You may be eligible to take part in a research study. The purpose of this Consent Form is to allow you to make an informed decision on participation in this study. This consent will tell you about what will happen during this research study, the risks of participating, and how information about you can be used and disclosed. Please take your time to make your decision. You may wish to talk about it with your family and friends. You may also talk about it with your health care team. It is important that you read and understand the principles that apply to everyone who takes part in research studies:
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- Taking part in the study is entirely voluntary.
- Taking part in this study may or may not make your health better. We hope that the knowledge gained from your taking part in this study may benefit others.
- You may leave the study at any time without losing any benefits you would have normally received.
The purpose, benefits, risks, discomforts and other information about the study is discussed below. The principal investigator (person in charge of this research study) is Paul Yonover, MD.
Why is this study being done?
This study is being done to determine if the results of the ConfirmMDx for Prostate Cancer test aids physicians and patients in the decision to undergo, or not undergo a repeat prostate biopsy, if they have had a previously negative (no cancer found) biopsy, but still have a concern of prostate cancer risk. There are many tests/evaluations available to your physician to aid in the decision to re-biopsy someone or not. The purpose of this study is to evaluate if having the ConfirmMDx for Prostate Cancer test aids with this decision to re-biopsy you or not.
How many people will take part in the study?
Approximately 2000 people are expected to take part in this study.
What will happen if I take part in this research study?
If you participate in this study no additional examinations, blood tests or medical procedures will be required of you. You will be asked to complete a questionnaire during a follow up visit with your regular urologist. The ConfirmMDx for Prostate Cancer test is performed using a portion of the tissue from your previous negative prostate biopsy. All patients will have their results reported. In all cases, your physician will use his standard tests/evaluations to determine if you need a repeat biopsy or not.
If you decide to participate in this study, MDxHealth will store the results of your ConfirmMDx for Prostate Cancer tests in a database with other clinical data about you collected from your doctor. Your doctor will be asked to provide standard clinical data from your medical chart over the course of 12 months from the time of enrollment in the study.
The protected health information (PHI) about you that will be provided by your doctor to MDxHealth includes, but is not limited to, your age, race/ethnicity, prostatic size measurements, prostate biopsy date, prostate pathology information, and clinical information if cancer is detected as a result of a repeat biopsy procedure.
During the study
No medical procedures or tests are required by this study, other than tests performed by your doctor as part of your routine care. Portions of the tissue from your previous prostate negative biopsy will be sent to the MDxHealth laboratory to run the ConfirmMDx for Prostate Cancer test.
How long will I be in this study?
If you decide to participate, you will be in this study for 12 months from the point of testing.
Can I stop being in the study?
You can decide to stop participation in this study at any time. Your participation may also be stopped without your approval by the study doctor, the sponsor, the Institutional Review Board (IRB –committee that reviews and approves research), or the United States Food and Drug Administration (FDA).
The study doctor may decide to take you off this study for any of the following reasons.ns.
- It would be not in your best medical interest to continue.
- The sponsor decides to end the study.
- Study sponsor has not received your survey
To stop participation in this study, or if you are thinking about stopping your participation, please tell your doctor. Your doctor will tell you how to stop safely and will work with you to obtain a written confirmation of your decision to end your participation.
What side effects or risks can I expect from being in the study?
There isno additional medical risk to you as a participantin this study. The most important non-medical risk to you is the disclosure of your protectedhealth information (PHI). PHI is any health information that is collected about you, including your medical history and new information collected during the course of thisstudy.
Are there benefits to taking part in this study?
Taking part in this study may or may not make your health better. We expect the information learned from this study will benefit other men and physicians who may be considering a repeat prostate biopsy in the future. No other benefits are expected from taking part in this study.
What other choices do I have if I do not take part in this study?
You have the choice to not take part in this study.If you choose not to take part in the study but want the ConfirmMDx test, your doctor may still order the test for you as part of your normal clinical care. This test would be billed to your insurance and you may be responsible for a co-pay or deductible in accordance with your plan benefits. If your insurance company denies coverage, MDxHealth will assist with appealing the denial.
Will my medical information and protected health information (PHI) be kept private?
We will keep your records private to the extent allowed by law. Medical records and research material of study participants are stored and kept confidential according to legal requirements. You will not be identified in any reports or publications about this study. However, certain people and entities will have access to your research and medical records. A Clinical Affairs Professional from the sponsor of the study may look at your research and medical records. The Institutional Review Board (IRB) and federal and state agencies that have authority over the study may look at your research and medical records. Members of the study staff will also have access to your research, protected health information (PHI), and medical records.
What are the costs of taking part in this study?
By choosing to participate in the clinical study, the Study sponsor has agreed to cover any patient out-of-pocket cost associated with the ConfirmMDx test. The Study sponsor will accept payment from your insurance company as payment in full.
Will I be paid for taking part in this study?
You will not be paid for participating in the study.
What if I am injured because I took part in this study?
In the event that you believe you have been injured because of taking part in this study, it is important that you call your study doctor. You can call Dr. Paul Yonover, principal investigator, at 773-281-1011 or 312-505-0335 (24 hours) and he/she will review your concerns with you.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose not to take part, or to withdraw at any time, without penalty or loss of benefit to which you are otherwise entitled. Leaving the study will not affect your medical care.0
Who can answer my questions about the study?
You can talk to your study doctor or study coordinator about any questions, concerns, or complaints you have about this study or the research or if at any time you feel you have had a research-related injury. Contact your study doctor Dr. Paul Yonover; at 773-281-1011 or 312-505-0335 (24 hours).
If you have questions about your rights as a research subject or if you have questions, concerns, or complaints about the research, you may contact:
Western Institutional Review Board® (WIRB®)
1019 39th Avenue SE Suite 120
Puyallup, Washington 98374-2115
Telephone: 1-800-562-4789 or 360-252-2500
E-mail: Help@wirb.com
WIRB is a group of people who perform independent review of research.
WIRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.
You should know that Paul Yonover, MD as the primary investigator is being paid by the MDxHealth, Inc., to conduct this research study.
Who will be authorized to use or disclose my protected health information (PHI)?
If you agree to participate in the study, you authorize the investigators and research study staff to use and disclose your protected health information contained in your clinical record.
To whom will the protected health information be disclosed?
- The sponsor of the study MDxHealth, to collect data at Uropartner LLC.
- IRB (Institutional Review Board) that oversees the research.
Your information may be given to:
Federal and state agencies that have authority over the study. Government agencies include the U.S. Food and Drug Administration (FDA), and the U.S. Department of Health and Human Services (DHHS).
Why is it necessary to share my protected health information with others?
Sharing protected health information (PHI) is necessary is to conduct the research as described in the consent form for the research study.
How long does my authorization remain in effect?
This authorization has no expiration date. It remains in effect unless you revoke it.
How can I revoke my authorization?
You may revoke your authorization at any time by sending a written request to Dr. Paul Yonover 1011 West Wellington Ave. #200 Chicago, Illinois 60657 United States. If you revoke your authorization, your participation in the study will end and no further private health information will be acquired. The study staff may keep or disclose information obtained before you revoked your authorization in order to preserve the scientific integrity of the study.
