Consent Form

Welcome to the MyAI Adrenal Insufficiency Study.

This is designed as a longitudinal study of people with known adrenal insufficiency along with two comparison groups (those who may be at-risk of future adrenal insufficiency and healthy people who do not have known risk factors). We would like to use the information from this study so that we can understand how adrenal disease progresses over time.

Although we primarily want to have people committed to the longitudinal study, individuals may complete only these initial surveys and not participate in the longitudinal part of the study. The initial study enrollment is a series of surveys/questionnaires to be completed online. They need to be completed in one sitting so please allow sufficient time (at least 15 - 30 minutes) to complete them. This first document is a consent to participate in the research project. You have the option to agree to continuing in this study longitudinally and also the option to be contacted in the future for other research studies within the consent.

Please read the consent carefully and sign it at the end using your mouse. A copy of the consent will be sent to you by email.

If you are participating in the study as a person with adrenal insufficiency, we need to have medical records from you to confirm the correct diagnosis category for you. There are several options for providing records. Those options include you uploading the medical records to a secure site, emailing the records to us securely, mailing them to us, securely faxing them to us, or signing a medical record release for us to obtain the records from your provider. The records will be coded with your assigned study ID number when you upload them through the link provided. The most important records that we need are results of hormone tests - particularly cortisol and ACTH level in the morning, an ACTH stimulation test and some kind of summary opinion from your physician about what your diagnosis is. 

You can save and/or print a copy of the consent form after completing the form.

Please note that there is a signature block where you use your mouse to create a signature. In order to complete the consent that must be signed, or you cannot move forward to the next survey.

If you have problems with any of the study documents, please email us at: adrenal@njhealth.org

Thank you!

You are being invited to participate in a research study. Participation in the study is completely voluntary. You don't have to participate and you can stop at any time.

This section will summarize key information about the study. There is more detailed information that you should know in Part II of this document. Please take time to read this entire form (Part I and Part II) before deciding whether to take part in this research study.

You are being asked to be in the study because you are over age 18 and either have some form of adrenal insufficiency, congenital adrenal hyperplasia, autoimmune disease, or an at-risk condition such as a history of using steroid (glucocorticoid) medication, or family history of adrenal insufficiency. You may also be invited to be in the study as a control subject because you are over age 18 and do not have any of those conditions. People who enroll in the study will be classified into specific groups based on their responses to the survey questions and the medical records that they provide.

This is a patient registry for individuals who have adrenal insufficiency (AI) and others who may be at risk of developing AI, along with a control group of normal subjects who do not have disease or risk factors for developing the disease. It involves sharing personal and health information through a series of questionnaires. It is a longitudinal study to gather information over years in order to understand how the disease develops and progresses. The main reason we are doing this study is to improve the diagnosis and treatment for people who have AI.

If you decide to be in this study you will be asked to complete several different online surveys now 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 30 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.

Inadequately completed surveys will be dropped from the study because we will not be able to properly classify people into groups.

If you do not actually have a physician-diagnosis of the conditions that we are studying (unless you intend to be a control or at-risk subject), please do not enroll in the study. If you find the questions that are asked are not comfortable for you to answer, you should also not enroll in the study or not complete the surveys.

We will request medical records from subjects who report specific conditions. These requests will be made by email, postal mail, or by phone after you complete the surveys. If you are not able to provide medical records within several months after completing the initial surveys you will be dropped from the study.

There may be approximately 4000 people who ultimately enroll in this research. The study will continue for 10 – 20 years.

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 breeches 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 in participation; however, knowledge gained from the study may benefit patients with adrenal insufficiency in the future.

In this consent and authorization form, "you", always refers to the subject.

You will not incur any costs to participate in the study and you will not be paid for participating.

Why is this study being done?

This is a research project to develop a group or cohort of people with and without adrenal problems in order to study the disease. In addition, for those with adrenal problems, the study goals are to understand the kinds of symptoms and problems that patients 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.

There are two major problems in adrenal insufficiency that have been previously identified – difficulty with diagnosis and inadequate disease treatment.

It is a relatively rare condition and many physicians may have difficulty recognizing the disease because the symptoms that are classically associated with the disease may differ from what patients experience and report. We will collect information about signs and symptoms of disease from people with and without adrenal disease over time.

