Conditions: Covid19 SARS-CoV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.

Detailed description:
This study is a pilot, randomized, placebo-controlled, single-center study of Fisetin in elderly nursing home participants with non-, mildly-, or moderately-symptomatic and confirmed SARS-CoV-2 infection.

Arms:
arm 1: Subjects will receive treatment drug (Fisetin) arm 2: Subjects will receive placebo

Interventions: intervention 1: Fisetin intervention 2: Placebo
Intervention descriptions: intervention 1: \~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9) intervention 2: Placebo looks exactly like the treatment drug, but it contains no active ingredient

Protocol document:
Prot_SAP_001.pdf: 
 
 
COVID-FIS: A PHASE 2 PLACEBO-CONTROLLED 
PILOT STUDY IN COVID-19 OF FISETIN TO 
ALLEVIATE DYSFUNCTION AND EXCESSIVE 
INFLAMMATORY RESPONSE IN OLDER ADULTS 
IN NURSING HOMES 
 
NCT04537299 
 
26May2023 









































































































































ICF_000.pdf: 
 
 
COVID-FIS: A Phase 2 Placebo-Controlled Pilot 
Study in COVID-19 of Fisetin  
to Alleviate Dysfunction and Excessive 
Inflammatory Response in Older Adults  
in Nursing Homes 
 
 
NCT04537299 
 
4/4/2024 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 1 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
RESEARCH PARTICIPANT CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Study Title: COVID-FIS: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin 
to Alleviate Dysfunction and Excessive Inflammatory Response in Older Adults 
in Nursing Homes  
 
IRB#:  
20-008867  
 
Principal Investigator: Dr. James L. Kirkland and Colleagues 
 
 
Key Study Information 
 
 
This section provides a brief summary of the study. It is important for you to understand why 
the research is being done and what it will involve before you decide. Please take the time to 
read the entire consent form carefully and talk to a member of the research team before 
making your decision. You should not sign this form if you have any questions that have not 
been answered. 
It’s Your Choice 
This is a research study. Being in this research study is your choice; 
you do not have to participate. If you decide to join, you can still stop 
at any time. You should only participate if you want to do so. You will 
not lose any services, benefits or rights you would normally have if 
you choose not to take part. 
Research Purpose 
The purpose of this research is to determine if Fisetin treatment can 
prevent progression of COVID-19 infection severity and deterioration 
of physical function (frailty) of nursing home residents and to evaluate 
the safety, effectiveness, and tolerability of Fisetin in this patient 
population. Fisetin is a naturally occurring substance found in 
strawberries and other foods, but at lower doses than used in this 
study. 
 
The study drug Fisetin used in the study is not approved by the U.S. 
Food and Drug Administration (FDA) for the uses being tested in this 
study. The uses in this study are considered “investigational.”  
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 2 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
However, the FDA has allowed the use of Fisetin in this research 
study. 
 
0You are being asked to take part in this research study because you: 
have tested positive for the COVID-19 infection, are at least 65 years 
of age and are a nursing home resident. 
What’s Involved 
 
To see if you can be in the study, a number of screening tests and 
procedures are required. If you are eligible, this study will take about 
6 months to complete. 
 
This study uses a placebo. A placebo looks exactly like the study drug, 
but it contains no active ingredient. We use placebos in research 
studies to learn if the effects seen in research participants are truly 
from the study drug.  
 
If you are eligible to participate, you will be randomized (by chance, 
like flipping a coin) to receive either Fisetin or placebo.  
 
Study participation involves blood and urine testing and monitoring of 
vital signs and oxygen needs. 
Key Information 
Some of the risks associated with this study include possible side 
effects from study medication and possible infection, bruising, or 
swelling from blood draw. 
 
The risks associated with study participation are completely described 
later in this form, be sure to review them carefully. 
 
There may or may not be any direct benefit to participating in this 
study; it is being done for research purposes. 
 
If you decide not to take part in this study, you will still be able to 
receive medical care. The research team will discuss other treatment 
options with you. 
Learn More 
If you are interested in learning more about this study, read the rest of 
this form carefully. The information in this form will help you decide 
if you want to participate in this research or not.  A member of our 
research team will talk with you about taking part in this study before 
you sign this form. If you have questions at any time, please ask us.    
 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 3 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
Making Your Decision 
 
 
Taking part in research is your decision. Take your time to decide. Feel free to discuss the study 
with your family, friends, and healthcare provider before you make your decision.  Taking part in 
this study is completely voluntary and you do not have to participate. 
 
