University of North Carolina at Chapel Hill  Consent to Participate in a Research Study: Adult Participants

University of North Carolina at Chapel Hill
Consent to Participate in a Research Study
Adult Participants

Consent Form Version Date: May 20, 2020
IRB Study # 20-0937
Title of Study: ScreenNC
Principal Investigator: David Peden, MD
Principal Investigator Department: Pediatrics – Allergy Immunology and Rheumatology
Principal Investigator Phone number: (919) 966-0768
Principal Investigator Email Address: david_peden@med.unc.edu
Study Contact Telephone Number: (919) 966-0759; 919-784-2164
Study Contact Email: martha_almond@med.unc.edu; Rameet.Sirpal@unchealth.unc.edu

 

CONCISE SUMMARY

This is a research study to help us understand how many people in North Carolina might actually be infected with the COVID-19 virus, but who don’t have any symptoms. If you decide you want to participate, we will collect a nasal or oral swab, and blood.  We will look at your medical record to see if there are trends in health issues or medications that people take that impacts if you show symptoms or not.  The benefit of this study is that you will have knowledge of your SARS-CoV-2 (COVID-19) status.  Risks include a little discomfort from the swab.

If you are interested in learning more about this study, please continue reading below.
What are some general things you should know about research studies?
You are being asked to take part in a research study.  To join the study is voluntary.

You may choose not to participate, or you may withdraw your consent to be in the study, for any reason, without penalty.

Research studies are designed to obtain new knowledge. This new information may help people in the future.   You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies. Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the researcher, your health care provider, or the University of North Carolina-Chapel Hill. If you are a patient with an illness, you do not have to be in the research study in order to receive health care.

Details about this study are discussed below.  It is important that you understand this information so that you can make an informed choice about being in this research study.

You will be given a copy of this consent form.  You should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time.

What is the purpose of this study?
The purpose of this research study is to help understand how many people have been exposed to SARS-CoV-2, which is the virus that causes the COVID-19 coronavirus disease, but don’t show any symptoms of the disease.  We want to learn if these people have similar amounts of the virus in their bodies, if certain pre-existing health conditions or if any medication use impacts how people respond when they are exposed to the virus.

You are being asked to be in the study because you don’t have signs of the COVID-19 disease, and you are a patient of the UNC Healthcare system.  If you were previously diagnosed with COVID-19, and it’s been more than 4 weeks since you first tested positive, and if you have had a negative test since then, you can participate.

Are there any reasons you should not be in this study?
You should not be in this study if you have symptoms of the COVID-19 disease.

How many people will take part in this study?
Approximately 10,000 people in the UNC Healthcare system will take part in this study.

How long will your part in this study last?
You will spend no more than an hour in this study, after you complete the consent process.

What will happen if you take part in the study?
Once you have completed your visit with your healthcare provider, we will collect one or both of these tests; a nasal or oral swab to send to LabCorp, INC, for testing for COVID-19, if it is available during your visit, and if the proper protective equipment for you and for the people who will be collecting the swab is available. The swab test is commonly done in a doctor’s office to diagnose flu, or whooping cough, and of course COVID-19.  We will ask you to blow your nose, then we will insert a swab into your nose, to the back of your throat, and we will rotate the swab for about 10-15 seconds.   If you cannot tolerate the swab in your nose we will do same but put the swab into the back of your throat.   These are tests that meet requirements for diagnosis of SARS-Cov 2 (Coronavirus) infection from the FDA and are used for clinical testing.  Your swab results will be placed in your medical record at UNC and those with a positive result will also be contacted by study staff to check on your clinical condition, given appropriate advice regarding self-isolation, and referred to their primary care physician. The result will also be reported to the NC State Health department.

