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What is your child's current age?
The consent to participate in a research study involves both the parent and the child. It also depends on the age of the child.
Please select the age group and capacity that your child belongs in for consent.
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NATIONAL JEWISH HEALTH
SUBJECT INFORMATION, INFORMED CONSENT, AND HIPAA AUTHORIZATION FORM FOR RESEARCH
Protocol Title: Longitudinal Adrenal Insufficiency Cohort
Protocol #: HS-3221
Principal Investigator: Elizabeth A. Regan
Institution: National Jewish Health
Address: 1400 Jackson St. Denver, CO
Telephone: 303- 398-1531 (Office hours)
Parent/Legal Guardian: Some of the people who may be able to take part in this study may not be able to give consent to participate because they are under 18 years of age. If you are consenting for someone else to take part in this study, note that the words ‘you’ and ‘your’ in this form refer to the person (subject) taking part in the study, not to you.
KEY INFORMATION ABOUT THIS RESEARCH STUDY
You are being asked to be a subject in a research study because you have some form of adrenal insufficiency.
The following table is a concise and focused presentation of key information to assist you in understanding why you might or might not want to participate in the research.
This is a patient registry, and it involves sharing personal and health information through a series of questionnaires. It is also a longitudinal study to gather information over years to understand how the disease develops and progresses. The main reason we are doing this study is to improve the diagnosis and treatment for children who have AI.
Your decision to be in this study is voluntary.
If you decide to be in this study and then change your mind, you can leave the study at any time without penalty.
Length of Participation
Your participation is expected to last up to 20 years.
After initial enrollment each subject will be contacted at six -twelve month intervals by email or telephone.
There will be up to 4000 subjects in this study at NJH.
If you decide to be in this study, you will be asked to complete several different online surveys at the start and will later be contacted by email to complete additional surveys to give updated information. There are no tests or procedures involved in this research project. The surveys will take approximately 15 minutes to complete.
Complete and accurate data collection is important to the scientific integrity of this study - to ensure that we arrive at the correct conclusions.
We will request that you obtain your child's medical records and provide them to us. These requests will be made by email after you complete the surveys. The email will give you options for you to get us your medical records. There are several options for providing records. Those options could include you uploading the medical records to a secure site, emailing the records to us securely, mailing them to us, or signing a medical record release for us to obtain the records from your provider. If you are not able to provide medical records within several months after completing the initial surveys you will be dropped/discontinued from the longitudinal study, although the data that you have provided for the registry will be retained and may be used. We may continue to contact you periodically to inform you about the registry and any opportunities to participate in other adrenal studies regardless of whether you are continuing in the longitudinal study. Risks
The potential risks involved in this study would be loss of confidentiality if there was a breach of data security. We have tried to minimize the risk to confidentiality by storing data securely behind firewalls and by using electronic data storage methods that are currently used for medical data storage. There could also be data security breaches from your computer system that we could not prevent but would still put your personal data at risk of exposure.
There are no direct medical benefits to you or your child in participation; however, knowledge gained from the study may benefit patients with adrenal insufficiency in the future.
Alternative(s) to Study Participation Your alternative is to not take part in this study. Costs
You will not be asked to pay anything to participate in this registry.
You will not be paid anything to be in the study. Confidentiality
There are provisions in place by the study protocol and study site to
help protect the privacy and confidentiality of your personal health information and study information.
This overview does not include all of the information you need to know before deciding whether or not to take part. Much additional detail is given in the full consent document, which can be found on the pages that follow. Be sure to review the rest of this consent form before deciding about participation.
INFORMED CONSENT FORM
This consent form explains the research study. Before you decide to be a part of this study, you need to know why the research is being done, what it will involve and the risks and benefits. Ask the study doctor and study staff to explain anything in this form or if you want more information.
Please take time to read this form carefully. Feel free to discuss it with your relatives, friends and your primary care physician. If you agree to take part in this research study, you must sign this consent form.
DISCLOSURE OF FINANCIAL INTERESTS National Adrenal Diseases Foundation, is providing funds to National Jewish Health for conducting this research study.
PURPOSE OF THE STUDY This is a research project to develop registry for children with adrenal insufficiency (AI). A registry collects information on a specific kind of disease and often focuses on rare conditions in order to gather more information about the disease. A registry can also be used to readily identify people with a particular disease to participate in other research projects related to that disease. Participation in other research is only done if the participant agrees to the other research.
The study goals for the registry are to understand the kinds of symptoms and problems that children with adrenal insufficiency have over the course of their disease. Adrenal insufficiency (AI) can occur at any age and is caused by a variety of different factors.
Individuals with AI are at risk of serious medical events over the course of time and there is evidence that current medications are not able to fully relieve symptoms or prevent negative events. However, there is inadequate evidence at this time to accurately address these problems because a comprehensive assessment of symptoms in AI has not been done systematically in a large population of patients. In addition, it is difficult to determine whether treatment is adequate, because there are no reliable blood tests for monitoring treatment and there is no agreement about what signs and symptoms are best to use for monitoring treatment.
