VRFD Consent Form

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KESSLER FOUNDATION
INSTITUTIONAL REVIEW BOARD
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
TITLE OF STUDY: Early Intervention to Promote Return to Work for People with Spinal Cord Injury or
Brain Injury
RESEARCH STUDY #: L-1171-21
I, _____________________________________, am being asked to consent to participate in a
research study led by an Executive Committee that includes Drs. John O’Neill, Trevor DysonHudson, Nancy Chiaravalloti, and Steven Kirshblum at Kessler and Dr. David Mann at
Mathematica. Other persons who work with them as study staff may be asked to help them. I
understand that taking part in this study is completely voluntary; I do not have to be part of this
study unless I choose to be. I am free to leave the study at any time if I change my mind. All
research studies carried out at Kessler Foundation are covered by the rules of both the Federal
Government and Kessler Foundation.
The Information provided may contain words I do not understand. I will ask the study leader or
the study staff to explain any words or procedures I do not understand.
The table below contains a brief summary of key information about this research study.
Additional information can be found throughout this document.
Why is this research
being done?

Study Summary
This study will compare two programs designed to help people with
spinal cord injury and brain injury pursue employment.

How long does the
study last?

The study will be ongoing through September 30, 2026. However, my
active participation in study-related activities will last only about 12
months from the time I enroll.

What will happen
during this research
study?

While I am part of this study, I will be randomly assigned (like the flip
of a coin) to participate in one of two programs. Both programs
involve services designed to help me reach my employment goals
but are coordinated differently. In one program, services are
coordinated by a counselor employed by the New Jersey State
Division of Vocational Rehabilitation Services, a state-based agency
that assists people with disabilities who are interested in pursuing
employment. In the other program, services are coordinated by a
facilitator who is employed by the rehabilitation hospital at which I am
receiving care. I also will be asked to complete a survey about my

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spinal cord injury or brain injury, physical and emotional health/wellbeing, employment status, education, earnings, and participation in
community activities. I will be asked to complete a follow-up survey
12 months after enrolling in the study. Information about my earnings,
benefits, and services received will be collected from state and
federal databases. My Social Security number and other information
that identifies me will be used to ensure information is collected
accurately from these databases and to enable me to access
services for which I am eligible.
What risks are
associated with
participating in this
study?

There are no physical or medical risks associated with this study. As
with all studies that involve collection of private information, there is a
small risk of a breach in confidentiality by Kessler Foundation or
Mathematica, but there are extensive procedures in place to prevent
this from happening. I will be informed immediately of any specific
threat to my privacy.
It is also possible that I may be uncomfortable responding to some
questions about my status. I may choose not to answer any question
that makes me uncomfortable.

What are the benefits
of participating in this
research study?

The benefits of participating in this study may be a greater likelihood
of employment after my injury because of the assistance I received.
However, I may receive no personal benefit from taking part in this
study.
The information obtained from this study may also help other people
with spinal cord injury or brain injury by enabling the researchers to
identify which programs and services are most helpful in enabling
people with these conditions to return to work.

What other options are
available to me if I
choose not to
participate in this
study?

Participation in this study is completely voluntary. If I choose not to
participate in this study, there will be no effect on my medical care,
employment status, or access to benefits to which I am otherwise
entitled.

The following sections offer more detail about the study.

