This is a research study. The information on this page will explain the study to you.
Please take your time time to make your decision about whether you want to participate in this study. You may discuss your decision with your family and friends and with any doctors or nurses. If you have any questions, you may contact the research team.
You are being asked if you want to take part in this study because you are getting a medication abortion online through a telehealth company.
Why is this study being done?
Ushma Upadhyay, PhD, is doing a research study. The study is trying to understand the experiences of people who get medication abortion care through a telehealth company.
This study is paid for by a few private foundations. These foundations include Tara Health Foundation, the Kahle/Austin Foundation, the Preston Werner Foundation, the Amalgamated Charitable Foundation, the BASE Family Fund, and two anonymous private donors.
How many people will be in this study?
Up to 3,000 people from several states including California, New York, and Washington will take part in this study.
What will happen if I take part in this research study?
If you participate in this study, you will complete 3 online surveys through the online telehealth website or app where you are getting your abortion care. You can complete these surveys from home or where you choose on a computer or smartphone with an internet connection. You will spend about 35 minutes over a period of 4-5 weeks in this study.
- Survey 1 (about 20 minutes): Today, after you give your consent to be in the study, you will take the 1st survey. You will answer questions about yourself, your medical history, your pregnancy, and the reasons why you chose to have a medication abortion online. We will ask you to provide contact information so the researchers can contact you about Survey 2. If you are in California, we will ask about your student status at public universities.
- Survey 2 (about 5 minutes): Within a week after you receive the package with your abortion pills, you will be asked to take the 2nd survey. You will answer questions about your experience taking your abortion pills, symptoms you experienced after you took the pills, and any other medical care you had.
- Survey 3 (about 10 minutes): 4 weeks after you receive the package with your abortion pills, you will be asked to take the 3rd survey. You will answer questions about how satisfied you were having a medication abortion online and any medical care you had since you completed the last survey. After you complete the last survey, we will send you a $50 cash card as a thank you for your time.
If you participate in the study, we will also use information you provide to your telehealth abortion provider to understand your experiences. We will ask you for contact information (your name, e-mail, and cell-phone number), and contact information for someone we can contact if we are not able to reach you. We will only contact you or this person directly if you do not complete the surveys from the links you are sent by text or e-mail after 5 reminders, to ask for information from any health facility or hospital where you get care related to your abortion.
Additionally, we may invite you to participate in an optional follow-up phone interview about the medication abortion pills. This optional interview will be recorded for research purposes only and only the researchers will hear the recording.
Can I stop being in the study?
Yes, you can decide to stop being in the study at any time. You do not have complete the surveys if you change your mind, even if you are in the middle of answering questions.
What other choices do I have if I do not take part in this study?
You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you and you will not lose any of your regular benefits.
Whether or not you complete these surveys will not affect your care. You can still get your abortion care with the telehealth company if you choose not to complete or participate in the study.
Are there any risks to me or my privacy?
Some of the survey questions may make you feel uncomfortable or raise unpleasant memories. You are free to skip any question.
No study can guarantee complete confidentiality, however, we have taken special precautions and we will do our best to protect the information we collect from you. Information that identifies you will be kept secure. The survey itself will not include details that directly identify you, such as your name or address. Please do not put this information on your survey. The completed surveys will be kept secure and separate from information that identifies you. Only a small number of researchers will have direct access to completed surveys. If this study is published or presented at scientific meetings, names and other information that might identify you will not be used.
Are there benefits to taking part in the study?
Although there is no direct benefit to you for participating in the study, the information you provide will help researchers, doctors, and nurses learn about the experiences of people who get abortion care abortion care online. This information may help other women and people in the future get medication abortion in a more convenient way.
How will information about me be kept confidential?
Being in a study can sometimes make you lose some privacy. We will do our best to make sure that information about you is kept private, but we cannot guarantee total privacy. Your name and other personal information will never be used when results of the study are presented at meetings or published in papers.
We have taken special care to protect your privacy. However, it is possible that someone else could learn that you are in this study if they see any communication you had about the study in your email or phone. Representatives and staff from the University of California may see information about you. These staff may see the information because they are monitoring the conduct of this study.
If you report in the surveys that you are having thoughts about suicide, we will inform your clinician who may be required to involve appropriate authorities.
If you under 18 years of age: If you report in the surveys that you have experienced abuse, such as child abuse, we will inform your clinician who may report it to Child Protective Services. CPS exists to help young people who are experiencing violence get the help they need. If a CPS or suicide report is made, your family might be contacted.
To help us protect your privacy, the research team has a Certificate of Confidentiality from the National Institutes of Health. Having this Certificate, means the researchers cannot be forced to share information about you, even if a court asks for it (by a court subpoena), in any government-related (federal, state, or local civil, criminal, administrative, legislative) proceedings.
Exceptions: You should know that a Certificate of Confidentiality does not mean you or a member of your family cannot share information about yourself or your involvement in this research. The Certificate of Confidentiality will not be used to prevent sharing to state or local authorities of child abuse or plans to hurt yourself or others. If an insurer, medical care provider, or other person gets your written consent to receive research information, then the researchers will not use the Certificate to keep from sharing that information. Finally, the Certificate may not be used to keep information from the federal government needed for reviewing federally funded projects or information needed by the FDA.
How will my information be used?
Researchers will use your information to conduct this study. Once the study is done using your information, we may share it with other researchers so they can use it for other studies 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.
Are there any costs to me for taking part in this study?
There are no costs to you to participate in this study. The study will not cover the cost of your abortion, or the costs of any additional tests or treatments related to your abortion.
Will I be paid for taking part in this study?
You will get $50 after completing the 3rd survey at the end of being in the study (4 weeks after your receive your abortion pills in the mail). The $50 payment will be in the form of a $50 cash card. Online cash cards will be website links sent by email or text message to the email address or phone number you provide.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose to take part or not to take part in the study. If you decide to take part, you may leave the study at any time. No matter what decision you make, there will be no penalty to you. Leaving the study will not affect your medical care. You can still get your abortion care with the telehealth company if you choose not to participate
in the study.
Who can answer my questions about the study?
- You can talk to the study Principal Investigator, Dr. Ushma Upadhyay about any questions concerns, or complaints you have about this study. You may contact Dr. Ushma Upadhyay at (510) 986-8946.
- If you want to ask questions about the study 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 study, please call the office of the Institutional Review Board at 415-476-1814.
You will be asked to sign a digital copy of this consent form after speaking with the telehealth clinician. You can download copies to keep.
You will be asked to sign a separate form authorizing access, use, creation or disclosure of health information about you.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to refuse to be in this study or to stop being in it at any point without penalty or loss of benefits.