If you decide to take part in this research study, you will sign this consent form to show that you 
want to take part. We will give you either a printed or electronic copy of this form to keep. A 
copy of this form will be put in your medical record. 
 
If you are signing this consent form for someone else, “you” in the consent form refers to the 
participant.  
 
For purposes of this form, Mayo Clinic refers to Mayo Clinic in Arizona, Florida and Rochester, 
Minnesota; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals, and 
entities. 
 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 4 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
Contact Information 
 
 
If you have questions about … 
You can contact … 
 Study tests and procedures 
 Materials you receive 
 Research-related appointments  
 Research-related concern or complaint 
 Research-related injuries or emergencies 
 Withdrawing from the research study 
 
Principal Investigator: Dr. James Kirkland 
Phone: (507) 266-9151 
 
Study Team Contact: Ashley Lind 
Phone: (507) 293-4487 
 
Institution Name and Address: 
Mayo Clinic 
200 First Street SW 
Rochester, MN 55905 
 Rights of a research participant 
 
Mayo Clinic Institutional Review Board (IRB)  
Phone: (507) 266-4000 
Toll-Free: (866) 273-4681 
 Rights of a research participant 
 Any research-related concern or complaint 
 Use of your Protected Health Information 
 Stopping your authorization to use your 
Protected Health Information 
 Withdrawing from the research study 
Research Participant Advocate (RPA) 
(The RPA is independent of the Study Team) 
Phone: (507) 266-9372 
Toll-Free: (866) 273-4681 
E-mail: researchparticipantadvocate@mayo.edu 
 Billing or insurance related to this research 
study 
Patient Account Services 
Toll-Free: (844) 217-9591  
 
Other Information: 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 5 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
Why are you being asked to take part in this research study? 
 
 
You are being asked to take part in this research study because you: have tested positive for the 
COVID-19 infection, are at least 65 years of age and are a nursing home resident. 
 
Eligible subjects will be assigned randomly (by chance like flipping a coin) to receive either 
Fisetin (the treatment drug) or placebo (which looks exactly like the treatment drug but contains 
no active ingredient). You will have a 50% chance of receiving Fisetin. 
 
The plan is to have about 150 people take part in this study. 
 
 
Why is this research study being done? 
 
 
Some people who become sick with COVID-19 develop a very serious disease.  
 
The purpose of this research is to determine if Fisetin can assist in preventing progression of 
COVID-19 infection severity and deterioration of physical function (frailty) of nursing home 
residents and to evaluate the safety, effectiveness, and tolerability of Fisetin in this patient 
population. 
 
Senescent cells accumulate with aging and in younger people, in tissues affected by chronic 
diseases, such as fat tissue in obesity and diabetes, in the brain in Alzheimer’s disease, in bones 
in osteoporosis, in joints in osteoarthritis, in the lungs from smoking, and in blood vessels and 
the heart in cardiovascular diseases, atherosclerosis, and high blood pressure.  Some senescent 
cells release factors that damage the tissues around them and at a distance, as well as interfering 
with the immune system. 
 
Fisetin selectively decreases the burden of senescent cells. It is a “senolytic” drug. It temporarily 
disables the factors in senescent cells that prevent them from dying due to the factors that they 
release to kill cells and damage tissues around them: it effectively allows senescent cells to kill 
themselves within a few hours. 
 
In this study, you will get either Fisetin or placebo. 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 6 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
The study drug Fisetin used in the study is not approved by the U.S. Food and Drug 
Administration (FDA) for the uses being tested in this study. The uses in this study are 
considered “investigational.” However, the FDA has allowed the use of Fisetin in this research 
study. 
 
 
Information you should know 
 
 
Who is Funding the Study? 
 
This study is being funded by the National Institute on Aging. 
 
