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 their 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?
||Kaleb Michaud, PhD, FORWARD
Joel Gelfand, MD, University of Pennsylvania
Alexis Ogdie, MD, University of Pennsylvania
|Location of Research
||FORWARD, 727 N. Waco, Suite 200, Wichita, Kansas 67203
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 3-6 months; 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 prejudice you 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 prejudice to you or effect on 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 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 is no known risk associated with this study. The information you give us 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.
What are the possible benefits from this research?
The possible benefits to you as a research subject in this research study are: your participation will help increase knowledge of and interest in psoriasis, and may help to better understand how to treat and improve this condition. The study will provide important information that will aid in the development of the most effective methods to treat psoriasis. However, there is no guarantee that you will benefit from being in this research.
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 follow-up questionnaire up to $200 over the entire study.
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.
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?
The identifiers and/or PHI collected, used, or disclosed are below:
Address (all geographic subdivisions smaller than a state)Your Content Goes Here
Dates (except year) directly related to an individual such as birth date
Ages over 89, including year of birth (can be grouped as age 90 or older)
Any other unique identifying number, characteristic, or code
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
- 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 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).
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 accepting this consent, you can change your mind and:
- Notify the investigators in writing that you have withdrawn your permission to disclose or use your protected health information (revoke the Authorization).
- Send your written letter to Rebecca Schumacher, 727 N. Waco, Suite 200, Wichita, KS 67203 to inform them of your decision. Your revocation is not effective until your letter is received.
- 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.
- If you withdraw the Authorization, you will not be allowed to continue to participate in the research.
If you have any questions or concerns about your privacy rights, you should contact the IRB, Solutions IRB., phone#.
This Authorization does not have an expiration date.
Your acceptance at the end of this consent acknowledges that you authorize FORWARD, Kaleb Michaud, PhD, University of Pennsylvania, Joel Gelfand, MD and Alexis Ogdie, MD to use and disclose your Protected Health Information (PHI) collected about you for research purposes as described above.
What happens if I withdraw from this research?
You may withdraw your consent at any time and discontinue further participation in this research study without affecting your eligibility for care or any other benefits to which you are entitled. Should you choose to withdraw, you must contact in writing Rebecca Schumacher, 727 N. Waco, Suite 200, Wichita, KS 67203.
Please note that withdrawing your consent to participate in this research does not fully revoke your HIPAA authorization to use/disclose your protected health information. To make that revocation, please send a letter to the principal investigator as discussed earlier in this document.
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.
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.
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.
||Kaleb Michaud, PhD, FORWARD
||Alexis Ogdie, MD, University of Pennsylvania and Joel Gelfand, MD, University of Pennsylvania
||727 N. Waco, Suite 200, Wichita, KS 67203
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 XXXX
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.
By clicking the button below you indicate that you have read this consent form and agree to participate in the study, and that you accept that personal information will be electronically supplied to the researcher to document their participation (such as name, email address, and date).
To retain a copy of this consent for your records:
- Print a copy of this page by clicking File and print from your browser menu. You must have a printer attached to your computer.
- Or, save a copy of this page to your own computer by clicking File and Save. Select a location for the file that you will be able to find again.