Purpose of the Study and Reason for Your Involvement:
If you are providing consent for someone else (e.g., your child, a next-of-kin, or someone for whom you are the legal guardian or are designated as a surrogate decision maker on a medical power of attorney), please note that in the sections that follow the word “you” refers to the person for whom you are providing consent.
You are being asked to participate in this research repository. A research repository is a special type of research also known as a tissue bank or data registry. A repository provides a way for researchers to store samples of tissues (for example, blood, tissue specimens obtained from biopsies, and tissues or organs removed during surgery) and medical information (for example, information from your medical record about your condition) about a person for future use in research studies. In this consent form, tissues of all types will be referred to as “tissue” and private medical information will be referred to as “data”. Together, tissues and data stored in a repository are referred to as “materials”.
Materials from a repository can be used in research to help find out more about the causes of disease, how to prevent it, and how to treat it. Storing tissue and information about the person who provided the tissue in a repository is one way that researchers plan for new research.
This research repository was designed because we want to learn about ways daily activity can improve cognitive behavior, and whether or how these behaviors change cellular and molecular functions in humans.
To achieve this overall goal, we are collecting the following data:
- Wearable device data by recording daily human activities (sleep, heartrate, oxygen levels and steps walked). Fitbit is the wearable fitness device we are currently using for this study, and henceforth it will be called “the device” or “activity tracker.”
a. Protocol personnel will provide the device to the subject.
b. Data from the device will be downloaded to UTSA research files and kept secure.
c. Participants will notify research team via phone or email if device activity tracker malfunctions or is lost. Another wearable device will be provided if participant is consistently compliant with wearing the activity tracker (>75% of time since the device was activated).
- Stem cell, proteomic, and DNA data from blood samples. DNA testing will be used to determine if you carry known genes that increase the risk of developing Alzheimer’s Disease.
a. Researchers from this protocol will identify, recruit, and consent you for this study. You will have your biospecimens collected at your clinic. Biospecimens will be sent to UTSA and/or collaborating testing facilities for processing storage, and research.
b. Identifying information about your health will be stored at UTSA, including name, gender, diagnosis, past medical history, and disease-relevant history. All identifying information will be kept secure at UTSA on UTSA servers. Samples and data will be de-identified before sharing with collaborators.
c. When a commercial DNA testing company is used for DNA testing (i.e. 23andMe), you will be given access to the data/app as provided by the company.
- Recorded PET/fMRI, PSG, and OCT retinal image data from a subset of the study
a. This data will be transferred from health science centers/collaborating hospitals over secure internet. All scans will be for research purposes only.
b. PET scans will be used to measure blood flow, oxygen use, and will be an outpatient procedure.
c. fMRI imaging will be used to measure brain activity (note, this does not use radiation). This will be used to detect changes in blood oxygenation.
d. PSG will be used to monitor EEG, EMG, EOG, EKG, and respiratory effort and flow during sleep.
e. OCT imaging will be used to look at the health of the optic nerve.
- Survey data on basic health questionnaires.
- Cognitive tests.
You may be placed into one of three groups to explore the connection between behavior patterns and the cellular and molecular changes in the body.
- One group will be asked to do cognitive training via the Tali Health app for 30 minutes per day over a 6 week period.
- One group will be asked to get 10,000 steps per day, 5 days a week for 6 weeks.
- One group will be asked to use artificial UV light exposure for 30 minutes per day over a 6 week period.
Blood draws will be done pre- and post- intervention from which proteomics data and neural network characterizations will be collected. Each group of 60 subjects will be unique to that cohort (no overlap between intervention subjects). 20 subjects of each cohort will be healthy controls, 20 subjects will have a 1st/2nd degree family member with Alzheimer’s Disease or a sleep disorder, and 20 subjects will have a diagnosis of AD.
This study will enable researchers to test and validate new technologies that will subsequently be applied to study and inform the treatment of Alzheimer's Disease and other forms of dementia.
Your materials may be helpful for research whether or not you have the disease or condition that is the focus of this repository.
Future research studies using materials from this repository may include genetic and proteomic testing. In some cases, genetic testing of tissues can be used to indicate a risk for the development of certain diseases or to discover possible changes in a person’s future health status or life expectancy, or that of his/her children and family members. If you provide us with your primary care physician’s name and phone number, we will provide them with a report on our findings and any subsequent imaging, test results, etc. We cannot provide this to you directly.