Information Regarding Conflict of Interest: 
 
This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is 
being conducted in compliance with Mayo Clinic Conflict of Interest policies. One or more of 
the investigators associated with this project and Mayo Clinic have a financial interest in 
technology used in the research and that the investigator(s) and Mayo Clinic may stand to gain 
financially from the successful outcome of the research. Both the Mayo Clinic Conflict of 
Interest Review Board and the Institutional Review Board have reviewed the financial interest 
for one or more of the investigators and/or Mayo Clinic related to this research and they have 
determined that this financial interest poses no additional significant risk to the welfare of 
participants in this research project or to the integrity of the research.  
 
Additional information is available to any interested study participant regarding the details of 
this financial interest and how it is being managed by contacting the study coordinator or the 
Office of Conflict of Interest Review at 507-284-0075. 
 
Your healthcare provider may be referring you to this research study. If your healthcare provider 
is also an investigator on this study, there is the chance that his or her responsibilities for the 
study could influence his or her recommendation for your participation. If you prefer, your 
healthcare provider will be happy to refer you to another investigator on the research study team 
for you to decide if you want to participate in the study and to see you for the research study 
activities while you are in the study. 
 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 7 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
How long will you be in this research study? 
 
 
To see if you can be in the study, a number of screening tests and procedures are required. If you 
are eligible, this study will take about 6 months to complete.  
 
Efforts will be made to make this study as minimally disruptive as possible. For your safety and 
convenience, study staff will obtain a majority of the data for this study by communicating with 
nursing home staff and obtaining relevant information from your nursing home records and/or 
electronic medical record. Ideally, you will be able to complete the study without having to 
travel to the hospital or clinic for any research visits.   
 
 
What will happen to you while you are in this research study? 
 
 
If you are eligible and decide to take part, we will assign you by chance (like flipping a coin) to 
either the Fisetin (treatment) group or to the placebo group. You and the Principal Investigator 
can’t choose your study group. You will have an equal chance of being assigned to one or the 
other. Whichever happens, you will still get standard of care treatment. 
 
Study drug (Fisetin or placebo) will be given on two consecutive days twice, on Days 0 and 1 
and then again on Days 8 and 9. Each dosing will take 10 to 30 minutes to complete, if possible. 
The study drug may be given orally or as NG or D (feeding) tube treatments. 
 
This study uses a placebo. A placebo looks exactly like the study drug, but it contains no active 
ingredient. We use placebos in research studies to learn if the effects seen in research participants 
are truly from the study drug. 
 
During the Screening Visit, we will do some tests and procedures to see if you are eligible to 
take part in this research study. The study investigators will review the results of these tests and 
procedures. If you aren’t eligible, study staff will tell you why. At this visit we will:  
 
Screening Visit will consist of the following: 
• Informed consent  
• Review of your current medications. 
• Review of your medical history and allergies, including the following (e.g., date of first 
COVID-19 symptoms, overall symptoms, exposure source, demographics, baseline 
characteristics). This information may be collected from your electronic medical record 
and/or nursing home records 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 8 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
• Eligibility confirmation. 
• Blood collection. 
• COVID-19 test (if it has been over 10 days since your last COVID-19 test). 
• Influenza test (if you have not had one completed in the past 10 days, if applicable). 
• 
RSV test (if you have not had one completed in the past 10 days, if applicable).  
• 
Collection of relevant information from your electronic medical record and/or nursing 
home records (physical examination results, blood pressures, temperatures, weight, 
height, respiratory rate, oxygen saturation (SpO2), etc.).  
 
Baseline (Days 0 and 1) will consist of the following: 
• Eligibility confirmation. 
• Collection of relevant information from your electronic medical record and/or nursing 
home records (physical examination results, blood pressures, temperatures, weight, 
respiratory rate, oxygen saturation (SpO2), etc.). 
• Review of any changes in your health or medications. 
• Randomization and administration of study drug (Fisetin or placebo) on Days 0 and 1.  
 
Days 8 and 9 will consist of the following: 
• Confirm eligibility to re-dose. 
• Collection of relevant information from your electronic medical record and/or nursing 
home records (physical examination results, blood pressures, temperatures, weight, 
respiratory rate, oxygen saturation (SpO2), etc.). 
• Assessment of Clinical Improvement 
• Review of any changes in your health or medications. 
• Administration of study drug on Day 8 and Day 9.  
 
