Page 7 - HFA Dateline 2022 Special Edition
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research. This group review serves an important role    setting, the first step to understanding is discovering
        in the protection of the rights and welfare of human    that a research study or clinical trial exists. Patients may
        research subjects. (The local IRB that approves the study   learn about the existence of a research project or clinical
        can provide more information about consent as it relates   trial via mail, telephone, through a friend or during an in-
        to children.)                                           person visit with a doctor.

        Research and Clinical Trials
        Consent works differently in a hospital setting versus a
        research/clinical trial setting. In the research/clinical trial

           Tips for Understanding Clinical Trials & Research Studies

           We cannot emphasize enough that participants, sometimes referred to as human subjects in a clinical research
           setting, should ask questions about their participation in a clinical trial or research study prior to signing up. Here are
           questions you should ask about a clinical trial or research study and the information you should glean from asking:

           WHAT SHOULD I ASK?                                  WHAT HAVE I LEARNED?

             Is a written copy of the research procedures available?     The purpose of the research.
             What are the benefits and risks of this research project?     The name, address and phone number of the
             How will I be informed if there are changes to     principal investigator, known as a PI.
             this project?                                       How long I am expected to participate.
             Am I waiving any of my rights by signing this      If any of the medications or procedures are
             consent form?                                       experimental.
             May I ask a person I trust to read this document?     The possible risks or discomforts.

             Will my name and address be kept confidential or will     If there are any alternative procedures or courses
             it be shared with others?                           of treatment.
             How will my information be stored to protect       If my information and medical records will be
             my privacy?                                         kept confidential.
             May I refuse to participate in this research project?     If I will be paid for my participation.
             What if I change my mind after I agree to participate?     The medical treatments available if I get injured.
             How do I withdraw my consent after I sign the form?     Who I can call if I have questions.
             If I withdraw my consent and stop participating,     If I am required to participate in this study.
             what will happen with the information already       If there is a penalty if I refuse to participate.
             collected from me?
                                                                 If there is a penalty if I stop participating at any time.
             Are there negative consequences if I withdraw
             my consent?
                                                               MORE THAN A SIGNATURE: Informed consent
             (In case of pharmaceutical trials) Will I be given the
             actual medication or a placebo?                   is about your understanding and willingness to
                                                               participate in a study, not about signing a form.
             (If English is not your first language) Is the
             information available in my preferred language?

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