Title of Research Study: Aging in Motion
Researcher Team Contact Information: For questions about the research study, research results, or
other concerns, call the study team at:
Principal Investigator Name: Dereck Salisbury, PhD,
University of Minnesota (UMN)
School of Nursing
Phone Number: 612-625-9308
Email Address: salis048@umn.edu
Student Investigator: Russell Spafford, MS
University of Minnesota (UMN)
School of Nursing
Phone Number: 805-550-7376
Email: spaff010@umn.edu
Supported By: This study is funded by Dr. Salisbury's professorship fund and the ACT and Exergame
studies.
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are 55 years or older.
What should I know about a research study?
● Someone will explain this research study to you.
● Whether or not you take part is up to you.
● You can choose not to take part.
● You can agree to take part and later change your mind.
● Your decision will not be held against you.
You can ask all the questions you want before you decide.
Why is this research being done?
The purpose of this study is to recruit and evaluate the mechanisms underlying the relationships among
diet, cognitive, physical, and emotional wellbeing in adults 55 and older.
How long will this research last?
We expect that the research activities will take 20 minutes or less to complete.
What happens if I do not want to be in this research?
There are no known alternatives, other than deciding not to participate in this research study
How many people will be studied?
We expect up to 216 people to participate in this research study.
What happens if I say "Yes, I want to be in this research"?
You will first take place in a screening questionnaire to determine if it is safe for you to participate. We
want to make sure you are safe to complete a short physical assessment. If you are cleared to participate
in this study, you will be asked to complete a short cognitive assessment, a short physical
assessment and a dietary assesssment. Prior to the physical assessment, we will measure your height, and weight. Finally, you will complete questionnaires gathering the following information: depression scale, emotional wellbeing, demographics, health history, and contact info.
What happens if I say “Yes”, but I change my mind later?
If you take part in this research study, and want to leave, you should tell us. Your choice not to be in this
study will not negatively affect your right to any present or future medical care, or your present or future
employment. We will make sure you stop the study safely. We will also talk to you about follow-up
care, if needed.
Can I be removed from the research?
The person in charge of the research study or the sponsor can remove you from the research study
without your approval. Possible reasons for removal include medical conditions which make ongoing
participation unsafe for you. For example, you feel severe shortness of breath that is made worse by the
study activity, you have severe depression, suicidal ideation, or have psychological or behavioral
symptoms that are difficult to manage by study staff or pose a threat to others. If we ask you to leave the
study before you finish it we will tell you why and will help arrange other care for you, if needed.
What are the risks of being in this study? Is there any way being in this study could be bad for
me?
The overall risks to you are expected to be minimal. There are some potential physical and
psychological risks. Our study has been set up to minimize all risks.
Physical risks:
Risk of fall is minimal during chair rise assessment. Trained staff/volunteers will be readily available,
and measures will be taken to mitigate adverse events, particularly in those with balance issues.
Standard procedures will be followed and are outlined on our data sheet that will be included in our IRB
submission. They include explicit pre-test instructions and staff/volunteers standing next to participants
to eliminate fall risk.
Psychological risks:
You may feel uncomfortable or frustrated during the memory and thinking tests. You may feel
uncomfortable answering sensitive questions on the depression and health history questionnaire.
Will it cost me anything to participate in this research study?
Taking part in this research study will not lead to any costs to you.
What will I get for being in the study?
If you try to complete all the measurements, you will receive a University of Minnesota String
Backpack.
Will being in this research study help me in any way?
There will likely not be any benefits to you from taking part in this research. The research is intended to
answer questions related to aging that may in some way benefit people in the future.
Your participation in this research will involve the collection and processing of your personal data, as
described above and in any HIPAA Authorization Form we have provided to you. Please indicate
whether you consent to the collection and processing of your personal data by placing your initials
underneath the appropriate selection.
(Your consent is entirely voluntary, but declining to provide it may materially impede your ability to
participate in this research and receive any treatment.)