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WHY IS THIS RESEARCH BEING DONE?
For many people with spinal cord injury or brain injury, seeking employment after injury is an important
goal. There are services available to help people with disabilities. However, the best ways to coordinate
and deliver these services are not yet known. This project will compare two ways of coordinating and
delivering services that are designed to help people with spinal cord injury or brain injury obtain
employment.
Researchers at Kessler Foundation and Mathematica will work with staff at organizations that provide
rehabilitation or employment-related services (Kessler Institute for Rehabilitation and the New Jersey
Division of Vocational Rehabilitation Services and service providers with whom they work) as well as the
organizations that store and manage data related to employment, earnings, and benefits I receive (New
Jersey Division of Department of Labor).
WHAT WILL HAPPEN DURING THIS RESEARCH STUDY?
While I am a part of this study, I will be asked to do the following:
Enrollment Survey
At the beginning of the study, I will complete a survey about my personal characteristics (such as
age and race/ethnicity), my spinal cord injury or brain injury, my work history, education, earnings,
thoughts and feelings about employment after injury, and physical and emotional health/wellbeing. This survey will be completed during an in-person interview while I am in the hospital or a
phone interview after I am discharged. My medical records will also be reviewed to gather
information about my injury that is needed for the study.
At the time that I enroll in the study, I will also be asked to provide my Social Security number and
other information that identifies me (referred to as Personally Identifiable Information or PII). This
information is needed to access services for which I am eligible and to accurately collect
information about me from state and federal databases. As will be discussed further below, many
procedures are in place to ensure my information is kept secure.
Program Participation
I will be randomly assigned (like a coin flip) to participate in one of two programs being examined
in this study. Both programs involve services designed to help me reach my employment goals
but are coordinated differently.
•

Program 1: In this program, services are coordinated by a counselor employed by the
New Jersey State Division of Vocational Rehabilitation Services (NJDVRS), a state-based
agency that assists people with disabilities who are interested in pursuing employment.
While I am in inpatient rehabilitation or soon after my discharge, a member of the research

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team will assist me in completing the necessary documentation to apply for services from
this agency. Services for which I am eligible will be provided directly through NJDVRS.
•

Program 2: In this program, services are coordinated by a facilitator who is employed by
Kessler Institute for Rehabilitation and works cooperatively with NJDVRS. The facilitator
will begin working with me during inpatient rehabilitation, or soon after discharge,
depending on when I enroll in the study. Some services for which I am eligible will be
provided through NJDVRS and others will be provided to me by the facilitator.

Both Program 1 and Program 2 provide services that consider my condition, needs, and goals.
Services I may receive include:
•
•
•
•
•

Education on programs designed to help people with spinal cord injury or brain injury
pursue employment
Advice and guidance from professional counselors who have special training in helping
people with disabilities pursue employment
Help completing applications for services
Assistance communicating with my employer about my needs and ways to accommodate
them
Referrals to and services from other health care or technology providers

Follow-Up Survey
I will be asked to complete a survey about 12 months after enrolling in the study. The survey will
ask me to describe employment, benefits I have received, satisfaction with services, well-being,
and other outcomes related to my pursuit of employment.
Database Information Collection
Information about my earnings, benefits, and services received will be collected from state and
federal program databases. My Social Security Number and other information that identifies me
will be used to ensure that the correct information is collected. The study team will take care to
obtain this information from me in a way that cannot be overheard and will store this form in a
locked location that can only be accessed by members of the study team. If I have questions or
concerns about collecting this information, I am encouraged to share these with the study team,
who will make sure they are addressed to my satisfaction before I consent to participate.

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WHAT RISKS ARE ASSOCIATED WITH PARTICIPATING IN THIS STUDY?
The study described above may involve the following risks and/or discomforts:
There are no physical or medical risks associated with this study. As with all studies that involve
collection of private information, there is the risk of a breach in confidentiality by Kessler
Foundation or Mathematica, but there are extensive procedures in place to prevent this from
happening. These include collecting this information in private settings (to prevent what I share
from being overheard or seen) and storing this information in secure databases that can only be
accessed by authorized personnel. I will be informed immediately of any specific threat to my
privacy.
Some study questions are about my financial status and physical and emotional health and
functioning. It is possible I may be uncomfortable as I respond to questions about these topics. I
may take breaks while completing the surveys and may decline to answer questions that make
me feel uncomfortable.
WHAT WILL BE DONE TO PROTECT INFORMATION ABOUT ME?
Every effort will be made to maintain the privacy of my study records.
Protected Health Information and Personally Identifiable Information
The researchers would like to use information about my health (“Protected Health Information”)
as well as information that identifies me (“Personally Identifiable Information”). My Protected
Health Information is given special protections under The Federal Health Insurance Portability
and Accountability Act (HIPAA) of 1996. The researchers must obtain my approval to use
Protected Health Information and Personally Identifiable Information.
If I participate in this research study, health information that will be used may include the
following:
•
•
•