Day 14 will consist of the following: 
• Collection of relevant information from your electronic medical record and/or nursing 
home records (physical examination results, blood pressures, temperatures, weight, 
respiratory rate, oxygen saturation (SpO2), etc.). 
• Assessment of Clinical Improvement 
• Review of any changes in your health or medications. 
• If possible, blood collection including collection of sample for future research. 
• If possible, urine collection including collection of sample for future research. 
 
Day 30 (-2 to +7 days) will consist of the following: 
• Collection of relevant information from your electronic medical record and/or nursing 
home records (physical examination results, blood pressures, temperatures, weight, 
respiratory rate, oxygen saturation (SpO2), etc.). 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 9 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
• Assessment of Clinical Improvement 
• Review of any changes in your health or medications. 
 
Days 90 and 180 (± 14 days) will consist of the following: 
• Collection of relevant information from your electronic medical record and/or nursing 
home records (physical examination results, blood pressures, temperatures, weight, 
respiratory rate, oxygen saturation (SpO2), etc.). 
• Assessment of Clinical Improvement 
• Review of any changes in your health or medications. 
• If possible, blood collection. 
• If possible, urine collection. 
 
If you have any chest imaging (e.g., chest x-rays) done as part of your regular care the results 
will be recorded for the research study. 
 
Tests done only for research purposes are not meant to provide clinical information or help care 
for you. The results are only important for research. Therefore, the results of tests done with your 
information and samples will not be provided to you. In the rare event that a finding might affect 
the health of you or your family, we will contact you and you can choose whether to receive or 
refuse the information. If you decide to follow up and further medical testing or care is needed, 
the costs will be billed to you or your insurance. 
 
 
What are the possible risks or discomforts from being in this research study? 
 
 
RISKS OF TAKING FISETIN  
As with any medication, allergic reactions are possible. In addition, you may have side effects 
while on this study. A side effect is an undesirable experience that may or may not be related to 
Fisetin, or any of the tests performed in the study.  
 
Fisetin was shown to cause DNA damage to human cells in the test tube. The relevance of this 
result to the study in which you are participating is unknown.  
 
There are possible drug interactions and behavior activities (caffeine use, tobacco or nicotine 
use) for which we established exclusion criteria or modification plans to minimize risks. 
 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 10 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
Your doctor does not know all the side effects that you may experience. Like all investigational 
drugs, all side effects may not have been identified at this time; some may be mild or others very 
serious. Everyone taking part in the study will be watched closely for any side effects. It is 
important that you tell your study doctor when you feel or seem different compared to your usual 
self while taking part in the study.  
 
The current supply of the study drug may contain lower than anticipated amounts of Fisetin.  In 
addition, the placebo contains trace amounts of Fisetin. It is not felt that this is a safety concern 
for study subjects and will not impact the study. 
 
BLOOD DRAW: The risks of drawing blood include pain, bruising, lightheadedness, fainting, 
or rarely, infection at the site of the needle stick.  
 
CONFIDENTIALITY: As with all research, there is a chance that confidentiality could be 
compromised; however, we take precautions to minimize this risk.  
 
Talk to the researcher and/or your healthcare provider about side effects and ask any other 
questions. 
 
 
Are there reasons you might leave this research study early? 
 
 
Taking part in this research study is voluntary. You may decide to stop at any time. You should 
tell the Principal Investigator if you decide to stop and you will be advised whether any 
additional tests may need to be done for your safety. 
 
In addition, the Principal Investigator or Mayo Clinic may stop you from taking part in this study 
at any time:  
• If it is in your best clinical interest, 
• If you don’t follow the study procedures,  
• If the study is stopped 
 
If you leave this research study early, or are withdrawn from the study, no more information 
about you will be collected; however, information already collected about you in the study may 
continue to be used.  
 
We will tell you about any new information that may affect your willingness to stay in the 
research study. 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 11 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
What if you are injured from your participation in this research study? 
 
 
Where to get help: 
 
If you think you have suffered a research-related injury, you should promptly notify the Principal 
Investigator listed in the Contact Information at the beginning of this form. Mayo Clinic will 
offer care for research-related injuries, including first aid, emergency treatment and follow-up 
care as needed. 
 