NUMBER OF SUBJECTS AND LENGTH OF STUDY
Up to 4000 subjects are expected to participate in this study at NJH. The periodic surveys will continue for up to twenty years. You/your child are invited to be in the study because your child has been diagnosed with adrenal insufficiency from any cause, by a physician. You/your child will first complete several survey forms about the cause of adrenal insufficiency and how that is affecting you. You will be asked to provide medical records that describe your child's diagnosis and to provide test results. Information about current medical conditions and current symptoms will be collected. In addition, specific information about the adrenal disease symptoms and events. Surveys about the impact of adrenal insufficiency on your child's development, activity, social effects and quality of life will be collected. After initial enrollment each subject will be contacted at six-twelve month intervals by email, or telephone. In the email you will be provided with an electronic link to a new set of surveys; during the phone call, you will have the option to complete the surveys on the phone. We will ask about current symptoms, other new medical problems, medications, and events that occur over time. If you report an event like a hospitalization or crisis we may send you a follow-up email or phone call asking for details of that event and medical records. We will randomly select a small number of enrolled subjects to repeat a questionnaire in order to test the reliability of the survey. If you are selected to repeat a survey we would send you an email with a link to that survey or call you to complete the survey over the phone. If you do not want to complete that survey you may still remain in the study and can simply not complete the survey. The periodic surveys may continue for up to twenty years. If we are able to continue the study beyond twenty years we will invite you/your child to continue. When your child becomes 18 years old we will ask her/him to decide if they want to continue to participate in the registry, and if they do they will provide a new consent through the adult registry.
If you/your child fails to respond to a survey request, we will email, postal mail, or telephone you and then your secondary contacts to get updated information about your health status, email address, physical address, and phone number. If we are unable to contact you after that attempt we will make two additional contact attempts at six month intervals and then stop contact attempts. We will continue to monitor your child’s vital status indefinitely unless you/your child requests to be removed from the study by writing or emailing the principal investigator, Dr. Regan.
Monitoring your child’s vital status means that we want to know If he/she has died. Because adrenal insufficiency is associated with an increased risk of death it is important for the research project to find out if you are dead and if so what was the cause of death. We will use the National Death Index to try and identify deaths in the cohort. Your next of kin can provide information to us about these events. It would be helpful for you to discuss participation in this study with your next of kin and give them guidance or permission to share information with the study. You may provide us with contact information for your next of kin either as your designated secondary contact or as an additional contact. In order to participate in the study, you must be able to receive emails and respond to surveys using a computer or other electronic device or answer the surveys over the phone with a member of the study staff. We will not ask you/your child to change any aspect of current medical care if you participate in the study. There are no study visits, sample collections or study procedures involved in this research project. However, you may be invited to participate in additional research studies as a member of this project. These invitations for additional studies could include study visits at National Jewish or other institutions, but you would have no obligation to participate when invited, and would be able to say “No” or not respond to any or all of these invitations. We would not share any identifying information about you to these other researchers interested in inviting you to participate in another project and would not allow them to contact you directly. We would just inform you of the opportunity to participate in another research study and give you information about how to contact the investigator. We will collect and store the information about your health and medical conditions in a secure electronic database at National Jewish Health in Denver, Colorado. We will analyze the information about your/your child’s health to understand the factors associated with adrenal insufficiency and may share that de-identified information (without your identity) with other researchers. We will present at conferences or publish the results of our analyses in professional journals to share with other researchers and doctors. These presentations or publications will not include any identifiable information about you/your child. We will separately store and protect the information about your address, email address, and other personal identifiers in order to maintain contact with you but will not allow the identifying information to be used by others beyond the research team at National Jewish.
Your information will be reviewed by the study investigators to ensure that your group assignment is correct. We may contact you by email, postal mail, or phone if we have questions about your medical records. Aggregated study information with no subject identification may be shared with other investigators who study adrenal diseases and other medical problems.
RISKS AND DISCOMFORTS
There is the potential risk of "loss of confidentiality", but your data will be encrypted, stored securely, and shared only with other researchers who are trained to protect your data.
Unknown Risks: There may be risks to study participation that are not known.
NEW INFORMATION You will be notified in a timely way if important new findings become known that may affect your willingness to continue in the study. The principal investigator can decide to stop your participation in the study if she believes that it may harm you, or if you do not meet the research criteria for the study after medical records are reviewed, or you cannot provide enough information about your disease for classification. The study may stop if there is not adequate funding to pay for it. BENEFITS There is no direct benefit expected for you from being in this study. However, the information learned from this study may help other people with this disease in the future. ALTERNATIVES TO STUDY PARTICIPATION The alternative to being in this study is to simply not participate. COSTS OF PARTICIPATION You will not be asked to pay anything to participate in this registry. PAYMENT You will not receive payment or reimbursement for your participation in this study. COMPENSATION FOR INJURY Individuals may participate in this registry from around the world and all aspects of the study participation are by electronic data entry. Illness or injury that occurs while participating in the study cannot be addressed by the investigators and the investigators will not provide medical care to you. You must obtain timely, local medical care for any events or illnesses. In accordance with general policy, National Jewish Health makes no commitment to provide free medical care or other compensation for injury or illness resulting from your participation in this study. By signing this form, you have not given up your legal rights. For further information, please contact Dr. Elizabeth Regan, the Principal Investigator of this study.
