SPECIMEN COLLECTION AND BANKING
CONSENT FORM

EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

 The rights below are the rights of every person who is asked to be in a research study.  As an experimental subject I have the following rights:

1. To be told what the study is trying to find out.

2. To be told what will happen to me and whether any of the procedures, drugs or devices is different than what would be used in standard practice.

3. To be told about the frequent and/or important risks, side effects, or discomforts associated with the things that will happen to me for research purposes.

4. To be told if I can expect any benefit from participating and, if so, what the benefit might be.

5. To be told the other choices of procedures, drugs or devices I have and how they may be better or worse than being in the study, including risks and benefits.

6. To be allowed to ask any questions concerning the study and procedures both before agreeing to be involved and during the course of the study.

7. To be told what sort of medical treatment is available if any complications arise.

8. To refuse to participate at all or to change my mind about participating after the study has started. This decision will not affect my right to receive the care I would receive if I were not in the study.

9. To receive a copy of the signed and dated consent form.

10. To be free of pressure when considering whether I wish to agree to be in the study or not participate.

If I have questions about the research study, I should ask a study team member or contact the researcher, Dr. Akinboboye. In addition, I may contact the Institutional Review Board (IRB), which is concerned with protection of volunteers in research projects.  I can reach the IRB office by calling 1-800-562-4789 during normal business hours, or by writing the 1019 39th Avenue SE Suite 120 Puyallup, Washington  98374-2115.

By signing below, I state that I have read and have had the opportunity to ask questions about the rights which all subjects in a research study have.

Signature of Participant or Legally Authorized Representative

1. Fever or chills
2. Cough
3. Shortness of breath or difficulty breathing
4. Fatigue
5. Muscle or body aches
6. Headache
7. New loss of taste or smell
8. Sore throat
9. Congestion or runny nose
10. Nausea or vomiting
11. Diarrhea

Dr. Akinboboye and his colleagues are engaged in a study designed to collect nasal/nasopharyngeal swab and blood sample specimens to use for COVID-19 testing [Polymerase Chain Reaction (PCR) and antibody] and for future genetic, biological and biomarker analysis. There is a possibility that genetic and/or other biological factors may predispose minority groups to more severe disease and higher mortality. This is a question that we hope to investigate in this study. The National Minority Quality Forum is leading this study. This is a research study and your participation is completely voluntary. Your involvement in the research may last up to five years. Up to 10,000 people may be enrolled in this study.

Participants who test (PCR) negative for COVID-19, will be contacted by the health center when your test results are back. If you test negative, you do not need to quarantine and you may receive follow-up calls from the study team periodically over the next five years.  You will be contacted to check to see if you remain asymptomatic, become symptomatic or need to be re-tested. You will also be asked about the COVID-19 status of people living in your household. Household members may be invited to join the study.

Participants who test (PCR) positive for COVID-19, will be contacted by the health center when your test results are back. If you are positive, you will be asked to quarantine in your home for 14 days starting on the day you are notified of your results. You will be asked to use your study-provided thermometer to complete and record your temperature twice a day. If you have respiratory symptoms or a history of respiratory illness (asthma, COPD, emphysema, etc.) you will be sent a pulse oximeter and be asked to measure and record your oxygen saturation twice a day. You may receive a phone call daily for 14 days from a study nurse or other qualified professional to monitor your health status and triage your care, if needed. After 14 days, you may receive follow-up calls once per month fro the next six months and then four times a year from the study team for the next five years. You will also be asked about the COVID-19 status of people living in your household. Household members may be invited to join the study.

What are the Possible Risks and Discomforts?

There are risks associated with getting a blood draw that include: infection at the site, bruising, clotting, and mild pain. Blood draws will be done by experienced clinicians and phlebotomists, which will reduce your risks listed above. Some people find the nasal/nasopharyngeal viral swab unpleasant or uncomfortable. There is a slight risk of a false positive or negative test. The tests being used in this study have been FDA approved for emergency use only and and have high specificity and sensitivity, which will increase the likelihood that your tests results will be accurate.

The use of this test is considered investigational in this study.

You may find some survey questions sensitive or upsetting. You may skip any questions that you wish not to answer without penalty.