Who will pay for the treatment of research related injuries? 
 
Care for such research-related injuries will be billed in the ordinary manner, to you or your 
insurance. Treatment costs for research-related injuries not covered by your insurance will be 
paid by Mayo Clinic. 
 
 
What are the possible benefits from being in this research study? 
 
 
This study may not make your health better. Others with COVID-19 infections may benefit in 
the future from what learned in this study. It is for the benefit of research that we are doing this 
study. 
 
 
What alternative do you have if you choose not to participate in this  
research study? 
 
 
You don’t have to be in this study to receive treatment for your condition. Your other choices 
may include antivirals, immune modulator drugs, glucocorticoids, hydroxychloroquine, 
azithromycin, remdesivir and/or convalescent plasma. Note that receiving the institutional 
standard of care treatment for COVID-19 with these medications does not exclude you from 
participating in this study.  Also, note that Fisetin can be obtained outside of this protocol. Talk 
to the Principal Investigator or your doctor if you have any questions about any of these 
treatments. 
 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 12 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
What tests or procedures will you need to pay for if you take part in this  
research study? 
 
 
You won’t need to pay for tests and procedures that are done just for this research study. These 
tests and procedures are:  
• Research blood draws and tests  
• Research urine tests  
• SARS-CoV-2 test (if applicable) 
• Influenza rapid test (if applicable) 
• RSV rapid test (if applicable) 
• Study drugs  
 
However, you and/or your insurance will need to pay for all other tests and procedures that you 
would have as part of your standard clinical care, including co-payments and deductibles. 
 
If you have billing or insurance questions call Patient Account Services at the telephone 
number provided in the Contact Information section of this form. 
 
 
Will you be paid for taking part in this research study? 
 
 
You will not be paid for participating in this study. 
 
There is a very small chance that some commercial value may result from the use of your 
sample. This could include new products like a drug or a test to diagnose a disease. If that 
happens, you will not be offered a share in any profits. 
 
 
Will your information or samples be used for future research? 
 
 
Identifiable information such as your name, Mayo Clinic number, or date of birth may be 
removed from your information or samples collected in this study, allowing the information or 
samples to be used for future research or shared with other researchers without your additional 
informed consent. 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 13 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
 
How will your privacy and the confidentiality of your records be protected? 
 
 
Mayo Clinic is committed to protecting the confidentiality of information obtained about you in 
connection with this research study. Your name will not be identified with your study data, 
results, or samples. A unique subject identification number assigned to you will be used as a 
code for this study. Data stored on a computer will be password-protected.  
 
During this research, information about your health will be collected.  Under Federal law called 
the Privacy Rule, health information is private.  However, there are exceptions to this rule, and 
you should know who may be able to see, use and share your health information for research and 
why they may need to do so.  Information about you and your health cannot be used in this 
research study without your written permission.  If you sign this form, it will provide that 
permission (or “authorization”) to Mayo Clinic. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or samples 
that may identify you in any action or suit unless you say it is okay. They also cannot provide 
them as evidence unless you have agreed.  This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena. 
  
There are some important things that you need to know.  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, some communicable diseases, and threats to harm yourself or others.  
The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. The Certificate DOES NOT 
stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate 
also DOES NOT prevent your information from being used for other research if allowed by 
federal regulations. 
  
Researchers may release information about you when you say it is okay. For example, you may 
give them permission to release information to insurers, medical providers or any other persons 
not connected with the research. The Certificate of Confidentiality does not stop you from 
willingly releasing information about your involvement in this research. It also does not prevent 
you from having access to your own information. 
 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 14 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
Your health information may be collected from: 
• Past, present and future medical records. 
• Research procedures, including research office visits, tests, interviews and 
questionnaires. 
 
Your health information will be used and/or given to others to: 
• Do the research. 
• Report the results. 
• See if the research was conducted following the approved study plan, and applicable rules 
and regulations. 
 
Your health information may be used and shared with: 
• Mayo Clinic research staff involved in this study.  
• Other Mayo Clinic staff involved in your clinical care. 
• Researchers involved in this study at other institutions. 
• The sponsor(s) of this study and the people or groups hired by the sponsor(s) to help 
perform this research. 
• The Mayo Clinic Institutional Review Board that oversees the research.  
• Federal and State agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health and other United States 
agencies) or government agencies in other countries that oversee or review research. 
• A group that oversees the data (study information) and safety of this research. 
 
