Knowledge about human studies or clinical trials you must know
1. What is “Clinical Trials”?
In the history of medical development clinical studies have been
crucially important because they establish the therapeutic effects of
new treatments so medical services can advance. Clinical studies
can be roughly classified into 2 categories: clinical trials and clinical
research. Clinical trials refer to the cases in which human subjects
receive new therapies or take new drugs to test their effects on the
treatment of the disease. Clinical research refers to the cases in
which specimens of blood, biopsies, etc. donated by healthy or sick
people are observed to obtain more information about various
diseases. Most of the specimens are from residual blood samples or
biopsies performed for treatment, so the risks are limited and
donators will not suffer from extra injury. However, the human
subjects of clinical trials run higher risks because the therapeutic
effects and complications of the new drugs or therapies are
unknown.
2. I am not sure whether I should participate in the clinical study.
Before you decide to participate in any clinical studies, be sure
that the study has been approved by the IRB of the hospital and
the Ministry of Health and Welfare. If after the introduction and
answer of all your questions of the clinical study you still can not
decide whether you want to participate in the study or not, it is
suggested that you wait until there is absolutely no doubt about
the study.
3. Is there any danger in participating in clinical trials? Will I be treated
as an experimental rat?
It is for sure that there are risks for the human subjects of clinical
trials. A trial refers to unknown results and complications. However,
a clinical trial will not be conducted before being approved by the
IRB of the hospital and the Ministry of Health and Welfare. When
the trial is undergoing it is regularly supervised and managed by
the IRB to make that the trial is conducted in accordance with the
reviewed proposal, and that the human subject’s rights are
protected. Therefore, the human subjects of clinical trials will not be
treated as experimental rats.
In addition, participation in a clinical trial is on a voluntary basis.
The research team will inform the subjects of related information,
and the subjects can withdraw from the trial at any time without
any influence on the treatment. If the subjects have any doubts or
complaint, they can respond to the IRB or the Ministry of Health
and Welfare.
4. What should I know before I participate in a clinical trial?
Participation in a clinical trial is on a voluntary basis, so one
should know in advance the following things:
(1) What’s the purpose of the trial?
You should know what the purpose of the trial is, and what kind
of knowledge is being targeted. The research team should
inform the subjects in a understandable manner of the above
information, and what other options the subjects have for
reatment if they decide not to participate in the trial.
(2) What will happen in the trial?
You should know what you will go through and how you
should adjust (for instance, how much blood will be drawn from
your body for what purpose, how often will you go back for follow
up), which might affect your daily life, such as not being able to
drive, the need to use contraceptive methods, etc..
(3) What are the possible side effects?
A trial always involves risks, so be sure to clarify what side-
effects might happen at what percentage in the known data, and
what measures to take, whom to go for help, who will provide
treatment at what cost, etc. should these side effects happen,
before you decide to participate the trial.
(4) Will participation in the trial do me any good or is there any
benefit?
Participation in a clinical trial is not mandatory, and it is not
necessarily beneficial for the participant. However, the results
might serve as reference for the subject and patients with the same
problem and help patients in the future. It is suggested that the
subject does not be over-optimistic about the result of the trial.
(5)Are there any other treatment alternatives if the patient does not
participate in a clinical trial?
The clinical trial is a chance to test new treatment, but it is not
mandatory, so the patient needs to know other alternatives for
treatment.
5. By signing the Informed Consent as a participant of a clinical trial,
have I given up my legal rights?
The fifth Article of the Human Subject Research Act, enacted in
Taiwan in 2012, stipulates that before the investigator can conduct
a human study a proposal should be submitted for review and
approval by the IRB (institutional review board). Therefore each
medical center in Taiwan has established an IRB to review clinical
studies and protect the rights of the human subjects.
Signed Informed Consents are required for the research team of
any clinical trials. Before the human subject of the trial signs the
consent, the research staff should inform the subject, in compliance
with the Declaration of Helsinki, of the following information: the
research purpose, methods, source of fund, possible conflict of
interest, employer of the research team, expected benefits, possible
complications and risks of the trial, etc. Only when the consent
form is signed on a voluntary basis with the subject fully informed
of the above information can justice be achieved for the human
subject.
According to the related laws in Taiwan, in any written
information provided to the human subject there should be no
requirement for the subject / legal agent / legal guardian to waive
the rights of the subject, or relieve the investigator/ research
institute/ contract research organization or its sponsor of their
liability. Any terms against this rule are invalid. So the human
subject’s rights will not be affected by signing this Informed
Consent Form.
6. Can I participate in the clinical trial without signing the Informed
Consent Form?
No. The Informed Consent Form is the most important tool to
ensure that the research team has fully informed the human subject
of related information and protect his/her rights. The Informed
Consent Form is not a contract but an evidence that the research
team has obtained the human subject’s consent before
conducting the study.
The human subject’s name will not appear in the clinical trial
except for the Informed Consent Form, so the research staff has the
responsibility to safeguard this Form. Should the human subject’s
data be disclosed, the research staff is liable for legal
responsibilities.
