Informed Consent

True North Therapeutics, Inc., which will be called “True North” throughout the rest of this informed consent process, is sponsoring a web-based research registry for patients with Cold Agglutinin Disease (CAD) and Autoimmune Hemolytic Anemia (abbreviated “AIHA”) which will be called the “COMPASS Registry”. We invite you to take part!

Create your account today if you:

  • Have been diagnosed with CAD or AIHA by a medical professional
  • Are at least 18 years old
  • Are able to understand and give consent for participation in English

Information about the COMPASS Registry

Before you agree to participate in the COMPASS Registry it is important that you understand what is involved and what will be done with the information you provide. This form provides information about the COMPASS Registry, so please read it carefully. If you have questions about the COMPASS Registry or if there is information that you do not understand you may reach the COMPASS Registry Coordinator by email at: This email address is being protected from spambots. You need JavaScript enabled to view it.. If you wish, you may also discuss your potential participation in the COMPASS Registry with your hematologist. We suggest that you print a copy of this form for your records. A copy of the information in this form will also be available to you via your website account.

What are the potential benefits of participating in the COMPASS Registry?

The COMPASS Registry will store detailed health and other basic information about people with CAD and AIHA. Registries such as COMPASS are designed to collect such information in one place. The information collected in the COMPASS Registry will be used to help medical researchers gain a better understanding of CAD and AIHA, and this research may guide the future treatment of this disease. As a participant in the COMPASS Registry you will be:

  • offered to have your health records related to CAD or AIHA collected from your health providers and organized into one integrated record, at no cost to you;
  • offered to have blood tests related to CAD or AIHA performed at Quest labs at no cost to you, and receive a $50 gift card to compensate you for your travel and time each time you give a blood sample;
  • able to see your own Quality of Life responses on-line and to compare these to those of the other participants;
  • • alerted to other medical research opportunities related to CAD and AIHA, potentially including some clinical trials of new treatments;

Participating in the COMPASS Registry

If you decide to participate in the COMPASS Registry you will be asked to contribute health information in the following ways:

  • You will be asked to enter basic demographic information about yourself (your age, gender, city & state of residence, employment status) via a form on-line.
  • You will be asked to answer questions about the impact of CAD or AIHA on your Quality of Life via a form on-line.
  • You will be offered the opportunity to have PicnicHealth, act on your behalf to collect and organize all of the elements of your health record that are CAD or AIHA related , viewable on the PicnicHealth platform. PicnicHealth will only do this at your request and with your permission, at no cost to you. The health record information that PicnicHealth retrieves for you will be shared with the COMPASS Registry. No one else will see any of this information in a manner that links it to your personal identity
  • You will be offered the opportunity to have some blood tests performed at any Quest Diagnostics Patient Service Center, at no cost to you. You will be compensated for your travel and time with a $50 gift card. These tests will be performed anonymously and your results will be provided only to the COMPASS Registry. No one else will see any of these results in a manner that links them to your personal identity. Your blood samples will always be destroyed within approximately 1 week of when they are collected.
  • Some of the participants in the COMPASS Registry will be prompted periodically by e-mail to update some of the information that they have entered on-line (for example, the Quality of Life questionnaire) and invited to repeat the blood tests for the COMPASS Registry. This will happen once every three months thereafter.
  • Additional optional surveys related to CAD or AIHA may be added in the future. The COMPASS Registry program staff will notify you at the time if/when additional surveys are made available.
  • Participants are allowed to invite other CAD or AIHA patients into the COMPASS Registry, as well as invite their physicians to enter their contact information into the Registry. Physicians are also allowed to invite CAD or AIHA patients to join the Registry.

You also should understand that the COMPASS Registry does NOT provide healthcare. It is not an expert medical consultative service and it is not a substitute for your own sources of regular medical care. The lab tests that will be performed on your blood samples are for research purposes only. Once the results of your blood tests have been entered into the COMPASS Registry database they will NOT be traced back to your personal identity and no one associated with the COMPASS Registry will contact you about them.

What happens to the information that I put in my account, and who has access to it?

Your information will be stored in a secure database built and maintained by a PatientCrossroads, a medical information technology company that has created and maintained similar patient registries for over 250 diseases on behalf of a wide variety of non-profit disease advocacy groups, governmental health research agencies, academic medical researchers, and biopharma companies. The Staff at PatientCrossroads will have access to your records, but no one else will be able to see information which identifies you or tells people who you are.

PatientCrossroads and the registry will not share any of your identifiable information. Your “de-identified” information will be labeled with a unique code number to protect your privacy. Your de-identified information will be aggregated into the pool of other participants’ answers to advance the understanding of CAD and AIHA. All personal identifiers, such as your name or email address, are removed before your information is shared. Medical researchers and other COMPASS Registry participants may have access to the questionnaire responses of all participants only after personal identifying information has been removed. In the event of any publication or presentation resulting from the study, no personally identifiable information will be shared.

