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 clinical
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 regulations.
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
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 2008.
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 Review
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 market.
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 private
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
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
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.
Many groups 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 staff.
What Are the Risks?
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.
The clinical 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 informed.
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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