Research Consent

Episona’s long-term goal is to improve our understanding how epigenetics impacts our health and fertility. We will continue to make and support scientific discoveries, which will be peer-reviewed in scientific journals. To support this effort, we need for you to participate in our ongoing research study. Your participation is required to use Episona’s Sperm test. Your personal information will NEVER be released to any third parties without your explicit written consent.

To get started, you must agree to terms in our full consent document below. For any questions, please contact support@www.episona.com.

UNIVERSITY OF PENNSYLVANIA
RESEARCH SUBJECT
INFORMED CONSENT FORM

Protocol Title: Episona Research Study (ERS)
Principal Investigator: Alan Horsager
Episona, Inc.
69 N. Catalina Ave
Pasadena, CA 91101
United States of America
323-207-0052

Support Contact: Episona, Inc.
Episona Customer Support
support@www.episona.com, (800) 942-2606

You are being asked to participate in a research study. Before you decide to participate, it is important that you understand why the research is being conducted and what your participation will involve. We estimate that your participation in this research study will take 30 minutes of your time. Please take time to read the following information carefully and ask questions if there is anything that is not clear or you would like more information. You may speak with the clinic staff or contact Episona directly at support@www.episona.com or (800) 942-2606.

You are invited to participate in an important research study evaluating different factors that may contribute to infertility or other health issues affecting men. This will involve the collection of a semen sample so that it may be possible to analyze the DNA. Your sample and data will be securely stored by Dr. Alan Horsager, the President & CEO of Episona (in cooperation with the National Genetics Institute).

DNA from the semen will be used to study and understand how 1) the genes function inside sperm cells, 2) these genes may function differently in cases of infertility, and 3) environmental factors impact function.

Why am I being asked to volunteer?
DNA from the semen will be used to study and understand how 1) the genes function inside sperm cells, 2) these genes may function differently in cases of infertility, and 3) environmental factors impact function.

What is the purpose of this research study?
Episona’s scientific team recently conducted a large study that suggests there are factors in sperm DNA that may impact reproductive health in men. These are called “epigenetic factors” and are molecules that bind to DNA and can influence what genes are active or inactive. When these molecules bind at the wrong places on the sperm DNA, this can impact the way the sperm works. In this study, Episona is measuring these epigenetic factors to predict two things: 1) if these molecular changes decrease a man’s fertility and 2) if these molecular changes impact the growth of the embryo, which is particularly important during in vitro fertilization (IVF). Please note that Episona’s diagnostic test is still experimental and under investigation. Your participation in the study will help Episona evaluate the test’s utility for future clinical use.

What am I being asked to do and how long will I be in the study?
Your active participation in the study will be brief. You simply will review and sign this consent form, register and answer a brief online questionnaire at https://www.episona.com, and provide a semen sample with the provided sample collection kit. Every step of this process can be done at the clinic or at home. Instructions on how to collect and mail the sample will be provided within the kit. Signing the consent form involves checking the appropriate box below and creating an account with an email and password. We estimate that your effort will require approximately 30 minutes.

What are the possible risks or discomforts?
There can be a risk in knowing genetic or epigenetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a research study. Even though your genes are unique, you share some of the same genes with your blood relatives. Although we are not able to know all of the risks from taking part in research on inherited traits, we believe that the risks to you and your family are very low, because your samples will be coded.

A federal law (Genetic Information Non-Discrimination Act, GINA) helps reduce the risk from health insurance or employment discrimination. The law does not include other types of misuse by life insurance or long term care insurance. If you want to learn more about GINA, you can find information about it on the internet or ask the study staff.

What if new information becomes available about the study?
During the course of the study, we may find more information that could be important to you. This includes information that, once learned, might cause you to change your mind about being in the study. We will notify you as soon as possible if such information becomes available.

What are the possible benefits of the study?
There are no immediate direct benefits for taking part in this study. You will be able to attain these results through your account at https://www.episona.com after a consultation with your physician to discuss the meaning of the results. Further, we believe the information we get from this study may help develop a greater understanding of male fertility.

