Form 2 Consent Form

OMB No.: 0925-0642
Expiration Date: 9/30/2014
Public reporting burden for this collection of information is estimated to be 5 minutes per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of information. An agency may not
conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments regarding this burden estimate or
any other aspects of this collection of information, including suggestions for reducing this burden to:
NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN:
PRA (0925-0642). Do not return the completed form to this address.

RESEARCH
 CONSENT
 FORM

Analyzing
 the
 SSA
 Disability
 Evaluation
 Process
 (Cognitive
 Testing)

Title
 of
 Project:
 Analyzing
 the
 SSA
 Disability
 Determination
 Process
 Phase
 2

Principal
 Investigator:
 Alan
 Jette,
 PhD
Background
This study aims to develop a series of computerized adaptive tests to be used in the process of
determining disability for the Social Security Administration.
Purpose
The purpose of this study is to improve the testing process of work related functioning for those who
apply for disability benefits due to an injury or illness.
What Happens In This Research Study
You will be one of approximately 70 subjects to be asked to participate in this study.
The research will take place at Boston University Medical Center.
As a participant in this study you are being asked to provide feedback on the clarity and meaning of
survey items that have been developed by study staff in a one on one interview setting.
Risks and Discomforts
We do not expect that participation will cause you any discomfort. However, there may be unknown
risks/discomforts involved. Study staff will update you in a timely way on any new information that
may affect your health, welfare or decision to participate in this study.
There is a small but important potential loss of confidentiality by taking part in this study, however, all
measures possible will be taken to prevent this loss.

Potential Benefits
You will receive no direct benefit from your participation in this study. However, your participation may
help the investigators better understand how to better improve assessments used in the Social
Security disability determination process
Alternatives
Your alternative is to not participate in the study.
Subject Costs and Payments
There are no costs to you for participating in this research study. You will receive $20.00 for your
participation in this research study.
Confidentiality
The information you provide will be kept confidential and will not be disclosed to anyone but the
researchers conducting this study, except as required by law.
Study data such as name, address and telephone number will be kept separately in locked filing
cabinets or secure servers at both institutions. The link to codes and names will be destroyed after
data collection is complete.
Information from this study and from your medical record may be reviewed and photocopied by the
Food and Drug Administration (FDA) and/or state and federal regulatory agencies such as the Office
of Human Research Protection as applicable, and the Institutional Review Board of Boston University
Medical Center. Information from this study and from your medical record may be used for research
purposes and may be published; however, your name will not be used in any publications.
Subject's Rights
By consenting to participate in this study you do not waive any of your legal rights. Giving consent
means that you have heard or read the information about this study and that you agree to
participate. You will be given a copy of this form to keep.
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to
which you are entitled.
You may obtain further information about your rights as a research subject by calling the Office of
the Institutional Review Board of Boston University Medical Center at 617-638-7207. If this study is
being done outside the United States, you can ask the investigator for contact information for the
local Ethics Board.
The investigator or a member of the research team will try to answer all of your questions. If you have
questions or concerns at any time, or if you need to report an injury while participating in this
research, contact Kara Bogusz at 617-638-1995.

Right to Refuse or Withdraw
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you
decide to be in the study and then change your mind, you can withdraw from the research. Your
participation is completely up to you. Your decision will not affect your being able to get health care
at this institution or payment for your health care. It will not affect your enrollment in any health plan
or benefits you can get.
If you choose to take part, you have the right to stop at any time. If there are any new findings during
the study that may affect whether you want to continue to take part, you will be told about them as
soon as possible.
The investigator may decide to discontinue your participation without your permission because
he/she may decide that staying in the study will be bad for you, or the sponsor may stop the study.

Signing this consent form indicates that you have read this consent form (or have had it
read to you), that your questions have been answered to your satisfaction, and that you
voluntarily agree to participate in this research study. You will receive a copy of this
signed consent form.

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Date

----------------------------------------------------------------------------------------------------Person Obtaining Consent (Signature and Printed Name)
Date