 

We will also collect a blood sample, which takes up to 5cc (about 1 teaspoon) of blood to look for markers to see if you have been exposed to the SARS-Cov 2 coronavirus. The blood test at present is a research test done at UNC Healthcare laboratories, and not used for diagnosis of acute COVID-19 infection. It can only tell us if you have been exposed to the SARS-Cov 2 virus, not if you have developed an infection or if you have any immunity to the illness based on the results.  If the result is positive, it means that you have been exposed and your body developed antibodies, which are proteins that your body produces once it has been exposed to a specific virus or bacteria. If the test is negative, it only means that you have not developed these antibodies. This test will be placed into your medical record and we will notify you of positive results, and speak with you to interpret these results. A positive blood test does not mean you are currently infected with virus. If in the future we learn new information on the meaning of the blood test that is important for your health, we will share it with you.

 

If there is sample remaining after this blood test is performed, we will further characterize the markers for SARS-CoV2 (which are antibodies against SARS-CoV2) can neutralize the activity of SARS-CoV2 virus in the test tube. This test will be done in the Virology Genetics Core Laboratory of the UNC Lineberger Comprehensive Cancer Center. A positive result of this test does not mean you have immunity from this virus.

 

We might want to contact you in the future regarding more studies to follow up with results we get from this one.  Please review the options below and select one of the choices by putting your initials on the line beside your choice:

 

______By selecting this box, I agree to both the Swab and blood collection, and understand that at this time I will only be informed of the results of the swab and that if additional information about my blood sample becomes available that the PI feels is relevant it will be shared with me as available.

 

_______By selecting this box, I agree to only a swab, and understand I will be informed of the results of the swab.

 

_______By selecting this box, I agree to only a blood draw, and I understand at this time a blood sample cannot be used to diagnose COVID-19 disease, but that I will be notified of this result and may be contacted again if information about my blood sample result becomes available in the future that the PI feels is relevant to my health.

 

Once LabCorp makes the analysis of the viral swab (if we get a swab sample), they will send any remaining sample back to us for further testing on the virus.  Your blood and swab samples will be destroyed after the UNC analysis is complete. However, study research staff will retain identifying information about you that may include medical record information.  This information may be shared with other collaborators or others who are studying the coronavirus.  However, any information that is shared outside of the study personnel would only be shared in a de-identified way, meaning that your identifiable information would not be given out.

 

What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge.  You will not benefit personally from being in this research study, aside from possible knowledge of having asymptomatic COVID-19.
What are the possible risks or discomforts involved from being in this study?

The swabs may be uncomfortable. There may be uncommon or previously unknown risks. You should report any problems to the researcher. You may experience anxiety if you are found to be infected with SARS-Cov 2, the virus that causes COVID-19.  There is a risk of bruising with a blood draw, and some people may get dizzy.  The staff taking your blood are trained to help you reduce these risks.  There is a risk of breach of confidentiality, meaning that it is possible that someone could learn of your COVID-19 results.

How will information about you be protected?

Any paper records will be secured in our office, in a secure building.  The result of your test will become part of your UNC Health medical record. Your sample will be given a number, which will be linked to your medial record number, but only researchers directly involved will have access to identifiable data.

 

Participants will not be identified in any report or publication about this study.  We may use de-identified data from this study in future research without additional consent.

Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information.  This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information.  In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety.

You will be asked to sign a separate form (“HIPAA Authorization”) to allow researchers to review your medical records.   A copy of both of the signed consent forms will be placed in your medical record.

 

What will happen if you are injured by this research?

All research involves a chance that something bad might happen to you.  If you are hurt, become sick, or develop a reaction from something that was done as part of this study, the researcher will help you get medical care, but the University of North Carolina at Chapel Hill has not set aside funds to pay you for any such injuries, illnesses or reactions, or for the related medical care.  Any costs for medical expenses will be billed to you or your insurance company.  You may be responsible for any co-payments and your insurance may not cover the costs of study related injuries.

 

If you think you have been injured from taking part in this study, call the Principal Investigator at the phone number provided on this consent form.  They will let you know what you should do.

By signing this form, you do not give up your right to seek payment or other rights if you are harmed as a result of being in this study.

 

What if you want to stop before your part in the study is complete?

