Institutional Review Boards (IRBs)
A set of Federal regulations known as the
“Common Rule” protects people who participate
in federally funded research.
The regulations require that a committee review
and approve a study before allowing people
to enroll in the research.
This video explains the role of these committees,
which are called institutional review boards
— or IRBs.
What is an IRB?
An IRB is a committee that reviews research studies
to make sure that they follow ethical standards
and regulations for research with people.
In addition to the Common Rule, there are
regulations to protect people who may need
more protection, such as prisoners and children.
When a research study involves human participants,
researchers submit the proposed study
to an IRB for review.
The IRB looks at many different aspects of
the study to make sure it meets the requirements
for protecting those people.
If it doesn’t, the IRB will not approve it
until the necessary changes are made.
IRB review does not always happen at the
institution doing the research.
Many institutions have their own IRBs
that review the research they conduct,
but they could also use a commercial IRB .
or an IRB from another institution
Who is on an IRB?
IRBs must have at least five members
with various backgrounds who can provide different
perspectives on the research.
Those members must include at least one who is not
connected to the institution doing the research,
and one who is not a scientist.
Each IRB must have members who can review the
specific types of research it oversees
and members who know the community
where the research takes place.
Researchers who serve as IRB members
cannot review their own research projects.
This helps the IRB make sure its review
is independent and free from other interests.
What does an IRB do?
An IRB reviews proposed research to check
and see that participants will be protected according to
ethical standards and regulatory requirements.
Except for some research that is very low risk,
an important role of the IRB is to verify that:
potential participants have the information they need
to make a decision about volunteering for the study;
they can understand the study,
including information about risks; and
they are free to choose whether or not to participate.
Much of this is done through the
informed consent process.
This is when researchers provide important
and relevant information to potential volunteers
so that they can decide whether to join the study.
In the case of some very low risk research,
the IRB may not require informed consent.
When this happens, the IRB still reviews the research
to make sure that participants are
protected even in the absence of informed consent.
The IRB also makes sure that the research
is not unnecessarily risky,
and checks that other protections for
participants are in place,
including protections for privacy and confidentiality.
The IRB can approve a study when these,
and other, requirements are met.
After the study starts, the IRB makes sure
that participants remain protected
according to the approved research plan.
IRBs play an important role in protecting
research participants,
but others share the responsibility as well.
Researchers, institutions, sponsors,
and even volunteers themselves
each play an important part.
Does all research require IRB review?
Not all research studies require IRB review.
For example, the Common Rule does not require
IRB review for studies with samples that are
left over from blood tests, as long as the
researchers don’t know who the samples came from.
This is because there is little risk to the
privacy and confidentiality of the patients,
and the patients do not have to do anything
since the samples are leftovers
that would otherwise go to waste.
There are also regulations that researchers
might follow instead of the Common Rule.
For example, the Food and Drug Administration (FDA)
has regulations for developing
and testing drugs and other products.
These also include protections
for research participants.
In addition, it is possible that a research study
might not fall under any of the Federal regulations.
An example is research funded by private money
from nonprofits or corporations
that is not regulated by FDA.
Who can address a research volunteer’s
concerns about protections?
If you have questions about a research study you
volunteered for, you can ask the research
team for more information.
But if you have concerns about how you,
as a a volunteer, are being protected,
or if something doesn’t seem right,
you can also contact the IRB.
The IRB’s job is to make sure the study meets
the ethical standards and Federal requirements
for research with humans,
and that the researcher is doing the study
in the way the IRB approved.
The IRB’s contact information should be on the consent
form you received when you initially joined the study.
To learn more about
participating in research studies, visit
www.hhs.gov/About-Research-Participation.