AUTHORIZATION AND INFORMED CONSENT FOR CORRONA REGISTRY
Site Phone Number:
“Corrona Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry”
Kevin Schlessel, MD
WHY ARE YOU BEING ASKED TO BE PART OF THIS REGISTRY?
You are being asked to be in a national research registry study called the Corrona Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry (the “Corrona Registry”) because you have a condition known as Rheumatoid Arthritis (RA). This form gives you information to help you decide if you want to be included in the registry. You should not join this registry study until all of your questions are answered.
The decision to join the registry study is completely up to you. Your decision will not change the care you are receiving from your doctor. This registry study is not designed to treat any illness or to improve your health. You should continue to be treated for your RA by your doctor
WHO IS PAYING FOR THE STUDY?
The sponsor, Corrona, will pay for this registry study. Corrona is providing financial support to the doctors who assist in data collection for the Corrona Registry.
WHAT IS THE CORRONA RA DRUG SAFETY & EFFECTIVENESS REGISTRY?
Corrona is a for-profit company started by doctors who want to improve care and treatment outcomes for patients suffering from autoimmune disorders like RA. Corrona tries to do this by, among other things, collecting and studying the health information provided by patients like yourself and the doctors who treat you. It is hoped researchers can compare safety and results seen with FDA-approved treatments for RA.
Corrona owns the Corrona Registry, which is a database that includes detailed clinical information, which is referred to in this consent form as “Health Information,” about people who have RA. People like you and your doctor provide the Health Information that makes up this database. Your doctor, research staff working for your doctor, and certain Corrona employees and contractors, such as statisticians and clinicians, can use the information in the Corrona Registry for the purposes explained below.
Other organizations such as pharmaceutical and biotechnology companies, academic researchers, foundations, and other types of researchers can ask questions that Corrona researchers answer by using the Health Information in the registry or buy or obtain copies of information from the Corrona Registry to learn more about RA and its treatment, drug safety, and for marketing and other business purposes.
WHY IS THIS REGISTRY STUDY BEING DONE?
The purpose of this registry study is to learn more about RA, how doctors treat RA, how well medications and other treatments work, the safety of those treatments, and to improve the care and outcomes of people with RA. Approximately 60,000 men and women ages 18 years and older with a diagnosis of RA in North America are expected to participate.
WHAT INFORMATION GOES INTO THE CORRONA REGISTRY AND WHAT HAPPENS TO IT?
If you decide to be in this registry, you will be asked to complete Corrona Registry Questionnaires during regularly scheduled visits with your doctor.
You will be providing information about yourself and your RA condition to be included in the Corrona Registry.
You will be asked to answer questions about any medical conditions you are experiencing and medications you are taking.
It should take you about 10 to 15 minutes to complete these questionnaires at each registry visit.
These questionnaires will not include your name, address, phone number, full date of birth, medical record number, or your social security number.
Your doctor will also be asked to complete questionnaires to be included in the Corrona Registry database. Your doctor will answer questions about things such as:
Your RA condition
Your laboratory findings
Any recent hospitalizations or new or worsening medical conditions that may be related to RA or medications you are taking for RA.
Your full medical record will not be included in the Corrona Registry database. Research staff at your doctor’s office will assign you a unique Corrona Subject ID number that will be used to enter the information in your questionnaires into the Corrona Registry database. Only the information that you and your doctor provide on these questionnaires, including treatment information and dates of events such as clinic visits, hospitalizations, when a certain medication was prescribed, and others, will be entered into the database. Your Personal Information will not be entered into the Corrona Registry database. The information in the Corrona Registry database can be accessed and shared by Corrona employees, contractors, and researchers for clinical, research, marketing, and other business purposes.
USE OF PERSONAL INFORMATION TO COLLECT ADDITIONAL HEALTH INFORMATION
On your first registry visit, you will also be asked to complete a separate form that asks for identifying information including personal, demographic, and contact information, which is referred to in this consent form as “Personal Information.” You may choose to only provide some of the Personal Information requested but not all of it.
The personal information you provide will NOT be included in the registry database that contains your Health Information. Instead your doctor will submit the Personal Information you choose to provide to a separate organization contracted by Corrona known as the “Honest Broker.” The Honest Broker is responsible for securely maintaining your Personal Information to be used to collect additional Health Information as described in the next section.
WHY ARE YOU BEING ASKED TO PROVIDE PERSONAL INFORMATION ON A SEPARATE FORM AND WHAT WILL HAPPEN TO THAT INFORMATION?
You are being asked to provide this information so that additional Health Information can be collected for the registry to help researchers and other organizations that collect Health Information better understand patients with RA. This is referred to in the consent form as “Health Outcomes Research.” In order to do this, the Honest Broker can use and disclose this information in the following ways:
To collect additional Health Information from sources like:
Public databases such as the Center for Medicare and Medicaid Services (CMS)
Other public or private clinical and administrative databases
Organizations focused on the care and treatment of RA for the purposes of clinical, market, or outcomes research
Other organizations that collect Health Information, such as health plans, laboratories, and pharmacies
If you lose contact with the registry, to get information from the Center for Disease Control’s National Death Index to determine whether you have passed away.
The Honest Broker may share your Personal Information with third parties to find and collect additional information held by the types of organizations mentioned above.
To provide updates or information about additional, optional research opportunities (if payment is available it is described at the time of the survey contact).
To perform other health status follow-up activities.
You will also be given the option to sign a Medical Records Authorization Form.
If you choose to sign this form, Corrona can use your Personal Information to request copies of your medical records if you are hospitalized or visit a specialist or other provider for a serious medical problem. This will provide additional information to the registry about your condition.