You can withdraw from this study at any time, without penalty.
If you withdraw or are withdrawn from this study all data collected up until the point of withdrawal will be retained, however no additional information will be collected unless you provide additional written permission for further data collection at the time of your withdrawal.

 

Will you receive anything for being in this study?
You will not receive anything for taking part in this study.

 

Will it cost you anything to be in this study?
It will not cost you anything to be in this study.

 

What if you are a UNC ,UNC FP employee, or an employee of any other UNC entity?

Taking part in this research is not a part of your University duties, and refusing will not affect your job.  You will not be offered or receive any special job-related consideration if you take part in this research. If you have obtain a swab test and it is positive, in addition to the actions described above for any participant, you will be instructed to contact employee health and asked to go into self-quarantine for 14 days, as directed by the appropriate occupational health policies outlined by your specific health care organization (e.g. UNC, UNC School of Medicine, UNC Health, UNC Physicians Network).

What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study (including payments), complaints, concerns, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form.

 

A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

What if you have questions about your rights as a research participant?
All research on human volunteers is reviewed by a committee that works to protect your rights and welfare.  If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.

University of North Carolina at Chapel Hill
Information about participating in a Research Study during COVID-19.

Version Date: June 15, 2020
IRB Study # 20-0937
Title of Study: ScreenNC
Principal Investigator: David Peden, MD

Study Contact Telephone Number: (919) 966-0768
Study Contact Email: david_peden@med.unc.edu

The “you” referenced in this information sheet either refers to the participant, “your child”, or the individual you are providing consent on behalf of as a legal authorized representative, as applicable.

 

The following information should be read as an addition to the original Consent process. Unless specifically stated otherwise in the following paragraphs, all information contained in that original Consent Form is still true and remains in effect. Your participation continues to be voluntary. You may choose not to participate or may withdraw your consent to participate at any time, and for any reason, without jeopardizing your future care at this institution or your relationship with your study doctor.

 

New or additional information

COVID-19 is a novel (previously unidentified) coronavirus and has been declared a pandemic due to its global spread.  The virus causing coronavirus disease 2019 (COVID-19), is not the same as the coronaviruses that commonly circulate among humans and usually cause mild illness, like the common cold.  Many countries, states, and local governments have implemented restrictions (e.g., physical distancing requirements, closure of public places) to attempt to limit the spread of the virus.  If your community does not permit travel or otherwise limits interaction, please tell the study team.  UNC’s permission for certain studies to continue is not intended to interfere with a person’s ability to follow their community’s requirements.

 

Physical distancing is the primary strategy used to prevent the spread of the virus that causes COVID-19. Physical distancing calls for people to increase the space between one another and to avoid gatherings and crowds. The Centers for Disease Control and Prevention (CDC). Says people should maintain a distance of at least six feet from others when possible.

 

If you choose to continue your participation in research at UNC project research personnel will do their best to follow the below recommendations described in this information sheet that were developed based on guidance from the CDC and in partnership with study teams, departments,  UNC’s Infectious Disease specialist.  Despite everyone’s efforts, there is still the risk that you may already have or may become infected with COVID-19 and may then infect others.

 

COVID-19 Symptoms

People with COVID-19 have had a wide range of reported symptoms – ranging from mild symptoms to severe illness which may lead to death.  Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19:

• Cough
• Shortness of breath or difficulty breathing
• Fever
• Chills especially repeated shaking chills
• Muscle pain
• Sore throat
• New loss of taste or smell
• Vomiting and diarrhea

This list is from the CDC but may not include all possible symptoms.  People experience the virus in many different ways.  Please contact your medical provider if you are experiencing symptoms that are concerning to you.

Pandemics can be stressful for everyone. Fear and anxiety about a disease can be overwhelming and cause strong emotions in both adults and children.  Please talk with the study team if you are experiencing COVID symptoms, fear or anxiety.

 

Please seek emergency medical care immediately if experiencing the following symptoms:

 

• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• Inability to wake or stay awake
• Bluish lips or face

*This list is not all possible symptoms. Please call your medical provider for any other symptoms that are severe or concerning to you.  Call 911 or call ahead to your local emergency facility: Notify the operator that you are seeking care for someone who has or may have COVID-19.

