AUTHORIZATION TO DISCLOSE HEALTH INFORMATION AND CONSENT FOR PARTICIPATION IN A MIRAKIND/MIRADX RESEARCH PROJECT

TITLE: Clinical validation of the role of microRNA binding site mutations in cancer risk, prevention and treatment

Funding Source: MiraKind/MiraDx, an independent research institute

Principal Investigator: Joanne Weidhaas, MD, PhD

Telephone: (203) 671-1308

Principal Investigator’s email address:: joanne@mirakind.org

Additional Contact email address: joanne@miradx.com

Address:
MiraKind/MiraDx
11600 Wilshire Blvd
Suite 410
Los Angeles, CA 90025

INVITATION TO PARTICIPATE AND DESCRIPTION OF PROJECT
You are invited to take part in a research study because you have been diagnosed with a cancer, have an altered immune system, or have a family history of either of these disease states.

In order to decide whether or not you wish to be a part of this research study you should know enough about its risks and benefits to make an informed judgment. This consent form gives you detailed information about the research study, which a member of the research team will be available to discuss with you and answer any questions. Once you understand the study, you will decide if you want to participate; if so, you will be asked to sign this form. Your participation is entirely voluntary and the decision to join or not join the research study will not cause you to lose any medical benefits to which you are entitled and there is no penalty.

PURPOSE
The aim of this study is to see whether we can validate new genetic “markers” or “mutations” that predict the risk of developing cancer, endometriosis or altered immunity, and which also predict response to cancer therapy. The markers being studied are found in the Deoxyribonucleic acid (DNA) in your body, called “germ-line DNA”. The types of markers we are studying are variations or difference between your DNA and other people’s DNA. We can test if you have these differences in a saliva collection from your mouth or in a blood sample.

HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Up to 250,000 people may take part in this study.

PROCEDURES
Once it has been determined by your personal physician or through review of your application to join a MiraKind/MiraDx research study that you fit the study criteria, and you have reviewed the protocol, you will be given this consent form. After you have all of your questions answered, and decide to participate, and sign the consent form, you, or you and your physician will send in a DNA sample.

The study involves:
A Salivary (Spit) Sample Collection or blood sample collected by you or you and your physician, and mailed to MiraKind/MiraDx’s lab.
Variant Assay Test – Once the lab receives your sample, your DNA will be analyzed to determine if you have certain genetic variations.
Storage of Sample and Result – You may opt to allow MiraKind/MiraDx to use your DNA (genetic) sample to do further research. If you do not give us your explicit permission, your sample will be kept but de-identified, so that it can no longer be traced to you.
Optional return of KRAS-variant or other genetic results – You will have the option of receiving your individual results through a physician of your choice. There is a processing fee associated with obtaining individual results.
Option to participate in secondary studies/registries. If you opt to, you will be invited to additional studies that you are eligible for, including testing of other biomarkers being developed. “Biomarkers” are biological materials that are associated with a disease, a treatment or an outcome. They can be markers of who is most likely to be helped by a medicine or a marker of who is at risk for a bad reaction to a medicine. They can also help doctors and scientists understand which patients need a certain treatment, which patients may not, and why.

If you elect to participate in a registry, you will be assigned a unique registry number and will be invited to complete surveys about your health history every 3 to 6 months. Any information you provide through registry surveys will be kept in a secure, encrypted database.

As a participant in this study, you should still continue to be followed as normally prescribed by your physician for routine healthcare and screening.

RISKS AND DISCOMFORTS
This study does not involve a new treatment.

Risks of Spit Collection:
There are no reported risks associated with spit collection.

Risks of Blood Collection:
There is minimal risk of blood collection. You may develop mild redness at the site.

Risks of Data Collection and Privacy:
There are no physical risks to you for donating and storing your clinical data for use in this study. However, there is a potential risk of a computer security breach, data breach, or unforeseen loss of privacy. Every effort will be made to keep your personal health information completely secure and confidential in this study. Please see the Confidentiality section for an explanation of how your information is protected below.

Known risks of a breach of confidentiality may include but are not limited to issues related to insurability or employability, or that family members may become aware of information related to the study and you, or that you may become aware of information about yourself or family members that you would have preferred not to know.

Risks of Genetic Testing:
Your genetic information potentially could be used in ways that could cause you or your family distress, such as by revealing that you (or a blood relative) carry a genetic trait. If you choose to obtain individual results, the results may create stress or anxiety for you, or fear that there will be discrimination.

A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information.

This law generally will protect you in the following ways:
Health insurance companies and group health plans may not request your genetic information that the sponsor will get from this research.
Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
Employers with 15 or more employees may not use your genetic information that the sponsor will get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

All health insurance companies and group health plans and all employers with 15 or more people must follow this law.

Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

Your individual results will be confidential, and only shared with your physician and you if you choose to obtain them. They will never be disclosed to a third party without your explicit permission.

ECONOMIC CONSIDERATIONS
There will be no costs to you for your participation in this trial, unless you choose to obtain your individual results. That cost may be covered by your clinic, which will be determined by your physician. You will not receive any payments for participating in this study.

BENEFITS
You will not benefit directly from this study. We hope that the information we learn and/or your doctors learn will increase our knowledge of human health and that this information will lead to better diagnoses and treatments in the future.

ALTERNATIVES
The alternative to being a part of this study is to not take part in this study.

