RWE 101 – What is the Difference Between an IRB and a REC?
RWE 101 – What is the Difference Between an IRB and a REC?
An Institutional Review Board (IRB) and a Research Ethics Committee (REC) are two different types of bodies that are responsible for ensuring that research involving human subjects is conducted in an ethical and responsible manner. While the terms are often used interchangeably, there are some differences between an IRB and a REC.
In the United States, an IRB is a committee that is established by an institution, such as a university or hospital, to review and approve research protocols that involve human subjects. The IRB is responsible for ensuring that the study is designed and conducted in an ethical manner, that the risks to participants are minimized, and that the potential benefits of the study outweigh any potential harms. The IRB also monitors ongoing studies to ensure that they continue to meet ethical and safety standards.
In other countries, such as the United Kingdom, a Research Ethics Committee (REC) may have a similar role to an IRB. RECs are independent committees that review research proposals to ensure that they meet ethical and legal requirements, and that they are designed in a way that respects the rights and welfare of human participants. RECs may also provide ongoing monitoring and review of ongoing studies.
While there are some differences in the way that IRBs and RECs are structured and operate, their overall purpose is the same: to ensure that research involving human subjects is conducted in an ethical and responsible manner. Both IRBs and RECs may require researchers to submit detailed study protocols and obtain informed consent from study participants, and both may monitor ongoing studies to ensure that they continue to meet ethical and safety standards.
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RWE 101 – Do I Need IRB Approval for My Observational Study?
RWE 101 – Do I Need IRB Approval for My Observational Study?
In general, observational studies that involve human subjects require Institutional Review Board (IRB) approval to ensure that the study is conducted in an ethical manner and that the rights and welfare of study participants are protected. This applies to both clinical trials and observational studies, including those using real-world evidence (RWE).
IRB approval is required because observational studies may involve the collection of personal or sensitive information from study participants, or the implementation of interventions or procedures that may pose risks to participants. IRBs review study protocols to ensure that the study design is scientifically sound, that the risks to participants are minimized, and that the potential benefits of the study outweigh any potential harms.
However, there are some exceptions to this requirement for IRB approval. For example, if the RWE study uses de-identified data and does not involve any interventions or interactions with human subjects, IRB approval may not be required. Additionally, certain types of RWE studies may be exempt from IRB review under certain circumstances, such as studies that use existing data and do not involve the collection of new data from human subjects.
It is important to note that the specific requirements for IRB approval may vary by country or region, and by the specific study design and research question. Therefore, it is important to consult with local regulations and guidelines, as well as with an IRB or ethics committee, to determine whether IRB approval is required for a specific observational study using RWE.
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