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The decision to participate in a research study should be made
after careful consideration of the risks, benefits, and
alternatives, and should involve input from a variety of sources
including friends, family members, and health care providers. The
following questions are meant to serve as a guide to help with this
decision-making process. Note that most of these questions are
relevant to clinical trials of medications as opposed to survey or
services research. Many of the questions also do not apply to
studies that involve routine testing procedures that are conducted
for the purpose of evaluating the causes and consequences of mental
illness.
What is the purpose of the
study?
You should have a clear understanding of what questions are
being addressed and how the information will be used to better
understand or treat the illness or symptoms under
investigation.
What are the risks?
- Are painful or uncomfortable procedures included in the
research study?
What are the known risks involved using treatments or procedures in
this protocol?
- What are possible risks based upon what is known in the
scientific and medical literature?
- Are there any known long-term or irreversible risks?
- If new information becomes available during the course of the
study concerning additional risks, how will I be informed of this
information?
- Who will be responsible for my care if I suffer an adverse
consequence as a result of participation in this study?
- If I suffer adverse consequences from the study participation,
what are my legal rights?
Will I have to stop my current
treatment (particularly medications)?
- If so, for how long?
- Will the medication be tapered or abruptly discontinued?
- How will I be cared for if my symptoms worsen?
- Who will make the decision and on what criteria will a decision
be made to stop the medication-free period (or experimental
treatment or placebo) and provide rescue medications or treatment?
(i.e., under what circumstances will my clinical condition take
priority over the experimental protocol?)
- What efforts will be made to ensure that I do not feel worse at
the time my study participation is terminated?
- What is the likelihood that I will respond equivalently to a
medication after being off of it for some period of time?
Is there a possibility that I
will be given a placebo?
- If yes, what is the likelihood that I will receive a placebo
(100%; 50%; 25%)?
- Will I have an opportunity to receive active treatment after
the completion of the study if such treatment appears
promising?
- If I suffer a relapse during this period, will the placebo
period be terminated?
- (As above, who will make that decision and on what
criteria?)
Is the study being conducted as
a single- or double-blind procedure?
- Will I know what treatment I am receiving during the
study?
- Will the researchers or staff know what treatment I am
receiving?
- If not, who will have this information in case my symptoms
worsen and I require assistance?
- When will I be informed about my treatment?
What follow-up care can I
expect when my participation in the study terminates (even if this
occurs before the trial is completed)?
- Will medication or treatment be reinstated prior to my being
discharged from the protocol?
- Will the investigators help coordinate my follow-up care?
- Will I be able to receive the study treatment if it appears to
be beneficial to my condition?
How will this affect my daily
life?
- How will the research protocol differ from my current
treatment?
- What is the time commitment required for my participation in
this study?
- Will I be compensated for my time?
- Will I be provided transportation to and from the study
site?
- Is daycare available?
- What criteria will be used to exclude or terminate me from the
study?
Will I have to be hospitalized
as part of the study?
- If so, for how long?
- Will there be recreational, educational and/or vocational
opportunities available during this period?
- Will there be any restrictions on visitors?
- Will it be possible to obtain a pass to leave the hospital
grounds?
What are the benefits I can
expect to receive from participation in this study?
- Are there any direct benefits to me?
- If not, how will this research contribute to a better
understanding or treatment of my disorder?
- Will I be informed about the results of this study? If so,
when?
How will informed consent be
assured?
- What safeguards are taken to ensure that I comprehend the
important aspects of the study (e.g., readability of consent
documents, videotapes, tests of comprehension, someone not
associated with the study to answer my questions)?
- What is the time frame that I have to decide?
- Will someone not associated with the research be available to
assist in my decision-making?
- If my condition worsens during the course of the study and my
decision-making capacity becomes impaired, how will my informed
consent to continue be assured?
What information will I be
given about the research personnel?
- Who will be a contact person for me or my family should any
problems arise (24 hours/7 days a week)?
- What are the researchers� credentials and/or experience in
conducting clinical trials?
Are there any conflicts of
interest for the personnel associated with this
research?
- Who is funding this research project?
- Are there financial or any other conflicts of interest for the
researchers with regard to this study?
- Is the researcher paid only when a participant completes a
clinical trial?
- Does the researcher or the institution have a significant
financial involvement with the trial sponsor?
Will my medical information be
kept confidential?
- Who will have access to my medical records?
- How will confidentiality be assured?
Will a sample of my DNA be
collected?
- What are the planned and potential uses of my DNA sample?
- How will you ensure confidentiality of the information
obtained?
- Will I be informed of the results?
- If there are unexpected findings that may affect my health
status will I be informed of these results?
- Will my relatives also be contacted to provide DNA samples? If
so, how will my health status be kept confidential?
- If unexpected personal information is obtained as a result of a
DNA analysis, will this information be revealed to me or the other
parties involved?
- If any patented information is derived from my DNA, will I be
entitled to financial compensation? (In general, the answer to this
is no.)
RIGHTS OF ALL RESEARCH
PARTICIPANTS
You have the right
to:
- withdraw from the study AT ANY TIME without consequence.
- provide advance directives for treatment or research prior to
participation in the study, which are to be followed by the
research staff.
- confidentiality of all medical records unless otherwise
specified in the consent form.
- be informed of alternatives to participation in the research
study.
- be informed of any new information that becomes available
during the course of the study that might affect continued study
participation (e.g., changes in the risk associated with the
research).
Prepared for the National Mental Health Association Annual
Conference (June, 2001) by:
E. Anne Riley, Ph.D., Research Associate, Clinical Brain Disorders
Branch/NIMH
Shannon Flynn, Research Assistant, Clinical Brain Disorders
Branch/NIMH
Susan R.B. Weiss, Ph.D., Senior Director, Research, National Mental
Health Association
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