Psoriasis Registry Informed Consent

Informed Consent

Please take time to review this information carefully. You should talk to the researchers about the research study and ask them any questions you have. You may also wish to talk to others (for example, your friends, family, or your personal physician) about your participation in this study. If you decide to take part in this research study, you will be asked to read the consent and agree to participate in the study and that you accept that personal information will be electronically supplied to the researcher to document your participation (such as name, email address, and date). Before you sign this document, be sure you understand what the research study is about, including the risks and possible benefits to you.

You do not have to take part if you don’t want to. You may also leave the research study at any time. If you choose not to take part in this research study or if you leave the study before it is finished, there will be no penalty and your decision will not affect your future care.

Who is conducting this research?

What is the purpose and duration of this research and who will take part?

You are being asked to take part in this research study because you have been diagnosed with psoriasis. The purpose of this research study is to learn about best treatments for psoriasis, to better understand the outcomes of your condition, and the safety of treatments. There will be several thousand people participating from all areas of the United States.

What will happen if you decide to be in this research?

If you agree to participate you will be asked to fill out a questionnaire by mail, internet, or phone every 6 months, along with a very short monthly follow-up questionnaire; allow your doctor to send us information about your diagnosis and laboratory tests, talk to an interviewer on the telephone from time to time; notify us of any change in address; and give us permission to contact your doctors or hospitals for additional information about your care.

The questionnaires will ask questions about your psoriasis, the treatments you are getting, the effects of the disease on your function, the amount of pain, and the costs which you incur. You will continue to receive questionnaires even if you move or decide to receive your medical care from other doctors.

No experimentation is involved in this study, and the study will not alter your care in any way. Your decision whether or not to participate will not affect you, your legal rights, or your medical care.

This is a long-term study, meaning that there is no fixed number of months or years in the study. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without affecting you, your legal rights, or your medical care. Data from this study may be linked with data supplied by the National Center for Health Statistics, the Center for Medicare and Medicaid Services, and other administrative databases. An administrative database has information about diagnoses, medical visits and laboratory tests. Your name, date of birth, city, state, and/or social security number may be used to match your data in the administrative database.

What are the risks or discomforts from being in this research?

There are no physical risks associated with this study. You have the right to not answer or skip any questions while completing the survey.

The main risk of participating is minimal and is related to confidentiality and privacy of data provided to, developed by, and used for this study. The information you give us, and data you allow us to have access to, will not be disclosed to anyone in any way which would reveal your identity. Any data that may be published in scientific journals will not reveal the identity of the subjects. Patient information may be provided to Federal and regulatory agencies as required. All reasonable and required measures will be taken to ensure privacy and confidentiality of this data but there is always a small chance that breaches of privacy and confidentiality could occur (see below).

Participants may receive text messages and/or phone call reminders from the research team. Standard voice and text messaging rates may apply. Participants will not be reimbursed for these charges.

What are the possible benefits from this research?

There are no direct benefits to you for participating. However, the knowledge gained from this study could help others with psoriasis in the future.

What are the alternatives to taking part in this research?

Your alternative is not to participate in this research.

Is there payment for my participation in this research?

Yes, you will receive $50 per completed 6-month follow-up questionnaire up to a max of $200 for the study. Payment will be done by either a gift card sent via email or mail OR a check sent by mail and sent two times a year after each 6-month questionnaire period is reconciled and closed.

Note that physicians will be paid up to $350 for each of their patients that enroll in this study to cover ongoing administrative costs associated with patient participation.

Are there additional costs for participation in this research?

No, there are no additional costs to you for taking part in this research study.

How will your privacy and the confidentiality of your research records be protected?

Records of your participation in this research study may only be disclosed in accordance with state and federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its implementing regulations.

Procedures to protect the confidentiality of the data in this study include but are not limited to: coded data, removal of personal information, computer password protection, creation of firewalls around the data, and locking of drawers and offices. A firewall is a protection or barrier within a computer to protect the information from being viewed by unauthorized people.

Researchers will make every effort to protect your privacy and confidentiality; however, there are risks of breach of information security and information loss.

By accepting this consent, you give your permission for information gained from your participation in this research study to be published in medical literature, discussed for educational purposes, and used generally to further medical science. You will not be personally identified; all information will be presented as anonymous data.

HIPAA Research Authorization

Authorization to use and disclose protected health information for this research:

You are being asked for permission to use and disclose your protected health information (PHI) for this research study. Protected health information is defined as individually identifiable health information.

The Health Insurance Portability & Accountability Act of 1996, Public Law 104-191 (also known as HIPAA), establishes privacy standards to protect your health information. This law requires the researchers to obtain your authorization (by signing this document) before they use or disclose your protected health information for research purposes in the study listed above.

What personal identifiers and/or protected health information (PHI) may be used and disclosed in this research?

In addition to information related to your medical history, surgical history, and laboratory results, the identifiers and/or PHI that will be collected, used, or disclosed may include:

How will your protected health information be used or disclosed in this research?

Your health information related to this study that you provided to us, including, but not limited to your medical history, symptoms, treatments, side effects, hospitalizations, infections, and work history. In addition, information from hospital or physician records used to clarify the information you provided.

The use and disclosure of your protected health information is necessary in order to be able to conduct the research described. Records of your participation in this research may only be disclosed in accordance with state and federal law, including the Privacy Act (5 U.S.C. 552a) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations (45 CFR 160 & 164).

By accepting this consent, you give your permission for information gained from your participation in this research to be published in medical literature, discussed for educational purposes, and used generally to further medical science. You will not be personally identified; all information will be presented as anonymous data.

