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Before entering into any clinical trial, it is extremely important that one understands
his or her rights as a trial volunteer and also the risks involved in clinical trials.*
Only treatments having acceptable safety profiles and showing the most promise are
then moved into clinical trials, otherwise known as clinical studies. Still, the
exploratory nature of scientific research means there is inherent uncertainty in all
research studies. The best way to make a decision on entering a trial is to be
fully informed about the process and procedure of clinical trials
(see our Steps in Research page).
Risks involved in Clinical Trials
Clinical trials often offer new, experimental treatments for serious diseases.
Frequently, people are attracted to them because they feel that they have exhausted all
existing treatments. While clinical trials may provide their participants with amazing
results and effective treatment, one must always enter them with the understanding that
side effects may occur and also that clinical trials often do not promise long-term care
for those with chronic diseases.
David Banks, an United States Food and Drug Administration (U.S. FDA) Pharmacist warns of
clinical trials that, “People lured by compensation may overlook the known risks. Or they
may fail to adequately appreciate the potential for discovery of serious new side effects
during clinical testing of a new treatment.” Still, he adds, “clinical trials often represent
an option to seriously consider.
Before entering a clinical trial, always make sure you understand any known side effects,
and have them explained to you by the researchers. Also know that the researchers, are
required by law to inform you if any new side effect information should arise.
Agencies Responsible for your Protection
According to the U.S. FDA, most clinical trials are federally regulated and have built-in
safeguards. The Office for Human Research Protections (OHRP) in the Department of Health
and Human Services (HHS) is responsible for the protection of human research participants
and oversees human protection in HHS-funded research. The U.S. FDA has authority to oversee
any clinical trials for drug, biologic, and medical device products that go through the agency
before approval and marketing.
Another key group that protects clinical trial participants is the Institutional Review Board
(IRB). This is not a federal, or even a state agency, per se. These are small groups of people
who have jurisdiction over research institutions, namely hospitals and medical laboratories.
They must review clinical trial protocols, which are the researcher’s proposed steps for their
studies.
They also check the participant inclusion and exclusion requirements to make sure that
the correct people have been chosen for the trial; they often examine how people are recruited for
clinical trials. Finally, they also examine the researchers’ informed consent document (see below)
to make sure that it contains all information required by law and that it is at an appropriate
reading level for potential volunteers. If the IRB finds the risks of the study to be too great,
they will not approve the research, or will specify changes to be made before the study can be
conducted.
Informed Consent
The U.S. FDA requires the potential participants to be provided with complete information,
in writing, about the study. This is known as the “informed consent” document.
Participants invited to a trial are by no means obligated to participate, but can agree to do so
if they find the potential risks and benefits acceptable. The informed consent process gives
researchers and participants the opportunity to discuss the possible risks and benefits, and also
for the participant to ask questions about the procedure in the trials.
Participants always have the right to leave a study whenever they so choose. On the other hand,
participants should also understand that circumstances may arise in which their participation is
terminated, such as the discovery of dangerous side effects or lack of effectiveness of the product.
Below is a list of information that the FDA requires in the informed consent document:
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that the study involves research of an unproven drug, biologic(such as a vaccine,
blood product, or gene therapy), or medical device
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the purpose of the research
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how long the participant will be expected to participate in the study
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what will happen in the study and which parts of the study are experimental
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possible risks or discomforts to the participant
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possible benefits to the participant
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other procedures or treatments that might be advantageous to the participant instead
of the treatment being studied
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that the FDA may look at study records, but the records will be kept confidential
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whether any compensation and medical treatments, if any, are available if the
participant is injured. If such compensation and treatments are available, then the
document must say what those treatments are, where they can be found, and who will
pay for the treatment.
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the person to contact with questions about the study, about participants' rights, and
about what to do if the participant gets hurt
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that participation is voluntary and that participants can quit the study at any time
without penalty or loss of benefits to which they are otherwise entitled.
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