuss with each participant the experience of other FES-rowing groups so that our
rowers are aware of the possibility of a muscle strain and let them know that they should tell us immediately
if they think they have experienced a muscle strain. Since this risk has actually been observed in two
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 21 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

FES-rowers in another research group, the possibility of a muscle strain is more than a theoretical possibility
and we want to minimize that possibility by adequately informing our participants.
3) Risk of a fall during transfers: The risk of falling during transfers can be minimized to a very low level by
using safe transfer techniques. Dr. Creasey, who has worked with patients with SCI for more than 30 years,
is knowledgeable in what constitutes safe transfer techniques. Dr. Creasey will observe each participant
when they are first required to perform transfer in the study and based upon his observations he will
recommendation for improving their transfer technique if needed.
4) Serious autonomic dysreflexia (AD) during FES training: To reduce the risk of an AD response, all
participants will be encouraged to completely empty their bladder prior to each muscle conditioning or
rowing session. We will also inform participants that the risk of an AD response is increased if they have an
underlying condition which their body perceives as a noxious stimulus, such as a bladder infection. We will
ask each participant to inform us if they have a known or suspected bladder infection. We will also inform
participants that it may be necessary for them to take a break from their training or rowing while a bladder
infection is treated.
The risk of an AD response should also decrease as training progresses and a participant's muscles become
conditioned from the electrical stimulation. Thus, the risk of AD will be highest during the initial muscle
conditioning session. During the initial muscle conditioning session for each participant, we will pay
particular attention to any signs of an AD response. At the first sign of an AD response, electrical
stimulation will be stopped. Additional medical treatment (e.g., the application of Nitropaste) in the case of
a severe AD response will be available in our research facilities. Given that no other FES-rowing group has
ever reported a severe AD response we believe the likelihood of a participatant having a severe AD
response is very low, however, all of our research staff and each participant will be informed about the
possibility of AD response and we will be vigilant in looking for an AD response.
5) Lower limb fracture during muscle conditioning, strength testing or FES-assisted rowing: To reduce the
risk of fracture, only participants who have never experienced a low-energy or fragility fracture will be
allowed to take part in this study. In addition, we will measure bone density for each participant at the
beginning of the study and those measurements will provide us with an initial assessment of the health of
each participant's femur and tibia. If we believe a participant's bones are too weak to safely undergo the
muscle conditioning and rowing exercise, we will not allow that participant to continue in the study. In
addition, participants will be educated on potential signs of a fracture for a person with SCI who is insensate
in the area; these include localized redness and swelling, excess spasticity, possibly excess sweating and/or
AD. We believe this is unlikely, but the added precaution of educating the participant will allow him/her to
be extra vigilant for this occurrence.
6) Increase in neuropathic pain to an unacceptable level: Some spinal cord injured individuals suffer from
neuropathic pain which can range from a mild tickling sensation to a severe burning sensation. It is not
known what effect, if any, electrical stimulation has on this condition. In addition, some individuals with
SCI who have some sensation in their thighs may find the electrical stimulation to be uncomfortable or even
intolerable. Any participant who finds the electrical stimulation to produce neuropathic pain or sensation
that is unacceptable to them will be withdrawn from the study.
7) Increase in spasticity to an unmanageable level: It is not known what effect FES has on the intensity and
frequency of spasticity. In other FES-rowing programs, a few participants have had an increase in spasticity,
while some participants have had a decrease. In general, spasticity levels should be reduced after a muscle
conditioning or rowing session, since the muscles will be fatigued. If a subject experiences increased
spasticity that is unmanageable, they will be withdrawn from the study.
d)
Explain the point at which the experiment will terminate. If appropriate, include the standards for the
termination of the participation of the individual participant Also discuss plans for ensuring necessary
medical or professional intervention in the event of adverse effects to the participants.
Given the low risk level and given the success of other FES-rowing research studies, we do not anticipate
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 22 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

terminating the study before the two-year funding period ends.
However, individual participants may be withdrawn from the study for several reasons, including, but not
limited to:
• Inadequate muscle response to electrical stimulation
• Severe AD reaction in response to exercise or electrical stimulation
• Markedly low bone density compared to other individuals with acute and sub-acute SCI
• An increase in neuropathic pain or pain sensation from electrical stimulation to an
unacceptable level
• An increase in spasticity to an unmanageable level
e)
Data Safety and Monitoring Plan (DSMP). See guidance on Data Safety and Monitoring.
A Data and Safety Monitoring Plan (DSMP) is required for studies that present Medium or High risk
to participants. (See Overall Evaluation of Risk above). If Low Risk, a DSMP may not be necessary.
Multi-site Phase III clinical trials funded by NIH require the DSM Plan to have a Data Safety
Monitoring Board or Committee (DSMC or DSMB). The FDA recommends that all multi-site clinical
trials that involve interventions that have potential for greater than minimal risk to study participants
also have a DSMB or DSMC.
The role of the DSMC or DSMB is to ensure the safety of participants by analyzing pooled data from
all sites, and to oversee the validity and integrity of the data. Depending on the degree of risk and the
complexity of the protocol, monitoring may be performed by an independent committee, a board
(DSMC/DSMB), a sponsor's Data Safety Committee (DSC), a Medical Monitor, a sponsor's safety
officer, or by the Protocol Director (PD).
Describe the following:
What type of data and/or events will be reviewed under the monitoring plan, e.g. adverse events,
protocol deviations, aggregate data?
We will look for and track any adverse events, including unanticipated problems, that may occur during
FES muscle-conditioning or FES rowing sessions. We will also be vigilant for any security breaches
involving paper or electronic records.
Identify who will be responsible for Data and Safety Monitoring for this study, e.g. Stanford
Cancer Institute DSMC, an independent monitoring committee, the sponsor, Stanford investigators
independent of the study, the PD, or other person(s).
The PI/PD, Dr. Gary Beaupre and Co-PD & Co-Investigator, Dr. Jenny Kiratli, will be responsible for
monitoring the data collected, including data related to unanticipated problems and adverse events.
Provide the scope and composition of the monitoring board, committee, or safety monitor, e.g.,
information about each member's relevant experience or area of expertise. If the Monitor is the
Stanford Cancer Center DSMC or the PD, enter N/A.
PD and co-PD have extensive experience with regards to monitoring and maintaining safety of
events/data related to this study.
Confirm that you will report Serious Adverse Events (SAEs), Suspected Unexpected Serious
Adverse Reactions (SUSARs), or Unanticipated Problems (UPs) to the person or committee
monitoring the study in accordance with Sponsor requirements and FDA regulations.
Serious Adverse Events (SAEs) and/or Unanticipated Problems (UAPs) are considered unlikely . Given
the nature of this study, with each participant closely supervised and monitored regularly during muscle
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 23 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

conditioning and rowing sessions, there should be minimal delay in reporting if any AE/UAP occur.
If applicable, how frequently will the Monitoring Committee meet? Will the Monitoring Committee
provide written recommendations about continuing the study to the Sponsor and IRB?
As needed. As above, these are not considered likely to occur at all nor are they expected to be frequent
occurrences. The total number of subjects to be enrolled is small and we plan to make notes of our
observations for each subject after each session.
Specify triggers or stopping rules that will dictate when the study will end, or when some action is
required. If you specified this in Section 2g [Study Endpoints], earlier in this application enter 'See
2g'.
N/A
Indicate to whom the data and safety monitoring person, board, or committee will disseminate the
outcome of the review(s), e.g., to the IRB, the study sponsor, the investigator, or other officials, as
appropriate.
If any AE or UAP occurs, we will follow the established timeframes for reporting to the IRB and the VA
R&D Committee; i.e., immediately for any SAE or serious UAP and at annual renewal for any
non-serious or expected occurrence.
Select One:
Y
The Protocol Director will be the only monitoring entity for this study.
This protocol will utilize a board, committee, or safety monitor as identified in question #2 above.
10. Benefits
a)
Describe the potential benefit(s) to be gained by the participants or by the acquisition of important
knowledge which may benefit future participants, etc.
It is possible that individuals who participate in the FES-Rowing group will increase (or
reduce loss of) bone mass in their legs and/or experience other health/fitness benefits. In
addition, findings from this study may contribute to the development of knowledge which
may eventually benefit individuals with spinal cord injury.
Subjects in both groups will be provided with the results of their DXA hip scans which they
will be encouraged to share with their personal physician. A knowledge of bone density at
the hip can be considered a minor benefit experienced by participants.
11. Privacy and Confidentiality
Privacy Protections
a)
Describe how the conditions under which interactions will occur are adequate to protect the privacy
interests of participants (e.g., privacy of physical setting for interviews or data collection, protections
for follow-up interactions such as telephone, email and mail communications).
Initial identification of potential participants will be done by a patient's personal physician
who is familiar with our planned study. Follow-up interactions with potential participants will
be by telephone for answering any additional questions a potential participant might have, or
in person in a private, laboratory setting, for any subject who prefers to meet in person.
Confidentiality Protections
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 24 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

b)
Specify PHI (Protected Health Information). PHI is health information linked to HIPAA identifiers
(see above). List BOTH health information AND HIPAA identifiers. If you are using STARR, use the
Data Privacy Attestation to ensure that your request will match your IRB-approved protocol. Be
consistent with information entered in section 15a.
Name, date of birth, telephone number and address will be obtained from each participant.
We will also obtain information on injury history, including date of injury for each participant.
We may also acquire photographs or video of participants while performing any research-
related tasks. This information will be stored on a secure VA server. We will also use the VA
Form 10-3203 ("CONSENT FOR USE OF PICTURE AND/OR VOICE") as required by VA
(attached).
c)
You are required to comply with University Policy that states that ALL electronic devices: computers
(laptops and desktops; OFFICE or HOME); smart phones; tablets; external hard disks, USB drives,
etc. that may hold identifiable participant data will be password protected, backed up, and encrypted.
See http://med.stanford.edu/datasecurity/ for more information on the Data Security Policy and links
to encrypt your devices.
Provide any additional information on ALL data security measures you are taking. You must use
secure databases such as RedCap https://med.stanford.edu/researchit/infrastructure/redcap.html
https://med.stanford.edu/researchit/infrastructure/redcap.html. If you are unsure of the security of the
system, check with your Department IT representative. Please see http://med.stanford.edu/irt/security/
for more information on IRT Information Security Services and
http://www.stanford.edu/group/security/securecomputing/mobile_devices.html for more information
for securing mobile computing devices. Additionally,any PHI data on paper must be secured in an
locked environment.
By checking this box, You affirm the aforementioned. Y
Any data on paper will be kept in a locked filing cabinet in Dr. Beaupre's locked office or in a
locked filing cabinet in a locked room designated for the storage of human subjects
documents, such as signed informed consent forms. These rooms are located in a secure VA
building accessible only by VA badge access. De-identified, electronic information will be
stored on a secure VA server. Data analysis will only occur on de-identified data and will
occur on password-protected computers.
d)
Describe how data or specimens will be labeled (e.g. name, medical record number, study number,
linked coding system) or de-identified. If you are de-identifying data or specimens, who will be
responsible for the de-identification? If x-rays or other digital images are used, explain how and by
whom the images will be de-identified.
Each subject will be given a code number and data for each subject will be identified by code
number only. The electronic file that links the code number with a subject's name will be
kept
on a secure VA server. Dr. Beaupre will be responsible for de-identification and coding of all
data files.
e)
Indicate who will have access to the data or specimens (e.g., research team, sponsors, consultants) and
describe levels of access control (e.g., restricted access for certain persons or groups, access to linked
data or specimens).
Only members of the research team will have access to the data.
f)
If data or specimens will be coded, describe the method in which they will be coded so that study
participants' identities cannot be readily ascertained from the code.
Data for each subject will be given a unique code number that is unrelated in any way to a
subject's III or PHI.
g)
If data or specimens will be coded, indicate who will maintain the key to the code and describe how it
will be protected against unauthorized access.
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 25 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

