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