Putting Together Your Children’s Healthcare of Atlanta IRB Submission Version: June 14, 2005

1. Putting Together Your Children’s Healthcare of Atlanta IRB SubmissionVersion: June 14, 2005

2. New Study • Please include the following, in the order indicated: • (1) Application Form • Use the appropriate type, either: (a) Initial Submission Form; (b) Request for Review of Medical Record and Existing Data Form; or (c) Research Request Form for Emory Faculty • (2) Protocol Summary • (3) Protocol • (4) Informed Consent/Assent Form(s) (not applicable if applying for a waiver of informed consent/assent) • (5) Authorization to Release Protected Health Information Form or Waiver of Authorization Form, as applicable • (6) Recruitment Material(s) if any will be used • (7) Study Questionnaire(s) if any will be used

3. New Study(Continued) • Multiple copies of your packet are needed to facilitate IRB review, as follows: • For expedited review, 2 copies • For full Board review, 14 copies of everything but the protocol; only 3 copies of the protocol needed • 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) if Children’s employees maintain operations, coordinating or statistical center • Investigator’s Brochure

4. New Study(Continued) • Determining Type of Review Required: • Expedited Review – the new study must fall into one of the categories listed in the Federal Register as qualifying for an expedited review. The list of categories is available at: http://www.hhs.gov/ohrp/humansubjects/ guidance/expedited98.htm • Full Board Review - required if the new study does not meet the criteria for an expedited review (as indicated in the Federal Regulations under 45 CFR Part 46.110)

5. Response to IRB Request • Please include the following, in the order indicated: • (1) Cover Memo (address the Children’s IRB’s comments point-by-point) • (2) Copy of Any Amended Document(s) with Changes Highlighted • (3) Clean Copy of Any Amended Document(s) • Multiple copies of your packet are needed to facilitate IRB review, as follows: • For expedited review, 2 copies • For full Board review, 14 copies with exception that only 3 copies of a revised protocol are needed

6. Response to IRB Request(Continued) • Determining the Type of Review Required: • Expedited Review – the response qualifies for an expedited review if: • (a) The original submission qualified for an expedited review per the categories listed in the Federal Register and as determined under 45 CFR Part 46.110; or • (b) The original submission was initially reviewed by the full Board and it was determined that it could be accepted pending minor changes • Full Board Review – required if the full Board determined that more than minor changes were needed in order to accept the submission

7. Amendment • Please include the following, in the order indicated: • (1) Request for Modification Form • (2) Copy of Any Amended Document(s) with Changes Highlighted • (3) Clean Copy of Any Amended Document(s) • Multiple copies of your packet are needed to facilitate IRB review, as follows: • For expedited review, 2 copies • For full Board review, 14 copies with the exception that only 3 copies of a revised protocol are needed

8. Amendment(Continued) • Determining the Type of Review Required: • Expedited Review – the amendment qualifies for an expedited review if it meets the requirements in the Federal Regulations under 45 CFR Part 46.110(b)(2), i.e., minor changes to an approved study • Full Board Review – required if the amendment does not qualify for an expedited review

9. Serious Adverse Event Report • Please include the following, in the order indicated: • (1) Serious Adverse Event Report Form • Use the appropriate type, either: (a) Report of Serious Adverse Event (SAE) at a Children’s Location or (b) Report of Serious Adverse Event (SAE) at a Non-Children’s Location • (2) Written Narrative Describing the Serious Adverse Event • (3) Any Supporting Documentation • (4) Copy of Any Resulting Amended Document(s) with Changes Highlighted • (5) Clean Copy of Any Resulting Amended Document(s) • Multiple copies of your packet are needed to facilitate IRB review, as follows: • For expedited review, 2 copies • For full Board review, 14 copies with the exception that only 3 copies of a revised protocol would be needed

10. Serious Adverse Event Report (Continued) • Determining Type of Review Required: • Expedited Review – types of reports that qualify: • (a) Event occurred at a Children’s location but did not result in changes to the study • (b) Event did not occur at a Children’s location • Full Board Review – required if: • Event occurred at a Children’s location, is serious and/or unexpected, AND resulted in changes to any of the study documents

11. IND Safety Report • Please include the following, in the order indicated: • (1) Cover Memo (include the applicable Children’s IRB number and name of PI) • (2) IND Safety Report • (3) Any Supporting Documentation • 2 copies of your packet are needed to facilitate IRB review. • The submission will be reviewed on an expedited basis.

