Informed Consent to Participate in Research
The University of Texas at Austin
You are being asked to participate in a research study. This form provides you with information about the study. The Principal Investigator (the person in charge of this research) or his representative will also describe this study to you and answer all of your questions. We will read the information below with you and answer any questions you have before you decide if you want to participate. Your participation is entirely voluntary and you can refuse to participate without penalty or loss of benefits to which you are otherwise entitled.
Title of Research Study: Border Contraceptive Access Study (BCAS)
Pharmacy and Clinic Users Study of Knowledge, Satisfaction, Compliance, Continuation, and Unintended Pregnancy – El Paso Residents
Principal Investigators and Telephone Numbers:
Joseph E. Potter, Principal Investigator |
Jon Amastae, PI, Subcontract, |
Dan Grossman, PI, Subcontract, |
Funding source: National Institute of Child Health and Human Development
What is the purpose of this study?
In this study, we will interview 1000 women who live in El Paso and 500 women who live in Ciudad Juárez and who use the pill. They will be asked what they know about using contraceptive pills, and their reasons for purchasing them where they usually do, either in Ciudad Juárez pharmacies or in El Paso family planning clinics. This project will help researchers to learn about what women in the El Paso-Ciudad Juárez border region know about oral contraceptives, how they take their pills, and will provide useful information about whether the pill could be made available over-the-counter in the U.S.
What will be done if you take part in this research study?
We will interview you in your home (or any place that is convenient for you) about what you know about the pill, the types of contraceptives you have used in the past and are using now, and some questions regarding your medical history for a total of four (4) times: first right away (within the next week or so) and then once every three months for nine months. At any time, you may refuse to answer any questions that you don’t want to answer. You may also choose to stop your participation in this study at any time.
What are the possible discomforts and risks?
There are no known physical risks associated with your participation in this study. You may feel discomfort answering questions about your medical history or your experiences using the pill. Although we cannot provide medical treatment, if you were to feel mental stress as you tell us about your experiences, the following facilities in El Paso could help you:
Centro de Salud Familiar La Fe, Inc. Thomason General Hospital
608 South Saint Vrain St., El Paso, TX 79901 4815 Alameda Avenue, El Paso, TX 79905
Phone number: 534-7979 Phone number: 544-1200
If you wish to discuss the information above or any other risks you may experience, you may ask questions now or any of the people listed on the top of this form to discuss your concerns.
What are the possible benefits to you or to others?
You may benefit from the opportunity to talk about your experiences. Also, you may benefit from the knowledge that you are contributing to a better understanding of the use of contraceptives among women in the border region.
If you choose to take part in this study, will it cost you anything?
It will not cost you anything to participate in this study.
Will you receive compensation for your participation in this study?
You will receive a gift card worth $20 for the first interview, $10 for each of the phone interviews, and $35 for the last interview, for a total of $75 if you participate in all four interviews.
What if you are injured because of the study?
Although the risks to participants in this study are minimal, some respondents may experience discomfort when they talk to the interviewer about their medical or contraceptive history. In those cases, unfortunately, we will not be able to provide medical treatment or pay for such treatment.
If you do not want to take part in this study, what other options are available to you?
Participation in this study is entirely voluntary. You are free to refuse to be in the study, and your refusal will not influence current or future relationships with The University of Texas at Austin, The University of Texas at El Paso or Ibis Reproductive Health.
How can you withdraw from this research study and who should you call if you have questions?
If you wish to stop your participation in this research study for any reason, you may do so at any time without penalty or loss of benefits for which you may be entitled. Throughout the study, the researchers will notify you of new information that may become available and that might affect your decision to remain in the study.
In addition, if you have questions about your rights as a research participant, please contact Lisa Leiden, Ph.D., Chair, The University of Texas at Austin Institutional Review Board for the Protection of Human Subjects, (512) 232-4383.
How will your privacy and the confidentiality of your research records be protected?
We will collect your name and address in order to contact you for an interview in your home (or place you choose). Once you have read and signed this consent form, the last page containing your name and contact information will be detached from the rest of the form and be kept in a locked file cabinet accessible only by the field coordinator and the researchers. Your contact information will only be given, as needed, to your assigned interviewer just prior to your interview, so that the interviewer can make arrangements to meet with you. After we have completed the last interview with you, the information sheet with your name and address will be destroyed. At all times, your responses to interview questions will only be identified by a number. Your name or other personal information will not be anywhere on the interview forms. The key that links your name with the number on the forms will be kept in a locked file cabinet accessible only by the field coordinator and the researchers.
Authorized persons from The University of Texas at Austin and the Institutional Review Board have the legal right to review your research records and will protect the confidentiality of those records to the extent permitted by law. If the research project is sponsored, then the sponsor also has the legal right to review your research records. Otherwise, your research records will not be released without your consent unless required by law or a court order.
If the results of this research are published or presented at scientific meetings, your identity will not be disclosed.
Will the researchers benefit from your participation in this study?
The results from this study will help researchers understand some of the reasons women purchase their pills where they do, and how they experience the pill. The results will provide helpful information about whether the pill should be made available over-the-counter in the U.S.