Study Submission Guidance

General guidance on submitting a new study can be found in the presentation, "10 Steps to IRB Approval."

To access this information, click on every accordion.  

Initial Submission Decision Charts

Departmental Review Help

  • Please look for the correct Departmental Approval department using this list. See FAQ (under Departmental Approval section) for more details. 

Lay Summary Guidance

Lay summaries are actually very important for efficient IRB review, throughout the life of the study. Please use the guidance below. Studies may be returned if lay summary is inadequate.

Protocol Guidelines - for use in investigator-initiated studies and HUDs.

Grant applications are not acceptable in lieu of protocols
Sponsor-developed multisite protocols are acceptable, no need to use the templates below
Emory Investigator-initiated protocols: Ensure the information from the relevant guideline below is in your protocol; exact order/format is not important (though the guidelines can be used as a template if desired). 
       

Advertisement, Recruitment, Compensation

"Costs" and "In Case of Injury" Policies

These policies are the basis for the required language you find in our consent form templates.

Data and Safety Monitoring Boards and Plans Guidance

Data Security and Mobile (Medical) Apps

For studies taking place at CHOA, please log in to CHOA intranet (Careforce) and access this link for information on how to submit for security review. Please refer all questions to BISRA@choa.org.

Department of Defense and ICH-GCP Checklists

Clinical Study Tools, Templates and Checklists

Please see the "Clinical Study Initiation" section at left.

Drugs, Devices, and Other FDA Regulated Products

HIPAA-Related Guidance

Ancillary Review

Review by applicable compliance/oversight offices is needed before IRB can issue final approval, or (in the case of Office of Quality) before IRB can issue stamped consent forms. eIRB has integrated approval buttons for each of these offices, but you must submit applications separately to each.

  • Biosafety Review Guidelines. Special Recombinant DNA review is also needed for studies falling under the NIH policy
  • Conflict of Interest Guidance for Emory University. When you disclose COI in our eIRB smartform, the IRB must receive a determination from the COI office prior to final IRB approval. The IRB also reviews all COI management plans, and may rarely add additional requirements to the plans.
  • CTRC: Reviews all cancer-related resarch involving Emory (not solely studies taking place at Winship Cancer Institute; includes chart reviews, public health studies, surveys, etc). CTRC approval usually must be in place before the IRB begins our review; eIRB sets this requirement automatically when "Cancer-Related Research" is checked off under "Biomedical Research" section (for chart reviews or other studies that don't trigger that page of the eIRB smartform, you can check it off via the jump-to mention at the top of each page; or, the IRB staff will catch it once the study comes to us and route it at that point). Please see https://winshipcancer.emory.edu/research/clinical-trials-office/clinical-translational-review-committee.html for information and application form (submit to CTRC directly, outside of eIRB; may be done prior to eIRB submission but you must have created a new study, to generate an eIRB number).
  • Office of Quality Checklist: The Office of Quality oversees completion of multiple sign-off's required before study initiation, e.g. nursing, pharmacy, laboratory, radiology. Some parts of the checklists for sign-off are now built into eIRB; the radiology and laboratory ones can be found here: http://irb.emory.edu/forms/clinical.html. Office of Quality final sign-off must be in place before the IRB releases stamped consent forms, but does not hold up IRB approval.
  • Radiation Safety: Complete Radiation Summary Form, and the Human Studies Application for Radiation Use, and print, sign, and submit by fax (404-727-9778) or scanned email to Ike Hall (mjhall@emory.edu). Also upload Radiation Summary Form into eIRB submission, under "Miscellaneous Documents." The Radiation Summary Form determines what consent form language to use for describing the risks of the radiation in your study. Call the office with questions:  http://www.ehso.emory.edu/about/contact.html 
  • RDRC: A radiation subcommittee that reviews basic research using radioactive drugs in humans without an IND (must be 30 or fewer subjects). Contact Ike Hall (mjhall@emory.edu) for the application.

Vulnerable Populations Worksheets and Guidance

Children's Healthcare of Atlanta, Grady and St. Josephs Hospital Studies

Additional Study Documents and Guidance