You may learn of other research opportunities through this registry, and may have the opportunity to contact other researchers. Any information you might choose to share in that manner would be outside of the scope of responsibility of the COMPASS Registry and would not be covered by the steps the COMPASS Registry takes to de-identify information.

What are the potential risks of participating?

Although we will take every precaution to protect your personal information, there is a risk that your privacy may be compromised. In the unlikely situation where this happens, you will be notified right away. Keeping the information from your survey in a secure computer database will limit that risk, but does not eliminate it.

Alternatives to Participating in the COMPASS Registry

Whether or not you take part in the COMPASS Registry is completely up to you, and either way it will not affect your regular medical care.

What if I change my mind about participating in the COMPASS Registry?

You can choose to stop taking part at any time you want— you don’t have to explain why and there will be no penalty or loss of benefits to which you are otherwise entitled. If you change your mind and no longer want to be part of the COMPASS Registry, you may contact the COMPASS Registry Coordinator by e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it., and your account will be closed. Only the de-identified information which has been collected before you decide to withdraw from the COMPASS Registry will continue to be used.

How long will my participation last?

You may decide to stop participating in this the COMPASS Registry at any time for any reason. It is possible that the COMPASS Registry may be closed at any time for other reasons, such as if the sponsor decides to stop the program. If this happens you will be told the reason at that time.

What are the costs of participating in the COMPASS Registry?

There are no costs to join the COMPASS Registry. You will not be paid any money for taking part in the COMPASS Registry, only compensated with a $50 gift card for your time and travel each time if you provide a blood sample at Quest labs.

Who do I contact if I have any questions?

If you have any questions about the COMPASS Registry or about your rights as a participant, you may contact the COMPASS Registry Coordinator by e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. You can ask questions about this consent form or the COMPASS Registry (before you decide to start the COMPASS Registry, at any time during the Registry.

If you have any questions or complaints about your rights as a research subject, contact: the Chesapeake Institutional Review Board:

  • By mail:

Study Subject Adviser
Chesapeake Research Review, Inc.
7063 Columbia Gateway Drive, Suite 110
Columbia, MD 21046

  • or call collect: 410-884-2900
  • or by email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Please reference the following number when contacting the Study Subject Adviser: Pro00013255.

Authorization to disclose health information

If you decide to be in the COMPASS Registry, the study and registry staff will use and share health data about you to conduct the program. Health data may include:

  • Age;
  • Gender;
  • Medical and health history;
  • Symptoms and complications of CAD or AIHA.

Health data may come from your medical records and assessments, your questionnaire responses or any additional information that you may choose to provide to the COMPASS Registry. The sponsor and those working for the sponsor may access and use only the health data that has been de-identified, meaning all your identifiable information such as your name or birth date have been removed for research purposes.

The COMPASS Registry may share de-identified health data about you with authorized users. Authorized users may include:

  • Medical researchers involved with the COMPASS Registry;
  • PatientCrossroads;
  • Quest Diagnostics;
  • Health Gorilla; who helps securely transfer the results from Quest Diagnostics to the COMPASS Registry
  • Representatives of Chesapeake Institutional Review Board (an ethics board that reviews the COMPASS Registry);
  • The Food and Drug Administration (FDA) and other US governmental agencies;
  • Governmental agencies of other countries;
  • Other authorized users.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protect the privacy and security of individual health information. In compliance with these regulations, the COMPASS Registry has multiple levels of security. These safeguards include data elements (e.g., restricted access to fields), user access (e.g., a password is needed to enter the COMPASS Registry), application (e.g., role-based access to features, access audit trails), and hosting services (e.g., firewall, secure sockets layer). These safety features help to make sure that private health information is protected from those who should not have access to it.

Your participation in this research will be kept private to the extent permitted by law. However, it is possible that other people may become aware of your participation in the COMPASS Registry. Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law. We might have to release your private information in a few specific situations—if it is required by the any of the following:

  • Food and Drug Administration (FDA) or representatives from regulatory agencies in other countries.
  • Chesapeake Institutional Review Board.
  • Law enforcement officials.

Your permission to use and share health data about you will not end unless required by state law. You may take back your permission to use and share health data about you at any time by contacting the COMPASS Registry Coordinator by email at This email address is being protected from spambots. You need JavaScript enabled to view it. . If you do this, you will not be able to contribute new health data to the COMPASS Registry. No new health data that identifies you will be gathered after your written request is received. However, de-identified health data about you that has already been gathered may still be used and given to others as described in this form.