Version 1 (03/01/2022 - 05/01/2023 Version 2 (05/02/2023 - 06/21/2023) Version 3 (1.21) (06/22/2023 - 04/18/2024) Version 3 (1.21) (4/19/2024 - 01/01/2100)
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View equation Your responses indicate that you are NOT ELIGIBLE to participate.
Your responses indicate that you are unfortunately NOT ELIGIBLE to participate. However, we would like to save your contact information to tell you about future studies.
Can we contact you to tell you about future studies?
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Thank you for taking the time to complete this survey and we appreciate for your interest in CARE.
Your responses indicate that you MAY BE ELIGIBLE to participate in the CARE study.
You may review the Informed Consent form at this time and when finished will have the options to:
Agree to Participate Decline Participation or Request More Information
Your responses indicate that you are potentially ELIGIBLE to participate in the CARE study.
You may review the Informed Consent form at this time and when finished will have the options to:
• Ask questions,
• Agree to Participate,
• or Decline Participation
WOULD YOU LIKE TO REVIEW THE CONSENT FORM NOW?
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Consent to Participate in a Research Study
CONCISE SUMMARYThe purpose of the study is to build a Community APOLl Research Engagement project (CARE) to promote community engagement & translational research. We will build CARE to help increase participation of African Americans in clinical research trials. With this local registry, we will establish a pathway to support APOLl patient-oriented research while providing chronic kidney disease (CKD) screening and referrals to nephrology for high-risk patients.
You will have one screening visit for collection of a blood and urine sample. The risk for the study includes the risk of the blood draw including momentary discomfort and possible bruising. We will screen all participants for CKD by measuring Urine Albumin Creatine ratio (UACR) and estimated glomerular filtration rate (eGFR); and for diabetes by measuring AlC. wWe will also measure and record blood pressure (BP) of all participants. Individuals with UACR ratio 2: 300 mg/g and eGFR 2:30 ml/min/1. 73m2 will be eligible for enrolment in the CARE project in addition to some other inclusion and exclusion criteria. This will enable you to participate in future clinical research studies.
Individuals with positive CKD screen result who currently have primary care physicians (PCP) will be given a written report of their UARC, eGFR, and BP to give to their PCP for appropriate follow up and evaluation for nephrology referral. Individuals without healthcare insurance or without a PCP will be referred to free nephrology clinics at Duke.
If you are interested in learning more about this study, please continue reading below
CONCISE SUMMARYThe purpose of the study is to build a Community APOL1 Research Engagement (CARE) project to promote community engagement, kidney disease screening & increase the participation of African Americans in clinical research trials. With this local registry, we will establish a pathway to support APOL1 patient-oriented research while providing chronic kidney disease (CKD) screening and referrals to nephrology for high-risk patients.
Saliva collection will be used to test for the presence of high-risk APOL1 genotype. You will have one screening visit for collection of a blood and urine sample. The risk for the study includes the risk of the blood draw including momentary discomfort and possible bruising. We will screen all participants for CKD by measuring Urine Albumin Creatine ratio (UACR) and estimated glomerular filtration rate (eGFR); and for diabetes by measuring A1C. We will also measure and record blood pressure (BP) of all participants. Individuals with UACR ratio 2: 300 mg/g and eGFR 2:30 ml/min/1. 73m2 will be eligible for enrollment in the CARE project in addition to some other inclusion and exclusion criteria. This will enable you to participate in future clinical research studies.
Individuals with positive CKD screen result who currently have primary care physicians (PCP) will be given a written report of their UACR, eGFR, and BP to give to their PCP for appropriate follow up and evaluation for nephrology referral. Individuals without healthcare insurance or without a PCP will be referred to free nephrology clinics at Duke.
If you are interested in learning more about this study, please continue reading below
You are being asked to take part in this research study because you are African American/Black and may be at risk for chronic kidney disease. Research studies are voluntary and include only people who choose to take part. Please read this consent form carefully and take your time making your decision. As your study doctor or study staff discusses this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. The nature of the study, risks, inconveniences, discomforts, and other important information about the study are listed below.
Please tell the study doctor or study staff if you are taking part in another research study.