Information from my medical records, such as my diagnoses, treatments I am receiving,
reported symptoms, ability to function, and other observations made by health
professionals as part of my medical care.
Surveys about my work history, services and benefits received, earnings, participation in
the community, and how I am feeling physically or emotionally
Other observations made by researchers during the course of the research study

If I participate in this research study, Personally Identifiable Information that will be used may
include the following:

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•
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My name, phone number, email, address, etc. so that the researchers can contact me as
needed during the study.
My Social Security number, sex, and date of birth (which is needed to determine if I
qualify for certain services and to accurately collect information about my earnings,
benefits, and services received).
Earnings and vocational rehabilitation program information from the state of New Jersey.

Protected Health Information and Personally Identifiable Information such as my name, address,
date of birth, Social Security number, etc., that is stored electronically by Kessler Foundation is
kept in a separate system called the Subject Information Management System (SIMS). SIMS is
managed using a database called REDCap. REDCap meets the requirements of laws that protect
health information. Access to study data in REDCap will be restricted to members of the study
team only. Data are secured by requiring multiple types of login information to reach the study
database. REDCap/SIMS also tracks access to and changes made to any records. Kessler
Foundation does not permit Protected Health Information to be kept electronically in documents
that are not protected in this way in order to ensure my privacy and the confidentiality of my
information. Hard copy documents that contain my name, phone number, address, date of birth,
Social Security number, etc., are kept in locked cabinets that only members of the research team
can access.
Mathematica also takes many actions to safeguard Protected Health Information and Personally
Identifiable Information. These actions comply with federal laws that protect this information.
These actions include (but are not limited to) staff training and signed confidentiality agreements,
use of appropriate technology, strict control of access to records, use of encryption (a way of
preventing unauthorized viewing of information) while information is being shared, and secure
methods of disposing data when it is no longer needed.
Sharing Protected Health Information and Personally Identifiable Information
My health information and information that identifies me may be shared with people and
researchers at this institution and associates of the sponsor(s), university, clinic or hospital who
help with the research or provide employment-related services to me. The researchers may share
this information with other people or organizations who are in charge of the research, others who
are helping the research study to be done, those who pay for the research, or those who make
sure that the research is done properly.
The study team may share a copy of this approval form and records that identify me with the
following people or organizations:



The Institutional Review Board - a committee that reviews research studies for the protection
of the people who participate in research.
Auditors from Kessler Foundation, the sponsor (Social Security Administration), or
government agencies responsible for the conduct of research to make sure the researchers
are following regulations, policies, and study plans.

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Members of the study team, including Dr. John O’Neill, Dr. Trevor Dyson-Hudson, Dr. Steven
Kirshblum, Dr. Denise Fyffe, Dr. Jay Verkuilen, Dr. Jeanne Zanca, Dr. David Mann, Ms.
Tessa Huffman, Dr. Anna Hill, Ms. Stacie Feldman, and Ms. Sarah Croake. Changes in this
list of personnel may occur over the years during which the study is taking place.
Other organizations:
o The New Jersey Division of Vocational Rehabilitation Services
o The New Jersey Department of Labor
o Mathematica, a research organization that is evaluating the programs being examined in
this study
o The U.S. Department of Health and Human Services, the government agency that
oversees and funds research involving human beings.

