Research Consent Form
Sponsor / Study Title: Tulane University /“Lupus Education Alliance Program (LEAP)”
Principal Investigator: H. David Chae, Sc.D., M.A.
Telephone: (504) 345-8409 (24 Hours)
Address: Tulane School of Public Health & Tropical Medicine, 1440 Canal St, Suite 811B, New Orleans, LA 70112
Key Information: The purpose of this study is to learn about the experiences of people living with lupus and their views on COVID. This study is being conducted entirely online over the Internet. Participating in this study involves completing an initial online visit which will take about 75-minutes of your time. A member of our research team will ask you questions about your background and health. They will then provide you with information about COVID for people living with lupus. You will then be asked to complete an online survey on your own. You will be compensated with a $50 gift card for completing this first online visit. We will then reach out to you after one month to complete another online survey which will take about 30 minutes of your time. You will receive a $25 gift card for completing this follow-up survey. After another month, we will reach out to you again to complete another 30-minute online survey, for which you will receive another $25 gift card. The potential for risk in this study is minimal and includes the potential for loss of confidentiality and minor discomfort when answering survey questions. The rest of this form has more information to help you decide whether you want to participate.
Research is not treatment
You are being invited to participate in a research study. Research is not treatment. The purpose of this research is to learn about your experiences living with systemic lupus erythematosus, or lupus for short. We also want to learn about your views on COVID. As part of this research, you will also participate in the Lupus Education Alliance Program (LEAP). The LEAP provides information about current recommendations for testing, treatment, and vaccination from the Centers for Disease Control and Prevention (CDC).
Whether you participate in research is up to you
It is your choice to decide whether to participate. Even if you decide to participate, you can stop participating at any time. If you do not participate, or if you participate but later stop, you will not lose any of your regular benefits, you will not be penalized, and you can still get care if you need it.
About this consent form
This form tells you about this study and has information to help you decide whether you want to participate. It is important for you to consider what this study involves, including what will be required of you and the risks and possible benefits of participation. You may want to discuss the information in the form with a family member, friend, or with your regular doctor.
What is the research study and why is it being done?
There are several things to consider when people with lupus decide whether to get tested or vaccinated for COVID. This study provides updated information about testing and vaccination for COVID from the CDC. The overall purpose of this study is to learn about factors influencing COVID-related behaviors among people with lupus.
About 500 participants will participate in this study.
Who is conducting this study?
This study is being carried out by Tulane University. The investigator in charge of the study is listed on the first page of this document. The Advarra Institutional Review Board (IRB) is an ethics board that is responsible for making sure that participants’ rights and well-being are protected. The National Institutes of Health (NIH), the study sponsor, is paying for the study to be done.
If you participate, it will involve the following:
This study is being conducted through video calls over the Internet. By agreeing to participate, you will take part in the following procedures:
Our research staff will begin by asking you questions about your background and health. This will take approximately 15 minutes.
You will then take part in the Lupus Education Alliance Program, or LEAP. A member of our research staff will provide you with information about how COVID affects people living with lupus, and go over options for COVID testing, treatment, and vaccination with you. The information and recommendations that we will provide you have all been gathered from the CDC. This will take approximately 20 minutes.
We will then ask you to read and respond to questions on your own computer, laptop, tablet, or smart phone. This part includes additional questions about your health, experiences related to COVID, and other experiences that you have had in your life that may impact your health. This will take another 40 minutes of your time. If you previously told us that you are uncomfortable with reading and responding to questions on your own, for whatever reason, we will offer to read the questions to you. However, please be aware that this portion will then take longer than 40 minutes.
Follow-Up Procedures: After you have finished, we would like to check in with you to see how you are doing. You will participate in these follow-up procedures:
One month later, we will reach out to you through your preferred method of contact to ask you to complete a follow-up survey online. The purpose of this survey is to see if there have been any changes to your health, and to ask you about any experiences you have had that may impact your health. This will take about 30 minutes of your time.