To the extent your personal data are protected by the GDPR, you have the right to—
∙ Know what data we are collecting, where they will be processed, and how they will be
used;
∙ View and correct your personal data;
∙ Obtain and transfer your personal data to another organization;
∙ Have certain personal data destroyed (except when data retention is otherwise required or
authorized under the GDPR or other controlling legal authority);
∙ Withdraw your consent to the continued collection of your personal data; and
∙ Certain other actions described in Chapter III of the GDPR.
What happens to the information collected for the research, including my health information?
None of the information can be linked back to you. We will store the study data in a secure computer
file where we will analyze the results. You can provide contact information if you are interested in being
contacted for future research with our study team. Your identifying information will not be shared with
anyone besides our study team, including anyone else at the University of Minnesota.
Efforts will be made to limit the use and disclosure of your personal information, including data
collected during the study participation, to people who have a need to review this information. We
cannot promise complete privacy. Organizations that may inspect and copy your information include the
IRB and other representatives of this institution. Any identifying information, including name, date of
birth, contact information, etc. will be kept confidential.
The sponsor, monitors, auditors, the IRB, the University of Minnesota Research Compliance Office, and
other University compliance units, the US Office of Research Integrity (ORI), the US Office for the
Protection of Human Research Protections (OHRP), and the FDA may be granted direct access to your
data to conduct and oversee the research. By signing this document you are authorizing this access. We
may publish the results of this research. However, we will keep your name and other identifying
information confidential.
We try to limit the use and sharing of your information, including research study records, any medical
records and other information about you, to people who have a need for this information. But we cannot
promise complete confidentiality.
If you participate in this study, your information, including your health information, will be used and
shared for purposed of conducting this research. As described later in this Consent Form, your
information may also be used and shared for publishing and presenting the research results, future
research, and any optional elements of the research you agree to in this Consent Form, which may
include creating audio and video recording of you. If you sign this Consent Form, you are giving us
permission to use and share your health information for these purposed, and if we are using your
medical records, you are giving permission to any health care providers who are treating you to share
your medical records with us.
What health information will be made available?
Health information about you to be used and shared for the research includes those items checked by the
research team below:
☐Your medical records, which may include records from hospital and clinic visits, emergency room
visits, immunizations, medical history and physical exams, medications, images and imaging reports,
progress notes, psychological test, EEG/EKG/ECHO reports, lab and pathology reports, dental records
and/or financial records. These records may be used and shared for as long as the research continues.
☒Information collected as part of this research study, including research procedures, research visits, and
any optional elements of the research you agree to, all as described in this Consent Form. This
information might not be part of your medical records, and may include things like responses to surveys
and questionnaires, and information collected during research visits described in this Consent Form.
What about more sensitive health information?
Some health information is so sensitive that it requires your specific permission. If this research study
requires any of this sensitive information, the boxes below will be marked and you will be asked to
initial to permit this information to be made available to the research team to use and share as described
in this Consent Form.
☐ My drug & alcohol abuse, diagnosis & treatment records _______ (initial)
☐ My HIV/AIDS testing records _______ (initial)
☐ My genetic testing records _______ (initial)
☐ My mental health diagnosis/treatment records _______ (initial)
☐ My sickle cell anemia records _______ (initial)
Who will access and use my health information?
If you agree to participate in this study, your information will be shared with:
The University of Minnesota research team and any institutions or individuals collaborating on
the research with us.
Others at the University of Minnesota and M Health/Fairview who provide support for the
research or who oversee research (such as the Institutional Review Board or IRB which is the
committee that provides ethical and regulatory oversight of research at the University, systems
administrators and other technical and/or administrative support personnel, compliance and audit
professionals (Such as the Quality Assurance Program of the Human Research Protection
Program (HRPP)), individuals involved in processing any compensation you may receive for
your participation and others);
The research sponsor(s), any affiliates, partners or agents of the sponsor(s) involved in the
research, organizations funding the research, and any affiliates, partners or agents of the funding
organization(s) involved in the research;
Organizations who provide accreditation and oversight for research and the research team, and
others authorized by law to review the quality and safety of the research (such as U.S.
government agencies like the Food and Drug Administration, the Office of Human Research
Protections, the Office of Research Integrity, or government agencies in other countries); and
Organizations that process any payments that may be made to you for participating in this study,
and any other individuals or organizations specifically identified in this Consent Form.
