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The Manhattan Adult ADD Support Group
We Have Offered Support
& Information To Adults
In NYC
And The Surrounding Communities
With ADD/ADHD Since 1992
We Are Not
"Lazy, Crazy, Or Stupid" |
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About Clinical Trials |
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(For links to sites
for clinical trials, scroll down to the bottom of this page) |
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(From The NIMH:
http://www.nimh.nih.gov/publicat/clinres.cfm#clinres1) |
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1-866-615-6464 or E mail:
nimhinfo@nih.gov. |
Foreword
Through the ages, disorders of the mind have been among the most
devastating and feared illnesses of humanity. Today, thanks to
ambitious and productive research on mental illnesses and to the
willingness of many persons to participate in research, highly
effective treatments for mental illnesses exist. As a result of
these treatments, many thousands of persons who have brain diseases
such as depression, manic-depressive illness, schizophrenia, and
anxiety disorders lead fulfilling and productive lives.
Just as the pace of progress to date would not have been possible
without the participation in research of patients with mental
illness and other volunteers, neither will the advances of tomorrow
be realized without their continued participation. It is important
to note that just as research on treatments has evolved and become
more effective, so too has our society's attentiveness to the
well-being of research volunteers grown. Procedures now in place to
protect volunteers are more effective than ever before.
The National Institute of Mental Health (NIMH) recognizes the
Nation's debt of gratitude to research participants, and is striving
to maintain the trust that human subjects place in the excellence of
the research enterprise. Thus, we prepared this booklet to highlight
some of the questions a person may have in thinking about joining a
research study. We hope that by anticipating some questions and
helping persons better understand why they might consider
participating in mental illness research, all Americans will benefit
in the years ahead.
Steven E. Hyman, M.D.
Director
Introduction
In research on mental illness, as in other areas of medical science,
volunteers are all-important. Thanks in large part to their help,
clinical researchers are learning more and more about the causes of
mental disorders and are finding new and better treatments.
If you wonder whether to take part in a mental illness-related
research study, this booklet may help. (It also may be useful as you
help a family member or friend with this decision.) Anything you
decide will, of course, be personal and will depend upon your
interests, needs, and expectations about research. In coming to your
decision, you need to understand your rights as a research
volunteer. Because your rights and well-being as a subject in
research come first, this booklet will review the safeguards
designed to protect you.
You also should know how scientists study mental illness. Research
volunteers are not merely "subjects" of research, but actively take
part in the search for knowledge. When you do participate, you
deserve to understand a few of the most important requirements for
good clinical research.
We encourage you to review the information in this booklet and
discuss it with others whom you trust. The topics are in a
question-and-answer format. As you read, make notes of any
additional questions you have for the director of the research
project you are considering. We hope this will help you to get the
facts, raise your concerns knowledgeably, and decide then about
taking part in a research study.
Why Do Patients Participate in Research on Mental Disorders?
Although remarkable progress has been made in defining and treating
mental illnesses, some treatments are not effective for all persons
or may have significant side effects. Thus, most people who agree to
take part in studies of mental illness hope the research will
produce knowledge about the disease itself?for example, the role of
genetics in illness?or about treatments that will benefit them
directly.
Research may allow you to try a new treatment before it is widely
available. Even if the aim of a study is not to test the
effectiveness of a new treatment, the research may offer a degree of
care that you might not get otherwise. Such care may allow the
investigators to monitor your symptoms very closely to be sure of
your diagnosis.
Medical, psychological, and behavioral research are our best hope
for better understanding of and treatments for mental illnesses.
Although most who take part in research hope to benefit themselves,
they may also simply wish to help others, which is a reward in
itself.
What Is Mental Health Clinical Research?
Scientists study and try different ways to diagnose, treat, and
prevent human disease more effectively. The needed research may take
place in a basic science laboratory, a clinic, or in the community.
In mental health clinical research, the term "clinical" means that
the research involves persons in actual patient care settings. These
may be inpatient settings (for patients whose illness requires
hospitalization) and outpatient settings (for those who live in the
community).
