🔍
How IRBs Protect Human Research Participants - YouTube
Channel: unknown
[4]
Institutional Review Boards (IRBs)
[11]
A set of Federal regulations known as the
[14]
“Common Rule” protects people who participate
[17]
in federally funded research.
[19]
The regulations require that a committee review
[22]
and approve a study before allowing people
[25]
to enroll in the research.
[27]
This video explains the role of these committees,
[30]
which are called institutional review boards
[33]
— or IRBs.
[37]
What is an IRB?
[40]
An IRB is a committee that reviews research studies
[44]
to make sure that they follow ethical standards
[46]
and regulations for research with people.
[50]
In addition to the Common Rule, there are
[52]
regulations to protect people who may need
[55]
more protection, such as prisoners and children.
[59]
When a research study involves human participants,
[63]
researchers submit the proposed study
[65]
to an IRB for review.
[67]
The IRB looks at many different aspects of
[70]
the study to make sure it meets the requirements
[72]
for protecting those people.
[75]
If it doesn’t, the IRB will not approve it
[78]
until the necessary changes are made.
[81]
IRB review does not always happen at the
[84]
institution doing the research.
[86]
Many institutions have their own IRBs
[89]
that review the research they conduct,
[91]
but they could also use a commercial IRB .
[94]
or an IRB from another institution
[100]
Who is on an IRB?
[103]
IRBs must have at least five members
[106]
with various backgrounds who can provide different
[109]
perspectives on the research.
[111]
Those members must include at least one who is not
[114]
connected to the institution doing the research,
[117]
and one who is not a scientist.
[120]
Each IRB must have members who can review the
[123]
specific types of research it oversees
[126]
and members who know the community
[128]
where the research takes place.
[131]
Researchers who serve as IRB members
[133]
cannot review their own research projects.
[136]
This helps the IRB make sure its review
[139]
is independent and free from other interests.
[144]
What does an IRB do?
[147]
An IRB reviews proposed research to check
[150]
and see that participants will be protected according to
[154]
ethical standards and regulatory requirements.
[158]
Except for some research that is very low risk,
[161]
an important role of the IRB is to verify that:
[165]
potential participants have the information they need
[169]
to make a decision about volunteering for the study;
[172]
they can understand the study,
[174]
including information about risks; and
[178]
they are free to choose whether or not to participate.
[181]
Much of this is done through the
[183]
informed consent process.
[185]
This is when researchers provide important
[188]
and relevant information to potential volunteers
[191]
so that they can decide whether to join the study.
[195]
In the case of some very low risk research,
[197]
the IRB may not require informed consent.
[201]
When this happens, the IRB still reviews the research
[205]
to make sure that participants are
[207]
protected even in the absence of informed consent.
[211]
The IRB also makes sure that the research
[214]
is not unnecessarily risky,
[217]
and checks that other protections for
[219]
participants are in place,
[221]
including protections for privacy and confidentiality.
[225]
The IRB can approve a study when these,
[228]
and other, requirements are met.
[230]
After the study starts, the IRB makes sure
[233]
that participants remain protected
[236]
according to the approved research plan.
[239]
IRBs play an important role in protecting
[242]
research participants,
[244]
but others share the responsibility as well.
[246]
Researchers, institutions, sponsors,
[249]
and even volunteers themselves
[252]
each play an important part.
[255]
Does all research require IRB review?
[260]
Not all research studies require IRB review.
[263]
For example, the Common Rule does not require
[266]
IRB review for studies with samples that are
[269]
left over from blood tests, as long as the
[272]
researchers don’t know who the samples came from.
[278]
This is because there is little risk to the
[279]
privacy and confidentiality of the patients,
[283]
and the patients do not have to do anything
[286]
since the samples are leftovers
[288]
that would otherwise go to waste.
[291]
There are also regulations that researchers
[293]
might follow instead of the Common Rule.
[296]
For example, the Food and Drug Administration (FDA)
[300]
has regulations for developing
[303]
and testing drugs and other products.
[306]
These also include protections
[308]
for research participants.
[310]
In addition, it is possible that a research study
[313]
might not fall under any of the Federal regulations.
[317]
An example is research funded by private money
[320]
from nonprofits or corporations
[323]
that is not regulated by FDA.
[327]
Who can address a research volunteer’s
[329]
concerns about protections?
[332]
If you have questions about a research study you
[335]
volunteered for, you can ask the research
[338]
team for more information.
[340]
But if you have concerns about how you,
[342]
as a a volunteer, are being protected,
[345]
or if something doesn’t seem right,
[347]
you can also contact the IRB.
[352]
The IRB’s job is to make sure the study meets
[356]
the ethical standards and Federal requirements
[358]
for research with humans,
[360]
and that the researcher is doing the study
[363]
in the way the IRB approved.
[365]
The IRB’s contact information should be on the consent
[369]
form you received when you initially joined the study.
[373]
To learn more about
[374]
participating in research studies, visit
[377]
www.hhs.gov/About-Research-Participation.
Most Recent Videos:
You can go back to the homepage right here: Homepage