OBSERVATIONAL MINI TRIALS PATIENT CONSENT FORM
Study Title: Observed changes in various longevity monitoring tools in patients on diverse interventions
Principal Investigator: Dr. Sajad Zalzala
Institute: AgelessRx Inc
Sponsor: AgelessRx Inc, Dr. Sajad Zalzala
Telephone number (24 hrs): 650-272-3169
Invitation and brief summary:
We invite you to participate in this study, which has been set up by AgelessRx. The study is funded by AgelessRx in collaboration with various lab and research partners. The study has been reviewed and approved by an institutional review board (IRB): The Institute of Regenerative and Cellular Medicine.
In this study, we will be assessing multiple biomarkers of aging and aging-related diseases. The goal is to determine the additional long-term health benefits of the medication and products you are prescribed through AgelessRx.
Taking part in this study is entirely voluntary. We urge you to discuss any questions about this study with the Principal Investigator or Research Coordinator of this study. If you decide to participate, you must e-sign this form to show that you want to take part and understand what the study entails.
Purpose of the study
We aim to determine the additional long-term health benefits of the medication and products you are prescribed through AgelessRx and to identify new effective methods to assess longevity and general health to guide the development of new products and therapies.
What would participating in this study entail?
If the principal investigator identifies you as someone eligible for this study, you will receive information about the tests that AgelessRx would like you to participate in. Most of the tests can be performed at home, but it is possible you are asked to visit a lab for a blood draw. You may also be asked to complete online health questionnaires about your health, medication history, family history of disease, and other health related questions. You may also be asked to monitor health associated measures using wearable devices (glucose monitoring, activity, etc.). Tests are performed when you start with a new therapy, and may be repeated every 1 to 6 months for a maximum total of 2 years.
Nothing will change in your regular health care if you decide to take part in this study. You will not be asked to stop or change the dosing of your medication.
Am I eligible to take part in this study?
If you are interested in this study, the AgelessRx team will assess your eligibility based on your medical intake questionnaire. Each prescription with AgelessRx will have its own eligibility criteria and depend on your health status.
What are the possible benefits of participating in this study?
There are no expected health benefits for participating in this study. However, your contribution to research could help patients in the future and might lead to a better understanding of how various therapies affect the aging process in humans. You will be provided with the results of the study and any personal test results obtained via blood draws and other samples.
What are the possible disadvantages or risks of taking part in this study?
There are no expected health risks in participating in this study. The information you provide will remain confidential. There might be a cost to participation in some of the tests in this study. You are free to decide which tests you want to participate in. You will receive the results of any tests you participate in as part of this study.
How will information about me be kept confidential?
All your information will be stored in the AgelessRx database and will be coded with a unique patient identification number. Your anonymous information and samples will be available only to researchers who have obtained approval from scientific and ethical committees for their research. Individuals working for the sponsor AgelessRx, the participating organizations, regulatory authorities, and the institutional review board might obtain access to your data. Insurance companies and employers will not have access to your personal information, samples, or test results. The data may be published in a scientific journal, at conferences, and other platforms, but your name and identity will not be used.
Any research information in your medical record will be kept indefinitely.
What happens next if I decide to participate in this study?
If the AgelessRx team finds that you are eligible for the study and you have signed this form, you will be notified of the available tests to you based on the prescription you are provided with AgelessRx. You will be provided with information about each test you are eligible for.
Where can I find more information about the institutional review of this study?
For more information about participation in a research study and about your institutional review board (IRB), a group of people who review the research to protect your rights, please visit The Institute of Regenerative and Cellular Medicine IRB’s website at https://ircm.org. Included on this website, under the heading “IRB Regulations,” you can access information
about the protection of human research participants. Relevant federal regulations can be found at the following websites:
How can I withdraw from the study?
If you decide you do not want to take part anymore during the study, you can withdraw from the study at any time. This will not impact your regular health care or any access to prescriptions on the AgelessRx platform. You do not have to give a reason for your withdrawal. You can do so by contacting the AgelessRx Research Team:
AgelessRx Research Team
Signature and consent/permission to take part in the research study
By signing this consent form, you indicate that you have read and understand this consent form, and volunteer to participate in this research study. You voluntarily choose to participate, but understand that your consent does not take away any legal rights in the case of negligence or other legal faults of anyone who is involved in the study. You further understand that nothing in this consent form is intended to replace any applicable federal, state, or local laws. You will receive a copy of the signed and dated form to keep for future reference.
Protocol Number: ALRx005 Approval Date: November 16, 2022 Approval Number: IRCM-2022-253 Continuing Review Date: June 14, 2023 4