Do I need IRB, IEC or REB approval?
You must obtain approval of your research plan and protocol
from each Institutional Review Board ( IRB
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 Official (PO)
Clinical TrialWebsites from OHRP
A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I
Phase I Clinical Trial, Phase II
testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II Clinical Trial, Phase III
study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
Phase III, Phase III(as defined by NIH)
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
Phase III(as defined by NIH), Phase IV
is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
Phase IV Clinical Trial)
studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.
Office for Human Research Protections (OHRP).
HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage.
Page Last Updated: February 2011