Dr. Opeyemi Olabisi will conduct the study and it is funded by the National Institutes of Health.
You are being asked to take part in this research study because you are African American/Black and may be at risk for chronic kidney disease. Research studies are voluntary and include only people who choose to take part. Please read this consent form carefully and take your time making your decision. As your study doctor or study staff discusses this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. The nature of the study, risks, inconveniences, discomforts, and other important information about the study are listed below.
Please tell the study doctor or study staff if you are taking part in another research study.
Dr. Opeyemi Olabisi will conduct the study and it is funded by the National Institutes of Health.
WHO WILL BE MY DOCTOR ON THIS STUDY?If you decide to participate, Dr. Olabisi, will be your doctor for the study and will be in contact with your regular health care provider throughout the time that you are in the study and afterwards, if needed.
WHY IS THIS STUDY BEING DONE?The purpose of the study is to build a Community APOLl Research Engagement project (CARE) for community engagement & translational research. We will CARE to help increase participation of African Americans in clinical research trials. With this registry, we will establish a pathway to support APOLl patient-oriented research while providing chronic kidney disease (CKD) screening and referrals to nephrology for high-risk patients.
WHY IS THIS STUDY BEING DONE?The purpose of the study is to build a Community APOL1 Research Engagement (CARE) project for community engagement & translational research. We will build CARE to help increase participation of African Americans in clinical research trials. With this registry, we will establish a pathway to support APOL1 patient-oriented research while providing chronic kidney disease (CKD) screening and referrals to nephrology for high-risk patients.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?Approximately 500 people will enrolled into this registry at Duke University Health System. We expect to screen up to 5000 people in order to recruit the final 500 eligible participants.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?Approximately 500 people will be enrolled into this CARE registry at Duke University Health System. We expect to screen up to 5000 people in order to recruit the final 500 eligible participants.
WHAT IS INVOLVED IN THE STUDY?
If you agree to be in this study, you will be asked to sign and date this consent form. You will have the following tests and procedures to make sure that you are eligible:
Blood test and urine test to measure your kidney function. We will screen all participants for CKD by measuring Urine Albumin Creatine ratio (UACR) and estimated glomerular filtration rate ( eGFR). Saliva collection will be used to test for the presence of high-risk APOLl genotype. Blood pressure (BP), height and weight will be collected on all participants. Two tubes of blood, approximately two tablespoons, will be obtained. Two ounces of urine will be collected by you in a sterile urine cup. Saliva will be collected by asking you to spit into a sterile saliva collection container.
Based on your screening results and other inclusion and exclusion criteria, you will be enrolled in the CARE registry for clinical research studies. Being in the registry does not automatically enroll you in a research study. You will be asked to participate in additional studies as a part of the cohort.
WHAT IS INVOLVED IN THE STUDY?
If you agree to be in this study, you will be asked to sign and date this consent form. You will have the following tests and procedures to make sure that you are eligible:
Saliva collection will be used to test for the presence of high-risk APOL1 genotype. Blood test and urine test to measure your kidney function. We will screen all participants for CKD by measuring Urine Albumin Creatine ratio (UACR) and estimated glomerular filtration rate (eGFR). Blood pressure (BP), height and weight will be collected on all participants. Two tubes of blood, approximately two tablespoons, will be obtained. Two ounces of urine will be collected by you in a sterile urine cup. Saliva will be collected by asking you to spit into a sterile saliva collection container.
If your blood and urine test indicate possible chronic kidney disease, you will be given a written report of your blood and urine tests to give to your primary care physician (PCP) for appropriate follow up and evaluation for nephrology referral. Individuals without healthcare insurance or without a PCP will be referred to free nephrology clinics at Duke.
We may use your saliva to sequence your whole genome. Your genomic information relates to the structure and function of all the genetic material in the body. We will use your genomic information to gain better understanding of how regions of the genome increase or decrease the risk of kidney disease.
If you allow us to sequence your genome we may put your genomic information in the repository. You can change your mind later and ask us to remove your information from the repository. It is important to remember that we cannot take back information that other researchers have already obtained from the repository.
* must provide value
Yes, I am willing to allow for whole genome sequencing.
No, I do not want to my whole genome sequenced.