After another month (2-months after your first online visit), we will reach out to you to complete another online survey. The purpose of this survey is to again see if there have been any additional experiences you have had that may be related to changes in your health. This will also take about 30 minutes of your time.
If you take part in this study, how will we protect your privacy?
In this study, identifiable information about you will be collected. Identifiable information, such as your name, birthdate, and address, will be collected from you through interviews and questionnaires.
We will do our best to make sure that the information gathered for this study that identifies you is kept private. However, we cannot guarantee total privacy. If we think that you intend to harm yourself or others, we may be required or permitted by law to notify the appropriate people with this information. If we learn about current or ongoing child or elder abuse or neglect, we may be required or permitted by law to report this information to authorities.
In order to help make sure that only the necessary people or groups see, use, and share your identifiable information, the researchers have implemented several safeguards. Information that can identify you will be held in a separate, secure file that is encrypted and password protected on a separate hard drive. This information can only be accessed by research staff. All computers used to collect data are password protected. Data are backed on a secure password-protected server. All research staff involved in the collection of data are trained in protocols and procedures to ensure the privacy of your data.
Also, when sharing your data with other people or groups for the study, your name and other information that identifies you will be removed from all other information, and the data that are shared will be labeled with a code instead of your name. In those cases, a key to the code connects your name to the information. We will keep the key to the code.
If you agree to participate in this study, your information will be shared with the Duke Clinical Research Institute, a research group chosen by the NIH to combine the information collected from everyone taking part in the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) studies. The Duke Clinical Research Institute will build a RADx-UP database (system that holds electronic information) which will be uploaded to the NIH RADx-UP Data Hub. This database will not hold any information that identifies you, such as your name, address, and contact information. The database will only hold your anonymous data. No information that could identify you will be shared.
Your data will be assigned a study code. Your data will only be identified in this database by this study code.
We may use your address to link your data with other information that describes the area where you live.
We will transfer these data to a secure database of the National Institutes of Health. These data will not be able to identify you.
Other researchers may use these data for future studies, but the data that we share with them are also anonymous and cannot be used to identify you.
Your data may be used or shared for research studies or other purposes without your permission. We will not ask your permission before sharing these data because it cannot be used to identify you.
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.
Certificate of Confidentiality:
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research participants.
The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by the agency which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you 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.
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of, for instance, child abuse or neglect, harm to self or others, and communicable diseases.
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document.
How we may use your identifiable information
At the completion of this study, we would like to store and be able to use your identifiable information for other research about lupus. We will keep this information separate from all your other data, in a secure file which will not be shared with anyone outside the study team. We will keep this information in the event you decide to participate in any future studies with us. This will allow us to connect data collected in this study to any future data that we collect about you. Under no circumstance will your identifiable information be shared with anyone outside of the study team.
At the end of this form, we will ask if you agree to be contacted about future research opportunities that you may be eligible for. However, you are not obligated to participate in these studies, and choosing not to participate in future research will not impact your involvement in this research and will have no effect on your regular benefits or care.
What are the risks and possible discomforts from being in the study?
The potential risks to participating in this study are minimal. However, all research carries some risk, and your participation may expose you to the risks or discomforts described below.
There is the potential for loss of confidentiality by participating in the study. Appropriate efforts will be made to protect the confidentiality of your identifiable information. Any information that could identify you will be separated from all other data.
Some of the questions we will ask you may be sensitive, and there is a possibility that you may experience psychological discomfort. Although we encourage you to answer each and every question, you may refuse to answer any question and may withdraw at any time.
Risks associated with the LEAP are also minimal. The purpose of the LEAP is to provide up-to-date information that the medical and scientific community has agreed on around testing, treatment, and vaccination for COVID. You may want to discuss this information with your regular doctor or rheumatologist before deciding whether to get tested or vaccinated. It is your choice after considering the potential risks and benefits. Whether or not you choose to get tested or vaccinated has no impact on your participation in the study. You will be compensated for your time regardless of whether or not you choose to be tested or vaccinated.
