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Do
I need IRB, IEC or REB approval?
You must obtain approval of your research plan and protocol
from each Institutional Review Board (IRB ), Institutional
Ethics Committee (IEC) or Research Ethics Board (REB), at
which the research will be conducted, before any subjects
can be enrolled in the study. (The term IRB will be
used to describe these committees in this tutorial.) The
purpose of the review is to:
- Ensure that human subjects will be protected in your
study.
- Evaluate risks versus benefits.
- Ensure equitable subject selection.
- Ensure proper administration of informed consent process.
- Ensure protection of privacy and confidentiality.
- Ensure protection of subjects from coercion.
You must contact your institution to determine which documents
to submit for review. Most IRBs require that you submit
the protocol, consent forms and any forms of advertisement
or patient education. You may be asked to send data
collection forms, surveys or questionnaires and institution-specific
paperwork, as well. The board or committee will meet
to discuss your research and may approve your research plan,
may require modifications or disapprove the research.
Once your protocol (which includes your data monitoring
plan) and consent forms are approved by your IRB, copies
must be sent to your Program
Director for review.
If you are planning to use a clinical trial website to advertise
for or enroll participants, you may need to obtain IRB approval
for this also. For details, read Guidance
on Institutional Review Board Review of Clinical Trial Websites from
OHRP.
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