Dr. Beaupre will maintain the key to the code. The key to the code will be kept on a secure
VA
server.
h)
If you will be sharing data with others, describe how data will be transferred (e.g., courier, mail) or
transmitted (e.g., file transfer software, file sharing, email). If transmitted via electronic networks,
describe how you will secure the data while in transit.See
http://www.stanford.edu/group/security/securecomputing/
http://www.stanford.edu/group/security/securecomputing/. Additionally, if you will be using or sharing
PHI see https://uit.stanford.edu/security/hipaa https://uit.stanford.edu/security/hipaa.
Data will not be shared outside of the investigator group.
i)
How will you educate research staff to ensure they take appropriate measures to protect the privacy of
participants and the confidentiality of data or specimens collected (e.g. conscious of oral and written
communications, conducting insurance billing, and maintaining paper and electronic data)?
All members of the research team will complete all trainings required by VA Research
Administation, including all human subjects related trainings. In his weekly meeting with
study staff, Dr. Beaupre will discuss and reinforce the importance of privacy.
12. Potential Conflict of Interest
Investigators are required to disclose any financial interests that reasonably appear to be related to this protocol.
Financial Interest Tasks
Investigators
Role
Email
Has
Financial
Interest?
Date Financial
Interest
Answered
Date OPACS
Disclosure
Submitted
Date OPACS
Review
Completed
Gary Scott
Beaupre
PD
Gary.Beaupre@va.gov
N
07/15/2014
N/A
N/A
Graham Harold
Creasey
OC
gcreasey@stanford.edu
N
07/15/2014
N/A
N/A
13. Consent Background
13. 1
Waiver of Documentation
Phone screening
Check if VA related
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 26 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
Dr. Beaupre or a member of his study team will obtain consent from participants. Consent for the phone
screen will be done over the phone. The subject will be assured that he/she has as much time as necessary to
review the consent document and ask any questions.
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The person obtaining consent will ask the participant if he/she has questions about the information
contained in the consent or about the study. We do not expect to enroll anyone with whom there will be
difficulty communicating nor will we enroll any non-English speakers and this well be determined from the
initial contact.
c)
What steps are you taking to determine that potential participants are competent to participate in the
decision-making process? If your study may enroll adults who are unable to consent, describe (i) how
you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains the
capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
Subjects will arrange for their own transportation to the study location. There is therefore sufficient reason
to believe that they will be participating at their own free will. The research team will repeatedly remind the
subject that they may withdraw at any time.
Select one of the following regulatory criteria for a waiver of documentation (signature) and provide a
protocol-specific justification:
1)
45 CFR 46.117(c)(i). For research that is not subject to FDA regulation, the only record linking
the participants and the research would be the consent document,and the principal risk would
be potential harm resulting from a breach of confidentiality; each participant will be asked
whether he/she wants documentation linking the participant with the research, and the
participant's wishes govern.
2)
45 CFR 46.117(c)(ii). For research that is not subject to FDA regulation, presents no more than
minimal risk of harm to participants and involves no procedures for which written consent is
normally required outside of the research context.
3)
45 CFR 46.117(c)(iii). For research not subject to FDA regulation, if subjects or legally
authorized representatives (LAR) are members of a distinct cultural group in which signing
forms is not the norm, the research presents no more than minimal risk and there is an
appropriate alternative mechanism for documenting that informed consent was obtained.
4)
Y
21 CFR 56.109(c)(1). For research that is subject to FDA regulation, presents no more than
minimal risk of harm to participants and involves no procedures for which written consent is
normally required outside of the research context.
Rationale for above selection:
The phone screen asks minimal risk questions that relate to their eligibility for the study.
13. 2
Consent
FES-Rowing Group Consent Sept 29-2014
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
(i) Dr. Beaupre or a member of his study team will obtain consent from participants. (ii) Consent will be
obtained upon arrival of the subject at the study location. (iii) As much time as necessary to address any
questions. (iv) Yes. (v) The subject will be assured that he/she has as much time as necessary to review the
consent document and ask any questions. (vi) N/A
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 27 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The person obtaining consent will ask the participant if he/she has questions about the information
contained in the consent or about the study. We do not expect to enroll anyone with whom there will be
difficulty communicating nor will we enroll any non-English speakers and this well be determined from the
initial contact.
c)
What steps are you taking to determine that potential participants are competent to participate in the
decision-making process? If your study may enroll adults who are unable to consent, describe (i) how
you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains the
capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
Subjects will arrange for their own transportation to the study location. There is therefore sufficient reason
to believe that they will be participating at their own free will. The research team will repeatedly remind the
subject that they may withdraw at any time.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
Dr. Beaupre, Dr. Kiratli, Dr. Creasey, or Dr. Lambach will obtain all consents. These people have or will
have completed appropriate training and each will have prior experience or specific training in performing
consents.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Legally effective informed consent will be obtained from each participant. No LARs will be used.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Yes
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
Yes
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
Yes
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
13. 3
Consent
Control Group Consent Sept 29-2014
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 28 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
(i) Dr. Beaupre or a member of his study team will obtain consent from participants. (ii) Consent will be
obtained upon arrival of the subject at the study location. (iii) As much time as necessary to address any
questions. (iv) Yes. (v) The subject will be assured that he/she has as much time as necessary to review the
consent document and ask any questions. (vi) N/A
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The person obtaining consent will ask the participant if he/she has questions about the information
contained in the consent or about the study. We do not expect to enroll anyone with whom there will be
difficulty communicating nor will we enroll any non-English speakers and this well be determined from the
initial contact.
c)
What steps are you taking to determine that potential participants are competent to participate in the
decision-making process? If your study may enroll adults who are unable to consent, describe (i) how
you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains the
capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
Subjects will arrange for their own transportation to the study location. There is therefore sufficient reason
to believe that they will be participating at their own free will. The research team will adequately remind
each subject that they may withdraw at any time.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
Dr. Beaupre, Dr. Kiratli, Dr. Creasey, or Dr. Lambach will obtain all consents. These people have or will
have completed appropriate training and each will have prior experience or specific training in performing
consents.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Legally effective informed consent will be obtained from each participant. No LARs will be used.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Yes
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
Yes
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
Yes
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
13. 4
Consent
Experienced Rower Consent Sept 29-2104
Check if VA related
Y
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 29 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
(i) Dr. Beaupre or a member of his study team will obtain consent from participants. (ii) Consent will be
obtained upon arrival of the subject at the study location. (iii) As much time as necessary to address any
questions. (iv) Yes. (v) The subject will be assured that he/she has as much time as necessary to review the
consent document and ask any questions. (vi) N/A
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The person obtaining consent will ask the participant if he/she has questions about the information
contained in the consent or about the study. We do not expect to enroll anyone with whom there will be
difficulty communicating nor will we enroll any non-English speakers and this well be determined from the
initial contact.
c)
What steps are you taking to determine that potential participants are competent to participate in the
decision-making process? If your study may enroll adults who are unable to consent, describe (i) how
you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains the
capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
Subjects will arrange for their own transportation to the study location. There is therefore sufficient reason
to believe that they will be participating at their own free will. The research team will adequately remind
each subject that they may withdraw at any time.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
Dr. Beaupre, Dr. Kiratli, Dr. Creasey, or Dr. Lambach will obtain all consents. These people have or will
have completed appropriate training and each will have prior experience or specific training in performing
consents.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Legally effective informed consent will be obtained from each participant. No LARs will be used.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Yes
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
Yes
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
Yes
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 30 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
14. Assent Background (less than 18 years of age)
15. HIPAA Background
15. 1
Waiver of Authorization for
Recruitment
pre-screening of potential participants
a)
Describe the protected health information (PHI) needed to conduct screening or recruitment. PHI is
health information linked to HIPAA identifiers. List BOTH health information AND HIPAA
identifiers. If you are using STARR, use the Data Privacy Attestation to ensure that your request will
match your IRB-approved protocol.
Potential participants will typically make their first contact with Dr. Beaupre by phone. During that initial
phone call, Dr. Beaupre will provide potential participants with a general overview of the project, including
the two possible groups to participate in, the total duration of the study and the time commitment. During
that phone call, Dr. Beaupre will also make an initial assessment of potential participants from the
perspective of the inclusion and exclusion criteria. This initial assessment is particularly important in terms
of convenience to potential participants since all participants will have spinal cord injuries which may make
it difficult for them in terms of transportation to and from the VA. The investigators do not want to
inconvenience a potential subject by requiring them to come to the VA only to learn after one or two
minutes of discussion that the subject is not really interested in the study or does not qualify, say, because of
age, or because of the time commitment, or because of one of the inclusion or exclusion criteria. During the
initial phone conversation with a potential participant, it is possible that the individual calling will provide
his or her name or reveal other III or PHI, such as the city where they live or some health information such
as the date or level of their spinal cord injury. It is not possible to have that phone conversation without
there being a reasonable likelihood that the individual will reveal some III or PHI. It is not practical or
reasonable to require that an individual make a special trip to the VA, sign an informed consent, and only
thereafter to determine if they are interested in the study or if they potentially qualify for inclusion.
b)
Please Answer:
Y
Do you certify that the use or disclosure of protected health information involves no more than a
minimal risk to the privacy of individuals?
Y
Do you certify that the research could not practically be conducted with out the waiver?
Y
Do you certify that you have adequate written assurances that the protected health information will
not be reused or disclosed to any other person or entity, except as required by law, for authorized
oversight of the research project, or for other research for which the use or disclosure of protected
health information would be permitted?
Y
Do you certify that the research could not practically be conducted with out access to and use of the
protected health information?
c)
Please describe an adequate plan to protect any identifiers from improper use and disclosure.
During the initial phone call by potential participants to Dr. Beaupre during which the potential participant
might disclose PHI or III, Dr. Beaupre will typically take hand-written notes about the potential participant.
After the phone conversation, those notes will be transcribed to a WORD document and stored on a secure
server at the VA. At that point the handwritten notes will be depositing in a secure bin for shredding. If it is
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 31 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

subsequently determined that a subject is not a candidate for inclusion or potential inclusion in the study the
electronics notes will be permanently deleted from the VA server. Candidates who ultimately do become
participants will have any PHI or III appended to their information in the file that contains the code number
for participants, which will only be stored on the secure VA server behind the VA firewall.
d)
Please describe an adequate plan to destroy the identifiers at the earliest opportunity consistent with
conduct of the research, unless there is a health or research justification for retaining the identifiers
or such retention is otherwise required by law.
All VA research records will be maintained consistent with existing VA record retention policies.
16. Attachments
Attachment Name
Attached Date
Attached By
Submitted Date
VA Required Questions
08/29/2013
beaupre1
VA Consent for use of photos,
etc.
08/29/2013
beaupre1
VA Proposal
09/26/2013
beaupre1
Phone Script
09/29/2013
beaupre1
Obligations
The Protocol Director agrees to:
•
Adhere to principles of sound scientific research designed to yield valid results
•
Conduct the study according to the protocol approved by the IRB
•
Be appropriately qualified to conduct the research and be trained in Human Research protection, ethical
principles, regulations, policies and procedures
•
Ensure all Stanford research personnel are adequately trained and supervised
•
Ensure that the rights and welfare of participants are protected including privacy and confidentiality of data
•
Ensure that, when de-identified materials are obtained for research purposes, no attempt will be made to
re-identify them.
•
Disclose to the appropriate entities any potential conflict of interest
•
Report promptly any new information, modification, or unanticipated problems that raise risks to
participants or others
•
Apply relevant professional standards.
Any change in the research protocol must be submitted to the IRB for review prior to the implementation of
such change. Any complications in participants or evidence of increase in the original estimate of risk should
be reported at once to the IRB before continuing with the project. Inasmuch as the Institutional Review
Board (IRB) includes faculty, staff, legal counsel, public members, and students, protocols should be written
in language that can be understood by all Panel members. The investigators must inform the participants of
any significant new knowledge obtained during the course of the research.
IRB approval of any project is for a maximum period of one year. For continuing projects and activities, it is
the responsibility of the investigator(s) to resubmit the project to the IRB for review and re-approval prior to
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 32 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