Signed Informed Consent Forms protect the human subjects for
their rights to be informed as well as the research team for
demonstrating their ethical conduct of the clinical trial. Therefore,
signing an Informed Consent Form is an indispensible procedure
of participation in a clinical trial.
7. Can I withdraw from a clinical trial after I joint it?
Yes. It is usually stated clearly in an Informed Consent Form that
"the human subject can withdraw any time from the clinical trial
without causing bad feelings or making any difference in the
medical care.” There is no need to provide any reason for
withdrawing from a clinical trial, and if there is any doubts or
unpleasant feelings the subject can respond to the IRB or the
Ministry of Health and Welfare.
8. Do I need to pay for participating in a clinical trial? Is there any
financial assistance?
According to Article 11 of the “Regulations on Human Trials”,
medical institutes can not charge human subjects any fees for
participating in clinical trials. Because the trials are not established
therapies so there is no need to pay for them.
However, travelling fees may arise due to medical visits to the
hospital for the clinical trials, and extra blood may be drawn for the
study purpose, so the participant may ask in advance if there is any
financial assistance to cover the transportation fee or fee for dietary
supplements.
9. What are my rights as a participant of clinical trials? Where can I
find details of liabilities, indemnity or compensation in case of
injuries?
Clinical trials are necessary to prom ote medical advances. A
human subject decides to participate in a clinical trial after being
fully informed and on a voluntary basis, while his/her rights to
receive regular medical care will not be affected. The following
information is what a participant should know:
A. The participation in a clinical trial is on a voluntary basis. You do
not have to participate in it, and you can withdraw from it at any
time after you decide to quit. This will not have any impact on
the relationship between you and your doctor (the investigator)
and you will be continued to be taken care of.
B. You may ask questions regarding the trial at any time, and the
investigator will answer them honestly in details. Your safety
and welfare will be the top concerns and the investigator will
reduce the risks and discomfort as much as possible.
C. Your personal data will be highly respected and kept
confidential.
D. You will own all rights which you own now without losing any of
them due to participation in a clinical trial.
E. You will be treated with respect and dignity throughout the time
you participate in the trial.
F. Details of liabilities, indemnity or compensation in case of
injuries will be stated in the Informed Consent.
10. Can I participate in two clinical trials at the same time or
consecutively?
If the clinical trials involve filling out questionnaires, using
residual biopsy specimens after medical treatment, drawing a
small amount of blood, or using your excretion or hair samples
for examination, that is allowable. But if your blood needs to be
drawn twice or more times within one week, I would suggest that
you postpone participation of the second or third clinical trial, or
discuss it with your doctor to clarify the issue.
If the clinical trial you participate in involves new drug, new
therapeutic technique, new medical materials or invasive
procedures, it is suggested that you do not participate in another
trial at the same time or within 3 months after the end of the
present trial to ensure your safety, unless the investigator of both
trials understand your condition and, after evaluation, consider
that participation of the second trial will not harm your health.
11. If I feel uncomfortable physically or mentally after participating in
a clinical trial, who should I go for help?
If the clinical trial you participate in only takes residual samples,
or draw a limited amount of blood, or use your excretion or hair for
study, this will not cause any obvious physical discomfort.
However, if you feel uncomfortable you may talk to the research
staff. They will address the issues which might have bothered you.
After that, if you still feel uncomfortable, you may contact the
research team and withdraw from the study.
If the clinical trial you participate in involves new drugs, new
therapeutic techniques, new medical materials or invasive
procedures, there are uncertain risks and it is suggested that you
consider this carefully before participating in the trial. After
participation in the study, if you feel uncomfortable physically or
mentally, you may contact the research team for further
management. If you feel seriously uncomfortable physically, please
go to the hospital for emergency medical care after informing the
contact of the research team.
12. If I visit another doctor for medical care after I participate in the
clinical trial, do I need to tell him/her about it?
If the clinical trial you participate in involves new drugs, new
therapeutic techniques, new medical materials or invasive
procedures, there maybe restrictions on using specific drugs or
receiving specific medical treatments to ensure your safety and the
accuracy of research data. These restrictions are listed in the
Informed Consent Form. If you seek medical help from non-
research-team doctors, please inform them of the restrictions or
put the restrictions on a card and show them the card to ensure
your safety and health.
13. May I take Chinese medicine, herb medicine, dietary supplements
or receive alternative therapies after I participate in a clinical study?
If the clinical trial you participate in involves new drugs, new
therapeutic techniques or new medical materials, please ask the
research team what kind of Chinese medicine, herb medicine,
dietary supplement or alternative therapy you want to take or
receive, and take or receive them only after the research team
make sure that this will not affect your safety and the accuracy of
the research data.
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Reference:
1. Tsai Fu-Chang, Should I participate in a clinical trial? National
Research Program for Biopharmaceutical
2. Human Subject Protection Manual, Ministry of Health and Welfare