About
Emory University fosters a Research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, Research conducted by or under the auspices of Emory University. Emory University is guided by applicable laws, regulations, and principles in its review and conduct of Human Subjects Research. To fulfill this mission, Emory University has established a Human Research Protection Program.
The mission of the Emory HRPP is:
- To safeguard and promote the dignity and well-being of participants in research conducted at or by Emory by assuring their rights, safety and welfare are protected;
- To provide timely and high-quality review and monitoring of human subjects research; and
- To facilitate excellence in human subjects research by providing accurate guidance and education to Emory investigators, IRB members, and research officials.
- To ensure compliance with all regulatory and ethical obligations involved in Human Subjects Research conducted at or by Emory.
The HRPP is a multi-tiered program involving the administration of the University, the Institutional Official, the Institutional Review Board, other research administration and compliance offices, investigators, and research support staff.
FWA, IRB Registration, and Part 11 Compliance
Emory University's Federalwide Assurance (FWA) number is 00005792.
Emory's Federalwide Assurance has been approved by the Office for Human Research Protections.
The current expiration date is November 18, 2029. You may also confirm our FWA status at NIH Search; search by our FWA number.
Please find here a copy of our FWA (PDF).
Here is a link to the "Terms of Assurance".
Emory's IORG #0000267
| Committee | Registration |
|---|---|
| Biomedical | 569 |
| Sociobehavioral | 453 |
Compliance and Registration Letter (PDF)
This letter describes the regulatory requirements under which the Emory IRB operates, and notes our FWA and IRB Registration information. (Previously, these were separated into two letters, but have been combined.)
A list of current Emory IRB Members, their committee appointments, and qualifications may be found on the Contact Us page.
eIRB and 21 CFR part 11 Compliance
The developer of Emory's eIRB system confirms that it "meets or exceeds the requirements in 21 CFR Part 11 (PDF) for “closed” systems by providing manageable name/password administration, strong passwords with rotation options and electronic signature components that are only executable by, and designed to be used only by, specified individuals for specific approval actions."
Governing Laws, Regulations and Principles
The Emory HRPP is established pursuant to and in accordance with the laws, regulations, and principles listed below regarding the protection of Human Subjects.
Emory University will adhere to these laws, regulations, and principles with regard to Research conducted by or under its auspices:
- The Department of Health and Human Services (HHS) policy and regulations at 45 CFR Part 46, also known as the Federal Policy for the Protection of Human Subjects or the "Common Rule" (collectively referred to in this document as the "HHS Regulations");
- Food and Drug Administration (FDA) regulations at 21 CFR Parts 51 and 56 (collectively referred to in this document as the "FDA Regulations");
- The principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (collectively referred to in this document as the "Belmont Report");
- The Department of Veterans Affairs policies for Human Subjects Research protection, including the regulations at 38 CFR Part 16 and the VHA Handbook Section 1200.05 (collectively referred to in this document as the "VA Regulations") for Research involving the Atlanta Veterans Administration Health Care System (AVAHCS) or Foundation for Atlanta Veterans Education and Research (FAVER);
- For projects conducted or supported by the DoD, any DOD Requirements.
- All other applicable federal, state and local laws and regulations.
Agreement to Abide by Principles and Regulations:
Emory University agrees to uphold the ethical principles of the Belmont Report and to abide by all requirements of the applicable HHS, FDA, DOD and VA Regulations. In this regard, Emory University has charged the Emory IRB with carrying out all responsibilities of a duly constituted Institutional Review Board as set forth in these governing regulations and principles. Emory University agrees to provide the Emory IRB with meeting space and sufficient staff and resources to support its review, oversight, record-keeping and other duties.