There is a minimal risk of a breach of confidentiality since you will be sharing private health information. However, only the National Minority Quality Forum, their affiliates, the approved investigators on this study and the health center where you enrolled will have access to your private information and will act in accordance with HIPAA regulations. Appropriate measures will be taken to minimize the risk as much as possible. 

In addition to these risks, taking part in this research may harm you in unknown ways.

How Will Information About You be Kept Private?

Your privacy is very important to us and we will make every effort to protect it:

• We will remove your name and other identifiers from your sample and personal information, and replace them with a code number. We will keep the list that links the code number to your name separate from your sample and personal information. Only select trained staff will have access to the list and they sign an agreement to keep your identity private and confidential.
• We will not give information that identifies you to persons or entities outside of this study except if required by Information that is shared with those who are not associated with this study may no longer be protected by HIPAA, the federal privacy law.
• Your information may also be inspected by governmental agencies such as the Food and Drug Administration (FDA), authorized representative(s) of the study sponsor (including its agents and/or contractors) and the Western Institutional Review Board (the committee overseeing the protection of research participants on this study). These groups may access your health information for study monitoring and/or auditing purposes, while maintaining your health information as confidential to the extent required by law.
• In addition, members of the healthcare team involved in your medical care will have access to your confidential health information, which may include information about you that involves your participation in this research study. As a result, these individuals may be able to see your research-related information and/or procedure results. All members of the healthcare team are bound by confidentiality laws to keep information about you confidential.

Genetic Information and Nondiscrimination Act (GINA)

The research will include whole genome sequencing (i.e., the process of decoding human DNA to gain information of interest, such as what genes are present and the sequence they are in). Whole genome sequencing will occur within 36 months of your specimen collection date.  Because you will be having genetic testing done on your blood or tissue, it is important to know about a federal law called the Genetic Information Nondiscrimination Act (GINA). This law generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

• Health insurance companies and group health plans may not request your genetic information that we get from this
• Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or
• Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your

Be aware that this Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance or long-term care insurance.

What are the Potential Benefits?

By participating in this study, you will receive COVID-19 PCR and antibody testing at no cost to you. All participants will receive a personal thermometer to keep, regardless of COVID-19 status. The information gained from this study may be used to benefit scientific understanding of COVID-19 in minority and rural communities and may help improve COVID-19 care in the future. Regardless of whether you test positive or negative for COVID-19, the health center where you are originally tested will offer study participants the opportunity to receive primary care medical services consistent with their enrollment policies.

Are There Any Costs or Payments?

There is no cost to you for participating in the study. There may be laboratory tests that are considered standard of care that can be billed to your insurance. If those tests are not covered by your insurance or you have no insurance, you will not be billed. You will not be paid to participate in this study.

What are my Choices?

Taking part in the research study is completely voluntary. Declining to participate will not affect your ability to receive COVID-19 testing or negatively impact your relationship with the health center or research team. You can still receive COVID-19 testing if you do not wish to participate in the research study. If you change your mind over the course of the study, you can withdraw your consent at any time.

Will I Find Out the Results of the Research?

Clinically relevant research results relating to COVID-19, including individual testing, will be disclosed to you. If you choose, a researcher may be able to give you information learned during the genome sequencing. This information may not be related to the study but could be important to your health. For example, it could be about a health issue or disease that is serious, and that cannot be treated or avoided. You can choose whether or not you would like to be re-contacted and informed of this information if any genomic findings relevant to your health are discovered.

What If I Change My Mind?

You are free to not participate or leave the study at any time or to change your mind about having your samples used for this research project at any time without penalty or loss of benefits to which you are otherwise entitled. If you no longer wish to participate in this research project and would like the sponsor to stop using your sample for research, you may contact Dr. LaTasha Lee at 202 223-7566.

Reimbursement of Research-Related Injury:

In the event that you believe participation in this research project has led to injury, you may contact Dr. Gary Puckrein at 202 223-7566 to identify the medical resources that may be available to you and to assist you in obtaining appropriate medical care. The study sponsor and the enrolling health center make no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Your medical expenses will be billed to you or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research. Your doctor, the investigators and their affiliated organizations do not have any program to provide compensation for persons who may experience injury while participating in research projects.

Participant's Signature and Date

Investigator’s Signature and Date

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