Some clinical research may examine how well a new treatment
works?perhaps a drug or other type of therapy. In other instances, a
clinical study might explore factors that affect mental disorders.
These factors might include the role of genes and their interactions
with life experiences in ways that might alter the chemistry of the
brain and lead to illness.
In making your decision to participate in a research study, you
should discuss the purpose of the research with the study director.
Ask where the research will take place and how long it will last.
What does the research involve? What are the potential benefits of
participation? What are the risks? Does the research involve
treatment of your illness? You will probably have many other
questions for the researcher. Again, it may be helpful to write them
down.
In the search for new knowledge, both you and the researcher will be
trying out new things. If you do not know about the many safeguards
that exist to protect research subjects, you may overestimate the
risks of research. On the other hand, if you expect to receive only
the most advanced new treatments, you may become disappointed.
How Will Treatment in a Clinical Research Study Differ from
Treatment Your Own Doctor Provides?
Clinical research often involves providing treatment. Yet, treatment
research is different from the care that you would get from your own
doctor. Usually, when you go to a doctor, you want help with a
particular problem. You count on your doctor to do what is best for
you. You know that anything your doctor suggests is meant to make
you well.
A treatment research project, however, is different. The
investigator wants to learn about your illness, and not just treat
you. Of course, a researcher will try very hard to see that you
benefit from the treatment research and that any risk will be small.
Yet one goal remains the most important: learning how well a new
treatment works for someone with your illness.
In research, the design of a study may call for standardized
procedures. For instance, when a researcher studies a medicine, or
drug, the research plan may require that only the drug under study
be available to you. It may mean that you will receive it only in a
fixed dose; that is, the researcher cannot tailor the amount of a
medication to your immediate needs. Or, standardized procedures may
mean that you will receive a medication only in one specific way?for
example, by a shot or as a pill.
In such a study, or drug trial, the treatment you will receive
likely will be based on your random assignment to a particular
medication or, sometimes, to an inactive pill (a placebo). You
should be told what is known about the relative benefits and risks
of each treatment used in the research study. You should also be
told what is known about alternative treatments that might be given
outside a research project. In contrast, treatment outside of a
research study seldom uses random choice of treatment and never uses
a placebo; your doctor will always prescribe a treatment that he or
she believes would be good for you. However, situations remain where
no one may know what treatment is best, and that is one instance
where the importance of research is clear.
It should help to know that even investigational treatments are
well-tested for safety before their use in a clinical study. Also,
remember that you always can decide to withdraw from a study. You,
or someone close to you, should know whom to contact if you want to
do so at any time.
How Are Clinical Studies of Mental Disorders Designed?
Clinical researchers call the standard scientific approach for
trying out treatments a double-blind, randomized, controlled
clinical trial. Understanding this term, and knowing how and why
this approach is used, should help you to decide whether to become a
research volunteer.
An important part of scientific research is comparison. Clinical
research often will compare an investigational treatment to one that
is used frequently and thus has familiar, or predictable, effects.
To make the comparison useful, the investigator must try both
methods on similar groups of subjects.
Researchers call the treatment with the predictable or known effect
the control. The control may be a standard, commonly used treatment,
or it may be a placebo. A placebo is something that does not
directly affect the illness or symptoms under study in any specific
way. (You may have heard a placebo described as a "sugar pill.")
Some studies use both a standard treatment and a placebo as
controls.
The control helps an investigator find out if any changes seen in
patients in the experimental group are, in fact, due to the new
treatment.
The term randomized means how a researcher assigns each patient to a
particular treatment under study. Researchers assign patients by
chance either to a group taking the new treatment (called the
treatment group) or to a group taking a standard treatment or a
placebo (called the control group). This method, called
randomization, helps avoid bias: having the study's results affected
by human choices or other factors not related to the treatments
being tested. In some studies, researchers do not tell the patient
whether he or she is in the treatment or control group (called a
single-blind study). This approach is another way to avoid bias,
because when people know what drug they are taking, it might change
the way they react. For instance, patients who knew they were taking
the new treatment might expect it to work better and report hopeful
signs because they want to believe they are getting well. This could
bias the study by making the results look better than they really
were.