Individuals with AI are also 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.

You are being asked to be in the study because you are one of the following:

1. Have been diagnosed by a physician with adrenal insufficiency from any cause

2. Are at-risk of developing adrenal insufficiency because you have been on steroids, have a family history of adrenal insufficiency or have an autoimmune condition that may increase your risk of adrenal disease. In addition, we will enroll people who are concerned that they may have "adrenal fatigue" or other undiagnosed adrenal problems in this group to assess whether they are at-risk of future overt adrenal disease by standard endocrine testing.

3. Are a healthy person without either adrenal insufficiency or an at-risk condition who is willing to be in the study group as a comparison subject.

You will complete a survey form that allows us to determine which category or group you are in and whether you are eligible to participate in the long-term study. You will also be asked to provide medical records that describe your diagnosis and to provide test results.

Information about current medical conditions and current symptoms will be collected from each of these three groups at the start of the study. In addition, specific information about the adrenal disease symptoms and events will be collected from the subjects with known adrenal disease.

After initial enrollment each subject will be contacted at six month intervals by email. In that email you will be provided with an electronic link to a new set of surveys. We will obtain information about current symptoms, other new medical problems, medications, and events that occur over time. 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. 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 will continue at six month intervals for up to ten years. If we develop funding to continue the study beyond ten years we will invite you to continue for up to twenty years total.

If you fail to respond to a survey request, we will email or telephone your secondary contacts to get updated information about your health status and email address. If we are unable to contact you after that attempt we will make two addition email attempts at six month intervals and then stop contact attempts. We will continue to monitor your vital status indefinitely unless you request to be removed from the study by writing or emailing the principal investigator, Dr. Regan.

Monitoring your vital status means that we want to know If you have died. We will try to find you using electronic searching, and will try to determine whether you are alive or dead. 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 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.

We will ask you to provide medical records about your original diagnosis of adrenal insufficiency, other medical problems, and any additional medical events. You may remain in the initial phase of the study if you do not wish to provide medical records but may be dropped from the study later (because we will not be able to fully classify your disease without the medical records).

We will not ask you to change any aspect of your 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 health to understand the factors associated with adrenal insufficiency and may share that de-indentified information (without your identity) with other researchers. 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.

There is a potential risk of loss of confidentiality, but your data will be encrypted and stored securely and shared only with other researchers who are trained to protect your data.

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 study is not designed to treat any illness or to improve your health. There will be
no direct medical benefits to you. Knowledge gained from the study may benefit future
patients with adrenal insufficiency

You may choose not to take part in this study – in which case you should not complete signing this consent form.

You may choose to only provide baseline information but not participate in the longitudinal contacts.

You may authorize future contacts about research projects from either pharmaceutical companies or investigator initiated projects to study aspects of adrenal diseases.

You may choose to participate in longitudinal contacts for this study but not participate in other research projects.

You will not be asked to pay anything to participate in this study.

You will not be paid to be in the study.

Taking part in this study is voluntary. You have the right to choose not to take part in
this study. If you choose to take part, you have the right to stop at any time. If you
refuse or decide to stop later, you will not lose any benefits or rights to which you are
entitled.

The study doctor may decide to stop your participation without your permission if the study doctor thinks that being in the study may cause you harm. You may be taken out of the study even if you do not want to leave the study - if you do not fit into any of the described research categories after your medical records are reviewed. You may be removed from the study if you are not able or willing to provide medical records, or are not willing to answer questions that are needed for classifying your disease or health status.

The study may stop if the investigators are unable to pay for the study to continue.

You may contact the study investigator at adrenal@njhealth.org with questions you have
at this time.

If you want to withdraw from the study after you have enrolled, you can email Dr. Regan at adrenal@njhealth.org 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.

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.

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 MyAI Adrenal Insufficiency Study, but we will share aggregated, de-identified data with other researchers in the A5 Alliance. The A5 Alliance and or the MyAI Adrenal Insufficiency Study 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 the MyAI Adrenal Insufficiency Study 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 has 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
1400 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, radiology studies, or procedure results.

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.