Based on your screening results and other inclusion and exclusion criteria, you will be enrolled in the CARE registry for clinical research studies. Being in the registry does not automatically enroll you in a research study. You will be asked to participate in additional studies as a part of the cohort.
Additionally, the Duke Research Equity and Diversity Initiative (READI) aims to better understand and improve participants' experiences in research studies. If you agree to share your contact information (name and email address), you may be invited to share additional information on your experience (e.g., through surveys). Sharing your contact information is completely optional and does not impact your participation in CARE study. Please indicate if you are willing to share your contact information:
* must provide value
Yes, I am willing to share my contact information with the READI project.
No, I do not want my contact information shared.
HOW LONG WILL I BE IN THIS STUDY?You will have one screening visit for the collection of the saliva, urine, and blood sample. You will be enrolled in the CARE registry if you meet all of the additional inclusion and exclusion criteria.
You can choose to stop participating at any time without penalty or loss of any benefits to which you are entitled. However, if you decide to stop participating in the study, we encourage you to talk to your doctor first.
Clinically relevant results of this research will be communicated with you.
WHAT ARE THE RISKS OF THE STUDY?There are limited risks associated with this study.
Risks of Drawing Blood:Risks associated with drawing blood from your arm include momentary discomfort and/or bruising. Infection, excess bleeding, clotting, or fainting are also possible, although unlikely.
There may be risks, discomforts, drug interactions or side effects that are not yet known.
Potential Risks and the Genetic Information Non-Discrimination Act (GINA): There is a potentialPlease notify us of any change in your contact information.
Please indicate your choice for incidental findings (choose only one). If you do not want to be notified of any incidental findings, please initial below..
Please do not notify me of any incidental findings obtained from this research.
If you prefer, we can ask you at the time of notification whether or not you want to receive incidental findings information. In this case, please initial below.
Please ask me at the time of notification whether or not I want to receive incidental findings information.
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Please choose only one. To remove the choice, please click on reset. If at any time during or after the study you change your mind about whether or not you would like to be notified, you can contact us at (919) 660- 6987. After providing the information to you, Dr. Olabisi may arrange for you to meet with him/her and/or a genetic counselor or refer you to another appropriate health care provider to review the incidental findings information with you or your physician.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?If you agree to take part in this study, there may not be direct medical benefit to you. We hope that in the future the information learned from this study will benefit other people with your condition.
WILL MY INFORMATION BE KEPT CONFIDENTIAL?
Participation in research involves some loss of privacy. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal information may be viewed by individuals involved in this research and may be seen by people including those collaborating, funding, and regulating the study. We will share only the minimum necessary information in order to conduct the research. Your personal information may also be given out if required by law.
As part of the study, results of your study-related laboratory tests, and procedures may be reported to the NIH. In addition, your records may be reviewed in order to meet federal or state regulations. In addition to the NIH, reviewers may include the Duke University Health System Institutional Review Board, and others as appropriate. If any of these groups review your research record, they may also need to review your entire medical record. Results of tests and studies done solely for this research study and not as part of your regular care will not be included in your medical record.
The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use. Research information protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:
1) there is a law that requires disclosure (such as to report child abuse or communicable diseases but not for legal proceedings); subjects.
Disclosure is required, however, for audit or program evaluation requested by the agency that is funding this project or for information that is required by the Food and Drug Administration (FDA). You should understand that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. This means that you and your family must also actively protect your own privacy. All of the blood and urine studies are being done only because you are in this study. The study results will be retained in your research record for six years.
This information may be further disclosed by the sponsor of this study. If disclosed by the sponsor, the information is no longer covered by federal privacy regulations. If this information is disclosed to outside reviewers for audit purposes, it may be further disclosed by them and may not be covered by federal privacy regulations.
Some people or groups who receive your health information might not have to follow the same privacy rules. Once your information is shared outside ofDUHS, we cannot guarantee that it will remain private. If you decide to share private information with anyone not involved in the study, the federal law designed to protect your health information privacy may no longer apply to the information you have shared. Other laws may or may not protect sharing of private health information.
WHAT ARE THE COSTS TO YOU?There are no additional costs to participate in this research.