What other choices do I have if I do not participate?
Participation in this study is entirely voluntary. If you choose not to participate, there are other diagnostic tests that your treating physician may deem valuable to your care, including the standard semen analysis. Please discuss these options with your provider.

Will I be paid for being in this study?
You will not receive any financial compensation for your participation in the study.

Will I have to pay for anything?
As we will be providing clinical results, you will be responsible for covering the cost of processing and analyzing the sample. You will still be responsible for any deductibles or applicable co-pays for your routine office visits, diagnostic tests, treatments, or any other aspects related to your care.

When is the study over? Can I leave the Study before it ends?
This study is ongoing. If you decide to no longer participate, you are free to leave the study at anytime. Withdrawal will not interfere with your future care. You may discontinue participation by closing your Episona account. Requests for account closure must be made in writing to Customer Support at support@www.episona.com.

What information about me may be collected?
In addition to your epigenetic data and questionnaire responses, data from your medical records at the participating fertility clinic may be collected, which may include personal and family medical history, and results from laboratory tests or physical examinations. Clinical outcome data around your treatment, such as whether a given intrauterine insemination (IUI) or in-vitro fertilization (IVF) cycle was successful, will be collected as part of the research study. Your personal identifying information (e.g., name, email) will only be available to Episona for the purpose of communication. Under no circumstances will this information be given to 3rd parties.

Why is my information being used?
Your personal identifying information is being used by the research team to contact you during the study. Your information about test results and procedures are used to a) conduct the research, b) oversee the research, and c) ensure that the research was conducted correctly.

How long may Episona use or disclose my personal health information?
Your authorization for use of your personal health information for this specific study does not expire. Your information may be held in a research database. However, Episona and its affiliates may not reuse or re-disclose information collected in this study for a purpose other than the study unless a) you have given written authorization, b) the University of Pennsylvania’s Institutional Review Board grants permission, or c) as permitted by law.

Can I change my mind about giving permission for use of my information?
Yes. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the investigator for the study. If you withdraw your permission, you will not be able to stay in this study.

What if I decide not to give permission to use and give out my health information?
Then you will not be able to be in this research study. By signing this document you are permitting Episona to use and disclose personal health information collected about you for research purposes as described above.

Who can see or use my information? How will my personal information be protected?
We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Who, outside of Episona, Inc., might receive my information?
Others who will have access to your information for this research study are employees of Episona, participating fertility clinics, and employees at the National Genetics Institute (NGI) who will need the information to perform their duties, which are necessary for completing this study.

Oversight organizations:
Episona, Inc.

Episona uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information, including your epigenetic data and your questionnaire responses. Episona and the participating fertility clinic are the only organizations that have access to your personal identifying information. All other groups (i.e., NGI) will only have access to a de-identified number that is associated with your sample.

Who can I call with questions, complaints or if I’m concerned about my rights as a research subject?
If you have questions, concerns, or complaints regarding your participation in this research study or if you have any questions about your rights as a research subject, you can contact Episona’s customer support by email at support@www.episona.com or by phone at (800) 942-2606. If a member of the research team cannot be reached or you want to talk to someone other than those working on the study, you may contact the Office of Regulatory Affairs with any question, concerns or complaints at the University of Pennsylvania by calling (215) 898-2614.

Please contact Episona at support@www.episona.com to obtain a downloadable or printable version of the consent form. You will also be able to download this consent form at any time from your Episona account.

Optional Component
If you give permission for your samples and data to be saved for future research by Episona, an Institutional Review Board may review and approve each new project. The designated Institutional Review Board may require that you be contacted for your permission prior to the use of the sample(s) in a new project if it determines new consent is required for your protection. The samples will be deidentified (i.e., not associated with your name, email, or other identifying information) and only associated with a unique 5 character alpha-numeric identifier. Only Episona’s research team will have access to you sample material and data.

You may withdraw consent to donate and ask that any remaining samples be destroyed at any time. However, there is no guarantee that this can occur, as the tissue may have already been used for research or destroyed. To withdraw consent to donate, you must tell the study doctor listed on the first page of this consent form in writing.