CONFIDENTIALITY AND PRIVACY
Any identifiable information that is obtained in connection with this study will remain confidential and will be disclosed only with your permission or as required by U.S. or State law. Examples of information that we are legally required to disclose include abuse of a child or elderly person, or certain reportable diseases, information which will not be collected in this study.

When the results of the research are published or discussed in conferences, your name will never be associated with the publications or presentations, and no information will be included that would reveal your identity. We understand that information about you obtained in connection with your health is personal, and we are committed to protecting the privacy of that information. If you decide to be in this study, MiraKind will receive information that identifies you and your personal health information. This may include information that might directly identify you, such as your name, date of birth, address, etc. This information will be de-identified immediately after the sample is obtained and recorded, as you will be given a unique study number. The data manager and database builder are the only individuals that will have a link that identifies you to your coded information, and this link will be kept secure.

Representatives from agencies such as the National Institutes of Health (NIH) or the Food and Drug Administration (FDA) may inspect study records during auditing procedures. However, these individuals are required to keep all donor information confidential. If you decide to participate in this study, you will be asked to authorize these uses and disclosures by signing this form. You must authorize these uses to participate in this study.

AUTHORIZATION TO USE OR DISCLOSE (REVEAL) YOUR HEALTH INFORMATION
Your privacy and confidentiality of the study records will be protected to the fullest extent provided by law.

The information about your health that will be collected in this study may include:
Pathology reports about your cancer
Date of diagnosis of your disease
Your record of family members’ medical history
Answers to a detailed questionnaire about personal life exposures
Information on how you respond to certain treatments

Research staff on this study will have access to research related information contained in your study record. Access to MiraKind’s information is limited to research staff involved in this study. Representatives from agencies such as the National Institutes of Health (NIH) or the Food and Drug Administration (FDA) may also have access to the study records.

By signing this form, you authorize the use and/or disclosure of the information described above for this research study. The purpose for the uses and disclosures you are authorizing is to ensure that the information relating to this research is available to all parties who may need it for research purposes. Authorization has no expiration date.

All health care providers subject to HIPAA (Health Insurance Portability and Accountability Act) are required to protect the privacy of your information. The research staff at MiraKind are trained to comply with HIPAA to ensure the confidentiality of your information. MiraKind has also implemented administrative and technical safeguards, such as encryption and password protection, to protect the security of all information collected in the study. MiraKind will immediately notify you if there were any breach to the confidentiality or security of your information.

Some of the individuals or agencies listed above may not be subject to HIPAA and therefore may not be required to provide the same type of confidentiality protection. They could use or disclose your information in ways not mentioned in this form. However to better protect your health information, agreements are in place with these individuals and/or companies that require that they keep your information confidential.

VOLUNTARY PARTICIPATION AND WITHDRAWAL
To help you make your decision to participate or not in this study, a MiraKind/MiraDx representative is available so that you can ask any questions you have about the research project. They can be contacted through the MiraKind website inquiry contact form, or directly through the email addresses or telephone number listed on the first page of this form. Sign the consent form only after you have had a chance to ask your questions and have received satisfactory answers from your physician, or a MiraKind/MiraDx staff member.

You may change your mind and decide to withdraw your permission for the sponsor to use health information from your medical records at any time by sending a written request to the principal investigator at the email address or MiraKind/MiraDx’s address listed on the first page of this form. There is no penalty or loss of benefits to you.

If you withdraw your permission, your participation in the study will end. You can request that your DNA be destroyed at any point this same way. However, this withdrawal will not affect your future treatment or medical management in any way, and you will not lose any benefits to which you are otherwise entitled. The study staff will stop using your information for the trial, but information already collected up to the time you withdrew your permission will still be used for the study. Keeping your health information may be necessary to analyze the study results properly. Your part in the research may stop at any time for any reason, such as, the sponsor or the investigator decides to stop the study.

NEW INFORMATION
You will be told about any new information found during the study that may affect whether you want to continue to take part.

INVESTIGATOR INTERESTS
Dr. Weidhaas, the study principal investigator, has a proprietary interest in this research study (e.g. patent, trademark, copyright, or licensing agreement). Due to this potential conflict of interest, Dr. Weidhaas will not be involved in the informed consent process or recruitment for this study. Dr. Weidhaas can answer questions about the study outside of these roles.

QUESTIONS
We have used some technical terms in this form. Please feel free to ask about anything you do not understand and to consider this research and the consent form carefully – as long as you feel is necessary – before you make your decision or if you have any questions at a later time. Please contact the principal investigator or study staff at the telephone number or email address listed on the first page of this form.

If you have any questions or complaints about your rights as a research participant contact Chesapeake IRB

By mail:
Study Subject Adviser
Advarra IRB
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
or call: 410-884-2900
or by email: cirbi@advarra.com

Please reference the following number when contacting the Study Subject Adviser: Pro00009633. An IRB is a group of people who review research projects to protect the rights and safety of participants.

WHERE CAN YOU GET MORE INFORMATION?
You may visit mirakind.org or miradx.com for more information about our organization and the aims of this study.

AUTHORIZATION: I have read this form and decided that I will participate in the study described above. Its general purposes, the particulars of involvement and possible hazards and inconveniences have been explained to my satisfaction. You will receive a PDF copy of this in your email inbox.