the end of the approval period. A Notice to Renew Protocol is sent to the Protocol Director 7 weeks prior to
the expiration date of the protocol.
Department Chair must approve faculty and staff research that is not part of a sponsored project. VA
applicants must have Division Chief or Ward Supervisor approval. E-mail the Department Chair approval to
IRBCoordinator@lists.stanford.edu.
All data including signed consent form documents must be retained for a minimum of three years past the
completion of the research. Additional requirements may be imposed by your funding agency, your
department, or other entities. (Policy on Retention of and Access to Research Data, Research Policy
Handbook,
http://doresearch.stanford.edu/policies/research-policy-handbook/conduct-research/retention-and-access-research-data)
PLEASE NOTE: List all items (verbatim) that you want to be reflected in your approval letter (e.g.,
Amendment, Investigator's Brochure, consent form(s), advertisement, etc.) in the box below. Include number
and date when appropriate.
Consent Form for Control Group
Consent Form for FES-Rowing Group
Consent Form for Experienced Rowers
Determination of non-significant risk with the use of Odstock O4CHS stimulator
Waiver of Individual Authorization for recruitment under 45 CFR 164.512(i)(2)(ii)(A),(B),(C), pursuant to
information provided in the HIPAA section of the protocol application.
Includes grant title: Using Musculoskeletal Models to Assess FES Rowing for Skeletal Health After SCI
Y
By checking this box, I verify that I, as the Protocol Director (PD) responsible for this research protocol,
have read and agree to abide by the above obligations, or that I have been delegated authority by the PD to
certify that the PD has read and agrees to abide by the above obligations.
Protocol # 28434 ( Modification )
PROTOCOL
PD: Gary Scott Beaupre
APPLICATION FORM
Page 33 of 33
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Skeletal Health in the Lower Limbs Following Spinal Cord Injury
Approval Period:
01/13/2015 - 09/02/2015

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 1 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
Are you participating in any other research studies? _____ yes _____no 
 
PURPOSE OF RESEARCH  
 
You are invited to participate in a research study to determine if a 36-week rowing 
exercise program can help to prevent the loss of bone in your lower limbs that typically 
accompanies a spinal cord injury (SCI). You were selected as a possible participant in 
this study because you sustained a spinal cord injury more than 3 months ago, but less 
than 24 months ago. This research study is looking for a total of five people with a spinal 
cord injury in the 3 to 24-month time frame who will participate in the rowing exercise 
program. 
 
VOLUNTARY PARTICIPATION  
 
Your participation in this study is entirely voluntary. Your decision not to participate will 
not have any negative effect on you or your medical care. You can decide to participate 
now, but withdraw your consent later and stop being in the study without any loss of 
benefits or medical care you are entitled to.  
 
DURATION OF STUDY INVOLVEMENT  
 
This research study is expected to take approximately two years in total. Each 
participant will be enrolled in the study for approximately 36 weeks or 9 months. During 
this approximately 36-week period, each participant will make multiple visits to the VA 
Palo Alto Health Care System campus. The approximate schedule of weekly visits is 
outlined near the end of the next section (PROCEDURES). 
 
PROCEDURES 
 
If you choose to participate in this study, you will be enrolled in a 36-week exercise 
program that may decrease bone loss in your legs. Weeks of participation will be 
measured based on completion of 3 training sessions per week with 85% compliance 
resulting in a minimum of 92 exercise sessions over at least 36 weeks. It may take 
longer than 36 consecutive calendar weeks to complete the 36-week exercise program. 
During part of this exercise program you will be trained to exercise using a rowing 
machine. Before you will able to use the rowing machine, however, you will participate 
in an approximately 8-week muscle conditioning program that will strengthen your thigh 
muscles. Both the muscle conditioning phase and the subsequent rowing phase will 
require the use of a device called a muscle stimulator. This device uses a technology 
known as Functional Electrical Stimulation or FES. The muscle stimulator is a battery-
powered device that delivers a small electrical signal to your muscles from electrodes 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 2 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
that are placed on the surface of the skin overlying your thigh muscles on both the front 
of your thighs (quadriceps muscles) and the back of your thighs (hamstrings muscles). 
These electrodes are connected by electrical cables to the battery-powered FES 
stimulator. The stimulator unit we will use is currently designated as an investigation 
device, however the exact model of stimulator has been used successfully for many 
years and continues to be used by a number of research laboratories throughout the 
world. Since your leg muscles will likely be weak from lack of use since your spinal cord 
injury, the purpose of the 8-week muscle conditioning phase is to strengthen your thigh 
muscles so that you are subsequently able to perform the rowing exercise. 
 
During the first four weeks of the muscle conditioning phase you will visit VA Palo Alto 
three times per week, typically Monday, Wednesday and Friday. Each training session 
will last for up to 60 minutes. During weeks 5 through 8 of participation, your muscle 
conditioning sessions may be increased to five sessions per week, provided you are 
able to attend that often. At a minimum, you are expected to have three muscle 
conditioning sessions each week during weeks 5 through 8.  
 
During the muscle conditioning phase, you will sit in your wheelchair or on the edge of a 
raised padded exam table with your knees flexed (bent) at 90 degrees. The muscle 
stimulator is initially programmed to provide stimulation for 5 seconds to activate the 
front thigh muscles in one leg, then stimulation to that leg is turned off. Following 1 
second of rest, the stimulator will apply stimulation for 5 seconds to activate the front 
thigh muscles of your other leg. When the stimulation is turned off to the front muscles 
of one leg, that leg will return to the 90 degree flexed position due to gravity. A pillow 
placed under your leg will cushion your leg when the stimulation to that leg is turned off. 
The goal of strengthening the front thigh muscles is to be able to raise your lower leg 
and fully extend your knee, such that is your knee can maintain a non-bent or extended 
position while the stimulation in turned on. This alternate leg extension exercise delivers 
5 repetitions per leg per minute. 
 
Similarly, the main muscles on the back of your thighs (hamstrings) will be incorporated 
into the leg muscle conditioning once the quadriceps have undergone initial 
strengthening. The hamstrings are activated in each leg only when the stimulation to the 
quadriceps is turned off. During hamstring stimulation, the knee will remain in the bent, 
90° flexed position. A pillow placed between your lower leg and a fixed support will 
prevent any additional flexion of your knee during hamstrings stimulation. Again, 
stimulation will alternate between legs (with stimulation to the quadriceps turned off), 
with 5 seconds of stimulation for one leg, followed by a 1 second rest and then 5 
seconds of stimulation for the other leg. 
 
Each session of muscle conditioning will last up to 60 minutes. 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 3 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
You will be ready to progress to the rowing exercise as soon as your front thigh muscles 
are able to extend one knee fully during 5 seconds of stimulation, and then extend the 
other knee fully during 5 seconds of stimulation and to repeat this alternating process 
for 30 minutes. The muscle conditioning phase of the exercise program typically takes 8 
weeks, although not all individuals respond at the same rate, and a given individual may 
take less or more time. It should be remembered that until your thigh muscles are 
adequately conditioned you will not be able to progress to the rowing phase, since 
rowing will not produce a skeletal benefit without adequate thigh muscle strength. 
 
Once you have achieved adequate muscle conditioning, the Functional Electrical 
Stimulation (FES) rowing phase can begin. During FES-rowing, the stimulation 
electrodes are placed over the same muscles that were strengthened during the muscle 
condition phase. In the case of rowing, you will be sitting on the seat of a rowing 
machine and your feet will be secured to foot plates on the stationary part of the rowing 
machine. The rowing machine is a commercial exercise machine that has been adapted 
for use by individuals with spinal cord injury. The FES-rowing machine that we will use 
is the same as machines in current use in multiple research laboratories around the 
world, including England, Boston and Alberta, CA. The seat on the rower has a backrest 
and a harness system. The seat, backrest and harness system will provide stability for 
your torso during rowing. You will use your hands to hold the handle of the rowing 
machine. The handle attaches via a chain to the part of the machine that uses 
resistance to exercise your arms as you pull. 
 
During rowing, the muscles on the front and back of your thigh will be alternately 
simulated by pressing and releasing a push button on the rowing handle . This button 
controls which muscles are being stimulated. When the push button is pressed, the 
muscles on the front of your thighs (quadriceps) are stimulated; when the button is 
released, the muscles on the back of your thigh (hamstrings) will be stimulated. This will 
cause your knees to automatically extend and flex in a cyclic pattern as the push button 
is pressed and released. With practice you will quickly learn to pull on the rower handle 
while pressing the push button to extend your legs, to push the seat rearwards, and 
extend your arms while releasing the push button, to flex your legs, moving the seat 
forwards. This technique will mimic the pattern used by experienced rowers. The 
ultimate goal of your rowing exercise is for you to be able to row for 30 minutes without 
stopping and to do this on alternate days, three times per week. 
 
At four points during the course of your participation, we will measure the bone density 
in your thigh bone (upper leg bone) and shank bone (lower leg bone) using two bone 
scanners that provide complimentary information on the health of your skeleton. These 
measurements are non-invasive and painless. 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 4 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
Your bone density measurements will take place at two laboratories located on the 
campus of the VA Palo Alto Health Care System. Prior to your visits we will provide you 
with instructions on where to meet a member of our staff who will escort you to the two 
laboratories. The measurements we will make are designed to give us a very precise 
assessment of how much bone there is in key parts of your skeleton; the quantity we 
will measure is called ‘bone mineral density.’ We will determine the bone mineral 
density for your spine, one of your hips, as well as locations above and below your 
knee, and above your ankle. 
The first scanner that we will use is called a Dual energy X-ray Absorptiometry scanner, 
often referred to as DXA scanner. This scanner provides us with a two-dimensional 
image of your bone and a quantitative bone density “score” for your spine and hip which 
can be used to compare your bone density to the bone density in young individuals with 
healthy skeletons. We will also use this scanner to measure the bone density above 
your knee, which is a region that is susceptible to fracture in individuals with long-
standing spinal cord injuries. During DXA scanning you will on your back on a padded 
table while a scan arm passes above the region of your body being scanned. 
The second scanner we will use is called a peripheral Quantitative Computed 
Tomography scanner, often referred to as a pQCT scanner. This scanner provides use 
with three-dimensional information, which compliments the information from the two-
dimensional DXA scan, and which we can use to estimate the strength of your bones. 
We will use this scanner to measure the bone density and bone geometry at two sites 
above your knee, one site just below your knee and one site just above your ankle. As 
stated previously, these regions are considered key skeletal sites since they are 
susceptible to fracture in individuals with long-standing spinal cord injuries. During 
pQCT scanning you will lie on your back on a padded table with one leg placed in the 
bore of the pQCT scanner. Since this scanner is designed to scan only peripheral sites, 
such as the legs, no part of the scanner will cover any other part of your body and there 
will be no sense of claustrophobia, like there could be with a whole-body CT scanner. 
At four times during your approximately 36-week participation we may conduct strength 
testing of your quadriceps and hamstrings. This will be done using the same muscle 
stimulator that you will use during muscle conditioning and rowing. The goal of this 
testing is to assess how strong your quadriceps and hamstrings muscles are at different 
phases of the exercise program. For these strength tests, we will use a strap around 
your ankle to prevent your leg from moving and we will use a force sensor connected to 
the strap to determine how much force you generate when your quadriceps and 
hamstrings are individually activated. 
The final measurements we will make involve a procedure called motion capture. For 
these tests we will tape a number of small (5/8” diameter) reflective markers to various 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 5 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
parts of you body and we will have you perform FES rowing while we capture the 
motion of the reflective markers using a series of special digital cameras. We will also 
record the forces that are created under your feet and in the chain that connects the 
handle to the rowing machine. With the motion and force data we will be able to 
estimate the internal forces that exist within your ankles and knees using three-
dimensional computer models while you are rowing. We believe that the magnitude of 
the estimated forces will provide us with new insights into how skeletal health can be 
maintained in individuals following a spinal cord injury. 
Visit Schedule: Your visits to VA Palo Alto will take place on the following schedule: 
Weeks 1-4: 3 visits per week 
Weeks 5-8: 3 to 5 visits per week 
Weeks 9-36: 3 visits per week 
 
The majority of visits will last approximately 1.5 hours. The four visits involving bone 
density measurements and muscle strength testing will last approximately 3.5 hours. 
The three visits involving motion capture experiments will last approximately 4 hours.  
 
