The Food and Drug Administration (FDA) has just posted FDA 101: Clinical Trials and Institutional
Review Boards (IRBs). The full article appears below. This may be in response to a congressional
investigation by the Government Accountability Office (GAO). A fake medical study for a fake
product was created to see if for-profit IRBs adequately supervise and protect human subjects in
Congress has raised concerns over whether IRBs routinely approve medical
studies for paying clients and are considering whether to introduce a bill to strengthen IRB
Coast IRB LLC of Colorado Springs, CO approved a fake study involving a fake
adhesive drug to be used in surgery called Adhesiabloc. Two of Coast's competitor IRBs refused to
approve the Adhesiabloc study.
Coast reviewed 356 study protocols over a five-year period
and rejected only one. Since 2004, the company's revenue has more than doubled, to $9.3 million in
The ethics of clinical trials is intricate and IRBs are only one of many parts of
trials that can be ethically compromised.
FDA 101: Clinical Trials and Institutional
Clinical trials test potential treatments in human volunteers to see
whether they should be approved for wider use in the general population. A treatment could be a
drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential
treatments are studied in laboratory animals first to determine potential toxicity before they can
be tried in people. Treatments having acceptable safety profiles and showing the most promise may
then be considered for use in clinical trials. It is not known whether a potential new medical
treatment offers benefit to patients until clinical research on that treatment is complete.
Clinical trials are an integral part of new product discovery and development, and are generally
required by the Food and Drug Administration (FDA) before a new product can be brought to the
How Are People Protected?
FDA has authority over clinical trials for drug,
biologic, and medical device products regulated by the agency. This authority includes studies that
are funded by the U.S. Department of Health and Human Services (with joint oversight by FDA and the
Office for Human Research Protections), as well as studies that are solely funded by industry or by
Clinical trial procedures are reviewed by institutional review boards
(IRBs). These boards are composed of at least five members that include scientists, doctors, and
lay people. They review and approve clinical trials taking place within their jurisdiction before
the trials can begin.
The purpose of an IRB review is to ensure that appropriate steps are
taken to protect the rights and welfare of participants as subjects of research. If the risks to
participants are found to be too great, the IRB will not approve the research, or it will specify
changes that must be made before the research can be done.
As part of their review, IRBs
consider participant inclusion and exclusion requirements to be sure that appropriate people have
been identified as eligible for the trial. They often look at how and where recruitment for
clinical trials will occur. IRBs review the adequacy of the informed consent document to ensure
that it includes all the elements required by law, and that it is at an appropriate reading level
and understandable to study participants.
To help protect the rights and welfare of
volunteers and verify the quality and integrity of data submitted for review, FDA performs
inspections of clinical trial study sites and anyone involved in the research.
play important roles in looking out for the safety of research subjects. These groups include FDA,
other government agencies, and institutional review boards. There is also monitoring of studies by
industry or private sponsors, as well as oversight and reporting by investigators and their
What Are the Risks?
Clinical trials should be carefully designed to answer
certain research questions. A trial plan called a protocol maps out what study procedures will be
done, by whom, and why. Products are often tested to see how they compare to standard treatments or
to no treatment. FDA often provides extensive technical input to researchers conducting clinical
trials, which may help them design better trials that can characterize effects of a new product
more efficiently, while reducing risks to those participating in the trials.
trial team includes doctors and nurses, as well as other health care professionals. This team
checks the health of the potential participant at the beginning of the trial and assesses whether
that person is eligible to participate. Those found to be eligible--and who agree to
participate--are given specific instructions, and then monitored and carefully assessed during the
trial. Some treatments being studied can have unpleasant, or even serious, side effects. Often
these are temporary and end when the treatment is stopped. Others, however, can be permanent. Some
side effects appear during treatment, and others may not show up until after the study is over.
The risks may vary depending on the treatment being studied and the health of the people
participating in the trial. All known risks must be fully explained by the researchers before the
trial begins. If new risk information becomes available during the trial, participants must be
FDA is committed to protecting the participants of clinical trials, as well as
helping to ensure that reliable information is provided to those interested in participating.
Although efforts are made to minimize risks to clinical trial participants, some risk may be
unavoidable because of the uncertainty inherent in clinical research involving new medical
products. It's important, therefore, that people make their decision to participate in a clinical
trial only after they have a full understanding of the entire process and the risks that may be
What Is Informed Consent?
FDA requires that potential participants be given
appropriate information about the study to enable them to decide whether to enroll in the clinical
trial. This process is known as "informed consent," and it must be in writing.
informed consent process provides an opportunity for the researcher and patient to exchange
information and ask questions. Patients invited to enter a trial are not obligated to join, but can
consent to participate if they find the potential risks and benefits acceptable. A consent form must
be signed by the participant prior to enrollment and before any study procedures can be
Participants also have the right to leave a study at any time. At the same time,
people need to know that circumstances may arise under which their participation may be terminated
by the researcher, without their consent.
For example, sometimes it becomes evident early on
that a trial is not working and researchers know they are not going to get enough meaningful
information to make continuation worthwhile.
This article appears on FDA's Consumer Health
Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated
products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
Clinical Trials: Interactive Tutorial
Good Clinical Practice in FDA-Regulated Clinical Trials
National Institutes of Health
Posted: April 14, 2009
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