With whom may your protected health information be shared through this research?

The following parties are authorized to use and disclose your health information in connection with this research study:

• The Director of FORWARD, Kaleb Michaud, PhD, and the research and data collection staff of FORWARD
• University of Pennsylvania
• University of Nebraska
• Joel Gelfand, MD
• Alexis Ogdie, MD
• A legally constituted review board charged to protect the safety of human subjects in medical research, called the Solutions Institutional Review Board (IRB)

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study: 1) Qualified medical researchers at other universities, 2) State and Federal Government representative, when required by law (such as the Food and Drug Administration (FDA)), 3) Sponsors of the research study, 4) Your dermatologist, rheumatologist, or physicians, 5) A legally constituted review board charged to protect the safety of human subjects in medical research, called the Solutions Institutional Review Board (IRB).

Other researchers interested in using the data may apply for access to the de–identified data through the FORWARD Databank. Applications will be reviewed by scientific and patient advisory boards before approval of data access.

Except for the last two parties listed, information that will allow you to be identified personally (e.g., name, address, social security number, etc) will be removed from all information used by 1) medical researchers at other universities, 2) State and Federal Government representative, when required by law (such as the Food and Drug Administration (FDA), 3) and study sponsors.

Those listed above who are covered entities under HIPAA agree to safeguard your protected health information by using and disclosing it only as permitted by you in this Authorization or as directed by state and federal law. You need to be aware that some parties receiving your protected health information may not have the same obligations to safeguard your protected health information and may re–disclose your protected health information to parties not named above. If your protected health information is re–disclosed, it may no longer be protected by state or federal privacy laws.

You do not have to accept this consent. If you decide not to accept this consent:

• It will not affect your treatment, payment or enrollment in any health plans or affect your eligibility for benefits.
• You will not be allowed to participate in the research.

After signing this consent document, you can change your mind (at any time and for any reason) and withdraw your authorization for this study to obtain and use your PHI by:

• Notifying the investigators in writing that you have withdrawn your permission to disclose or use your protected health information (revoke the HIPAA Authorization).
  • Send your written letter to Rebecca Schumacher, 727 N. Waco, Suite 200, Wichita, KS 67203 to inform them of your decision to revoke your HIPAA Authorization. Your revocation is not effective until your letter is received.
• Note that researchers may continue to use and disclose your PHI that was obtained before your revocation became effective to the extent that the researchers have taken action in reliance on your earlier authorization. Researchers may also continue to use or disclose your PHI as necessary to maintain the integrity or reliability of the current research, as, for example, to account for your withdrawal from the study, to conduct misconduct investigations, or to report adverse events. For FDA–regulated research, retention and analysis of already collected data, including PHI, is considered necessary to protect the integrity of the research study.
• Note that if you withdraw your HIPAA Authorization, you will not be allowed to continue to participate in the research.

Deciding to not participate or to withdrawing from participation will not impact your medical care or legal rights. The Sponsor, the investigators and others involved with this study may not condition treating you on whether or not you sign this Authorization and consent document.

If you have any questions or concerns about your privacy rights, you should contact Solutions IRB at (855)226–4472.

To quit the study:

To stop participating in this study:

You may withdraw your consent at any time and stop participating in this research study without affecting your eligibility for care or any other benefits to which you are entitled. Withdrawing consent will not affect your care at your doctor’s office. To withdraw, you must write Rebecca Schumacher 727 N. Waco, Suite 200, Wichita, KS 67203.

To revoke HIPAA Authorization (for PHI):

Note that withdrawing your consent to participate in this research does not revoke your HIPAA authorization to use/disclose your protected health information. To revoke the HIPAA Authorization, you must also write Rebecca Schumacher 727 N. Waco, Suite 200, Wichita, KS 67203.

Participation stopped by the principal investigator:

The principal investigator of this research study may terminate your participation in this research study at any time if he determines this to be in your best interest, if you are unable to comply with the procedures required, or if you no longer meet eligibility criteria.

Voluntary Participation:

The decision to take part in this research study is completely voluntary on your part. If significant new findings develop during the course of this research study that may relate to your decision to continue participation, you will be informed.

Contact Information:

Principal Investigator (PI)

The Principal Investigator, Associate Investigators, or a member of the research staff will be available to answer any questions throughout this study.

The Institutional Review Board

The Institutional Review Board (IRB) is an independent committee that reviews, approves and provides ongoing oversight of research studies to ensure the safety, rights and welfare of research subjects.

If you have any questions about your rights as a research subject, or if you have concerns or complaints about the research study, you can
contact:

• Institutional Review Board, Solutions IRB at (855)226–4472 or [email protected]

IF THERE IS ANY PORTION OF THIS CONSENT THAT YOU DO NOT UNDERSTAND, ASK THE INVESTIGATOR BEFORE ACCEPTING. YOU MAY CONSULT WITH YOUR PERSONAL PHYSICIAN OR LEGAL ADVISOR, IF YOU WISH.

Consent

By clicking the button below and filling out the survey(s), you indicate that you have read this consent form, you are consenting to your answers being used for this research, and agree to participate in the study, and that you accept that personal information will be electronically supplied to the researcher to document your participation (such as name, email address, and date).

To retain a copy of this consent for your records:

1. Print a copy of this page by clicking print from your browser menu. You must have a printer attached to your computer.
2. Or, save a copy of this page to your own computer by clicking Save Page as or print and save as a PDF from your browser menu. Select a location for the file that you will be able to find again.

Registration

On the next page when registering, choose “Psoriasis Registry” for your project.