WHAT ABOUT COMPENSATION?You will receive a $10 gift card for completing the screening visit.
WHAT ABOUT COMPENSATION?You will receive $10 cash for completing the screening visit.
WHAT ABOUT RESEARCH RELATED INJURIES?Immediate necessary medical care is available at Duke University Medical Center in the event that you are injured as a result of your participation in this research study. However, there is no commitment by Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary compensation or free medical care to you in the event of a study-related injury. For questions about the study or research-related injury, contact at Dr. Opeyemi Olabisi, M.D., Ph.D. during regular business hours at (919) 660-6987 and at 919-684-8111 (the Duke paging operator) after hours and on weekends and holidays.
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE STUDY?You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the study at any time. If you withdraw from the study, no new data about you will be collected for study purposes other than data needed to keep track of your withdrawal. All data that have already been collected for study purposes will be sent to the study sponsor. Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to which you are entitled, and will not affect your access to health care at Duke. If you do decide to withdraw, we ask that you contact Dr. Olabisi in writing and let him know that you are withdrawing from the study. His mailing address is: Opeyemi Olabisi, M.D., Ph.D. Department of Medicine-Nephrology Duke University Medical Center 2424 Erwin Road, Hock Plaza Suite 605 Durham, NC 27710 We will tell you about new information that may affect your health, welfare, or willingness to stay in this study. Your doctor may decide to take you off this study if your condition gets worse, if you have serious side effects, or if your study doctor determines that it is no longer in your best interest to continue. If this occurs, you will be notified and your study doctor will discuss other options with you.
Your samples and/or data may be stored and shared for future research without additional informed consent if identifiable private information, such as your name and medical record number, are removed. If your identifying information is removed from your samples or data, we will no longer be able to identify and destroy them.
A description of this clinical trial will be available on https://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.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?For questions about the study or a research-related injury, or if you have problems, concerns, questions or suggestions about the research, contact Dr. Opeyemi Olabisi, M.D., Ph.D. during regular business hours at (919) 660-6987 and at 919-684-8111 (the Duke paging operator) after hours and on weekends and holidays. For questions about your rights as a research participant, or to discuss problems, concerns or suggestions related to the research, or to obtain information or offer input about the research, contact the Duke University Health System Institutional Review Board (IRB) Office at (919) 668-5111.
Would you be interested in participating in this study?
Yes
No
Please indicate your choice for incidental findings (choose only one). Do you have any questions about the consent form or the study?
Yes
No
Thank you for your interest in the CARE study and for reviewing the Informed Consent Form.
Please approach any study team available or call CARE team at 919-613-9905 to ask any questions or concerns that you may have.
Please know that you have NOT consented yet to participate in the study.
STATEMENT OF CONSENT"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I have been allowed to ask questions, and my questions have been answered to my satisfaction. I have been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to the research, or to obtain information or offer input about the research. I have read this consent form and agree to be in this study, with the understanding that I may withdraw at any time. I have been told that I will be given a signed and dated copy of this consent form."
I have reviewed the CARE Informed Consent Form and would like to:
Agree to participate by signing the consent.
Decline study participation.
Request more information about the study before deciding.
Yes
No
For more information about participating in the CARE study please contact the study team by:
email: care.justice@duke.edu
telephone: 919-613-9905
Thank you for agreeing to participate in the CARE study.
A copy of your signed consent form will be emailed to the address you provide below.
Please provide your signature and today's date to document your decision.
A copy of your signed consent form will be emailed to the email address you provided above.
Signature:
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First and Last Name used in Signature:
Date and Time Consent Signed:
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Now M-D-Y H:M
Thank you for your interest in the CARE study and for reviewing the Informed Consent Form.
Thank you for agreeing to participate in the CARE study.
You may now SCHEDULE YOUR SCREENING VISIT by contacting the study team by phone or email at:
919-613-9905 or care.justice @duke.edu.
Thank you,
CARE and JUSTICE study team
Consent Version Date: 03/01/2022
Consent Expiration Date: 05/01/2023
IRB REFERENCE DATE: 05/02/2023
IRB REFERENCE DATE: 06/22/2023
IRB EXPIRATION DATE: 01/01/2100
