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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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