Consent for In Person Interview
UNIVERSITY OF MICHIGAN
CONSENT TO BE PART OF A RESEARCH STUDY
Title of the Project: National Survey of American Life: 25 Year Follow-Up
Principal Investigator: Briana Mezuk, PhD, University of Michigan
Toni C. Antonucci, PhD, University of Michigan
Co-Investigators:
DeAnnah Byrd, PhD, Arizona State University
Viktoryia Kalesnikava, PhD, University of Michigan
Tam E. Perry, PhD, Wayne State University
Deborah Robinson, PhD, University of Michigan
Rodlescia S. Sneed, PhD, Wayne State University
Ketlyne Sol, PhD, University of Miami
Courtney S. Thomas Tobin, PhD, University of California Los Angeles
Irving E. Vega, PhD, Michigan State University
Sponsor: National Institutes of Health
You are invited to take part in a research study because you were a participant in the National Survey of American Life (NSAL) in 2001-2003. This form contains information that will help you decide whether to join the study.
Things you should know
- The purpose of our study is to understand factors that shape risk of and resilience for dementia and other health difficulties as people age.
- If you choose to participate, you will be asked to do several things:
- An interviewer will meet with you at your home or another quiet location you choose. During the interview, they will ask questions about your experiences, behaviors, social connections, health, and related topics. The interview typically lasts about 2 hours and 20 minutes.
- The interviewer will have you complete some memory, drawing, and problem-solving tasks that assess brain
- The interviewer will measure your blood pressure, grip strength, height, weight and waist circumference.
- There are a few risks and discomforts related to your participation but these are not greater than you would normally experience in daily li
- Some questions might be upsetting because they ask about personal information related to your health, family, and wellbeing. You can skip any questions you do not wish to answer.
- While we take very stringent security measures, there is a very small risk of loss of confidentiality in the information that you provide.
- You will be provided with some of the results from your physical measures.
Taking part in this study is voluntary. You can refuse to answer any question or skip any assessment. You do not have to participate and you can stop at any time. Please read this entire form and ask questions before deciding whether to take part in this research project.
Purpose of the study
The purpose of our study is to understand how factors such as social support, mental health and wellbeing, physical health conditions, neighborhood environments, and stressful life events relate to the risk of dementia and other health and functional challenges as people age.
Who can take part in this study
We are seeking to re-interview people who took part in the National Survey of American Life (NSAL) in 2001-2003. Only those who took part in the previous study are eligible for this 25-year follow-up. Our goal is to reach about 2,600 of these original participants.
What participation involves
What will happen to me in this study? If you agree to continue to be a part of this research study, you will meet with a University of Michigan interviewer at a place and time of your choosing. The interviewer can come to your house or meet you in an agreed-upon quiet space, such as in a library. During the interview, they will ask questions about your experiences, behaviors, social connections, health, and related topics. Parts of the interview will be audio recorded for research and quality control purposes. You can still participate if you do not want to be recorded. You will also complete a cognitive assessment that involves a variety of tasks and exercises to assess brain health. The interviewer will measure your blood pressure, grip strength, height, weight, and waist.
How much of my time will be needed to take part in this study? The interview will last approximately 2 hours and 20 minutes. Your interview may be longer or shorter depending on your responses to questions.
The researchers may reach out to you in the future about taking part in another study. You can make a decision at that time about whether or not you want to participate.
Information about study risks and benefits
What risks will I face by taking part in the study? What will the researchers do to protect me against these risks? There may be some risk of discomfort from your participation in this study. You may find some of the interview questions sensitive or embarrassing. You can skip any questions that you do not want to answer. We will provide you with a list of resources that can help you with any negative feelings that these questions may bring up.
One of the risks of participating in this study is a loss of confidentiality. The risk of this happening is rare. The study team will retain your identifying information, such as your name and address, and this information will be stored separately from your study data and kept confidential. In order to protect your confidentiality, your name will be removed from your study data and will be replaced with an anonymous study ID number. All data are stored and transmitted in a secured, encrypted form to help protect your privacy (see Protecting and Sharing Research Information for more details about how we protect your information).
The research team may report evidence of abuse, neglect, or endangerment that is discussed or observed. We may also share information if we believe you are at risk of harming yourself or others. These situations are rare.
How could I benefit if I take part in this study? How could others benefit? We will provide you with some results from your physical measurements that may help you and your doctor understand your health. Others may benefit from your participation because it will provide us with important information about the factors that contribute to risk and resilience for Alzheimer’s disease and health conditions related to aging. The knowledge gained from this study can help scientists understand these processes, and may lead to changes to regulations and approaches that may allow people to experience healthier aging in the future.
