Application Information

Proposals for Institutional Review Board review should be sent to:

Georgia Williams
Children’s Healthcare of Atlanta
Institutional Review Board Office
1920 Briarcliff Road, Atlanta, GA 30329
404-785-7503
Fax: 404-785-9470

Deadlines

The deadline for submissions is the first Thursday of each month. The IRB meets the fourth Thursday of each month. (For more information, please see the IRB Meeting Schedule.) Submissions meeting criteria for expedited or exempt review are not subject to deadlines.

Application Requirements

  • Application Form (please see forms and instructions page)
  • Protocol Summary Guidelines
  • Protocol
  • Informed Consent/Assent Form(s) (not applicable if applying for a waiver of informed consent/assent)
  • Authorization to Release Protected Health Information Form or Waiver of Authorization Form, as applicable
  • Recruitment Material(s) if any will be used
  • Study Questionnaire(s) if any will be used
  • Multiple copies of your packet are needed to facilitate IRB review, as follows:
  • As applicable, please also submit 1 copy of the following:
    • FDA Form 1572
    • Copy of Funded Grant (appendices excluded)
    • Approval Notice (s) from the IRB of the Collaborating Institution(s)
    • Investigator's Brochure 

HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law passed to protect the privacy of patient Protected Health Information (PHI).

HIPAA defines PHI as the following:

Name

Email or IP address

Address

Dates of admission, discharge, treatment or death

Telephone #

Health Plan #'s

Date of Birth

Full face photogenic images or comparable images

Social Security #

Certificate/License #'s

Fax #

Vehicle identifiers, vehicle serial #’s or license plate #’s

Medical Record #

Device identifiers and serials #’s

Account #

Biometric identifiers, including finger and voice prints

When using any PHI please see special instructions under "Forms" for Instructions for Stand Alone Authorization to Release Protected Health Information for Research Purposes. After months of experience with HIPAA, the IRB now requires that a separate, stand-alone authorization form be used for new protocols. Protocols that have previously been approved with the authorization included in the consent may continue to be used.

When the protocol is due for Continuing Review you may submit a new consent with a stand-alone authorization if you choose however it is not required. The IRB feels that including the authorization in the consent form obscures the information about the study. The stand along authorization requires IRB approval prior to its utilization, the IRB will stamp the authorization form with an approval date.