This research project will be involved in the American-Australian-Asian Adrenal Alliance (A5). There are currently 12 institutional members of the Alliance who have agreed to work collaboratively on adrenal research. None of your personal identifiers will be shared with members of the alliance or anyone outside the AIS study, but we will share aggregated, de-identified data with other researchers in the A5 Alliance.
The A5 Alliance and/or the AIS project may invite you to participate in other research studies including collection of biospecimens such as blood or DNA. You will have the opportunity to learn about those projects and decide if you want to participate.
National Jewish Health has rules to protect information about you. Federal and state laws, including the Health Insurance Portability and Accountability Act (HIPAA), also protect your privacy. This part of the informed consent form tells you what information about you may be collected in this study and who might see or use it. The institutions involved in this AIS project include: • National Jewish Health • Institutional Members of the A5 Alliance We cannot do this study without your permission to see, use, and give out your information. You do not have to give us permission. If you do not, then you may not join the study. We will see, use, and share your information only as described in this form and in our Notice of Privacy Practices; however, people outside National Jewish Health may not be covered by this promise. We will do everything we can to keep your records private, however, it cannot be guaranteed. At minimum, we will store your health data without identifying information using a coded number and the data will be stored on password protected, secure computers and servers. The use and sharing of your information have no time limit. You can withdraw your permission to use and share your information at any time by writing to the Corporate Compliance Officer at the address listed below. If you do withdraw your permission, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected for the study. Corporate Compliance Officer National Jewish Health 400 Jackson Street M113a Denver, CO 80206
The records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information. Your information may be shared with:
1. The study doctor and his/her team of researchers. 2. Officials at National Jewish Health who are in charge of making sure that we follow all of the rules for research. 3. National Jewish Health Institutional Review Board (IRB) - the ethics board responsible for overseeing this research. 4. Federal agencies such as the Office for Human Research Protections that protect research subjects like you. 5. Department of Health and Human Services. We might talk about this research study at meetings. We might also print the results of this research study in medical journals or medical magazines. But we will always keep the names or other information that could identify you private. Information about you that will be seen, collected, used, and shared in this study: 1. Health information about medical conditions, medications, symptoms, and events. 2. If you provide medical records - de-identified portions of your previous and current medical records that are relevant to this study, including but not limited to diagnosis(es), history and physical, laboratory or tissue studies. Scientists at National Jewish Health work to find the causes of and cures for disease.
The data collected from you during this study are important. If you join this study: - The data you provide no longer belong to you. - The investigators may study your data. - If data are in a form that identifies you, National Jewish Health or other organizations involved in this study may use them only in a manner consistent with this form and with Institutional Review Board approval. - Any product or idea created by the researchers working on this study will not belong to you. - There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea. Collection of Identifiable Private Information or Identifiable Biospecimens Identifiers might be removed from your identifiable private information or identifiable biospecimens. After such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent (or consent from your legally authorized representative).
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. You may decide not to participate or you may stop your participation at any time, without penalty or loss of benefits or medical care to which you are otherwise entitled. If you decide to leave the study, please tell the study doctor. Your participation in this study may be stopped without your consent at any time and for any reason by the study doctor or other regulatory authorities. Reasons you may be withdrawn from the study include it is determined to be in your best interest, you need treatment not allowed in this study, you do not follow the study instructions, the study is stopped, or for other administrative reasons. You may be taken out of the study even if you do not want to leave the study. CONTACTS FOR QUESTIONS, COMPLAINTS, CONCERNS If you have any questions or requests for information relating to this research study or your participation in it, or if you want to voice a complaint or concern about this research, or if you have a study related injury, you may contact the study doctor at firstname.lastname@example.org. If you want to withdraw from the study after you have enrolled, you can email Dr. Regan at email@example.com or send a letter to her at 1400 Jackson St., Denver CO 80209. If you have questions, concerns, or complaints later, you may email the same address or call 303-398-1531. If you have questions or concerns about your rights as someone in this study, please call the National Jewish Health Institutional Review Board (IRB) at 303-398-1477. If you have any questions about your rights as a research subject or complaints regarding this research study, or you are unable to reach the research staff, you may contact a person independent of the research team at the Biomedical Research Alliance of New York Institutional Review Board at 516-318-6877. Questions, concerns or complaints about research can also be registered with the Biomedical Research Alliance of New York Institutional Review Board at www.branyirb.com/concerns-about-research.
STATEMENT OF CONSENT
By signing this form, I confirm the following: • I have read each page of this informed consent and HIPAA authorization form (or it was read to me). • I was informed about the possible risks and benefits of being in this study. • I know that being in the study is voluntary. • I choose to be in this study. • I know that I can stop being in this study at any time. • I can print or download a copy of this form after it is signed.
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