What is necessary when I am working with human subjects in research, including data and bio-specimens?

Emory Institutional Review Board (IRB) facilitates ethically responsible human subjects research by assuring the rights and welfare of study participants.

Phone:     (404) 712-0720

Toll Free: (877) 503-9797

Fax:          (404)727-1358

Email:       IRB@emory.edu (link sends e-mail)

Website:  http://www.irb.edu

  Staff Directory

 

The IRB Office is open for visitors from 10:00 – 3:00 each day (except Mondays, open at 10:30).  To ensure that someone will be available to meet with you, call or email before stopping by (irb@emory.edu, or (404) 712-0720.  Times outside above hours can be arranged by appointment.
Add: RAS, IRB

If your research project meets the regulatory definition of “human subjects research”, you are required to obtain approval from the Institutional Review Board (IRB).

 

If you are unsure whether your project needs IRB review, access the Request Determination of IRB Review form to expeditiously submit information about your project to the IRB.  After receiving the information, the IRB will email a determination about whether your project should be submitted in eIRB for further review.

 

If you think that your project is indeed research involving human subjects or a clinical investigation, you can go ahead and submit your project in the eIRB system for IRB review. 

Upon conducting its preliminary review the IRB will confirm that it meets the definition and the review will move forward.  

a.     Review the IRB New Submission Guidance

b.     Learn about Emory’s web-based IRB application and review system called eIRB

c.      Review the general guidance on submitting a new study found in the presentation, "10 Steps to IRB Approval."

All employees, faculty, staff, students and/or agents of Emory University engaged in the conduct of human subject research must have reviewed and be familiar with the principles of “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research”, along with applicable Federal and State laws and institutional policies regarding Human Subjects Research.

Training Requirement:
Prior to submitting research protocols for review and approval by the EU IRB, all Key Research Personnel listed on an Emory IRB submission, regardless of their position, must complete the web-based Collaborative IRB Training Initiative (CITI) Program in the Protection of Human Subjects in Research available athttp://www.citiprogram.org/. Clinical Investigators will also need to complete the training required by the Emory Office of Clinical Research.

a.     Your application will be reviewed by the Administrative support staff prior to being sent to the IRB Chair or IRB convened board for final review and approval.  

 

b.     If the IRB has questions regarding the eIRB application submission, you will be contacted via workflow (email).

c.      Depending on the risks posed to potential subjects, your projects will be reviewed by one of the three methods:
Full Board Review
 Expedited Review
 Exempt Review

Collaborative Research and Central IRBs (including WIRB) is defined as research conducted in cooperation with an institution or faculty that is not affiliated with Emory.  When two or more institutions are engaged in research, multiple IRBs are responsible for providing oversight.  As such, separate applications may be necessary; however, to avoid duplicate review an IRB Reliance Agreement may be arranged to establish one IRB as the designated IRB of Record.

 

Detailed information about the review process can be found on the IRB website.

Investigators have a variety of IRB communication and record-keeping responsibilities after the research project is initiated. The Policies and Procedures define important terms (see the Glossary at end of document) and define the roles, structure, and responsibilities of all parts of the Emory University Human Research Protection Program (HRPP).

1.     Modifications, Continuing Review, Various Reporting Requirements, Other University Committees Reviewing Human Subjects Research (i.e. RAS (Refer to RAS unit and link to RAS webpage), COI, OSP, CT.gov, OCR, WCI, CTAC, Biosafety, Rad Safety, OoQ, Affiliates)

More guidance and recommendations on a panoply of issues can be found in the “Forms and Guidance” section of our website.

Emory IRB Policies & Procedures (ver. 7/1/2016)

Section 7 of the eIRB application allows documentation your needs for EHC services.  Clinical tools/checklist necessary for utilization of EHC clinical services (lab and radiology) are available on the IRB website.

If all human subjects research activities have concluded, you may close out/terminate a study in eIRB. To do this, you must "create a Close-Out request” in eIRB.