I have the right to look at my study information at Kessler Foundation and to ask (in writing) for
corrections of any of my information that is wrong.
If the findings from the study are published, I will not be identified by name. My identity will
remain private unless its release is required by law.
Information shared with the Social Security Administration by Kessler Foundation will not be used
to determine current or future benefits.
The Social Security Administration will protect any information collected from me consistent with
applicable Federal law, regulations, and directives.
Removing Approval
I can change my mind at any time and remove my approval to allow my information to be used in
the research. If this happens, I must remove my approval in writing. Beginning on the date I
remove my approval, no new information will be collected about me if I revoke permission for
those activities. However, researchers may continue to use any information that was collected
before I withdrew my approval.
If after signing this form, I want to remove my approval, I can contact the person(s) below.
He/she will make sure the written request to remove my approval is processed correctly.
John O'Neill, Ph.D.
Director, Employment and Disability Research
Kessler Foundation
120 Eagle Rock Rd., Suite 100
East Hanover, NJ 07936-3147
Tel. (973) 324-8387; Fax. (973) 324-8373
joneill@kesslerfoundation.org
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Approval Expiration
This approval has no expiration date. However, as stated above, I can change my mind and
remove my approval at any time.
Questions should be directed to the research staff person who is reviewing this form with me. I
can also call the Kessler Foundation Privacy Board – John DeLuca, Ph.D., ABPP at (973) 3243572.
WHERE ELSE CAN I FIND INFORMATION ABOUT THIS STUDY?
A description of this clinical trial is available on http://www.ClinicalTrials.gov (ClinicalTrials.gov
Identifier: NCT05508802). This website will not include information that can identify me. At most,
the website will include a summary of the results. I can search this Web site at any time.
WILL IT COST ANYTHING TO PARTICIPATE IN THIS STUDY?
There will be no cost to me for my taking part in this study. However, some of the services I may
be offered may have costs associated with them. These costs may be paid by a combination of
insurance, my own funds, or other sources. The cost for these services is the same as would be
the case if I were not participating in this study.
WILL I BE PAID FOR PARTICIPATING IN THIS STUDY?
I will receive a $25 gift card in appreciation of my completing the one-year follow-up survey.
CAN I CHANGE MY MIND ABOUT PARTICIPATING IN THIS STUDY?
I understand that taking part in this study is my choice, and I may refuse to take part, or may stop
taking part in the study at any time without penalty or loss of benefits to which I am otherwise
entitled. I also understand the investigator has the right to withdraw me from the study at any
time.
If I choose to withdraw from the study, researchers will ask if I want to revoke permission to
access my information in state or federal databases. Researchers will also ask whether I still want
to participate in the one-year follow up survey. The study team will retain access to any data
collected about me before my withdraw from the demonstration.

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WHO CAN I CONTACT FOR MORE INFORMATION?
If I have any questions about my treatment or the research procedures, I can contact:
Trevor Dyson-Hudson, M.D.
Director, Center for Spinal Cord Injury Research
Kessler Foundation
1199 Pleasant Valley Way
West Orange, NJ 07052
Tel. (973) 324-3576; Fax.(973) 243-6984
tdysonhudson@kesslerfoundation.org
John O'Neill, Ph.D.
Director, Employment and Disability Research
Kessler Foundation
120 Eagle Rock Rd., Suite 100
East Hanover, NJ 07936-3147
Tel. (973) 324-8387; Fax. (973) 324-8373
Joneill@kesslerfoundation.org
If I have concerns only regarding my rights as someone taking part in a research study, I may
contact Donna Servidio, IRB Manager, at 1-800-648-0296, extension 6972.
I will receive a copy of this consent form if I agree to take part in this research study.

