2011 02 18 09-SQOL Adult consent form v2.1

A Pilot Multicenter Study of Stem Cell Recipient Quality of Life
Recipient/Subject Research Consent Form
The CIBMTR is inviting you to take part in a research study. You are being invited to take part in this
study because you may be undergoing a stem cell transplant. The goal of this research study is to address
the following question:
Is it possible to easily and comprehensively collect Quality of Life (QoL) data on large numbers of
children and adults who undergo stem cell transplants and their families?
Health-related Quality of Life (HRQOL) describes how your physical, emotional, and social well-being
are affected by your disease or the medical treatments you may receive to fight the disease. Often the
treatments involved with a stem cell transplant can cause many difficult physical and emotional side
effects while at the same time trying to cure the disease. Some of these side effects can continue to impact
a person for a long time after the transplant.
It has been shown that maintaining good physical, emotional and social health after transplant is
important to long-term recovery. Because of this the researchers hope to learn ways to collect this
important information in order to learn from it and eventually improve patient outcomes. This is a small
pilot study to prepare for a larger study.
This study will collect quality of life data from children and adults undergoing stem cell transplants to see
the best way to collect information about how you are doing physically, emotionally, and socially. We
will gather data from about 270 stem cell recipients over the next two years at 8 medical centers.
You should read this form and ask any questions you may have before agreeing to participate.
In order to take part in the study you must be able to answer “yes” to the following three questions:
Can you read and speak English?
Do you have access to a phone?
Do you have a valid United States mailing address?
Two different surveys will be used over the course of the study and include questions to see how the stem
cell transplant has affected your life. They are called the Short Form 36 Health Survey or SF 36, and the
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation or FACT-BMT. You will also
be asked to complete a CIBMTR Self Report form that asks demographic and limited economic
If you decide to participate the following questionnaires will be given to you at these times:
Within 30 days before your transplant. (SF36, FACT BMT, Contact Information Form,
CIBMTR Socio-demographic Self Report Form)
100 days after your transplant. (SF36, FACT BMT)
6 months after your transplant. (SF36, FACT BMT)
12 months after your transplant. (SF36, FACT BMT, Satisfaction Survey)
09-SQOL Adult Consent Form
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Some examples of the items you will be asked to respond to include the following questions and
During the past 4 weeks, have you had any of the following problems with your work or other
regular daily activities as a result of your physical health?
During the past 4 weeks, have you had any of the following problems with your work or other
regular daily activities as a result of any emotional problems (such as feeling depressed or
Because of my physical condition, I have trouble meeting the needs of my family.
I feel close to my friends.
Participating in this study will take about 2-3 hours of your time over a one year period.
During the study, the questionnaires will be mailed to the address you provide at the beginning of the
study. If your contact information changes during the study, please contact the CIBMTR by phone at xxxxxx-xxxx, or by email at XXXXXXX@nmdp.org.
If we are unable to contact you because we do not have your updated contact information, it might be
necessary to use an internet-based search service (such as Accurint®) to find you. By choosing to
participate in the Quality of Life Study, you are giving the CIBMTR authorization and instruction to use
such a service to search public and non-public information solely for the purpose of attempting to locate
You can choose not to participate in the quality of life study.
There are no physical risks to you if you agree to take part in this research study.
There is small risk that an unauthorized person could find out which data are yours. Your medical center
and the CIBMTR will take every precaution to make sure that this does not happen. Your data will only
be labeled with a number code. Your name will never be used in any research studies that are published or
presented at scientific meetings.
If you agree to participate in the study it is possible you may feel awkward or uncomfortable answering
questions about yourself. Depending on the outcome of transplant, you may be uncomfortable answering
questions. You may skip any questions that bother you. You may also choose to skip an entire quality of
life mailing (for example, 100 days after transplant) and request that the next surveys be mailed to you at
the next scheduled time.
The QOL instruments that will be used in this study are not meant to detect depression or other
psychological illness. Therefore, the survey data collected will not be reviewed by the CIBMTR in realtime to detect any forms of distress. If you have or develop any concerns about your mental health during
this study, you should contact your health care provider/team in order to get timely medical assistance.
There is no benefit to you by taking part in this study; however this research may help future recipients
who undergo a stem cell transplant.
Any information that is obtained in connection with this study and that can be identified with you will
remain confidential and will be disclosed only with your permission or as required by law.
Confidentiality will be maintained by means of unique identifier and data will be maintained in a secure
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location accessible to study personnel only. The following parties are authorized to use and/or disclose
your health information in connection with this research study:
· CIBMTR- Minneapolis
· CIBMTR- Milwaukee
· NMDP Institutional Review Board (IRB)
· National Marrow Donor Program (NMDP)
Scientific and medical findings resulting from a study may be presented at meetings and published so that
the information can be useful to others. You will not be identified in these presentations or publications.
You will not be paid for taking part in this research study. It will not cost you anything to take part in the
It is up to you if you want to participate in this research study. If you choose not to take part, you will
still be able to get all the medical services that it is your right to receive, and you will not lose any
benefits which you should receive.
If you decide to take part in this study you may quit at any time in the future. Withdrawing will not affect
your relationship with your medical center or the CIBMTR. If you decide to withdraw from the study
please tell _____________________ (Principal Investigator) or the CIBMTR.
You may choose not to take part in this research study.
If you have questions, concerns, or complaints about the study or about potential risks and injuries, please
contact _____________________________ (Site Principal Investigator) at _______________ or
_____________________________(Site Coordinator) at ___________________.
If you have questions or concerns about your rights as a research subject or about potential risks and
injuries, please contact Roberta King, NMDP Institutional Review Board Administrator at
If you wish to speak with an independent third party not connected with this study about problems,
concerns, questions, information, or input, please contact NMDP Office of Patient Advocacy at
1-888-999-6743 to speak with a Patient Services Coordinator or E-mail: patientinfo@nmdp.org. You will
be given a copy of this consent form for your records. You do not waive any legal rights by signing this
09-SQOL Adult Consent Form
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NMDP IRB Approved 02/18/2011 through 02/17/2012
NMDP IRB-2009-0245 Version 2.1
I have read this consent form and I have been given the opportunity to ask questions. I voluntarily
agree to take part in the Quality of Life Study. My data may be used as defined in this consent
________________________________________________________ __________________
Subject Signature
_____________ __________________________________________
Print Name of Subject
FEBRUARY 18, 2011
Certification of Counseling Healthcare Professional
Do not sign this form after the
Expiration date of: February 17, 2012
I certify that the nature and purpose, the potential benefits, and possible risks associated with
participation in this study have been explained to the above individual and that any questions
about this information have been answered.
Counseling Healthcare Professional
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NMDP IRB Approved 02/18/2011 through 02/17/2012
NMDP IRB-2009-0245 Version 2.1