12. Continuing Study • Please include the following, in the order indicated: • (1) Request for Continuing Renewal Form • Any Relevant Multi-Center Trial Reports or Other Information about the Study’s Findings • (2) Protocol Summary • (3) Currently Approved Informed Consent Document and HIPAA Authorization Form (not applicable if a waiver has been granted) • (4) Newly Proposed Informed Consent Document and HIPAA Authorization Form (if requesting changes) • (5) Recruitment Material(s) if any are used • (6) Newly Proposed Versions of Other Study Materials (if requesting changes) • (7) Protocol Including All Approved Amendments • (8) Adverse Event Reports Not Previously Submitted (use Children’s IRB report forms and attach supplementary information) • (9) Copy of Collaborating Institutions’ Approval Notices if Children’s staff runs the operations, coordinating or statistical center

13. Continuing Study(Continued) • Multiple copies of your packet are needed to facilitate IRB review, as follows: • For expedited review, 2 copies • For full Board review, 14 copies of items listed in (1) through (6) and 3 copies of items listed in (7) through (9)

14. Continuing Study(Continued) • Determining the Type of Review Required: • Expedited Review – the continuing study must fall into one of the categories listed in the Federal Register as qualifying for an expedited review. The list of categories is available at: http://www.hhs.gov/ohrp/humansubjects/ guidance/expedited98.htm.  • Full Board Review - required if the continuing study does not meet the criteria for an expedited review (as indicated in the Federal Regulations under 45 CFR Part 46.110)

15. Where to Send Submissions • Send Children’s IRB Submissions to: Children’s IRB Office Clinical Research Department Children’s Healthcare of Atlanta 1711 Tullie Circle Atlanta, GA 30329 • If responding to an IRB Request that may be emailed, send submission to: pam.quintana@choa.org

16. Resources • Children’s IRB Office Staff • The IRB Office Staff is available to help you navigate the IRB process, from the origin of your research idea to the completion of your study. Their contact information is as follows: Pam Quintana IRB Coordinator (404) 785-7503 pam.quintana@choa.org Nancy Meck, M.S. IRB Manager and Senior Administrator (404) 785-7484 nancy.meck@choa.org

17. Resources(Continued) • Web Access to Children’s IRB Forms and Guidelines • Within the Children’s system, log onto Careforce, then go to Departments and select Clinical Research. The IRB information is found here, divided among different pages. • Outside the Children’s system, log onto www.choa.org, then select For Professionals, then Clinical Research, then Institutional Review Board.

18. Resources(Continued) • Web Access to Federal Regulations and Guidelines • 45 CFR Part 46 contains the Federal Regulations for the Protection of Human Subjects. It can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Take special note of Subpart D, “Additional DHHS Protections for Children Involved as Subjects in Research.” • The Office for Human Subjects Protections (OHRP) website is located at http://www.hhs.gov/ohrp/. Here you will find a host of information about the IRB process and the regulations that govern it.

19. Resources(Continued) • The United States Federal Drug Administration (FDA) website is located at www.fda.gov. Here you will find a host of information that pertains to the agency’s oversight of and guidance for clinical trials. • 21 CFR Part 50 and 21 CFR Part 56 are the Federal Regulations for Human Subject Protections in Research Involving Food and Drugs. They can be found at: http://www.fda.gov/oc/ohrt/irbs/appendixb.html and http://www.fda.gov/oc/ohrt/irbs/appendixc.html

20. Resources(Continued) • FDA Information Sheets • These provide helpful guidelines IRBs and Clinical Researchers. They are found at: http://www.fda.gov/oc/ohrt/irbs/toc4.html.  • IRB Forum • This online forum’s mission is to promote “the discussion of ethical, regulatory and policy concerns with human subjects research.” It is located at: http://www.irbforum.org. Membership to the forum is free, and allows you to initiate, contribute to, or review discussions of human subject research issues and provides links to helpful resources.