Women of Childbearing Potential 
If you are a woman who is able to become pregnant, it is expected that you will use an 
effective method of birth control to prevent exposing a fetus to a potentially dangerous 
agent with unknown risk. If you are pregnant or currently breast feeding, you may not 
participate in this study. You understand that if you are pregnant, if you become 
pregnant, or if you are breast-feeding during this study, you or your child may be exposed 
to an unknown risk. 
 
To confirm to the extent medically possible that you are not pregnant, you agree to begin 
the study after the onset of your next menstrual period. You must agree to avoid sexual 
intercourse or use a birth control method judged to be effective by the investigator and 
which will not interfere with the proposed investigation. You must accept the risk that 
pregnancy could still result despite the responsible use of a reliable method of birth 
control. You agree to notify the investigator as soon as possible of any failure of proper 
use of your birth control method, or if you become pregnant, either of which may result in 
your being withdrawn from the study. 
 
Access to Medical Records: 
We may access your medical records in order to identify any medical conditions that 
could be relevant to the research study and/or which may influence the safety of your 
participation. 
 
PARTICIPANT RESPONSIBILITIES  

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 6 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
 
As a participant, your responsibilities include: 
 
• Follow the instructions of the investigators and study staff. 
• Keep your study appointments. If it is necessary to miss an appointment, please 
contact the investigators or research study staff to reschedule as soon as you 
know you will miss the appointment. 
• Tell the investigators or research study staff about any side effects, doctor visits, 
change in medications, or hospitalizations that you may have. 
• Tell the investigators or research staff if you believe you might be pregnant. 
• Ask questions as you think of them. 
• Tell the investigators or research staff if you change your mind about staying in 
the study. 
 
WITHDRAWAL FROM STUDY 
 
If you first agree to participate and then you change your mind, you are free to 
withdraw your consent and stop your participation at any time. If you decide to 
withdraw from the study, you will not lose any benefits to which you would otherwise be 
entitled.  
 
If you want to stop being in the study you should tell the investigators or study staff. You 
can do this by phone by calling Dr. Beaupre at (650) 493-5000 extension 64272. 
 
The investigators may also withdraw you from the study without your consent for one or 
more of the following reasons: 
 
o Failure to follow the instructions of the investigators and/or study 
staff. 
o The investigators decide that continuing your participation could be 
harmful to you. 
o Pregnancy (if applicable). 
o You need treatment not allowed in the study. 
o The study is cancelled.  
o Other administrative reasons. 
o Unanticipated circumstances. 
 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 7 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
This study involves the following risks, discomforts, and possible inconveniences:  
 
Inconveniences and discomforts: 
 
1. Time required for participation in the study 
2. Travel to and from our study site 
3. Time lying still for the bone density scans 
4. Muscle strain 
5. Mild autonomic dysreflexia 
6. Increase in neuropathic (“nerve”) pain 
7. Increase in spasticity 
8. High physical exertion when rowing 
 
Risks: 
Privacy Risk: Though all possible precautions will be followed to ensure your privacy, 
there is a very small risk of privacy loss. This could have legal, employment, and social 
consequences. 
Risks of Radiation: This research study involves exposure to radiation from bone 
density scanners. This radiation exposure is not necessary for your medical care and is 
for research purposes only. The additional amount of radiation is approximately equal to 
2 days of radiation exposure from natural sources like the sun, ground and water. This 
amount of radiation involves minimal risk and is necessary to obtain the research 
information desired. 
Risk of a fall during transfer to or from rowing machine: There is a possibility that you 
may fall while transferring to or from the rowing machine or to or from the table you will 
lie on while having your bone density scans. The risk of falling can be minimized to a 
very low level by using safe transfer techniques. You will be required to demonstrate the 
use of a safe transfer technique during your initial assessment visit. 
 
Soft tissue reaction during FES training: A soft tissue reaction to muscle conditioning 
and FES-rowing can be associated with several causes. The first is a local reddening of 
the skin under the electrodes. This reddening is thought to be due to an increase in 
blood flow beneath the electrode caused by the electrical stimulation. This reddening 
typically lasts for less than one hour after stimulation is stopped. This reddening is 
expected to occur to some degree with all participants. 
 
Reddening may also potentially occur as a result of an allergic reaction to the gel used 
to adhere the surface electrode to the skin. If reddening of the skin persists for much 
longer than one hour after removal of the electrode, then an allergic reaction is a 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 8 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
possible cause. If a participant has an allergic reaction to the gel, we can try a different 
electrode with a different gel. 
 
The third and final potential skin reaction is reddening suggestive of the initiation of soft 
tissue breakdown (e.g., a "pressure sore") due to excessive pressure or shear stress. 
This potential for skin breakdown exists for all individuals who utilize a wheelchair for 
prolonged periods. To the best of our knowledge no prior FES-rowing participants have 
experienced a skin breakdown or pressure sore caused by their participation in an FES-
rowing program. Nevertheless, before and after each session, we will look for any signs 
of bruising or swelling that might be suggestive of tissue breakdown, paying particular 
attention to the shoulders, back, buttocks, upper calves and knee areas. 
 
Serious autonomic dysreflexia during FES training: Autonomic dysreflexia (AD) is a 
condition which can occur in people who have sustained a spinal cord injury. Autonomic 
dysreflexia is more common in individuals with tetraplegia (quadriplegia), but it can also 
occur in individuals with paraplegia. Autonomic dysreflexia can be brought on by a 
variety of stimuli, including a full bladder or bowel, a pressure sore or infection, exercise, 
or by Functional Electrical Stimulation. Possible symptoms of an AD reaction include: 
 
• Severe headache 
• Flushing or blotching of the skin above the level of the spinal cord injury 
• Profuse sweating, particularly above the level of the spinal cord injury 
• Increased blood pressure 
• Decreased heart rate 
 
Generally, an AD reaction will quickly diminish once the initiating stimulus that caused 
the reaction is removed. To reduce the risk of an AD response, all participants will be 
encouraged to completely empty their bladder prior to each muscle conditioning or 
rowing session. The risk of an AD response should also decrease as training 
progresses and your muscles become conditioned from the electrical stimulation. Thus, 
the risk of AD is highest during the initial muscle conditioning session. During your first 
muscle conditioning session we will assess the ability of your muscles to respond to the 
electrical stimulation and we will pay particular attention to any signs of an AD 
response. It is possible that an AD response that is greater than mild might be identified 
at your initial session and that could mean that you are not an acceptable candidate for 
continuation in the study. 
  
It is important to note that FES-rowing researchers in England and Boston have never 
had a participant in their FES-rowing programs experience a severe case of AD, and 
those participants who have experienced mild cases of AD also typically experience 
mild cases of AD during their everyday lives. Therefore, we believe the risk of 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 9 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
experiencing a severe case of AD from participation in this study is very low, although 
the possibility of experiencing a mild case of AD is higher. At the first sign of an AD 
response, electrical stimulation will be stopped. Additional medical treatment in the case 
of a severe AD response will be available in our testing facilities. 
 
It should also be noted that an individual's likelihood of having an AD episode in 
response to exercising part of the body below the level of a spinal cord injury will be 
heightened if an individual already has an underlying condition that is perceived by their 
body as a noxious stimulus. For example, an individual with a bladder infection might be 
more prone to an AD episode from an additional stimulus, such as Functional Electrical 
Stimulation of the legs, compared to an individual without a bladder infection. Therefore, 
it is important that any underlying noxious stimulus that might predispose an individual 
to an AD response is identified as early as possible and addressed before commencing 
or continuing with the rowing exercise. 
 
Muscle strain during muscle conditioning, strength testing or FES-assisted rowing: As 
with participating in any exercise program, there is a risk of experiencing a muscle 
strain. Based on the experience of other researchers with FES-rowing programs, only 
two out of thirty FES-rowing participants have ever experienced a muscle strain. Muscle 
strains have never been observed in the lower limbs. For both participants with muscle 
strains, the strain occurred in the torso, between innervated and paralyzed muscle. 
These strains were treated by ceasing FES training for 48 to 72 hours and by the use of 
ice and over-the-counter analgesics. Neither of the two individuals who experienced a 
muscle strain has had a repeat incident and we believe the risk of a muscle strain is 
low. 
 
Lower limb fracture during muscle conditioning, strength testing or FES-assisted rowing: 
The use of FES to stimulate paralyzed muscles in individuals with SCI has been studied 
for more than 50 years. Over that 50-year period there have been two reported cases of 
a fracture related to the use of functional electrical stimulation. One individual fractured 
their knee cap and a second individual fractured their thigh bone. Although the total 
number of individuals with SCI who have used functional electrical stimulation to 
exercise the lower limbs is not known, we believe the risk of a fracture is very low given 
that there have only been two reported fractures in 50 years of FES use. To further 
reduce the risk of fracture, only participants who have never experienced a low-energy 
fracture will be allowed to take part in this study. In addition, we will measure your bone 
density at the beginning of the study and those measurements will provide us with an 
initial assessment of the health of your bones. If we believe your bones are too weak to 
safely undergo the muscle conditioning and rowing exercise, you will not be able to 
continue in the study. 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 10 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
Increase in neuropathic (“nerve”) pain or an increase in sensory pain from FES: Some 
individuals with spinal cord injuries individuals have what is known as neuropathic pain. 
Neuropathic pain can range from a mild tickling sensation to a severe burning 
sensation. It is not known what effect, if any, electrical stimulation has on this condition. 
In addition, some individuals with SCI who retain some sensation in their thighs may 
find the electrical stimulation to be uncomfortable or even intolerable. If you experience 
an increase in neuropathic pain to an unacceptable level or if the electrical stimulation 
produces a sensation which you find unacceptable, it may be necessary for you to 
withdraw from the study. 
 
Increase in spasticity to an unmanageable level: It is not known what effect FES has on 
the intensity and frequency of muscle spasticity. In other FES-rowing programs, a few 
participants have had an increase in spasticity, while some have had a decrease. In 
general, spasticity levels should be reduced after a muscle conditioning or rowing 
session, since the muscles will be fatigued. However, if you experience increased 
spasticity that is unmanageable, it may be necessary for you to withdraw from the study. 
Unforeseen Risks: There may be other risks to participating in this study that are not 
foreseeable. 
POTENTIAL BENEFITS 
We cannot and do not guarantee that you will received any benefits from this study. 
Nevertheless, it is possible that participating in an FES-rowing exercise program may 
reduce bone loss in parts of your legs. Since the spine and hip DXA scans that we will 
perform represent a clinical standard by which osteoporosis is assessed, we will provide 
you with copies of the results of your spine and hip DXA scans which you are free to 
share with your personal physician, who should be able to help you interpret your bone 
density results. 
Please note that at the present time rowing with FES is not available within the VA 
clinical facility, and stimulators are not available for distribution outside of research use.  
However, the VA Palo Alto SCI Center is developing a program to support adaptive 
rowing under the auspices of recreation therapy, and so in the future there may be 
opportunities for veterans with SCI to access this program as part of inpatient or 
outpatient therapy.  
ALTERNATIVES 
 
Your alternative is simply to not participate in this study.  
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 11 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
PARTICIPANT’S RIGHTS 
 
You should not feel obligated to agree to participate. Your questions should be 
answered clearly and to your satisfaction.  
 