Random assignment helps to make sure that those in the group who
receive an investigational treatment are similar to those in the
group who receive the control treatment. By making certain that all
who take part are similar, random assignment helps a researcher to
make better conclusions.
The term double-blind in research design means that neither you nor
the researcher will know if you are assigned to the experimental or
to the control group. The aim is to avoid letting either the
investigator's hopes or expectations about a particular treatment or
your hopes and expectations influence the manner in which he or she
views improvements and side effects.
Your random assignment to a particular treatment group usually will
occur after the researcher decides that you can be in the study, and
after you agree to join the research by signing an informed consent
form. Informed consent, which is key to the successful conduct of
all clinical research, is discussed later in this pamphlet.
What Is a "Placebo Control" in a Medication Trial?
Studies of new drugs often compare the effects of an investigational
drug with the effects of a placebo. If you are considering whether
to take part in a drug trial, the director of the study must tell
you if the study will use a placebo control. The informed consent
form that you will sign if you agree to join the study must also
explain any plans to use a placebo control.
The reason for using a placebo control is that the benefits from
taking medications are not always due to the drug itself. These
benefits are called "placebo effects." An example is when an
investigator's enthusiasm about a new medication sometimes
influences the patient's response.
A researcher must be able to separate placebo effects from the
actual effects of the drug being studied. When equal numbers of
patients receive either a placebo or another standard drug that will
help treat their symptoms, the researcher can better judge the
actual effects of the drug being tested.
In a "double-blind, placebo-controlled" research design, the doctors
and nurses working directly with patients in the study will not know
which group patients are in. Only members of the research team not
involved in providing day-to-day clinical care will know which
patients are receiving an active treatment or a placebo. This
information is shared only when there is a medical necessity to do
so to protect the patient and at the end of the study.
Some scientists have questioned the use of placebo controls in
clinical research. They argue that if any drug is effective in
treating a given condition, then only that drug, and not a placebo,
should be given as the control. Other researchers, however, believe
that without a placebo control, it is harder to know whether an
investigational medication is better than existing drugs. The choice
depends on what is being studied, the medicine, and the illness.
If, during a study, an investigational drug seems to work very well,
the researcher may stop using the placebo. In some instances, as
discussed in a later section, participants may have a chance to use
the investigational drug after a study is completed.
It is important that the director of a medication trial explain
thoroughly any planned use of a placebo. Ask how the researcher
plans to keep track of your symptoms. Also, ask if there is a
possibility that your symptoms could become severe during the
research project. If your symptoms worsen, at what point will the
researcher decide to remove you from the study and provide standard
treatment? In talking about these possibilities with the researcher,
you must remember that participating in a study does not guarantee
that you will receive a promising new medication. Indeed, you must
consent to that fact. Also, you should remember that even if you
receive an investigational drug, it may not be helpful for you.
Remember you can always withdraw from a study.
What Is the Investigator's Responsibility if a Patient Has a
Clinical Crisis?
You read earlier about the differences between clinical research and
the care you receive from your personal doctor. In most research, an
investigator will try to follow the research design: Following a
research plan that has met all of the conditions described in the
next section of this pamphlet? conditions meant to ensure that any
proposed clinical research has scientific merit and is fully
attentive to participants' well-being? takes precedence over
"tailoring" treatments to a patient's unique needs. However, a
patient who becomes much worse during a study will be withdrawn from
the project and given immediate personal care, even though the
worsening may not be related to the treatment being given.
You and, if it is appropriate, your legally authorized
representative should discuss with the investigator the possibility
that your illness could worsen during the research study. Then you
can decide how to handle any emergencies that might arise during the
study.
Among the issues you may wish to discuss is how the researcher will
judge the nature and severity of your symptoms. Another issue could
be that, under certain conditions such as a medication washout or a
pharmacologic challenge, you might decide to reject all treatment.
If you are seriously ill, you might not recognize how dangerous that
decision could be. Thus, you should agree in advance on how to
handle this situation.
What Protections Exist for Research Subjects?
