SUBJECT RESEARCH INFORMED CONSENT AND AUTHORIZATION FORM
Univfy Inc. - Research Consent Form
Protocol Title: Population-based Predictive Modeling for Fertility Outcomes
Protocol Director: Dr. Mylene Yao
or call our IVF Prediction Test Specialists at 1-877-9-UNIVFY (1-877-986-4839).
Purpose of the Study: The goal of this research is to advance our understanding of factors influencing an individual's chances of fertility treatment outcomes, and to improve the quality of information that can be provided to women suffering from infertility.
You are invited to participate in a research study on factors affecting fertility treatment outcomes, including outcomes of affecting in vitro fertilization (IVF). If, and only if you agree to participate, we will send a link to a short research survey to your email address within a year of your registration with Univfy. If you agree to participate, you will receive a link to follow up research surveys, from time to time, as they become available. You have no obligation to respond to, or complete, any of these research surveys, and can decide whether to respond on a case by case basis. You will also receive communications for research purposes through the email address that you have designated when you registered.
This research consent is required for us to use your anonymized information (information that is stripped of any personal identifiers) in research projects that are aimed to provide greater understanding of the factors affecting fertility treatment outcomes, and publication in scientific or medical research journals.
The main risk to participating in this study is that in the event your email account is breached, the email hacker may see survey links that Univfy has sent to your email account. Some of the questions on the survey may cause embarrassment or anxiety, or may be upsetting or make you uncomfortable. If you do not wish to answer a question, you can skip it and go to the next question. If you do not wish to participate you can stop.
There is also a small risk that a security breach into Univfy's servers may expose results of surveys that you have completed. However, those results are not stored together with your personal information, and the risk that a hacker could determine the personal identifiers for each set of survey results is extremely remote.
Although you will likely not benefit directly from participating in this study, we hope to gain more information to improve counseling and learn about fertility treatment options for women who have concerns about their fertility or who are diagnosed with infertility.
Ultimately, we hope that gaining a better understanding of the factors affecting treatment outcomes can break down barriers and make reproductive treatments more accessible and effective. Your decision whether or not to participate in this study will not affect your use of Univfy's websites, services or products.
Your participation in this study will cause you to receive 1-5 research surveys per year. Responding to each survey will require 5 to 30 minutes of your time.
You will receive no compensation for your participation.
There will not be any costs to you if you agree to participate in this study.
If you have read this form and have decided to participate in this research, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or compromise of services to which you are otherwise entitled.
You may also choose to respond to some research surveys and not others. You have the right to refuse to answer particular questions.
This research consent pertains specifically to research surveys that are designed to gain general research knowledge that will be reported in the scientific/medical literature or conferences.
There is a separate option to agree to receiving other market or research surveys that are designed to assist us with marketing or product development. The results of those surveys may be used to improve our products and communications, but they will not be reported in the scientific/medical literature or conferences.
Your individual privacy will be maintained in all published and written reports resulting from the study.
This is a research survey and participation is voluntary. Since this survey is not related to treatment, the alternative is to not participate in this research study.
If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, you should ask the Protocol Director, Dr. Mylene Yao by providing your contact information to Customer Support at (650) 961-1307, or email ResearchAdmin@univfy.com.
If you have questions about your rights or role as a research subject, please contact the Institutional Review Board (IRB Company) during regular working hours. You may also contact IRB Company if you would like to report problems in a research study, express concern, ask questions, request information or provide input.
IRB Company, Inc.
As a voluntary study participant, your personal health information (PHI) will be used and may be disclosed to Third Parties such as the Food and Drug Administration (FDA) and other regulatory agencies, the sponsor of the study, facilities used in the study, and the Institutional Review Board (IRB) overseeing the study. In addition, your PHI may be disclosed by research team, without prior notice to you, in response to a valid order by a court or other governmental body as required by law.
Efforts will be made by all research team and third parties to protect the confidentiality and security of your personal health information during and after the study. You have a right to obtain your PHI collected or used as part of the research study. This form allows the study doctor (identified in the consent form) to use your records to carry out the study as described in the consent form. If you do not sign this form, you cannot participate in the study.
You have the right to refuse to continue in the study, revoke the consent form and withdraw from the study, now or any time in the future without loss of benefits, or legal rights to which you are otherwise entitled. This authorization does not have an expiration date. If you do not cancel this authorization in writing, it will remain in effect indefinitely.
I have read and understand this addendum to the consent form as well as the original consent form and I authorize the release of my PHI as relates to this study, including consent form and this addendum, to the sponsor, the FDA, IRB and other regulatory agencies as described above. I voluntarily consent to be a research participant in this study.