There may be potential commercial benefits from the repository’s use of your materials. There are no plans to provide you with money or other compensation.
The repository is maintained at the University of Texas San Antonio. The Principal Investigator is responsible for the repository.
Amina Ann Qutub, Ph.D.
One UTSA Circle
San Antonio, TX 78249
You may discontinue all further participation in this research repository at any time and request that your currently stored materials no longer be used. Contact the repository at the address provided above to notify them of your decision. After you discontinue participation, the repository will not collect any new materials from you and will not use your banked specimens or identifiable information for any research purposes.
This study requires that you be an adult volunteering yourself or an adult with medical power-of-attorney volunteering on behalf of your charge, and you (or your charge) have the capacity to: a) give consent to participate in this study and b) wear a Fitbit tracker continuously for at least 6 months, or a child (age< 18 years) with parent or guardian’s permission.. For those volunteering for the bioassays, this also requires you are willing to blood samples and provide permission to access your retinal scan, MRI and polysomnography data (where relevant).
In order to participate in this study, you must wear the offered fitness device every day and night, including while asleep, and allow your de-identified activity data to be part of the study. You must commit to at least 6 months of activity tracking
Participation in the Study:
- Whether or not you take part is up to you.
- Participation is totally voluntary.
- You can agree to take part in the study and later change your mind.
- Your decision not to participate will not be held against you.
- You may ask all the questions you want about the study before you decide.
If you have questions, concerns, complaints, or think the research has harmed you, you may talk to the research team at: Phone: (210) 458-7092/ Email: firstname.lastname@example.org
This research is being overseen by an Institutional Review Board (“IRB”). You may also talk to them at (210) 458-6473 or IRB@utsa.edu if you have questions regarding your rights as a research participant or other questions, concerns, or complaints.
Future Use of Your Information or Biospecimens Collected as Part of Your Participation
All of your data and specimens will be held at UTSA indefinitely or at the discretion of the research team unless you contact the research team and request otherwise.
Risks, Benefits, Costs and Compensation:
The risks and discomfort associated with participation in this study are no greater than those ordinarily encountered in daily life.
RISK: Bruising, soreness at blood draw site | LIKELIHOOD of occurrence (probability): Common | SERIOUSNESS (Magnitude): Not serious – same risk as normal doctor appointment blood draw | DURATION: Brief
RISK: fMRI – feeling claustrophobic | LIKELIHOOD of occurrence (probability): Infrequent | SERIOUSNESS (Magnitude): Not serious – subject may withdraw | DURATION: Brief
RISK: PET scan – exposure to radiation | LIKELIHOOD of occurrence (probability): Likely | SERIOUSNESS (Magnitude): Not serious- radiation levels will be within normal standard-of-care levels | DURATION: Brief
RISK: PSG – allergic reaction of adhesives | LIKELIHOOD of occurrence (probability): Infrequent | SERIOUSNESS (Magnitude): Not serious – alternatives can be used | DURATION: Brief
RISK: FitBit tracking – exposure to EM radiation/heavy metals | LIKELIHOOD of occurrence (probability): Infrequent | SERIOUSNESS (Magnitude): Not serious- subject may withdraw | DURATION: Brief
Participant Privacy and Research Record Confidentiality:
By participating in the study, you understand and agree that University of Texas, San Antonio may be required to disclose your consent form, data and other personally identifiable information as required by law, regulation, subpoena or court order. Otherwise, your confidentiality will be maintained in the following manner:
Your data and consent form will be kept separate. Your consent form will be stored in a locked location on University of Texas, San Antonio property and will not be disclosed to third parties. By participating, you understand and agree that the data and information gathered during this study may be used by University of Texas, San Antonio and published and/or disclosed by University of Texas, San Antonio to others outside of University of Texas, San Antonio. However, your name, address, contact information and other direct personal identifiers in your consent form will not be mentioned by University of Texas, San Antonio in any such publication or dissemination of the research data and/or results.
The researchers will take the following steps to protect participants’ identities during this study:
- Each participant will be assigned a number and all identifying information in the database will be stripped out.
- Any original recordings or data files will be stored in a secured location accessed only by authorized researchers.
Your research records will not be released without your consent unless required by law or a court order. Your records may be viewed by the Institutional Review Board, but the confidentiality of your records will be protected to the extent permitted by law. The data resulting from your participation may be used in publications and/or presentations, but your identity will not be disclosed.
Your signature documents your permission for the named participant to take part in this research.
My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant, and that consent was freely given by the participant.