You will be told of any important new information that is learned during the course of 
this research study, which might affect your condition or your willingness to continue 
participation in this study. 
 
ClinicalTrials.gov 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify 
you.  At most, the Web site will include a summary of the results.  You can search this 
Web site at any time. 
 
CONFIDENTIALITY 
 
We will keep your name and all the information you tell us in this study as confidential 
as possible. We may publish the results of this study for others to read about, but you 
will not be identified in any articles about the study by name, social security number, 
address, telephone number, or any other direct personal identifier. Also, other federal 
agencies as required, such as the VA Office of Research Oversight and the VA Office of 
the Inspector General may have access to your information.  
 
FINANCIAL CONSIDERATIONS 
 
Payment 
 
As a token of our appreciation for your participation, you will receive a total of $450 for 
your full participation in this study. You will receive a $150 payment after you complete 
each of three phases of the study, according to the following milestones: 
Milestone 1) 12-weeks of participation and completion of 31 exercise sessions:  $150 
Milestone 2) 24-weeks of participation and completion of 61 exercise sessions:  $150 
Milestone 3) 36-weeks of participation and completion of 92 exercise sessions:  $150 
 
Payments may only be made to U.S. citizens, legal resident aliens, and those who have 
a work eligible visa. 
 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 12 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
Costs 
 
There will be no costs to you for any of the treatment or testing done as part of this 
research study. However, medical care and services provided by the VA that are not 
part of this study (e.g., normal hospital and prescription expenses which are not part of 
the research study) may require co-payments if your VA-eligibility category requires co-
payment for VA services. 
 
You will not have to pay anything to be in this study, although you will have to provide 
for your own transportation to and from the VA Palo Alto Campus.  
 
Sponsor 
 
The Department of Veterans Affairs is providing financial support and/or material for this 
study.  
 
COMPENSATION for Research Related Injury 
 
If you are injured as a direct result of being in this study, medical treatment will be 
available. If you are eligible for veteran’s benefits, the cost of such treatment will be 
covered by the VA. If not, the cost of such treatments may still be covered by the VA 
depending on a number of factors. In most circumstances, the treatment must be 
provided in a VA medical facility. No other form of compensation for injuries is available. 
However, by signing this form you have not released the VA from liability for negligence. 
For further information, you may call the Human Protections Administrator at (650) 493-
5000, ext. 67593 or the V.A. Regional Counsel at (415) 750-2288. 
 
CONTACT INFORMATION  
 
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints 
about this research study, its procedures, risks and benefits, or alternative courses of 
treatment, you should ask the principal investigator, Dr. Beaupre at (650) 493-5000 
extension 64272. You should also contact him at any time if you feel you have been hurt 
by being a part of this study.  
 
Independent Contact:  If you are not satisfied with how this study is being conducted, 
or if you have any concerns, complaints, or general questions about the research or 
your rights as a participant, please contact the Stanford Institutional Review Board 
(IRB) to speak to someone independent of the research team at (650)-723-5244 or toll 
free at 1-866-680-2906.  You can also write to the Stanford IRB, Stanford University, 
3000 El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306.. 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 13 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
 
Appointment Contact: If you need to change your appointment, please contact Dr. 
Lambach at (650) 493-5000 extension 69411. 
 
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS 
 
As a research participant you have the following rights. These rights include but are not 
limited to the participant's right to: 
• 
be informed of the nature and purpose of the experiment;  
• 
be given an explanation of the procedures to be followed in the medical 
experiment, and any drug or device to be utilized;  
• 
be given a description of any attendant discomforts and risks reasonably to be 
expected;  
• 
be given an explanation of any benefits to the subject reasonably to be expected, 
if applicable;  
• 
be given a disclosure of any appropriate alternatives, drugs or devices that might 
be advantageous to the subject, their relative risks and benefits; 
• 
be informed of the avenues of medical treatment, if any available to the subject 
after the experiment if complications should arise;  
• 
be given an opportunity to ask questions concerning the experiment or the 
procedures involved;  
• 
be instructed that consent to participate in the medical experiment may be 
withdrawn at any time and the subject may discontinue participation without 
prejudice;  
• 
be given a copy of the signed and dated consent form; and  
• 
be given the opportunity to decide to consent or not to consent to a medical 
experiment without the intervention of any element of force, fraud, deceit, duress, 
coercion or undue influence on the subject's decision. 
 
May we contact you (by phone or mail) about future research studies that may be of 
interest to you? ____Yes ____No 
 
Signing your name means you agree to be in this study and that you were given a copy 
of this consent form. 
 
 
 
 
Signature of Participant 
 
 
 
 
 
Date 
 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Skeletal Benefits from FES-Rowing in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 14 of 14 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
________________________________ 
Print Name of Participant  
 
 
 
 
 
 
 
Signature of Person Obtaining Consent  
 
 
Date 
 
 
________________________________ 
Print Name of Person Obtaining Consent  
 
 
 
 
 
 
 

 
  
This page separates the  
Informed Consent Document (above) 
from the  
HIPAA Authorization document 
(below) 
 
To preserve formatting, please  
DO NOT DELETE this page 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 1 of 3 
HIPAA (Health Insurance Portability & Accountability Act) is a federal 
privacy law that protects the confidentiality of health information collected 
about you. The following explains how health information collected about 
you will be used by the investigators and who they may share your health 
information with as part of this research.  
 
What is the purpose of the research study, and how will my health 
information be utilized in the study? 
 
In this study we hope to determine if the amount of bone loss at skeletal 
locations in the lower limbs in individuals with a spinal cord injury can be 
positively influenced by participating in a 36-week FES muscle conditioning 
and rowing program. We plan to use the information obtained in this study 
to compare to the results in a companion study of individuals with SCI who 
are not participating in an FES exercise program. 
 
What Personal Health Information Will Be Used or Shared? 
 
The following health information, linked to you by name, address, e-mail 
address, phone number and/or date of birth, will be used for this research: 
 
• 
Medical history and physical examination information 
• 
Bone density scans 
• 
Photographs, videotapes, other images 
 
Who May Use or Share Your Health Information? 
 
By signing this document, you allow the following individuals and entities to 
obtain, use and share your health information for this research study:  
 
• The Principal Investigator, Gary Beaupre, and members of the VA 
research team.  
• Departments within the VA Health Care System responsible for the 
oversight, administration, or conduct of research.  
• The Stanford University Administrative Panel on Human Subjects in 
Medical Research and other Stanford University Officials responsible 
for the oversight, administration, or conduct of research. 
 
 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 2 of 3 
Who May Receive and Use Your Health Information 
 
The investigators may share your health information with the following 
individuals/entities as part of this research study.  
 
• The Office for Human Research Protections in the U.S. Department 
of Health and Human Services 
• The Food and Drug Administration 
 
Health information shared pursuant to this authorization may no longer be 
protected by Federal laws or regulations and may be further shared by the above 
individuals/entities who receive the health information.  
 
Do I have to sign this form? 
 
No. Signing this form is voluntary. The VA may not condition treatment, 
payment, enrollment or eligibility for benefits based on signing this form. If 
you decide not to sign the form, you will not be able to take part in this 
study.  
 
If I sign now, can I decide later not to continue in the study? 
 
Yes. You are free to take back your permission and stop being in the study. 
The investigators will not collect any more information about you after you 
take back your permission, but they can continue to use your information 
that was collected before you took back your permission.  
 
Your request to take back your permission must be done in writing. Either 
give or send your written request to the investigator: 
 
Dr. Gary S. Beaupre 
Musculoskeletal Research Laboratory (Mail Code 153) 
VA Palo Alto Health Care System 
3801 Miranda Avenue 
Palo Alto, CA 94304 
 
 
 
 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 3 of 3 
Does My Permission for the use my Personal Health Information 
Expire? 
 
Yes. Your information cannot be used forever. Your permission related to 
the use and sharing of your health information expires on 12/31/2023. 
 
HIPAA regulations require you to give separate written permission 
(signature) for the use of your protected health information. 
 
 
__________________________________________ __________ 
Signature of Participant 
 
 
 
 
 
Date 
 
 
 
__________________________________________ 
Printed Name of Participant  
 
 
 
 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 1 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
Are you participating in any other research studies? _____ yes _____no 
 
PURPOSE OF RESEARCH  
 
You are invited to participate in a research study to monitor changes to the skeleton in 
the lower limbs after spinal cord injury and with participation in a program of rowing with 
electrical stimulation of the legs. You are not a participant in the rowing exercise part of 
the study either because you did not want to participate or because of a medical reason 
that prevented you from qualifying. We hope to determine whether the rowing exercise 
may slow the rate of bone loss in the legs. You were selected as a possible subject in this 
study because you had a spinal cord injury more than 3 months ago, but less than 24 
months ago, and your information can be used for comparison with information from the 
individuals who do participate in the rowing program. We are hoping to enroll five people 
in the rowing study and five people who are not participating in rowing. 
 
VOLUNTARY PARTICIPATION  
 
Your participation in this study is entirely voluntary. Your decision not to participate will 
not have any negative effect on you or your medical care. You can decide to participate 
now, but withdraw your consent later and stop being in the study without any loss of 
benefits or medical care you are entitled to.  
 
DURATION OF STUDY INVOLVEMENT  
 
This research study is expected to take approximately two years in total. Each 
participant will be enrolled in the study for approximately 36 weeks or 9 months. During 
this approximately 36-week period, each participant will have a total of four visits to the 
VA Palo Alto Health Care System campus. Your first visit will take approximately 3.5 
hours, including the time to assess your enrollment eligibility, to complete the informed 
consent process, and to complete your initial bone density scans if you are eligible and 
elect to participate in the study. The subsequent three visits should take no more than 
2.5 hours each. Your total participation time for the four visits combined will be about 11 
hours. After your first visit, we will schedule you for return visits approximately 12 
weeks, 24 weeks, and 36 weeks later. 
 
PROCEDURES 
 
If you choose to participate, the investigators will measure the bone density in your thigh 
bone (upper leg bone) and shank bone (lower leg bone) using two bone scanners that 
provide complimentary information on the health of your skeleton. These measurements 
are non-invasive and painless. 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 2 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
 
Your bone density measurements will take place at two laboratories located on the 
campus of the VA Palo Alto Health Care System. Prior to your visits we will provide you 
with instructions on where to meet a member of our staff who will escort you to the two 
laboratories. The measurements we will make are designed to give us a very precise 
assessment of how much bone there is in key parts of your skeleton; the quantity we 
will measure is called ‘bone mineral density.’ We will determine the bone mineral 
density for your spine, one of your hips, as well as locations above and below your 
knee, and above your ankle. 
The first scanner that we will use is called a Dual energy X-ray Absorptiometry scanner, 
often referred to as DXA scanner. This scanner provides us with a two-dimensional 
image of your bone and a quantitative bone density “score” for your hip which can be 
used to compare your bone density to the bone density in young individuals with healthy 
skeletons. We will also use this scanner to measure the bone density above your knee, 
which is a region that is susceptible to fracture in individuals with long-standing spinal 
cord injuries. During DXA scanning you will lie on your back on a padded table while a 
scan arm passes above the region of your body being scanned. 
The second scanner we will use is called a peripheral Quantitative Computed 
Tomography scanner, often referred to as a pQCT scanner. This scanner provides use 
with three-dimensional information, which compliments the information from the DXA 
scan, and which we can use to estimate the strength of your bones. We will use this 
scanner to measure the bone density and bone geometry at two sites above your knee, 
one site just below your knee and one site just above your ankle. As stated previously, 
these regions are key skeletal sites since they are susceptible to fracture in individuals 
with long-standing spinal cord injuries. During pQCT scanning, you will lie on your back 
on a padded table with one leg placed in the pQCT scanner. Since this scanner is 
designed to scan only peripheral sites, such as the legs, no part of the scanner will 
cover any other part of your body and there will be no sense of claustrophobia, like 
there could be with a whole-body CT scanner. 
Although bone density measurements are typically not done as part of the standard of 
care following a spinal cord injury, we require bone density measurements in both the 
non-exercise group and in the exercise group in order for us to determine if exercising 
has any benefit to bone health compared to not exercising. 
Visit Schedule: Your bone density measurements will take place during four visits to VA 
Palo Alto at the following time points: 1) at your first visit, after signing an informed 
consent; 2) approximately 12 weeks later; 3) approximately 24 weeks after your first 
visit; and 4) approximately 36 weeks after your first visit. 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 3 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
 
Women of Childbearing Potential 
If you are a woman who is able to become pregnant, it is expected that you will use an 
effective method of birth control to prevent exposing a fetus to a potentially dangerous 
agent with unknown risk. If you are pregnant or currently breast feeding, you may not 
participate in this study. You understand that if you are pregnant, if you become 
pregnant, or if you are breast-feeding during this study, you or your child may be exposed 
to an unknown risk. 
 