WILL INFORMATION ABOUT ME BE USED FOR OTHER RESEARCH STUDIES IN THE FUTURE?
The information collected in this research study may be useful in future research studies.
In some future studies, the researchers may want to use my information in a way that identifies
me. This means that the researchers would have access to my name, contact information, Social
Security number, medical record number, or other identifying information, and would know that I
am the person who provided the information. If, in the future, researchers wish to use information
that can identify me, they will be required to obtain my specific permission, in writing, for the use
of my information.
In other cases, researchers may want to use my information in a way that does NOT identify me.
In this situation, the researchers do not have access to my name (or other identifying information)
and would not know that I am the person who provided the information. In this section, I am being
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asked whether it is acceptable to me for researchers to use information that does not identify me
without asking for my specific permission at the time of the future research study.
[ ] Yes, I agree to allow information collected in this study that does not identify me to
be used in future research without my specific permission.
Participant Signature: ______________________________________
[ ] No, I do not agree to allow information collected in this study that does not identify
me to be used in future research without my specific permission.
Participant Signature: ______________________________________
CONSENT TO DISCLOSE SOCIAL SECURITY ADMINISTRATION RECORDS
As part of my agreement to participate in this research study, I authorize the Social Security
Administration (SSA) to release the following information to Kessler Foundation for purposes of
this research study:







The diagnoses/impairments used to determine my eligibility for benefits,
My applications for benefits and eligibility,
How long I have been enrolled in benefit programs,
Benefit amounts I received,
Employment supports I received, and
Employment milestones I reached.

Information released by the Social Security Administration under this consent will be released to
Kessler Foundation at the following address:
Kessler Foundation
Center for Employment and Disability Research
120 Eagle Rock Ave., Suite 100
East Hanover, NJ 07936-3147
The end date of my consent to allow SSA to release information to Kessler Foundation for
purposes of this research study is January 1, 2029.

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SIGNATURE OF PARTICIPANT
I have read this entire form, or it has been read to me, and I understand it completely. All of my
questions regarding this form or this study have been answered to my complete satisfaction. I
agree to participate in this research study and authorize the release of my information to the
Social Security Administration as described above.
Participant Name:

Signature:

Date of Signature:
Date of Birth: ____________________________________
Social Security number: ___________________________
SIGNATURE OF WITNESS*
I was present when the researcher(s) described the study to the participant (or his/her parent or
legal guardian) and I am a witness to the fact that the participant (or his/her parent or legal
guardian) consented to participation in this study and to the authorization to release his/her
information to the Social Security Administration as described above.
Witness Name:

Signature:

Date:
*If the Signature of Participant section was completed with a mark (X) rather than a full signature,
please have two witnesses complete the section on the following page in lieu of the witness
section above. Please print the signee’s name next to the mark (X) on the signature line above.

Witness 1:
Witness Name:

Signature:

Date:
Street Address: _____________________________________________________
City, State, Zip: _____________________________________________________
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Witness 2:
Witness Name:

Signature:

Date:
Street Address: _____________________________________________________
City, State, Zip: _____________________________________________________
SIGNATURE OF INVESTIGATOR OR RESPONSIBLE INDIVIDUAL
To the best of my knowledge, the participant,
, (or his /her
parent/legal guardian) has understood the entire content of the above consent form, and
comprehends the study and its risks as well. The participant’s questions and those of his/her
parent/legal guardian have been accurately answered to his/her/their complete satisfaction.
Investigator Name:

Signature:

Date:
SIGNATURE OF READER/TRANSLATOR IF THE PARTICIPANT DOES NOT READ ENGLISH WELL
The person who has signed above,
, does not read English well. I
read English well and am fluent in (name of the language)
, a language this person (his/her parent/legal guardian) understands well. I
have translated for him/her (his/her parent/legal guardian) the entire content of this form. To the
best of my knowledge, he/she (his/her parent/legal guardian) understands the content of this form
and has had an opportunity to ask questions regarding the consent form and the study, and that
these questions have been answered.
Reader/
Translator Name:

Signature:

Paperwork Reduction Act Statement
This information collection meets the requirements of 44 U.S.C. § 3507, as amended by section 2 of the Paperwork Reduction Act of 1995.
You do not need to answer the survey questions unless we display a valid Office of Management and Budget (OMB) control number. The
OMB control number for this collection is xxxx-xxxx; expiration date x/xx/20xx. We estimate that it will take about xx minutes to read the
instructions, gather the facts, and answer the questions. You may send comments about our time estimate to: Social Security Administration,
6401 Security Blvd, Baltimore, MD 21235-6401.
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