Ending the study
If I want to stop participating in the study, what should I do? You are free to leave the study at any time. If you leave the interview before it is finished, there will be no penalty to you. You will not lose any benefits to which you may otherwise be entitled. If you decide to leave the study before it is finished, please tell one of the people listed at the end of this form. If you choose to withdraw, no more information will be collected from you. Any information collected up to the point when you notify us that you want to withdraw will remain in the study unless you request that we delete it. If you choose to tell the researchers why you are leaving the study, your reasons may be kept as part of the study record.
Financial information
Will I be paid or given anything for taking part in this study? As a token of our appreciation for your time, you will receive $100 for participating in the interview. You will be paid by the interviewer upon the completion of the interview.
Will I need to pay anything to be part of the study? There is no cost to you for participating in this study.
Because this study provides some payment for participating, we must provide your name and address to the University of Michigan finance department for record keeping purposes. If and only if you receive payments of greater than $400, in total, from participating in studies conducted by the University of Michigan during the calendar year, the finance department will also require your Social Security Number for tax reporting purposes. This study will not ask for your Social Security Number under any other circumstances. If you do not wish to provide your Social Security Number, you may continue to participate in research studies, but you will not be able to receive payment for the remainder of the calendar year.
Protecting and sharing research information
How will the researchers protect my information? We plan to publish the study results, but will not include any information that could identify you. Your privacy will be protected, and your research records will remain confidential. We use strict methods to protect your data and identity. Identifying information, such as your name and address, will be stored separately from your study data and kept confidential. All information will be kept on secure, encrypted University of Michigan servers. Your name will be replaced by a study ID number, and only members of the study team can link this number to your identity.
Certificate of Confidentiality. In addition to everything we will do to protect your confidentiality, this study holds a Certificate of Confidentiality from the National Institutes of Health. This means that we cannot release or use information, documents, or samples that may identify you in any action or suit except as described below. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other legal proceedings. An example of a situation in which the Certificate would apply would be a court subpoena for research records. There are some important things that you need to know:
- The Certificate does not stop reporting or information-sharing that you agreed to in this consent document. For example, we may share information with appropriate authorities if we think you may harm yourself or others. We may also share your information with other researchers, but not your audio recordings.
- The Certificate does not stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse.
- The Certificate cannot be used to stop a sponsoring United States federal or state government agency from checking records or evaluating programs.
- The Certificate of Confidentiality does not stop you from personally releasing information about your involvement in this research if you wish.
- More information about Certificates of Confidentiality and the protections they provide is available online at https://grants.nih.gov/policy/humansubjects/coc.htm
Who will have access to my records? There are reasons why information about you may be used or seen by the researchers or others during or after this study. For example, University, government officials, study sponsors or funders, auditors, and/or the Institutional Review Board may need the information to make sure that the study is done in a safe and proper manner.
What will happen to the information and audio recordings collected in this study? We will securely store your information and research audio recordings for study recordkeeping and future research using an ID number. The audio recordings collected for quality control purposes will be deleted at the end of the study.
Will my information or audio recordings be used for future research? We may use your information and research audio recordings for future research studies. This future research may be similar to this study or completely different. We will not ask for your additional informed consent for these studies. Even in future research, we will not share information that could be combined to identify you.
Will my information or audio recordings be shared with others? We plan to share your research information in a secure data repository so that other scientists can do additional research. This information will not contain your name or any other information that could identify you. Your audio recording will never be shared with scientists outside the research team.
Contact information
Who can I contact about this study? Please contact the researchers listed below to:
- Obtain more information about the study
- Ask a question about the study procedures
- Leave the study before it is finished
- Express a concern about the study
Principal Investigator: Briana Mezuk
Email: [email protected]
Phone: 734-615-9204
Study Coordinator: Ask for the NSAL project
Email: [email protected]
Phone: 800-759-7947
If you have questions about your rights as a research participant, or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact the following:
University of Michigan
Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) 2800 Plymouth Road
Building 520, Room 2144 Ann Arbor, MI 48109-2800
Telephone: 734-936-0933 or toll free (866) 936-0933
Fax: 734-936-1852
E-mail: [email protected]
You can also contact the University of Michigan Compliance Hotline at 1-866-990-0111.
Your consent
Consent to Participate in the Research Study
By signing this document, you are agreeing to be in this study. Make sure you understand what the study is about before you sign. I will give you a copy of this document for your records and I will keep a copy with the study records. If you have any questions about the study after you sign this document, you can contact the study team using the information provided above.
I understand what the study is about and my questions so far have been answered. ___
I agree to take part in this study.
I agree to be audio recorded for research purposes. YES NO
You can still participate if you decline audio recording.
|
Printed Participant Legal Name
|
Date |
|
Signature |
|