Title of Research Study: Levels of physical activity in individuals after stroke
Investigator Team Contact Information: For questions about research appointments, the research study, research results, or other concerns, call the study team at:
Investigator Name: Sharyl Samargia-Grivette, Ph.D. CCC-SLP
Investigator Departmental Affiliation: Communication Sciences and Disorders
Phone Number: 218-726-8347
Email Address: samargia@d.umn.edu
Student Investigator Name: Lakken Meredith, B.S.
Investigator Departmental Affiliation: Communication Sciences and Disorders
Phone Number: 715-559-7125
Email Address: mered080@d.umn.edu
This research is supported by the Department of Communication Sciences and Disorders at the University of Minnesota-Duluth.
Key Information About This Research Study
The following is a short summary to help you decide whether or not to be a part of this research study. More detailed information is listed later on in this form.
What is research? The goal of research is to learn new things in order to help people in the future. Investigators learn things by following the same plan with a number of participants so they do not usually make changes to the plan for individual research participants. You, as an individual, may or may not be helped by volunteering for a research study.
Why am I being asked to take part in this research study?We are asking you to take part in this research study because
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?
This research is being done to identify the relationship between level of physical activity and quality of life post-stroke and identify factors that may influence this relationship.
How long will the research last?
We expect that you will be in this research study for approximately 45-60 minutes. This is the time it will take you to complete the survey questions.
What will I need to do to participate?
You will be asked to read and answer questions about your daily activities and quality of life on an online survey. You will need to have access to a smartphone, iPad or computer to access the survey. If you do not have access, the research team can set up an appointment for you to complete the survey at the research lab on the UMD campus.
Is there any way that being in this study could be bad for me?
There are no risks to participating in this study.
Will being in this study help me in any way?
There are no benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research.
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.
Detailed Information About This Research Study
The following is more detailed information about this study in addition to the information listed above.
How many people will be studied?
We expect about 100 people will be in this research study.
What happens if I say “Yes, I want to be in this research”?
If you decide you would like to take part in this research, once you consent on this form, you will be taken directly to the research survey via the device you are currently using.
If you choose the first option, you will not require any contact with research staff unless you have questions, in which case we are available via email, telephone or zoom. If you choose the second option, we will greet you at the door of the Chester Park building and escort you to the research lab to complete the survey and we will be present for questions. Covid-19 prevention measures will be taken.
Once you access the survey, you will be asked a few questions to determine if you are eligible for the study. If you are eligible, the link will automatically take you to a consenting page and then directly to the survey questions. After you answer the survey questions, click “submit”. Responding to the survey questions is estimated to take between 45-60 minutes. Once you submit your survey responses, your participation in the study is complete.
One of the last questions on the survey will ask if you would like to be contacted for research projects in the future. Your response to this question will not have an effect on our use of your survey responses.
Your identity will be kept confidential and your name will not be used in any written or oral presentation of this study.
What happens if I say “Yes”, but I change my mind later?
You can leave the research study at any time and no one will be upset by your decision.
If you decide to leave the research study, contact the investigator so that the investigator can remove your responses from the database. The investigator may contact you to ask why you chose to leave the study in hopes of improving future studies.
Choosing not to be in this study or to stop being in this study will not result in any penalty to you or loss of benefit to which you are entitled. This means that your choice not to be in this study will not negatively affect your right to present or future services at the Robert F. Pierce Speech-Language and Hearing Clinic, your academic standing as a student, or your present or future employment.
What are the risks of being in this study? Is there any way being in this study could be bad for me? (Detailed Risks)
Privacy and confidentiality risks :
There is some risk of a data breach involving the information we have about you. We comply with the University’s security standards to secure your information and minimize risks, but there is always a possibility of a data breach.
Will it cost me anything to participate in this research study?
There will be no cost to you for any of the study activities or procedures.
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete confidentiality. Organizations that may inspect and copy your information include the Institutional Review Board (IRB), the committee that provides ethical and regulatory oversight of research, and other representatives of this institution, including those that have responsibilities for monitoring or ensuring compliance.
We may publish the results of this research. However, we will keep your name and other identifying information confidential.
Will I receive research test results?
YES
The overall results of the research will be shared with you via email or telephone.
What will be done with my data when this study is over?
We may use and share data for future research. We will not ask for your consent before using or sharing the data. We will remove identifiers from your data, which means that nobody who works with them for future research will know who you are. Therefore, you will not receive any results or financial benefit from future research done on your data.
Will anyone besides the study team be at my consent meeting?
You will go through the consenting process through the survey link. Before you have access to the research survey questions, you will be asked if you consent to participate in this study. If you have questions about the study before you consent, we will provide you with a phone number and email address of research staff to help answer your questions. If you prefer to complete the survey on the iPad in our research lab, you will still complete the consenting process through the online link. However, a research staff member will be present to answer questions You may be asked by the study team for your permission for an auditor to observe your consenting process. Observing the consent meeting is one way that the University of Minnesota makes sure that your rights as a research participant are protected. The auditor is there to observe the consent meeting, which will be carried out by the people on the study team. The auditor will not document any personal (e.g. name, date of birth) or confidential information about you. The auditor will not observe your consent meeting without your permission ahead of time.
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. You do not have to complete the survey if you do not want to. If you do choose to complete the survey, your responses will be anonymous.
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.
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.
Use of Identifiable Health Information
We are committed to respect your privacy and to keep your personal information confidential. When choosing to take part in this study, you are giving us the permission to use your personal health information that includes health information in your medical records and information that can identify you. For example, personal health information may include your name, address, phone number or social security number. Those persons who get your health information may not be required by Federal privacy laws (such as the 1099
Rule) to protect it. Some of those persons may be able to share your information with others without your separate permission. Please read the HIPAA Authorization form that we have provided and discussed.
The results of this study may also be used for teaching, publications, or for presentation at scientific meetings.
Optional Elements:
The following research activities are optional, meaning that you do not have to agree to them in order to participate in the research study. Please indicate your willingness to participate in these optional activities by placing your initials next to each activity.
The investigator may contact me in the future to see whether I am interested in participating in other research studies by Sharyl Samargia-Grivette, Ph.D.
* must provide value
Yes, I agree
No, I disagree
Signature Block for Capable Adult:
Your signature documents your permission to take part in this research. You will be provided a copy of this signed document.
Electronic Signature - Typed Name of Participant
* must provide value
First Last
Now M-D-Y H:M Click on Now
Signature Block for Person Obtaining Consent If Participant is Unable:
Electronic Signature - Typed Name of Person Obtaining Consent
First Last
Now M-D-Y H:M Click on Now
Witness Statement:
The participant was unable to read or sign this consent form because of the following reason:
The participant is unable to read the information
The participant is visually impaired
The participant is non-English speaking
The participant is physically unable to sign the consent form
If the participant is physically unable to sign the consent form for another reason, please describe:
Other reasons why the individual was unable to sign the consent form:
Next Page >>
Save & Return Later