Questions and Answers
for Research Participants
Before you decide to participate
in a research study, you should
discuss the research with study
personnel. If you do not understand
the answers to the questions
shown below, be sure to ask
the researchers for clarification.
You may also want to consult
with a family member or close
friend before making a decision.
Frequently
Asked Questions for Research
Participants
What is research?
"Research" means a systematic investigation designed
to develop or contribute to generalizable knowledge. Activities that
meet this definition constitute "research" for the purposes
of the regulations that guide and govern how research is conducted
in the United States, whether or not they are supported or funded
under a program which is considered research for other purposes.
For example, some "demonstration" and "service" programs
may include research activities. It may be important to understand
the following about research:
- It is basically a study that is done to answer a question.
- Scientists do research because they don’t know for sure
what works best or to better understand why or how things happen
.
- Some other words that describe research are clinical trial,
protocol, survey, or experiment.
- Research is not the same as treatment.
Who participates in research studies?
Anyone can participate in a research study. Some
studies will ask that participants meet certain criteria:
such as being an adult or a child, male or female; having
a specific condition or experience; or, belonging to an
identified group of people, such as a specific ethnic,
cultural, or social group.
How do I get involved in a research study?
There are many ways to find out about research
studies. Information and links to additional resources
are included on the UW Human Subjects Division web site
in the section For
Participants. If you have a specific interest, such
as a certain disease, condition, or topic, the internet
is a tremendous resource. Many college and university departments
will also list studies that are going on and how to participate
on their departmental web sites.
Once you find a study in which you might want to participate,
follow their instructions for how to participate. As you proceed
toward involvement, as lots of questions about the study and what
participation might mean for you.
What are some good questions to ask before
deciding to participate?
- Where will the research take place? How do I get there?
- How long will it last? How much of my time will it take?
- What exactly will happen to me in the research?
- What are the potential risks? How likely are they to occur?
- Is participating in the study likely to benefit me? Will the
study benefit others?
- Are there other options – such as alternative procedures
or treatments besides the ones being studied? How do the alternatives
compare with this study?
- How will my privacy be protected? Can anyone find out that
I am participating in this study?
- Will I have to pay for any of the study procedures or treatments?
If so, how much? Will my insurance pay?
- When I am in the study, will the researchers work with my
regular caregiver or doctor or teacher?
- What if I am harmed by the study?
- Will I be paid for participating in the study? What if I drop
out of the study before it’s over?
- Whom do I call if I have questions or problems?
If I’m
a student, do I have to participate if it’s
a class or program requirement?
No (and yes) . . .
Does research involve special risks?
Before the study begins, the researchers attempt
to reduce any risk of physical or psychological discomfort
or harm to you and others who take part in the study. Yet,
for research to be absolutely "risk-free," every
possible outcome would have to be known-and if it were,
the research would not be necessary. The amount or level
of risk will vary from one study to another. It is important
to ask the researcher and/or research staff about the specific
risks in an individual study and to think carefully about
what the risk described would potentially mean for you.
What protection exists for research subjects?
Many "checkpoints" ensure that research
meets strict scientific guidelines for safety and ethical
conduct and follows rules to protect the participants.
Several groups who are not part of the research team examine
the scientific plan and the study procedures to protect
the interests of participants. This must be done before
an investigator may begin the research. For example, each
proposed study, including the steps to be taken for the
protection of human subjects and its consent form, must
be approved by the Institutional Review Board (IRB). Every
organization that conducts research with human subjects,
for example, a university or hospital, must have an IRB.
As a research participant, you also may stop participating
in a study at any time, bring concerns to the researcher
and research staff, or bring to the IRB issues of safety
and/or ethics.
What is an "IRB" and who are its members?
An Institutional Review Board (IRB) is the group
or committee that is given the responsibility by an institution
to review that institution’s research projects involving
human participants. The primary purpose of the IRB review
is to assure that the safety, rights, and welfare of the
human participants are protected.
Each committee is constructed so as to comply with Federal regulations
about IRBs. Follow this link to more
information about member composition.
What is informed consent?
Federal regulations have been created to protect
the well-being and rights of those who volunteer for research.
Basically, the regulations state that no investigator may
involve anyone in research without first obtaining the
person’s consent (agreement) to participate, with
full information about what the research involves. This “informed
consent,” is obtained either directly from the potential
research participant or - if the person is not competent
or is younger than a certain age - from the person's legal
guardian or representative.
Informed consent is the participant's agreement to be in a study
after being fully informed about what participating will involve.
Informed consent begins with a discussion between the researchers
and the prospective participants. The discussion includes important
information about the research study such as:
- The purpose of the study
- The procedures involved
- The risks of participating in the study
- The benefits of participating in the study
- How long the study will last
- How the participant's confidentiality will be protected
- What will happen if the study causes harm to the participants
- That participation is voluntary
- That participants are free to withdraw from the study at any
time.
Based on this discussion with the researcher, participants are
asked to sign a consent form that includes this same important
information in writing. Prospective study participants can take
the consent form home to discuss it with family and friends before
signing it. Once the form is signed, participants are given a copy
of the signed consent form so that they can review it at any time.
Participants should feel free to ask the researchers questions
before, during, and after the study. Informed consent is an ongoing
process.
Will my participation in research be
kept private?
Yes, researchers are required to keep all information
confidential. One way of protecting participants is by
assigning identification numbers so that names do not appear
on any forms. Only staff directly related to the study
should have access to the information. It is mandatory
for researchers to ask for the participants' permission
if they want to use any part of the information for other
purposes, such as education or training.
There is an important exception to the confidentiality rules
described above. In the case of children, the law requires researchers
to report if they suspect a child has been subjected to physical
or sexual abuse or neglect. This requirement applies to all settings
that deal with children, such as schools, doctors, or hospitals.
What happens if I have an emergency?
A person who has an emergency during a study should immediately notify the treating
doctor and/or available research staff. Personal care should always be available,
even when the emergency may not be related to the treatment being given.
What if I want to stop participating in the study?
You are free to stop participating in a research study or to “withdraw” at
any time and for any reason. Your withdrawal will not affect other services you
may be getting or are entitled to in the institution. If possible, you should
talk with the research staff (investigators) about why you wish to stop participating – as
this will help them to better understand what you have experienced and the reason/s
for you decision.
Will I be told the results of the research?
You may always ask to be informed of the results of the study you participated
in. These results sum up the responses of everyone who took part in the study.
Sometimes the results of the study are published. In some instances, researchers
routinely share what is learned from the study with participants. The researcher
may discuss with you any results that relate to your diagnosis or that may be
useful in deciding on the best treatment for you – but, this is not always
the case and depends upon the individual study. Keep in mind that oftentimes
it takes years before the results of a study are available. This is because of
the time it takes to conduct the study, including getting enough people in the
study to make the results meaningful.
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