Many "checkpoints" ensure that research meets strict scientific
guidelines and follows rules that protect the subject. Several
groups who are not part of the research team examine both the
scientific plan and procedures to protect the interests of
participants before an investigator may begin the research.
Each proposed study, including its provisions for the protection of
human subjects and its consent form, must be approved by an
Institutional Review Board (IRB). Every organization that conducts
research, for example a university or hospital, must have an IRB.
The membership of these boards includes scientists, persons who are
not scientific experts, and at least one "public" member who is not
associated with the organization.
An important IRB responsibility is to review the informed consent
materials that an investigator develops for those who take part in
the study. This information allows the IRB and?more critically? you
to judge the value, risks, and potential benefits of a research
project. If an IRB has concerns about any part of the research
proposal, the committee will tell the director of the study. The
researcher must attend to these concerns before submitting the
research proposal to a funding agency.
A funding agency, such as the National Institute of Mental Health (NIMH),
provides the next review of human subject provisions for clinical
research proposals. The funding agency also judges the scientific
importance of a research proposal, and how the researcher will learn
from it. Both the IRB and the funding agency conduct regular reviews
to be sure that the researchers are meeting all the rules for the
protection of human subjects.
You can be certain that a range of persons, both scientists and
others, have reviewed any IRB-approved research that you may be
asked to join. Nonetheless, having a general understanding yourself
of how scientists conduct clinical research will help you feel more
confident when talking about the project with the research director.
Does Research Involve Special Risk?
Well before a clinical study begins, the researcher has attempted to
reduce any risk of physical discomfort or harm to you and others who
take part. The effort likely began with preclinical, or basic,
laboratory research that probably included animal studies, for
example, to test the safety of a new drug. Yet, for research to be
absolutely "risk-free," every possible outcome would have to be
known? and if it were, then the research would not be necessary.
In fact, various different causes or forms of discomfort could
result from a particular research study. A patient/subject may have
to take off from work, or pay for some of the treatment. These
requirements could be inconvenient or expensive. As you will see in
the next section describing informed consent, you will be told about
any foreseeable risks or discomforts that may occur in the research
before you agree to participate.
Naturally, the chance that there might be pain or harm worries most
people who are thinking about joining a clinical research project.
Some discomforts may be like what you are used to in routine health
care, such as a needle prick when blood is drawn for testing
purposes. However, sometimes a research design may call for more
uncomfortable procedures, procedures with known risks, or procedures
for which the risk may not be fully known. These could include, for
example, being deprived of sleep, receiving injections, having a
spinal tap, receiving a small dose of a radioactive substance needed
for a brain scan, or treatment with an investigational drug.
Remember, nothing is without risks, including illness itself, and
risks in clinical research are minimized as best as possible. Also
remember that the research plan is reviewed by an IRB to insure the
protection of people who participate in the research study, and any
known risks should be described in the consent form.
What Is Informed Consent?
Federal regulations have been created to protect the well-being and
rights of volunteers in biomedical research. These regulations
(Title 45 Code of Federal Regulations Part 46 or 45 CFR 46) say no
investigator may involve anyone as a subject in research without
getting that person's informed consent, either directly or from the
person's legal representative.
A researcher must ask you to sign a written informed consent form in
which you agree to take part in a certain study. The form contains a
description of the study, possible risks, and benefits of the
research.
The director of the research must prepare the form and an IRB must approve it. The researcher must then
go over this form with
you and get your permission to enter you into the study.
Having a mental disorder does not necessarily mean that a person
cannot understand and see the value and risks of taking part in
research. Most people, therefore, who enter research studies on
mental disorders can provide informed consent. Additional guidelines
and safeguards exist for patients who are not able to give their
permission with full understanding. In those cases consent is
obtained both from the participant and the legally authorized
representative.
Informed consent is not a one-time event, but a continuing process.
Throughout a study, the research team must continue to provide
information about participating in the study. They must respond to
any questions you have about the research and inform you if any new
risks are identified. You may, at any time, reappraise your decision
to take part in the project and withdraw your consent. It is
advisable to discuss any concerns with the director of the study.