To confirm to the extent medically possible that you are not pregnant, you agree to begin 
the study after the onset of your next menstrual period. You must agree to avoid sexual 
intercourse or use a birth control method judged to be effective by the investigator and 
which will not interfere with the proposed investigation. You must accept the risk that 
pregnancy could still result despite the responsible use of a reliable method of birth 
control. You agree to notify the investigator as soon as possible of any failure of proper 
use of your birth control method, or if you become pregnant, either of which may result in 
your being withdrawn from the study. 
 
Access to Medical Records: 
We may access your medical records in order to identify any medical conditions that 
could be relevant to the research study and/or which may influence the safety of your 
participation. 
 
PARTICIPANT RESPONSIBILITIES  
 
As a participant, your responsibilities include: 
 
• Follow the instructions of the investigators and study staff. 
• Keep your study appointments. If it is necessary to miss an appointment, please 
contact the investigators or research study staff to reschedule as soon as you 
know you will miss the appointment. 
• Tell the investigators or research study staff about any side effects, doctor visits, 
change of medications, or hospitalizations that you may have. 
• Tell the investigators or research staff if you believe you might be pregnant. 
• Ask questions as you think of them. 
• Tell the investigators or research staff if you change your mind about staying in 
the study. 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 4 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
WITHDRAWAL FROM STUDY 
 
If you first agree to participate and then you change your mind, you are free to 
withdraw your consent and stop your participation at any time. If you decide to 
withdraw from the study, you will not lose any benefits to which you would otherwise be 
entitled.  
 
If you want to stop being in the study you should tell the investigators or study staff. You 
can do this by phone by calling Dr. Beaupre at (650) 493-5000 extension 64272. 
 
The investigators may also withdraw you from the study without your consent for one or 
more of the following reasons: 
 
o Failure to follow the instructions of the investigators and/or study 
staff. 
o The investigators decide that continuing your participation could be 
harmful to you. 
o Pregnancy (if applicable). 
o You need treatment not allowed in the study. 
o The study is cancelled.  
o Other administrative reasons. 
o Unanticipated circumstances. 
 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
 
This study involves the following risks, discomforts, and possible inconveniences:  
 
Inconveniences and discomforts: 
 
1. Time required for participation in the study 
2. Travel to and from our study site 
3. Time lying still for the bone density scans 
 
Risks: 
Privacy Risk: Though all possible precautions will be followed to ensure your privacy, 
there is a very small risk of privacy loss. This could have legal, employment, and social 
consequences. 
Risks of Radiation: This research study involves exposure to radiation from bone 
density scanners. This radiation exposure is not necessary for your medical care and is 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 5 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
for research purposes only. The additional amount of radiation is approximately equal to 
2 days of radiation exposure from natural sources like the sun, ground and water. This 
amount of radiation involves minimal risk and is necessary to obtain the research 
information desired. 
Unforeseen Risks: There may be other risks to participating in this study that are not 
foreseeable. 
POTENTIAL BENEFITS 
We cannot and do not guarantee that you will receive any benefits from this study. 
Since the hip DXA scans that we will perform represent a clinical standard by which 
osteoporosis is assessed, we will provide you with copies of the results of your hip DXA 
scans which you are free to share with your personal physician, who should be able to 
help you interpret your bone density results. 
ALTERNATIVES 
 
Your alternative is simply to not participate in this study.  
 
PARTICIPANT’S RIGHTS 
 
You should not feel obligated to agree to participate. Your questions should be 
answered clearly and to your satisfaction.  
 
You will be told of any important new information that is learned during the course of 
this research study, which might affect your condition or your willingness to continue 
participation in this study. 
 
ClinicalTrials.gov 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify 
you.  At most, the Web site will include a summary of the results.  You can search this 
Web site at any time. 
 
CONFIDENTIALITY 
 
We will keep your name and all the information you tell us in this study as confidential 
as possible. We may publish the results of this study for others to read about, but you 
will not be identified in any articles about the study by name, social security number, 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 6 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
address, telephone number, or any other direct personal identifier. Also, other federal 
agencies as required, such as the VA Office of Research Oversight and the VA Office of 
the Inspector General may have access to your information.  
 
FINANCIAL CONSIDERATIONS 
 
Payment 
 
As a token of our appreciation for your participation, you will receive a $50 payment 
after you complete each of the four DXA assessments. 
 
Payments may only be made to U.S. citizens, legal resident aliens, and those who 
have a work eligible visa. 
 
Costs 
 
There will be no costs to you for any of the treatment or testing done as part of this 
research study. However, medical care and services provided by the VA that are not 
part of this study (e.g., normal hospital and prescription expenses which are not part of 
the research study) may require co-payments if your VA-eligibility category requires co-
payment for VA services. 
 
You will not have to pay anything to be in this study, although you will have to provide 
for your own transportation to and from the VA Palo Alto Campus.  
 
Sponsor 
 
The Department of Veterans Affairs is providing financial support and/or material for this 
study.  
 
COMPENSATION for Research Related Injury 
 
If you are injured as a direct result of being in this study, medical treatment will be 
available. If you are eligible for veteran’s benefits, the cost of such treatment will be 
covered by the VA. If not, the cost of such treatments may still be covered by the VA 
depending on a number of factors. In most circumstances, the treatment must be 
provided in a VA medical facility. No other form of compensation for injuries is available. 
However, by signing this form you have not released the VA from liability for negligence. 
For further information, you may call the Human Protections Administrator at (650) 493-
5000, ext. 67593 or the V.A. Regional Counsel at (415) 750-2288. 
 
CONTACT INFORMATION  

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 7 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
 
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints 
about this research study, its procedures, risks and benefits, or alternative courses of 
treatment, you should ask the principal investigator, Dr. Beaupre at (650) 493-5000 
extension 64272. You should also contact him at any time if you feel you have been hurt 
by being a part of this study.  
 
Independent Contact:  If you are not satisfied with how this study is being conducted, 
or if you have any concerns, complaints, or general questions about the research or 
your rights as a participant, please contact the Stanford Institutional Review Board 
(IRB) to speak to someone independent of the research team at (650)-723-5244 or toll 
free at 1-866-680-2906.  You can also write to the Stanford IRB, Stanford University, 
3000 El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306.. 
 
Appointment Contact: If you need to change your appointment, please contact Dr. 
Lambach at (650) 493-5000 extension 69411. 
 
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS 
 
As a research participant you have the following rights. These rights include but are not 
limited to the participant's right to: 
• 
be informed of the nature and purpose of the experiment;  
• 
be given an explanation of the procedures to be followed in the medical 
experiment, and any drug or device to be utilized;  
• 
be given a description of any attendant discomforts and risks reasonably to be 
expected;  
• 
be given an explanation of any benefits to the subject reasonably to be expected, 
if applicable;  
• 
be given a disclosure of any appropriate alternatives, drugs or devices that might 
be advantageous to the subject, their relative risks and benefits; 
• 
be informed of the avenues of medical treatment, if any available to the subject 
after the experiment if complications should arise;  
• 
be given an opportunity to ask questions concerning the experiment or the 
procedures involved;  
• 
be instructed that consent to participate in the medical experiment may be 
withdrawn at any time and the subject may discontinue participation without 
prejudice;  
• 
be given a copy of the signed and dated consent form; and  
• 
be given the opportunity to decide to consent or not to consent to a medical 
experiment without the intervention of any element of force, fraud, deceit, duress, 
coercion or undue influence on the subject's decision. 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Bone Changes in the Lower Limbs in Individuals with Spinal Cord Injuries 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 8 of 8 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:   September 1, 2015 
Expiration Date: August 31, 2016 
 
 
May we contact you (by phone or mail) about future research studies that may be of 
interest to you? ____Yes ____No 
 
 
 
Signing your name means you agree to be in this study and that you were given a copy 
of this consent form. 
 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
Date 
 
 
________________________________ 
Print Name of Participant  
 
 
 
 
 
 
 
Signature of Person Obtaining Consent  
 
 
Date 
 
 
________________________________ 
Print Name of Person Obtaining Consent  
 
 
 
 
 
 
 

 
  
This page separates the  
Informed Consent Document (above) 
from the  
HIPAA Authorization document 
(below) 
 
To preserve formatting, please  
DO NOT DELETE this page 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 1 of 3 
HIPAA (Health Insurance Portability & Accountability Act) is a federal 
privacy law that protects the confidentiality of health information collected 
about you. The following explains how health information collected about 
you will be used by the investigators and who they may share your health 
information with as part of this research.  
 
What is the purpose of the research study, and how will my health 
information be utilized in the study? 
 
In this study we hope to determine the rate of bone loss at skeletal 
locations in the lower limbs that are susceptible to fracture as an individual 
with a spinal cord injury ages. We plan to use this information to compare 
with the results in a companion study to determine the extent to which a 
new exercise program may reduce the amount of bone loss after sustaining 
a spinal cord injury. 
 
What Personal Health Information Will Be Used or Shared? 
 
The following health information, linked to you by name, address, e-mail 
address, phone number and/or date of birth, will be used for this research: 
 
• 
Medical history and physical examination information 
• 
Bone density scans 
 
Who May Use or Share Your Health Information? 
 
By signing this document, you allow the following individuals and entities to 
obtain, use and share your health information for this research study:  
 
• The Principal Investigator, Gary Beaupre, and members of the VA 
research team.  
• Departments within the VA Health Care System responsible for the 
oversight, administration, or conduct of research.  
• The Stanford University Administrative Panel on Human Subjects in 
Medical Research and other Stanford University Officials responsible 
for the oversight, administration, or conduct of research. 
 
Who May Receive and Use Your Health Information 
 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 2 of 3 
The investigators may share your health information with the following 
individuals/entities as part of this research study.  
 
• The Office for Human Research Protections in the U.S. Department 
of Health and Human Services 
• The Food and Drug Administration 
 
Health information shared pursuant to this authorization may no longer be 
protected by Federal laws or regulations and may be further shared by the above 
individuals/entities who receive the health information.  
 
Do I have to sign this form? 
 
No. Signing this form is voluntary. The VA may not condition treatment, 
payment, enrollment or eligibility for benefits based on signing this form. If 
you decide not to sign the form, you will not be able to take part in this 
study.  
 
If I sign now, can I decide later not to continue in the study? 
 
Yes. You are free to take back your permission and stop being in the study. 
The investigators will not collect any more information about you after you 
take back your permission, but they can continue to use your information 
that was collected before you took back your permission.  
 
