Emory University's Institutional Review Board (IRB) is responsible for reviewing research proposals to ensure that they meet the ethical standards for conducting research involving human subjects. The IRB is composed of faculty members, staff, and community representatives who are trained to review research protocols and provide guidance to researchers. The primary goal of the IRB is to protect the rights and welfare of human subjects participating in research studies.
Overview of the IRB Review Process
The IRB review process at Emory University involves several steps. First, researchers submit their proposals to the IRB, which includes a detailed description of the research study, the methods used to collect data, and the procedures for obtaining informed consent from participants. The IRB then reviews the proposal to ensure that it meets the federal regulations and guidelines for conducting research involving human subjects. The IRB review process typically takes several weeks to several months, depending on the complexity of the study and the level of review required.
Levels of IRB Review
There are three levels of IRB review at Emory University: exempt, expedited, and full board review. Exempt review is for studies that involve minimal risk to participants, such as surveys or secondary data analysis. Expedited review is for studies that involve more than minimal risk, but do not require full board review, such as studies that involve collecting biological samples or using existing datasets. Full board review is required for studies that involve more than minimal risk, such as clinical trials or studies that involve vulnerable populations.
The following are the specific categories for each level of review:
| Level of Review | Description |
|---|---|
| Exempt | Studies that involve minimal risk to participants, such as surveys or secondary data analysis |
| Expedited | Studies that involve more than minimal risk, but do not require full board review, such as studies that involve collecting biological samples or using existing datasets |
| Full Board | Studies that involve more than minimal risk, such as clinical trials or studies that involve vulnerable populations |
IRB Requirements for Researchers
Researchers at Emory University are required to complete several steps before submitting their proposals to the IRB. First, they must complete the CITI Program, which is an online training program that provides education on human subjects research and the IRB review process. Researchers must also obtain informed consent from participants, which involves providing participants with information about the study, the risks and benefits, and their rights as participants. Additionally, researchers must ensure that their studies are conducted in accordance with the Belmont Report, which provides the ethical principles for conducting research involving human subjects.
IRB Forms and Templates
Emory University provides several forms and templates to help researchers navigate the IRB review process. The IRB Application Form is used to submit proposals to the IRB, and the Informed Consent Template is used to create informed consent documents for participants. Researchers can also use the Protocol Template to create a detailed description of their study, including the methods, procedures, and risks and benefits.
The following are the specific forms and templates available:
- IRB Application Form
- Informed Consent Template
- Protocol Template
- Consent Form Template
- Assent Form Template
What is the purpose of the IRB review process?
+The purpose of the IRB review process is to ensure that research studies involving human subjects are conducted in an ethical and responsible manner, with the primary goal of protecting the rights and welfare of participants.
What are the different levels of IRB review?
+There are three levels of IRB review: exempt, expedited, and full board review. The level of review required depends on the type of study and the level of risk involved.
What is informed consent, and why is it required?
+Informed consent is the process of providing participants with information about the study, the risks and benefits, and their rights as participants. It is required to ensure that participants understand the study and can make an informed decision about whether to participate.