 

Children and Multisystem Inflammatory Syndrome (MIS-C)

Multisystem Inflammatory Syndrome (MIS-C), is a condition in children where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.  We do not yet know what causes MIS-C, however we know that many children with MIS-C had the virus that causes COVID-19, or had been around someone with COVID-19.  MIS-C can be serious, even deadly, but most children who have been diagnosed with this condition have gotten better with medical care.

Contact your child’s doctor, nurse, or clinic right away if your child is showing symptoms of MIS-C:

• Fever
• Abdominal pain
• Vomiting
• Diarrhea
• Neck pain
• Rash
• Bloodshot eyes
• Feeling extra tired

 

Be aware that not all children will have all the same symptoms.  Seek emergency care right away if your child is showing any of these emergency warning signs of MIS-C or other concerning signs:

• Trouble breathing
• Pain or pressure in the chest that does not go away
• New confusion
• Inability to wake or stay awake
• Bluish lips or face
• Severe abdominal pain

What steps are the study team and UNC taking to prevent the spread of COVID?

To help prevent the spread of COVID study teams across UNC are taking the following steps:

 

If the subject would like to participate but is in a high-risk group as defined by the CDC including those over the age of 65, live in a nursing home or long-term care facility, or who have underlying medical conditions, particularly if not well controlled, they should discuss if study activities can be safely delayed with the study team or if participation should continue.

 

1. Prior to a face-to-face visit, research personnel must confirm your appointment and perform telephone wellness screenings no more than 24 hours prior to the scheduled visit.

1. 1. You and anyone required to attend the visit with you must be rescreened by front desk staff or research personnel upon arrival before the study visit begins (i.e., to confirm there are no symptoms, no fever, etc.). You and anyone required to attend the visit must be masked upon arrival at the clinic/research site. Anyone who fails rescreening will be immediately isolated in a private room. Clinical study personnel will be contacted and recommendations from Infection Prevention regarding referral for testing should be followed.  You may be responsible for cost of testing, and treatment of COVID-19 unless this is specifically part of the study you are participating in or otherwise covered.  The study specific consent form will cover this if applicable.
2. During face-to-face visits, research personnel and you should maintain a physical distance of 6 feet whenever possible, wear a facemask and eye protection, and perform hand hygiene before and after face-to-face interaction with all participants.
3. Interactions should take place in an outdoor setting, if possible.
4. Research personnel have developed and implemented a regular schedule for frequently cleaning and wiping touched surfaces and objects (e.g., door and cabinet handles, faucets, light switches, keyboards, and other frequently touched objects) with an approved disinfectant or disinfectant wipes. Research personnel will also follow routine surface decontamination of common equipment like instrumentation and computers. Disinfecting any surfaces that may be thought to be contaminated and use an approved disinfectant such as a 1:10 dilution of bleach or 60% to 90% alcohol solution.
5. Research that involves participants of 10 or fewer individuals in a group, such as a focus group, is allowed. Seating should be arranged to allow 6 feet between group members, and all focus group participants must wear masks.
6. If research involves travel or overnight stays, accommodation and meals should allow for adequate physical distancing (6 feet or more) wherever feasible. Vehicle occupancy should be limited to no more than two people in a standard car, with open windows while travelling, if possible. Vehicle occupants should wear masks.
7. Some locations may have additional safety procedures.  If your visit is at such a location, the study team will describe what to expect when they call to confirm your study visit.

If you feel as though the above precautions are not being followed please either talk with the study staff, submit an anonymous request through Ethics Point by calling 1-866-294-8688, or reach out to the UNC OHRE IRB at 919-966-3113.

You should receive a copy of this form when possible. Please discuss with your study team, ask all questions you may have, and confirm whether you would like to continue your participation.  The study team may also withdraw you from the study or request to delay study activities if they have concerns about safety.