WHO WILL SEE YOUR COMPLETE MEDICAL RECORD OR OTHER PERSONAL INFORMATION, INCLUDING ANY PROTECTED HEALTH INFORMATION?
Records of your participation in this study will be kept confidential except as disclosure is permitted by law or as described in this consent form.
Your medical record is available for use by your doctor and research staff in connection with this study. The following people and groups of people may also look at and/or copy your medical records to make sure that the registry is being done properly and to check the quality of the data:
Corrona’s study monitors, auditors, or representatives contracted by Corrona to perform quality review activities and audits.
The Institutional Review Board (IRB) which is responsible for protecting the rights and safety of research subjects.
Regulatory health authorities (government agencies that oversee research or are involved in trying to keep research safe), such as the Food and Drug Administration (FDA).
If information from this study is published in a medical journal or presented at scientific meetings, you will not be identified by name or any other Personal Information.
Your Personal Information, including any protected health information may be used and disclosed as set forth in this document.
DO YOU HAVE TO PARTICIPATE IN THE STUDY?
Your participation in this registry is voluntary. You may decide not to participate or you may leave the registry at any time. Your decision will not result in any penalty or loss of benefits.
WHAT ARE THE RISKS?
There is time and effort associated with the completion of the questionnaires. There are no anticipated physical risks. There is a potential risk of a breach of confidentiality of your health and Personal information.
WHAT ARE THE BENEFITS?
Your participation in this research registry will not necessarily benefit you. The information gathered from this registry may help people with RA in the future.
WILL YOU BE PAID FOR PARTICIPATING?
You will NOT be paid for participating in this research registry.
WHAT IF YOU DO NOT GIVE PERMISSION TO USE AND GIVE OUT YOUR HEALTH INFORMATION?
By signing this authorization and informed consent, you are giving permission to use and give out your Health Information as described in this consent. If you do not give your permission then you will not be able to be in this registry. If you are not in the registry, your relationship with your doctor will continue as is.
IS YOUR HEALTH INFORMATION PROTECTED AFTER IT HAS BEEN GIVEN TO OTHERS?
There is a risk that your Health Information will be passed on to others without your permission. The sponsor of this study shall take all the appropriate measures to ensure that your Health Information is protected and secured from unauthorized disclosure.
WHAT IF YOU DO NOT GIVE PERMISSION TO USE YOUR PERSONAL INFORMATION?
By signing this authorization and informed consent, you are giving permission to use and give out your Personal Information as described in this consent. If you do not give your permission then you will not be able to be in this registry. If you are not in the registry, your relationship with your doctor will continue as is.
IS YOUR PERSONAL INFORMATION PROTECTED AFTER IT HAS BEEN GIVEN TO OTHERS?
There is a risk that your Personal information will be passed on to others without your permission. The Honest Broker is responsible for ensuring your personal Information is protected and secured from unauthorized disclosure.
WHAT HAPPENS IF YOU DECIDE AT A LATER TIME THAT YOU NO LONGER WANT TO PARTICIPATE?
You can withdraw from participation in the registry at any time by notifying your doctor of your decision in writing, in person, or by telephone. You may choose to withdraw from only the questionnaire part of the registry and continue to permit the use of your personal information for the collection of additional health information, as described earlier in this consent form, or you can choose to withdraw from both parts of the registry.
After your withdrawal, neither you nor your doctor will be asked to complete any more registry questionnaires; however, Health Information that has already been collected and stored in the registry database may still be used and provided to others.
After your participation in the registry has ended, Corrona may ask your doctor for more information about previously reported events, such as hospitalizations and other serious medical problems that occurred during your participation in the Corrona Registry. This information is important in evaluating the safety of medications and would only be requested for events reported in the Corrona Registry during your participation.
CAN MY PARTICIPATION BE STOPPED FOR ANY OTHER REASON?
Your participation in this registry may be stopped at any time by your doctor, the sponsor or the IRB without your consent for any reason, including:
If it is in your best interest
If you do not consent to continue in the study after being told of changes in the registry that may affect you
If you lose contact with the registry and your doctor for an extended period of time
DOES MY PERMISSION EXPIRE?
Unless you cancel your permission, this authorization does not have an expiration date because the registry database will be maintained indefinitely.
WHO DO YOU CONTACT IF YOU HAVE QUESTIONS?
Contact the investigator or a member of the study staff at the number below if you have any questions about your participation in this registry or if you have questions, concerns, or complaints about the registry, or feel you have been injured.
Kevin Schlessel, MD
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact New England Independent Review Board (NEIRB), the IRB responsible for reviewing this research study. NEIRB’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:
Mailing Address: OR Email Address:
197 First Avenue, Suite 250
Needham, MA 02494
If you are unable to provide your concerns/complaints in writing contact our office at:
Between 9 AM and 5 PM Eastern Time
NEIRB has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean NEIRB has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this registry.
WHAT ABOUT MY LEGAL RIGHTS?
You will not lose any of your legal rights by signing this consent form. If you agree to be in this registry, you will receive a signed and dated copy of this consent form for your records.
WHAT IF THERE IS NEW AND IMPORTANT INFORMATION THAT MAY AFFECT MY WILLINGNESS TO PARTICIPATE?
If there is new information or any significant new findings that could relate to your willingness to continue participation we will tell you. You can then decide if you still want to be in the registry.
AUTHORIZATION AND CONSENT
I have read this consent form (or it has been read to me). I have talked with my doctor about being in the registry. All my questions about the registry have been answered. I freely consent to be in this registry study.
I authorize the use and disclosure of my information, including information for the Corrona Registry, my personal information, including any Protected Health Information, to the parties specified in this Authorization and Informed Consent and for the purposes described in this document.