Page 11 - HFA Dateline 2020-2021 Special Issue

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? my consent?
• Is a written copy of the research procedures • (In case of pharmaceutical trials) Will I be given
available? the actual medication or a placebo?
• What are the benefits and risks of this research • (If English is not your first language) Is the
project? information available in my preferred language?
• How will I be informed if there are changes to WHAT HAVE I LEARNED?
this project?
• Am I waiving any of my rights by signing this • The purpose of the research.
consent form? • The name, address and phone number of the
• May I ask a person I trust to read this Principal Investigator.
document? • How long I am expected to participate.
• Will my name and address be kept confidential • If any of the medications or procedures are
or will it be shared with others? experimental.
• How will my information be stored to protect • The possible risks or discomforts.
my privacy? • If there are any alternative procedures or
• May I refuse to participate in this research courses of treatment.
project? • If my information and medical records will be
• What if I change my mind after I agree to kept confidential.
participate? • If I will be paid for my participation.
• How do I withdraw my consent after I sign the • The medical treatments available if I get injured.
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
• Are there negative consequences if I withdraw time.
More than a signature: Informed consent is about your understanding
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and willingness to participate in a study, not about signing a form.