Your request to take back your permission must be done in writing. Either 
give or send your written request to the investigator: 
 
Dr. Gary S. Beaupre 
Musculoskeletal Research Laboratory (Mail Code 153) 
VA Palo Alto Health Care System 
3801 Miranda Avenue 
Palo Alto, CA 94304 
 
 
 
 
Does My Permission for the use my Personal Health Information 
Expire? 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 3 of 3 
 
Yes. Your information cannot be used forever. Your permission related to 
the use and sharing of your health information expires on 12/31/2023. 
 
HIPAA regulations require you to give separate written permission 
(signature) for the use of your protected health information. 
 
 
__________________________________________ __________ 
Signature of Participant 
 
 
 
 
 
Date 
 
 
 
__________________________________________ 
Printed Name of Participant  
 
 
 
 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 1 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
Are you participating in any other research studies? _____ yes _____no 
 
PURPOSE OF RESEARCH  
 
You are invited to participate in a research study to measure the motions and forces 
during Functional Electrical Stimulation (FES)-assisted rowing, as well as bone density. 
You were selected as a possible participant in this study because you sustained a spinal 
cord injury and you already have more than one year of experience performing FES-
rowing. This research study is looking for at least one individual with a spinal cord injury 
who has at least one year of FES-rowing experience. 
 
VOLUNTARY PARTICIPATION  
 
Your participation in this study is entirely voluntary. Your decision not to participate will 
not have any negative effect on you or your medical care. You can decide to participate 
now, but withdraw your consent later and stop being in the study without any loss of 
benefits or medical care you are entitled to.  
 
DURATION OF STUDY INVOLVEMENT  
 
This research study is expected to take approximately two years in total. Your 
participation will last approximately one week. During this week you will make several 
visits to the VA Palo Alto Health Care System campus. The approximate schedule of 
your visits is outlined near the end of the next section (PROCEDURES). 
 
PROCEDURES 
 
If you choose to participate in this study, we will measure your bone mineral density and 
we will perform movement and force measurements while you perform FES-rowing.  
We will measure the bone density in your thigh bone (upper leg bone) and shank bone 
(lower leg bone) using two bone scanners that provide complimentary information on 
the health of your skeleton. These measurements are non-invasive and painless. 
Your bone density measurements will take place at two laboratories located on the 
campus of the VA Palo Alto Health Care System. The measurements we will make are 
designed to give us an accurate assessment of how much bone there is in key parts of 
your skeleton; the quantity we will measure is called ‘bone mineral density.’ We will 
determine the bone mineral density for your spine and hips, as well as locations just 
above and just below your knees, and just above your ankles. 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 2 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
The first scanner that we will use is called a Dual energy X-ray Absorptiometry scanner, 
often referred to as DXA scanner. This scanner provides us with a two-dimensional 
image of the spine and hip region and a quantitative bone density “score” which can be 
used to compare your bone density to the bone density in young individuals with healthy 
skeletons. We will also use this scanner to measure the bone density above your knees, 
which is a region that is susceptible to fracture in individuals with long-standing spinal 
cord injuries. We will scan you left and right sides separately. During DXA scanning you 
will on your back on a padded table while a scan arm passes above the region of your 
body being scanned. 
The second scanner we will use is called a peripheral Quantitative Computed 
Tomography scanner, often called a pQCT scanner. This scanner provides us with 
three-dimensional information, which complements the information from the two-
dimensional DXA scan. We will use this information to estimate the strength of your 
bones. We will use this scanner to measure the bone density and bone geometry at two 
sites slightly above your knees, one site just below your knees and one site just above 
your ankles. As stated previously, these regions are considered key skeletal sites since 
they are susceptible to fracture in individuals with long-standing spinal cord injuries. 
During pQCT scanning you will lie on your back on a padded table with one leg placed 
in the bore of the pQCT scanner. We will scan your left and right sides separately. Since 
this scanner is designed to scan only peripheral sites, such as the legs, no part of the 
scanner will cover any other part of your body and there will be no sense of 
claustrophobia, like there could be with a whole-body CT scanner. 
The final measurements we will make involve a procedure called motion capture. For 
these tests we will tape a number of small (5/8” diameter) reflective markers to various 
parts of you body and we will have you perform FES rowing while we capture the 
motion of the reflective markers using special digital cameras. We will also record the 
forces that are created under your feet and in the chain that connects the handle of the 
rower to the rowing machine. With the motion and force data we will be able to estimate 
the internal forces that are created within your ankles and knees using three-
dimensional computer models. We believe that the magnitude of the estimated forces 
will provide us with new insights into how skeletal health can be maintained in 
individuals following a spinal cord injury. 
Visit Schedule: Your visits to VA Palo Alto will take place on the following schedule: 
Day 1 visit, lasting 4 to 8 hours 
Day 2 visit, lasting 4 to 8 hours 
 
Women of Childbearing Potential 
If you are a woman who is able to become pregnant, it is expected that you will use an 
effective method of birth control to prevent exposing a fetus to a potentially dangerous 
agent with unknown risk. If you are pregnant or currently breast feeding, you may not 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 3 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
participate in this study. You understand that if you are pregnant, if you become 
pregnant, or if you are breast-feeding during this study, you or your child may be exposed 
to an unknown risk. 
 
To confirm to the extent medically possible that you are not pregnant, you agree to begin 
the study after the onset of your next menstrual period. You must agree to avoid sexual 
intercourse or use a birth control method judged to be effective by the investigator and 
which will not interfere with the proposed investigation. You must accept the risk that 
pregnancy could still result despite the responsible use of a reliable method of birth 
control. You agree to notify the investigator as soon as possible of any failure of proper 
use of your birth control method, or if you become pregnant, either of which may result in 
your being withdrawn from the study. 
 
Access to Medical Records: 
We may access your medical records in order to identify any medical conditions that 
could be relevant to the research study and/or which may influence the safety of your 
participation. 
 
 
PARTICIPANT RESPONSIBILITIES  
 
As a participant, your responsibilities include: 
 
• Follow the instructions of the investigators and study staff. 
• Keep your study appointments. If it is necessary to miss an appointment, please 
contact the investigators or research study staff to reschedule as soon as you 
know you will miss the appointment. 
• Tell the investigators or research study staff about any side effects, doctor visits, 
change in medications, or hospitalizations that you may have. 
• Tell the investigators or research staff if you believe you might be pregnant. 
• Ask questions as you think of them. 
• Tell the investigators or research staff if you change your mind about staying in 
the study. 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 4 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
WITHDRAWAL FROM STUDY 
 
If you first agree to participate and then you change your mind, you are free to 
withdraw your consent and stop your participation at any time. If you decide to 
withdraw from the study, you will not lose any benefits to which you would otherwise be 
entitled.  
 
If you want to stop being in the study you should tell the investigators or study staff. You 
can do this by phone by calling Dr. Beaupre at (650) 493-5000 extension 64272. 
 
The investigators may also withdraw you from the study without your consent for one or 
more of the following reasons: 
 
o Failure to follow the instructions of the investigators and/or study 
staff. 
o The investigators decide that continuing your participation could be 
harmful to you. 
o Pregnancy (if applicable). 
o You need treatment not allowed in the study. 
o The study is cancelled.  
o Other administrative reasons. 
o Unanticipated circumstances. 
 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
 
This study involves the following risks, discomforts, and possible inconveniences:  
 
Inconveniences and discomforts: 
 
1. Time required for participation in the study 
2. Travel to and from our study site 
3. Time lying still for the bone density scans 
4. Muscle strain 
5. Mild autonomic dysreflexia 
6. Increase in neuropathic (“nerve”) pain 
7. Increase in spasticity 
8. High physical exertion when rowing 
 
Risks: 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 5 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
Privacy Risk: Though all possible precautions will be followed to ensure your privacy, 
there is a very small risk of privacy loss. This could have legal, employment, and social 
consequences. 
Risks of Radiation: This research study involves exposure to radiation from bone 
density scanners. This radiation exposure is not necessary for your medical care and is 
for research purposes only. The total amount of additional radiation from all scans 
combined is approximately equal to 2 days of radiation exposure from natural sources 
like the sun, ground and water. This amount of radiation involves minimal risk and is 
necessary to obtain the research information desired. 
Risk of a fall during transfer to or from rowing machine: There is a possibility that you 
may fall while transferring to or from the rowing machine or to or from the table you will 
lie on while having your bone density scans. The risk of falling can be minimized to a 
very low level by using safe transfer techniques. You will be required to demonstrate the 
use of a safe transfer technique during your initial assessment visit. 
 
Soft tissue reaction during FES training: A soft tissue reaction to muscle conditioning 
and FES-rowing can be associated with several causes. The first is a local reddening of 
the skin under the electrodes. This reddening is thought to be due to an increase in 
blood flow beneath the electrode caused by the electrical stimulation. This reddening 
typically lasts for less than one hour after stimulation is stopped. This reddening is 
expected to occur to some degree with all participants. 
 
Reddening may also potentially occur as a result of an allergic reaction to the gel used 
to adhere the surface electrode to the skin. If reddening of the skin persists for much 
longer than one hour after removal of the electrode, then an allergic reaction is a 
possible cause. If a participant has an allergic reaction to the gel, we can try a different 
electrode with a different gel. 
 
The third and final potential skin reaction is reddening suggestive of the initiation of soft 
tissue breakdown (e.g., a "pressure sore") due to excessive pressure or shear stress. 
This potential for skin breakdown exists for all individuals who utilize a wheelchair for 
prolonged periods. To the best of our knowledge no prior FES-rowing participants have 
experienced a skin breakdown or pressure sore caused by their participation in an FES-
rowing program. Nevertheless, before and after each session, we will look for any signs 
of bruising or swelling that might be suggestive of tissue breakdown, paying particular 
attention to the shoulders, back, buttocks, upper calves and knee areas. 
 
Serious autonomic dysreflexia during FES training: Autonomic dysreflexia (AD) is a 
condition which can occur in people who have sustained a spinal cord injury. Autonomic 
dysreflexia is more common in individuals with tetraplegia (quadriplegia), but it can also 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 6 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
occur in individuals with paraplegia. Autonomic dysreflexia can be brought on by a 
variety of stimuli, including a full bladder or bowel, a pressure sore or infection, exercise, 
or by Functional Electrical Stimulation. Possible symptoms of an AD reaction include: 
 
• Severe headache 
• Flushing or blotching of the skin above the level of the spinal cord injury 
• Profuse sweating, particularly above the level of the spinal cord injury 
• Increased blood pressure 
• Decreased heart rate 
 