Every informed consent form developed by an investigator and
submitted to an IRB for approval must include eight basic parts.
These parts are:
A statement that the study involves research and that tells what its
goals are, how long the research will last, and what methods will be
used.
A description of any reasonably foreseeable risks or discomforts you
could experience as a result of the research.
A description of any benefits that the research may be reasonably
expected to yield to you or to others.
A description of alternative courses of treatment, or therapies, if
any, which might help you.
A statement describing how the researcher will protect the
confidentiality, or privacy, of your medical records.
For research in which risk is somewhat more likely than you would
expect in routine health care, an explanation and description of the
availability of compensation or medical treatments if injury occurs.
The name and phone number of the person to contact about the
research and your rights, and whom to contact in case the research
causes an injury.
A statement that your taking part in the research is voluntary, and
that if you change your mind, or quit later on, you will not be
penalized in any way, or lose any benefits you have coming to you.
The informed consent process must include the following items when
they apply to you:
A statement that the particular treatment or method used may not
work as planned and may be risky for you.
The reasons why the investigator might have to drop you from the
study without asking you first.
A list of any extra charges you may have to pay to take part in the
research.
A description of what would happen if you decide to drop out of the
study, and what the researcher will
do to make sure you keep
receiving appropriate treatment if you do drop out.
A statement that you will be told of any important results of the
research which may help you to decide whether to continue taking
part in the study.
Approximately how many subjects are in the study.
Clinical researchers try to write informed consent forms that are
brief and understandable by people without scientific or medical
training. Even so, some informed consent forms appear long and
complicated. Thus, it is important that you are given the
opportunity to read the form thoroughly, perhaps discuss it with a
family member or a trusted friend, and raise any questions you have
with the investigator. We hope you will feel comfortable talking to
the investigator or other members of the research team and asking
questions until you are satisfied that you understand the informed
consent form.
Some investigators prepare additional material to help research
subjects understand the contents of an informed consent form. These
might include, for example, a videotape that describes the illness
under study, the research project, and the methods it will use.
There may be a short quiz you can take to help identify issues you
wish to discuss further with the researcher. You may be able to
complete such a quiz
at home at your convenience. If these ideas
sound useful, ask the director of the research if these or similar
items are available. You can ask for a copy of the protocol to take
home to discuss with family members, your physicians and others.
Involvement of Family Members and Others.
You may wish to involve family members in some parts of a research
study. For example, you might consult with a family member about
taking part in the study, or you may wish to look over this booklet
with a family member or close friend and discuss being a research
subject with that person. If you are a parent
or otherwise legally
authorized representative of someone who might be a research
subject, you may wish to involve other concerned family members in
any decision you make.
Many family members welcome the chance to make sure, along with the
research team, that no one will take advantage of you during the
study. This role is clear if a family member is a patient's formal
legally authorized representative; but even lacking such legal
status, families usually do all they can to protect
a family member
who is ill.
Remember that Federal regulations protect your right to privacy in
the handling of your records throughout (and following) a study. You
must give clear permission if you wish the researcher to share
personal information about you with family members. Still, you
should be aware that, with your consent, your family members or
other friends may have several opportunities to provide information
during the study.
Will You Have Access to Those Drugs That Work After a Trial Is
Complete?
Understandably, if an investigational drug helps you, you may wish
to continue to take it after the trial has been completed. In some
instances, a medication that is being investigated for use in
treating your illness may have been approved by the Food and Drug
Administration (FDA) for other uses. If you find that you benefit
from such a medication, your own doctor can prescribe it for you.
Often, the company developing a new drug may try to see that you can
continue to get it, even before the FDA has approved it for sale.
You may be able to do this under what is termed a compassionate plea
basis. This means that because the new drug has been so helpful, the
manufacturer can give it to a physician, who may then prescribe it
for you.
While companies often make such a new drug available, there may also
be good reasons why a company cannot. Perhaps only a very small
amount of a drug was prepared for the research project, and no more
is available for use afterwards. Then again, a manufacturer may want
to further test the drug under certain conditions, or to examine the
results of a research study more fully before releasing it for
compassionate plea use. A company would be especially careful if a
new medication required that the doctor who prescribed it have some
special knowledge or skill to monitor its safe use.
