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What
happens at a study appointment? Are other couples there too?
Study appointments are private appointments where you and/or your
partner meet with a Research Assistant. No other people are present.
At the visit, the Research Assistant will give you additional information
about the study and answer any questions you have. If you decide
to join the study, you will read and sign a consent form that details
the risks and benefits of study participation. You will also answer
some personal questions about your background, medical history,
and sexual history. Your answers to these questions will be kept
private, even from your partner. The Research Assistant will also
explain to you how to use the study method and how to complete any
questionnaires or diary forms you will be taking home. You will
receive the study products to test at home. And you will discuss
how to keep in touch with us over the course of your participation.
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Is
information about me kept confidential?
Our participants' privacy is of utmost importance to us. All study
appointments take place in the private offices of a professional
office building or clinic. Participants' identities are kept a secret.
The information we collect is marked with study identification numbers,
not names. With our participants' help, we work out a way to leave
them messages discreetly. When the results of the research are published,
participants' names are never shown.
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Do
we have to be married to participate?
You do not need to be married to participate in any of our studies.
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How
flexible are the appointment times? Are you open on weekends?
We try to offer as many different appointment days and times as
possible. We have appointment times as early as 8:30 am and as late
as 8:30 pm Monday through Thursday, and we're also open until 6:00
pm on Fridays. Unfortunately we do not offer Friday evening or weekend
appointments.
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Do
I have to have a physical exam to be in the study?
For most studies, there is no requirement for any type of physical
examination. In some studies, exams are offered as an added benefit
of participation, and are available to those participants who want
them. There are occasionally studies where examinations are required,
but if this is the case, the study description will give all the
details.
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Can
we do our interviews over the phone?
Our studies almost always involve in-person meetings with participants.
Some studies involve a preliminary face-to-face meeting but allow
some follow-up interviews to be done by phone. We feel that in-person
meetings allow us to get the best possible feedback from our participants.
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Do
both partners have to come to the appointments?
Some studies require that both partners come in for study appointments.
Other studies require only one partner, and still other studies
require that one partner come for all the visits and the other comes
for only the first and last visit. When you call us to get more
information about a particular study, we'll explain to you what
visits are required for that study.
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Have
these new methods been studied before?
Before a new method is tested by people, it first undergoes a series
of laboratory and animal tests. Once the method passes these tests,
then it is tested by people to make sure it is safe and acceptable
to use. After preliminary safety testing, further human tests are
done to look at how well the method works. These may be performance
tests, where couples who are not at risk of pregnancy use them and
report on performance (they report things like condom breaks or
slips). Often, after all these tests have been successfully completed,
couples who are at risk of pregnancy will use the method for birth
control to see how well it prevents pregnancy. We do all these different
types of human studies, including safety studies, performance studies,
and pregnancy prevention studies. When you call to ask us about
a particular study, we'll be happy to tell you about all the earlier
testing that has been done on that method.
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What
if I / my partner become(s) pregnant while participating?
Some of our studies involve using a new method for birth control.
No method is 100% effective, and the methods we are studying may
be more or less effective than other methods couples are using.
If a woman becomes pregnant during one of our studies, we will pay
for a visit to one of our clinic sites, where the woman can receive
pregnancy testing and referral information. We are not responsible
for any other pregnancy-related expenses.
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What
if we join a study and we don't like the method we are given?
Any person who joins a study may leave the study at any time for
any reason. You do not have to stay in the study if you do not wish
to- we just ask you to let us know why you want to stop. If people
don't like a method we are studying, we want to know! This is important
information for us to collect.
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