As part of this research, you may be required to use one or more of the following: a phone or web app/site, an electronic study diary (eDiary), or a device that tracks information about you. While using these, information about you may be collected and shared with the researchers or people outside of the study. This data might include personal health information, location, call logs, text message history, web browsing history, or social media use. A complete description of the data collection and sharing for an app, eDiary, or device can commonly be found in the Terms of Use, End User License Agreement, or Privacy Policy associated with the device. If you would like to read these documents, request a copy or instructions about how to access this information from the investigator.
While the Terms of Use, End User License Agreement, or Privacy Policy may include statements limiting your rights if you are harmed as a result of your use of the app/site, eDiary, or device in this study, you do not release the investigator, sponsor, institution, or agents for responsibilities from mistakes. You also do not waive any of your rights as a research participant.
There may be other risks of study participation that are unknown.
What are the possible benefits from being in the study?
You may benefit from receiving up-to-date information about how COVID affects people living with lupus, and current recommendations for testing, treatment, and vaccination, which may help you in making informed decisions about your health. Information learned from the study may help other people in the future.
What will you have to pay for if you take part in the study?
There are no costs to you to participate in the study.
Will you be paid to take part in the study?
You will receive the following payments for completing the following study activities or visits:
Initial survey and taking part in the LEAP $50.00
1-month follow-up survey $25.00
2-month follow-up survey $25.00
If you leave the study early, you will receive payment for only the study components that you completed.
You will be paid following each completed visit.
If you have any questions regarding your compensation for participation, please contact the study staff.
What if new information about the study or the study procedures becomes available after you have given consent to participate?
Sometimes new information is learned about a study or about study procedures after the study has started. The study site investigator will tell you if new information is learned that could lead you to change your mind about participating in the study. Some research requires that the full purpose of the study not be explained before you participate. You will be given a full explanation at the end of the study.
What are your other options besides study participation?
This research study is for research purposes only. The only alternative is to not participate in this study. You have the option to not participate in the study. If you participate in the study and want to stop, you can do so at any time. You may withdraw your consent at any time. You should tell the study site investigator or another member of the study site team if you want to stop participating. If you stop participating in the study, all information that was collected before you stopped participating will remain in the study database and may not be removed.
Is it possible that you will have to stop participating in the study even if you want to complete it?
Even if you want to complete the study, it is sometimes necessary to take study participants out of the study before finishing all the study procedures. For example, this may happen if there are safety concerns with continued participation.
What happens at the end of the study?
At the end of the study, you may be offered additional information on how to get tested or vaccinated for COVID. However, your participation in this research study will be over and you will receive no further payments.
We will not provide you or your regular doctor with information about the results of this study, or information about your individual participation in the study, even if those results may be relevant to your health.
It is possible that information you provide for this study will be used for other studies in the future. The results of the study may be presented at meetings or in publications. You will not be identified in any summary, presentation, or publication of the study results. Your individual privacy will be maintained in all published and written data resulting from the study.
What if you have questions or concerns about the study?
Take as much time as you like before you decide whether to participate in this study. If you have any questions or concerns about the study, before or after agreeing to participate, you can contact the investigator listed on the first page of this document. You can call about any matter having to do with the study, including complaints or questions about your rights as a study participant.
WHOM TO CONTACT ABOUT THIS STUDY
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:
Whom to contact in the case of a research-related injury or illness;
Payment or compensation for being in the study, if any;
Your responsibilities as a research participant;
Eligibility to participate in the study;
The Investigator’s or study site’s decision to withdraw you from participation;
Results of tests and/or procedures;
Please contact the Investigator at the telephone number listed on the first page of this consent document.
If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:
By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
or call toll free: 877-992-4724
or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser: Pro00073870.
Statement of Consent
Choose one:
[ ] I agree that I may be contacted about future research studies I may be eligible for.
[ ] I DO NOT agree to be contacted about future research studies I may be eligible for.
Choose one:
[ ] I agree to participate in the research described in this form.
[ ] I DO NOT agree to participate in the research described in this form.
Please type your full name below to indicate your agreement to participate in this research.