You and any family members interested in your well-being should
discuss with the director of the research your questions about
compassionate plea use. Each case is different, so the agreement has
to be between the drug manufacturer and your own doctor.
Obtaining Care After a Research Project Has Ended;
If you decide to take part in a research study? and, especially one
that takes place in a hospital? you may find that you will have to
stop, or interrupt, the care you now are getting for a mental
disorder. Doing that, even temporarily, may result in your losing
access to a program of personal care that had been expensive and
hard to come by. The director of research on your study often will
help you to get back into a program of care when the study is
finished. The investigator's institution may assist in arranging for
follow-up care.
Learning About the Results of Research;
In most informed consent forms, the researcher promises to share
what is learned from the study with you. These results will sum up
the responses of everyone who took part in the study. In addition,
the researcher will discuss with you any results that relate to your
diagnosis or that may be useful in deciding on the best treatment
for your disorder.
Be sure to ask the director of research when you can expect to hear
about the results. Ask how you will get this information. Will the
researcher write an article describing the study, or will those who
took part be invited to a meeting with the study director when all
the results are in? If you have questions about the results when you
receive them, ask the researcher who can help you to understand what
they mean.
A frustrating thing about research is that it often 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. Be patient, but
remember to ask for the results if you have not received them when
you expected them.
Checklist of Questions
So you have been asked to take part in a research study! This can be
a very satisfying experience, allowing you to help yourself now and
to help others in the future. After all, without research, treatment
cannot improve, and without those who take part, there would be no
research! You are the one who makes research possible.
But how do you know if you want to take part? What questions should
you ask? The researcher should answer these basic questions clearly
for you. Others undoubtedly will arise during the discussion.
Q: Why do you want me in your study?
Q: What is the research about? How will this research help in
treating or understanding my disorder?
Q: What do I need to do and how much time will this take?
Q: How might this study help me, my relatives, or other people with
my disorder?
Q: What possible risks are there to me or my relatives if I take
part?
Q: How will this be different from the care I am getting now, and do
I have other options or choices?
Q: Could my illness become worse during the study? What will happen
if it does?
Q: What will happen to me at the end of the study?
Q: What should I do if I want to drop out of the study?
Q: May I get back to you after I discuss this with my
family/friend/case manager/doctor?
Remember to ask again if you do not understand the explanation to
any question you have. And, if you forget the answers to these
questions during the study, just ask them again.
NIH Publication No. 4379
NIMH publications are in the public domain and may be reproduced or
copied without the permission from the Institute (NIMH). NIMH
encourages you to reproduce them and use them in your efforts to
improve public health. Citation of the National Institute of Mental
Health as a source is appreciated. However,
using government
materials inappropriately can raise legal or ethical concerns, so we
ask you to use these guidelines:
NIMH does not endorse or recommend any commercial products,
processes, or services, and publications may not be used for
advertising or endorsement purposes.
NIMH does not provide specific medical advice or treatment
recommendations or referrals; these materials may not be used in a
manner that has the appearance of such information.
NIMH requests that non-Federal organizations not alter publications
in a way that will jeopardize the integrity and "brand" when using
publications.
Addition of Non-Federal Government logos and website links may not
have the appearance of NIMH endorsement of any specific commercial
products or services or medical treatments or services.
If you have questions regarding these guidelines and use of NIMH
publications, please contact the NIMH Information Center at
1-866-615-6464 or E mail:
nimhinfo@nih.gov. |
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| LEARNING ABOUT TRIALS
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| A commercial site that lists clinical trials:
www.centerwatch.com |
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| A government site listing clinical trials and offering a guide to
participating:
www.clinicaltrials.gov |
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| A government site listing clinical trials and offering a guide to
participating:
www.nci.nih.gov/clinicaltrials/understanding |
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A trade group's Web site offering a guide to participating in
clinical trials:
www.acrpnet.org/resources/trial/questions.html |
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