Generally, an AD reaction will quickly diminish once the initiating stimulus that caused 
the reaction is removed. To reduce the risk of an AD response, all participants will be 
encouraged to completely empty their bladder prior to each muscle conditioning or 
rowing session. The risk of an AD response should also decrease as training 
progresses and your muscles become conditioned from the electrical stimulation. Thus, 
the risk of AD is highest during the initial muscle conditioning session. During your first 
muscle conditioning session we will assess the ability of your muscles to respond to the 
electrical stimulation and we will pay particular attention to any signs of an AD 
response. It is possible that an AD response that is greater than mild might be identified 
at your initial session and that could mean that you are not an acceptable candidate for 
continuation in the study. 
It is important to note that FES-rowing researchers in England and Boston have never 
had a participant in their FES-rowing programs experience a severe case of AD, and 
those participants who have experienced mild cases of AD also typically experience 
mild cases of AD during their everyday lives. Therefore, we believe the risk of 
experiencing a severe case of AD from participation in this study is very low, although 
the possibility of experiencing a mild case of AD is higher. At the first sign of an AD 
response, electrical stimulation will be stopped. Additional medical treatment in the case 
of a severe AD response will be available in our testing facilities. 
It should also be noted that an individual's likelihood of having an AD episode in 
response to exercising part of the body below the level of a spinal cord injury will be 
heightened if an individual already has an underlying condition that is perceived by their 
body as a noxious stimulus. For example, an individual with a bladder infection might be 
more prone to an AD episode from an additional stimulus, such as Functional Electrical 
Stimulation of the legs, compared to an individual without a bladder infection. Therefore, 
it is important that any underlying noxious stimulus that might predispose an individual 
to an AD response is identified as early as possible and addressed before commencing 
or continuing with the rowing exercise. 
Muscle strain during muscle conditioning, strength testing or FES-assisted rowing: As 
with participating in any exercise program, there is a risk of experiencing a muscle 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 7 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
strain. Based on the experience of other researchers with FES-rowing programs, only 
two out of thirty FES-rowing participants have ever experienced a muscle strain. Muscle 
strains have never been observed in the lower limbs. For both participants with muscle 
strains, the strain occurred in the torso, between innervated and paralyzed muscle. 
These strains were treated by ceasing FES training for 48 to 72 hours and by the use of 
ice and over-the-counter analgesics. Neither of the two individuals who experienced a 
muscle strain has had a repeat incident and we believe the risk of a muscle strain is 
low. 
Lower limb fracture during muscle conditioning, strength testing or FES-assisted rowing: 
The use of FES to stimulate paralyzed muscles in individuals with SCI has been studied 
for more than 50 years. Over that 50-year period there have been two reported cases of 
a fracture related to the use of functional electrical stimulation. One individual fractured 
their knee cap and a second individual fractured their thigh bone. Although the total 
number of individuals with SCI who have used functional electrical stimulation to 
exercise the lower limbs is not known, we believe the risk of a fracture is very low given 
that there have only been two reported fractures in 50 years of FES use. To further 
reduce the risk of fracture, only participants who have never experienced a low-energy 
fracture will be allowed to take part in this study. 
Increase in neuropathic (“nerve”) pain or an increase in sensory pain from FES: Some 
individuals with spinal cord injuries individuals have what is known as neuropathic pain. 
Neuropathic pain can range from a mild tickling sensation to a severe burning 
sensation. It is not known what effect, if any, electrical stimulation has on this condition. 
In addition, some individuals with SCI who retain some sensation in their thighs may 
find the electrical stimulation to be uncomfortable or even intolerable. If you experience 
an increase in neuropathic pain to an unacceptable level or if the electrical stimulation 
produces a sensation which you find unacceptable, it may be necessary for you to 
withdraw from the study. 
Increase in spasticity to an unmanageable level: It is not known what effect FES has on 
the intensity and frequency of muscle spasticity. In other FES-rowing programs, a few 
participants have had an increase in spasticity, while some have had a decrease. In 
general, spasticity levels should be reduced after a muscle conditioning or rowing 
session, since the muscles will be fatigued. However, if you experience increased 
spasticity that is unmanageable, it may be necessary for you to withdraw from the study. 
Unforeseen Risks: There may be other risks to participating in this study that are not 
foreseeable. 
POTENTIAL BENEFITS 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 8 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
We cannot and do not guarantee that you will received any benefits from this study. 
Nevertheless, it is possible that participating in an FES-rowing exercise program may 
reduce bone loss in parts of your legs. Since the spine and hip DXA scans that we will 
perform represent a clinical standard by which osteoporosis is assessed, we will provide 
you with copies of the results of your spine and hip DXA scans which you are free to 
share with your personal physician, who should be able to help you interpret your bone 
density results. 
Please note that at the present time rowing with FES is not available within the VA 
clinical facility, and stimulators are not available for distribution outside of research use. 
However, the VA Palo Alto SCI Center is developing a program to support adaptive 
rowing under the auspices of recreation therapy, and so in the future there may be 
opportunities for veterans with SCI to access this program as part of inpatient or 
outpatient therapy.  
ALTERNATIVES 
 
Your alternative is simply to not participate in this study.  
 
PARTICIPANT’S RIGHTS 
 
You should not feel obligated to agree to participate. Your questions should be 
answered clearly and to your satisfaction.  
 
You will be told of any important new information that is learned during the course of 
this research study, which might affect your condition or your willingness to continue 
participation in this study. 
 
ClinicalTrials.gov 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify 
you.  At most, the Web site will include a summary of the results.  You can search this 
Web site at any time. 
 
CONFIDENTIALITY 
 
We will keep your name and all the information you tell us in this study as confidential 
as possible. We may publish the results of this study for others to read about, but you 
will not be identified in any articles about the study by name, social security number, 
address, telephone number, or any other direct personal identifier. Also, other federal 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 9 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
agencies as required, such as the VA Office of Research Oversight and the VA Office of 
the Inspector General may have access to your information.  
 
FINANCIAL CONSIDERATIONS 
 
Payment 
 
You will not be paid to participate in this study. 
Costs 
 
There will be no costs to you for any of the treatment or testing done as part of this 
research study. However, medical care and services provided by the VA that are not 
part of this study (e.g., normal hospital and prescription expenses which are not part of 
the research study) may require co-payments if your VA-eligibility category requires co-
payment for VA services. 
 
You will not have to pay anything to be in this study, although you will have to provide 
for your own transportation to and from the VA Palo Alto Campus.  
 
Sponsor 
 
The Department of Veterans Affairs is providing financial support and/or material for this 
study.  
 
COMPENSATION for Research Related Injury 
 
If you are injured as a direct result of being in this study, medical treatment will be 
available. If you are eligible for veteran’s benefits, the cost of such treatment will be 
covered by the VA. If not, the cost of such treatments may still be covered by the VA 
depending on a number of factors. In most circumstances, the treatment must be 
provided in a VA medical facility. No other form of compensation for injuries is available. 
However, by signing this form you have not released the VA from liability for negligence. 
For further information, you may call the Human Protections Administrator at (650) 493-
5000, ext. 67593 or the V.A. Regional Counsel at (415) 750-2288. 
 
CONTACT INFORMATION  
 
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints 
about this research study, its procedures, risks and benefits, or alternative courses of 
treatment, you should ask the principal investigator, Dr. Beaupre at (650) 493-5000 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 10 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
extension 64272. You should also contact him at any time if you feel you have been hurt 
by being a part of this study.  
 
Independent Contact:  If you are not satisfied with how this study is being conducted, 
or if you have any concerns, complaints, or general questions about the research or 
your rights as a participant, please contact the Stanford Institutional Review Board 
(IRB) to speak to someone independent of the research team at (650)-723-5244 or toll 
free at 1-866-680-2906.  You can also write to the Stanford IRB, Stanford University, 
3000 El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306.. 
 
Appointment Contact: If you need to change your appointment, please contact Dr. 
Lambach at (650) 493-5000 extension 69411. 
 
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS 
 
As a research participant you have the following rights. These rights include but are not 
limited to the participant's right to: 
• 
be informed of the nature and purpose of the experiment;  
• 
be given an explanation of the procedures to be followed in the medical 
experiment, and any drug or device to be utilized;  
• 
be given a description of any attendant discomforts and risks reasonably to be 
expected;  
• 
be given an explanation of any benefits to the subject reasonably to be expected, 
if applicable;  
• 
be given a disclosure of any appropriate alternatives, drugs or devices that might 
be advantageous to the subject, their relative risks and benefits; 
• 
be informed of the avenues of medical treatment, if any available to the subject 
after the experiment if complications should arise;  
• 
be given an opportunity to ask questions concerning the experiment or the 
procedures involved;  
• 
be instructed that consent to participate in the medical experiment may be 
withdrawn at any time and the subject may discontinue participation without 
prejudice;  
• 
be given a copy of the signed and dated consent form; and  
• 
be given the opportunity to decide to consent or not to consent to a medical 
experiment without the intervention of any element of force, fraud, deceit, duress, 
coercion or undue influence on the subject's decision. 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
 
Title of Consent: Measuring Motion, Forces, and Bone Density in an Experienced FES-Rower 
Principal Investigator: Gary Beaupre 
VAMC: 
VA Palo Alto HCS 
 
Page 11 of 11 
_____________________________________________________________________________ 
VA Form 10-1086  
IRB Use Only 
Approval Date:  September 1, 2015 
Expiration Date: August 31, 2016 
May we contact you (by phone or mail) about future research studies that may be of 
interest to you? ____Yes ____No 
 
Signing your name means you agree to be in this study and that you were given a copy 
of this consent form. 
 
 
 
Signature of Participant 
 
 
 
 
 
Date 
 
 
________________________________ 
Print Name of Participant  
 
 
 
 
 
 
Signature of Person Obtaining Consent  
 
 
Date 
 
 
________________________________ 
Print Name of Person Obtaining Consent  
 
 
 
 
 
 

 
  
This page separates the  
Informed Consent Document (above) 
from the  
HIPAA Authorization document 
(below) 
 
To preserve formatting, please  
DO NOT DELETE this page 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 1 of 3 
HIPAA (Health Insurance Portability & Accountability Act) is a federal 
privacy law that protects the confidentiality of health information collected 
about you. The following explains how health information collected about 
you will be used by the investigators and who they may share your health 
information with as part of this research.  
 
What is the purpose of the research study, and how will my health 
information be utilized in the study? 
 
In this study we plan to measure the motions, forces and bone density in 
individuals with more than one-year of experience using FES-rowing 
exercise program. We plan to use the information obtained in this study to 
compare to the results in a companion study of individuals with SCI who 
are not participating in an FES exercise program. 
 
What Personal Health Information Will Be Used or Shared? 
 
The following health information, linked to you by name, address, e-mail 
address, phone number and/or date of birth, will be used for this research: 
 
• 
Medical history and physical examination information 
• 
Bone density scans 
• 
Photographs, videotapes, other images 
 
Who May Use or Share Your Health Information? 
 
By signing this document, you allow the following individuals and entities to 
obtain, use and share your health information for this research study:  
 
• The Principal Investigator, Gary Beaupre, and members of the VA 
research team.  
• Departments within the VA Health Care System responsible for the 
oversight, administration, or conduct of research.  
• The Stanford University Administrative Panel on Human Subjects in 
Medical Research and other Stanford University Officials responsible 
for the oversight, administration, or conduct of research. 
 
 
Who May Receive and Use Your Health Information 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 2 of 3 
 
The investigators may share your health information with the following 
individuals/entities as part of this research study.  
 
• The Office for Human Research Protections in the U.S. Department 
of Health and Human Services 
• The Food and Drug Administration 
 
Health information shared pursuant to this authorization may no longer be 
protected by Federal laws or regulations and may be further shared by the above 
individuals/entities who receive the health information.  
 
Do I have to sign this form? 
 
No. Signing this form is voluntary. The VA may not condition treatment, 
payment, enrollment or eligibility for benefits based on signing this form. If 
you decide not to sign the form, you will not be able to take part in this 
study.  
 
If I sign now, can I decide later not to continue in the study? 
 
Yes. You are free to take back your permission and stop being in the study. 
The investigators will not collect any more information about you after you 
take back your permission, but they can continue to use your information 
that was collected before you took back your permission.  
 
Your request to take back your permission must be done in writing. Either 
give or send your written request to the investigator: 
 
Dr. Gary S. Beaupre 
Musculoskeletal Research Laboratory (Mail Code 153) 
VA Palo Alto Health Care System 
3801 Miranda Avenue 
Palo Alto, CA 94304 
 
 
 
 

VA Palo Alto Health Care System – HIPAA Authorization Form 
Protocol Title: Skeletal Health in the Lower Limbs Following Spinal Cord Injury 
Principal Investigator: Gary Beaupre 
Date of Review: October 1, 2013 
 
 
Page 3 of 3 
Does My Permission for the use my Personal Health Information 
Expire? 
 
Yes. Your information cannot be used forever. Your permission related to 
the use and sharing of your health information expires on 12/31/2024. 
 
HIPAA regulations require you to give separate written permission 
(signature) for the use of your protected health information. 
 
 
__________________________________________ __________ 
Signature of Participant 
 
 
 
 
 
Date 
 
 
 
__________________________________________ 
Printed Name of Participant