Focus Group Consent - Women 18 years old

Appendix G. Consent form for focus groups with women enrolled and not enrolled in Z-CAN

Introduction: The University of Puerto Rico and the Centers for Disease Control and Prevention (CDC) invite you to be in a research study. The study involves being in a focus group. A focus group is a group gathering to discuss an issue. The purpose of this focus group is to learn what women in Puerto Rico think and know about birth control and how to get it and what women know about Zika virus and pregnancy.

We plan to conduct 24 focus groups, each with 8 to 10 women.

Please ask questions if there is anything that you do not understand.

Joining the study is voluntary. You may decide not to join, or you may withdraw at any time, for any reason, without penalty. You will be given a copy of this consent form. You may ask questions at any time. Contact information is provided at the bottom if you have questions about your rights as a participant or concerns about the study.

Who can participate?

Women ages 18 and older can participate if they:

• Are not currently pregnant or seeking pregnancy

• Are capable of becoming pregnant

• Have been sexually active in the last 3 months

• Are residents of Puerto Rico

• Are fluent in Spanish

How long will you need me?

The focus group will last about 90 minutes.

What do you want me to do if I decide to be in this study?

If you agree to participate in the focus group, you will be asked to sign this consent form after all of your questions have been answered. Once you have signed the consent form, this study involves a group discussion led by two staff from the Behavioral Science Research and Evaluation Center at the University of Puerto Rico (UPR-CIES). As part of the group, you will be asked questions about pregnancy, birth control, the Zika Contraception Access Network (Z-CAN) program, and the Zika virus. The research staff will take notes and tape the discussion. Tapes will be destroyed after notes are taken and translated.

Are there any risks to me if I decide to be in this study?

There are no known physical risks to being part of this study. If you feel uncomfortable with a question, you do not need to answer or you may drop out of the focus group at any time. We will take steps to not let anyone outside this project know of your participation.

Are there any benefits from being in this study?

You will not personally benefit from being in this study. You will be helping to improve a program that gives birth control to women at no cost who want to delay or prevent pregnancy during the Zika outbreak.

Will I receive anything for being in this study?

At the end of the focus group, you will be given a $50 gift card to thank you for your time.

Where will the information collected during this evaluation be stored?

• We will store the consent forms and any information collected during this focus group in a locked file cabinet that only study staff can access.

• We will store all electronic files in a password-protected database that only study staff can access.

• All of the paper-based, audio, and digital information will be stored in locked facilities at CIES, Floor M, Plaza Universitaria, 3 Avenida Universidad, University of Puerto Rico.

Will the information I give you be kept private?

• The information you give us as part of this study will be protected under the Privacy Act (System of Records Notice 09-20-0136). We will do all we can to keep your information private, except when required to share specific information by law.

• To further protect your privacy, we will ask you to choose a name other than your real name to use during the focus group. Although we will ask participants to not share what is discussed during the focus group, we cannot assure that other participants will keep all information confidential.

• When we present or publish the results of this research, we will not include information that could identify you or any participants.

Who should I call if I have questions about this study, have been harmed by the study, or have questions about my rights as a research volunteer?

If you have questions about the study, wish to cancel your participation in the study, or believe you may have been harmed by being in the study, please contact xxx at (xxx)-xxx-xxxx (toll free number) or xxx (email).

If you have questions about your rights as a participant in this study, please contact the Human Subjects Protections Office (IRB) at (787) 758-2525 or xxx (email).

Do I have to be in this study?

Joining the study is voluntary. You may decide not to join or you may stop your participation at any time, for any reason, without penalty. Your choice to participate in this study will not affect the services you receive or may receive in the future.

Signature

I have been told about the study. I have been allowed to ask questions. I had all of my questions answered. I would like to be in the study. By signing this form, I agree to participate.

Do not sign this consent form until you have had the chance to ask questions and get satisfactory answers. If you sign, agreeing to participate in this study, you will receive a signed and dated copy of this document with the IRB’s approval seal on each page.

______________________________________________________________________________Participant Name Date

______________________________________________________________________________Participant Signature Date

I have discussed the purpose of the study with the participant, including the risks, benefits and alternatives to participating (including the alternative of not participating). The participant has had the opportunity to ask questions and in my opinion the participant is able to freely consent to participate in the study.

______________________________________________________________________________ Name of staff person obtaining consent Date

______________________________________________________________________________ Signature of staff person obtaining consent Date