Why participate in research?
Research studies can help us learn more about different diseases and conditions. For example, we have studied:
• How a pregnant woman’s environment and diet affect her pregnancy
• How cancer treatments affect fertility
• Different ways to help women who have PCOS get pregnant
We also need to do research to make sure medications and medical devices are safe and they work. For example, we do studies to look at new versions of birth control products. We want to make sure they work and people can use them the right way.
People participate in these studies for different reasons. Many volunteers want to help others. For example, we have lots of volunteers who are healthy women who want to help doctors learn more about fertility so cancer survivors can have a better chance of starting their own families. Some volunteers are cancer survivors who know that doctors don’t understand a lot about their fertility yet, and they want to help doctors learn more. Other people are interested in learning more about their own health or fertility through the tests and doctor’s visits that are part of some studies.
There might be other benefits to participating in research. Depending on the study, you could get the medical product we are studying for free (like the vaginal ring). You could have access to certain medical tests free of cost (like STD testing or Pap smears). If the study doctors or nurses find anything abnormal in these tests, they will tell you about it so you can see your doctor. Many studies compensate for time and travel too.
We need a wide range of volunteers of all races and ethnicities, to make sure that the information we learn can be applied to everybody. One reason to participate in research is to help make sure that the information we learn from a study is applicable to a wide range of people.
What are my rights?
YOU HAVE THE RIGHT TO:
1. Know About the Study
You have the right to be informed about the study before you decide whether you wish to participate. Here are some of the things you should know before enrolling:
• What is the question the research study is hoping to answer?
• What are the risks and benefits of participating?
• What are the procedures involved in the research and what will you be expected to do?
• What should you do if you experience a serious side effect?
• Will you receive anything for taking part? Will there be costs involved in participating?
• How long you will be in the study and are there are reasons why it might stop early?
• Who will have access to your information and what will be done to protect your privacy?
You have the right to a copy of the informed consent form.
2. Not Join or Stop Any Time
Participating in research is completely voluntary. You do not have to participate and you have the right to stop participating even if you have already started. You have the right to refuse to answer questions you are not comfortable answering.
You must talk to the research coordinator about your wish to stop so that she can help you withdraw from the study safely and get information about why you don’t want to be in the study anymore. This is very important information for us because we want to do everything we can to make sure our participants have a good experience.
3. Know Who Is Doing the Research
You have the right to know who is conducting and paying for the research. You should be provided with a phone number for the person in charge of the study (the PI).
4. Know Who You Can Call with Concerns
If you have a question, concern or complaint about your participation in a research study at Penn, you have the right to call the University of Pennsylvania Office of Regulatory Affairs, the group responsible for making sure your rights are respected, at 215-898-2614.
What are my responsibilities?
YOU ARE RESPONSIBLE FOR:
1. Your Decision to Participate
You are responsible for asking questions about the research and taking the time to make a careful decision about whether it is right for you. If you aren’t comfortable or you don’t really have time, you should not enroll.
2. Doing What You Agreed to Do
You are responsible for faithfully doing what you have agreed to do, for example, using the medicine or device as we ask you to or filling out diaries. This is the point of being in the study.
3. Telling Us About Problems
You are responsible for telling us about how you are doing with the study and if you are experiencing any side effects or other unrelated health issues. Contact your coordinator as soon as possible if you are worried or something affects your ability to participate.
4. Being Honest
You are responsible for giving us honest answers and information.
Some of the information we ask for is to protect your safety, to make sure you are not involved in a study that might put you at more risk or experiencing something during a study that is abnormal. Some of the information we ask is to protect the safety of others who will benefit from the results of the research. We need to make sure the people in the study are very similar to the people who we are trying to help with the research. If you don’t end up qualifying for a study because of your answers, it’s not the right study for you but there may be another one in the future that could be.
The purpose of the research is to answer a question and you are our partner in finding that answer. If you don’t give us accurate information, the answer we find is not likely to be completely right. If there is something you don’t feel comfortable telling us, please let us know. We know that some of the questions we ask in women’s health are very personal. We promise to do everything we can to make sure your information stays private.
5. Telling Us You Want to Withdraw
If you decide you don’t want to participate any more, you are responsible for telling the research coordinator or doctor.
Failure to come to appointments or return phone calls or emails will not necessarily withdraw you from a study. We may continue trying to reach you until you tell us you don’t wish to be involved anymore. Please let us know if you wish to end your participation!
6. Showing Up
You are responsible for coming to your appointments on time or calling or emailing in advance to reschedule.