Additional sharing of your information for mandatory reporting
If we learn about any of the following, we may be required or permitted by law or policy to
report this
Information to authorities:
Current or ongoing child or vulnerable adult abuse or neglect;
Communicable, infectious or other diseases required to be reported under Minnesota’s
Reportable Disease Rule;
Certain wounds or conditions required to be reported under other state or federal law; or
Excessive use of alcohol or use of controlled substances for non-medical reasons during
pregnancy.
How will my information be used in publications and presentations?
We may publish the results of this research in scientific, medical, academic or other journals or
reports, or present the results at conferences. Information that makes it easy to identify you (such
as your name and contact information, SSN and medical records number) will not be part of any
publication or presentation. If you have an extremely unique or rare condition that is not shared
by many others, it is possible that some people may be able to determine your identity even
without these identifiers.
What will be done with my data and specimens when this study is over?
Your data and samples will not be used for any future research after this study is complete.
Do I have to sign this Consent Form and give my permission to make my information, including my
health information, available for use and sharing?
No, you do not have to sign this Consent Form. But if you do not sign, you will not be able to participate
in this research study. Treatment available outside of the study, payment for such treatment, enrollment
in health insurance plans and eligibility for benefits will not be impacted by your decision about signing
this Consent Form.
Does my permission for making my health information available for use and sharing ever expire?
No, there is no expiration date.
May I cancel my permission for making my health information available for use and sharing?
Yes. You may cancel your permission at any time by writing to the researcher at the address on the first
page of this Consent Form. If you cancel your permission, you will no longer be in the research study.
You may also want to ask someone on the research team if canceling will affect any research related
medical treatment. If you cancel your permission, any health information about you that was already
used and shared may continue to be used and shared for the research study and any optional elements of
the study to which you agree in this Consent Form.
What happens to my health information after it is shared with others?
When we share your information with others as described in this Consent Form, privacy law may no
longer protect your information and there may be further sharing of your information.
Will I be able to look at my records?
It is possible that the research team may not allow you to see the information collected for this study.
However, you may access any information placed in your medical records after the study is complete.
Will I receive research test results?
Most tests done on samples in research studies are only for research and have no clear meaning for
health care. The investigator(s) will not contact you or share your individual test results.
Whom do I contact if I have questions, concerns, or feedback about my experience?
This research has been reviewed and approved by an IRB within the Human Research Protections
Program (HRPP). To share feedback privately with the HRPP about your research experience, call the
Research Participants’ Advocate Line at 612-625-1650 (Toll Free: 1-888-224-8636) or go to
z.umn.edu/participants. You are encouraged to contact the HRPP if:
● Your questions, concerns, or complaints are not being answered by the research team.
● You cannot reach the research team.
● You want to talk to someone besides the research team.
● You have questions about your rights as a research participant.
● You want to get information or provide input about this research.
Will I have a chance to provide feedback after the study is over?
The HRPP may ask you to complete a survey that asks about your experience as a research participant.
If you choose to complete the survey, your responses will be anonymous, however, you do not have to
complete the survey if you do not want to.
If you are not asked to complete a survey, but you would like to share feedback, please contact the study
team or the HRPP. See the “Investigator Contact Information” of this form for study team contact
information and “Whom do I contact if I have questions, concerns or feedback about my experience?” of
this form for HRPP contact information.
What else do I need to know?
In the event that his research activity results in an injury, treatment will be made available, including
first aid, emergency treatment, and follow-up care as needed. Care for such injuries will be billed in the
ordinary manner, to you or your insurance company. If you think that you have suffered a research
related injury let the study investigator know immediately.