How your information may be shared with others: 
While taking part in this study, you will be assigned a code that is unique to you, but does not 
include information that directly identifies you. This code will be used if your study information 
is sent outside of Mayo Clinic. The groups or individuals who receive your coded information 
will use it only for the purposes described in this consent form. 
 
If the results of this study are made public (for example, through scientific meetings, reports or 
media), information that identifies you will not be used. 
 
In addition, individuals involved in study oversight and not employed by Mayo Clinic may be 
allowed to review your health information included in past, present, and future medical and/or 
research records. This review may be done on-site at Mayo Clinic or remotely (from an off-site 
location). These records contain information that directly identifies you.  
 
However, the individuals will not be allowed to record, print, or copy (using paper, digital, 
photographic or other methods), or remove your identifying information from Mayo Clinic. 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 15 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
Is your health information protected after it has been shared with others? 
Mayo Clinic asks anyone who receives your health information from us to protect your privacy; 
however, once your information is shared outside Mayo Clinic, we cannot promise that it will 
remain private and it may no longer be protected by the Privacy Rule. 
 
 
Your Rights and Permissions 
 
 
Participation in this study is completely voluntary. You have the right not to participate at all.  
Even if you decide to be part of the study now, you may change your mind and stop at any time.  
You do not have to sign this form, but if you do not, you cannot take part in this research study. 
 
Deciding not to participate or choosing to leave the study will not result in any penalty.  Saying 
‘no’ will not harm your relationship with your own doctors or with Mayo Clinic. 
 
If you cancel your permission for Mayo Clinic to use or share your health information, your 
participation in this study will end and no more information about you will be collected; 
however, information already collected about you in the study may continue to be used. 
 
You can cancel your permission for Mayo Clinic to use or share your health information at any 
time by sending a letter to the address below: 
 
Mayo Clinic 
Office for Human Research Protection 
ATTN:  Notice of Revocation of Authorization 
Plummer Building PL 3-02 
200 1st Street SW 
Rochester, MN  55905 
 
Alternatively, you may cancel your permission by emailing the Mayo Clinic Research 
Participant Advocate at: researchparticipantadvocate@mayo.edu. 
 
Please be sure to include in your letter or email: 
• The name of the Principal Investigator, 
• The study IRB number and /or study name, and 
• Your contact information. 
 
Your permission for Mayo Clinic to use and share your health information lasts forever, unless 
you cancel it. 
 


 
 
Approval Date:  
April 4, 2024 
Not to be used after: April 3, 2025  
 
 
IRB#: 20-008867 00   e-sign AS 
Page 16 of 16 
IRB Doc. Ctrl # 10013.34 
 
 
 
 
 
Name and Clinic Number 
Protocol #: 20-008867 
Subject ID: 
Version #: 
Version Date: 
{{$prtPartName                                          }} 
{{$dteParticipantSig                                }} 
{{!$sigWitness}} 
{{$sigParticipant                    }} 
{{$sigLAR                }} 
{{$prtLARName                }} 
{{$prtPartRelation                      }} {{$dteLARSig        }} 
{{$prtPOCName                                       }} 
{{$dtePOCSig                                        }} 
{{$sigPOC                                 }} 
 
Enrollment and Permission Signatures 
 
 
Your signature documents your permission to take part in this research.  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
Printed Name  
 
 
Date (mm/dd/yyyy) 
 
 
Time (hh:mm am/pm)  
 
 
 
 
 
 
 
 
_______________________________ 
Signature 
 
 
Signature of Legally Authorized Representative for Adult Participant  
• I give permission for the participant to take part in this research study and agree to allow 
his/her health information to be used and shared as described above.  
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
         
Signature 
 
Printed Name  
 
Relationship to Participant 
Date \ Time 
 
 
Person Obtaining Consent  
• I have explained the research study to the participant. 
• I have answered all questions about this research study to the best of my ability. 
 
 
 
Printed Name  
 
 
Date (mm/dd/yyyy) 
 
 
Time (hh:mm am/pm) 
 
 
_______________________________ 
Signature