Consent

Consent to Donate Specimens for Research

You have the option to contribute to important research at PS Fertility. Opting in will enable us to research possible connections between fertility and health conditions. Results from this research may help others struggling with fertility issues and in the future, we would like to reflect this information back to you to help improve your reproductive and overall health.

Consent to donate specimens for future research

This is a consent for you to donate semen specimens for medical research. The following document will explain the research to you. Take your time to make your decision about participating. You may discuss your decision with anyone you choose. If you have any questions, you may ask the researchers who can be contacted at the following email address: [email protected].

Why is this research being done?

The purpose of this study is to collect semen samples that can be used in future clinical studies. These data may be used to understand associations between semen samples and fertility. Combined with survey data (for example, health history, lifestyle factors, environmental exposures, quality of life), we can examine associations between these factors, semen samples, and fertility.

This research is sponsored by a private company focused on developing new diagnostic technologies in the men’s health space. The principal investigator has a financial interest in the company that is sponsoring this research. Steps have been taken to ensure the integrity of all the data collected as well as ensure privacy of the participants. If you have any questions regarding biobank sponsorship, please contact [email protected].

What will happen if I agree to donate my specimens?

If you agree to let researchers store your specimens for future research, the following will happen:

After a semen analysis test is performed, instead of discarding your leftover specimen, it may be stored for use in future investigational research studies. This sample will NEVER be used for the purpose of creating an embryo.
Your sample will not be physically connected to your personal information to ensure privacy throughout the course of the research. Data that will be stored under this consent includes: the results of your semen analysis and the associated data you provided when requesting or purchasing a kit. We do not guarantee your specimens or records will be used for future research, but they might be used in research about men’s health, fertility, or other clinical purposes.
Sometimes specimens are used for genetic research (about diseases that are passed on in families). Even if we use the specimen for genetic research, we will not put the results in your medical record. Your specimen and any information about you will be kept until it is used up or destroyed. It may be used to develop new drugs, tests, treatments, or products. In some instances, these may have potential commercial value. Your personal health information cannot be used for additional research without additional approval from a review committee.
Your specimens may be kept indefinitely. If you decide later that you do not want your specimens and information to be used for future research, you can notify the investigator in writing at [email protected], and we will destroy any remaining identifiable specimens and information. However, if any research has already been done using portions of your specimens, the data will be kept and analyzed as part of those research studies.
Separately, we will collect information regarding your lifestyle and health characteristics stored in separate encrypted databases accessed only by the research staff. We will be able to examine associations between your semen analysis, your semen sample, and these lifestyle and health characteristics. These survey data are collected using a separate consenting process.

What risks are involved with donating specimens for research?

There is little risk in donating semen samples for research. The main risk associated with donating specimens is the embarrassment associated with providing a semen sample. Your donated sample will never be used for gamete donation or the creation of embryos.

Confidentiality: Donating specimens may involve a loss of privacy and/or confidentiality, but information about you will be handled as confidentially as possible. Biobank data will be physically and electronically secured. As with any use of electronic means to store data, there is a risk of breach of data security. Your name will not be used in any published reports from research performed using your specimen. The biobank Principal Investigator and select staff members will have access to information about you but they will not release any identifying information about you to researchers using your specimen. Taking part in a biobank may also have a negative impact or unintended consequences on family or other relationships. If you do not share information about taking part in this biobank, you will reduce this risk. Although your name will not be with the sample, it will have other facts about you such as your specimen ID and semen analysis data. These facts are important because they will help us better understand how these variables are associated with men’s health and fertility. Thus, it is possible that a study using your sample could one day help people of the same race, ethnicity, or sex as you. However, it is also possible through these kinds of studies that certain traits might come to be associated with your group. In some cases, this could reinforce harmful stereotypes.

How will my specimens and information be used?

Researchers will use your specimens and associated information that is stored in a biobank. Your specimens may be analyzed with your survey responses. Your specimens may be shared with other researchers in the future. We will not share your name or any other personal information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information.

Commercial Use: Your specimens may be used for commercial use. If this happens, you will not share in any profits.

What happens if I am injured because I took part in this biobank?

It is important that you tell the Principal Investigator of the study if you feel that you have been injured because of taking part in this study. You can tell the Principal Investigator about what you have experienced by contacting them through email at [email protected] or at the phone number provided at the beginning of this consent form.

Treatment and Compensation for Injury: If you are injured as a result of being in this study, the biobank sponsor will provide necessary medical treatment. The costs of the treatment may be billed to you or your insurer just like any other medical costs or covered by the biobank sponsor depending on a number of factors. The biobank sponsor does not routinely provide any other form of compensation for injury.

For further information about this, you may call the office of the Institutional Review Board at 855-818-2289.

What are the benefits of donating specimens for research?

By donating your semen for research, you can contribute to the development of novel treatments and diagnostics that may improve patient lives. You also have the potential to support multiple different types of research studies as multiple researchers can submit research protocols for approval to use samples within the biobank.

What financial issues should I consider before donating?

You will not be charged for donating your specimens. If the data or any new products, tests, or discoveries that result from this research have potential commercial value, you will not share in any financial benefits. The biobank sponsor may receive payment from researchers requesting specimens in order to cover the costs of collecting and storing the specimens.

What alternatives do I have?

This is not a treatment study. Therefore, your alternative is not to participate. If you choose not to participate in donating to this biobank, it will not impact the care or services that you receive. You may always choose to order another semen analysis kit and donate a future sample to the biobank if desired.

What are my rights if I take part in this study?

Taking part in this biobank is your choice. You may choose either to take part or not to take part in the biobank collection. No matter what decision you make, there will be no penalty to you, and you will not lose any of your regular benefits. In the case of injury resulting from this biobank, you do not lose any of your legal rights to seek payment by signing this form.

This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or [email protected] if:

You have questions, concerns, or complaints that are not being answered by the research team.
You are not getting answers from the research team.
You cannot reach the research team.
You want to talk to someone else about the research.
You have questions about your rights as a research subject.

Who can answer my questions about the biobank?

You can talk with the biobank researcher about any questions, concerns, or complaints you have about this biobank or if you feel you have been harmed by this research. Contact the biobank researchers at [email protected] or 866-207-6555. If you wish to ask questions about the biobank or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the biobank, please call the office of the Institutional Review Board at 855-818-2289.

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point without penalty or loss of benefits to which you are otherwise entitled.