Putting Together Your Children’s Healthcare of Atlanta IRB Submission Version: August 2010

1. Putting Together Your Children’s Healthcare of Atlanta IRB SubmissionVersion: August 2010

2. What Studies Need To Be Reviewed and Approved by Children’s IRB? • A study needs to be reviewed and approved by Children’s IRB if it: 1) Involves use of identifiable private information or interactions/interventions with living human beings; 2) Is intended to contribute to generalizable knowledge about the topic researched; 3) Engages Children’s in the research as outlined in www.hhs.gov/ohrp/humansubjects/assurance/engage.htm; and 4) Is not one in which Children’s is relying on the review and approval of the Emory University IRB.

3. What If My Study Is One In Which Children’s Is Relying on the Emory IRB Review and Approval? • For studies in which Children’s is relying on the Emory IRB review and approval, Children’s IRB does not conduct a review. A review is instead conducted by the Director of Clinical Research and Manager of Operations and Finance. A copy of the submission is kept on file in the Children’s IRB Office. The submission shall include a copy of all approved documents.

4. What If My Study Is One In Which Children’s Is Relying on the Emory IRB Review and Approval? (continued) Address the submission to: Children’s IRB Office Clinical Research Department Children’s Healthcare of Atlanta 1920 Briarcliff Road - Atlanta, GA 30329 3rd Floor, Room 371 The slides that follow apply only to submissions requiring Children’s IRB review and approval.

5. New Study • Include the following in the order indicated: • Application Form • Use the appropriate type, either Initial Submission Form or Initial Request for Review of Existing Data or Specimens Form • Protocol (follow IRB template) • Review Preparatory to Research Form or Decedent’s Information Form, as applicable • Informed Consent/Assent Forms (follow IRB template; 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 Materials and Questionnaires, if any will be used

6. New Study(Continued) • Two copies of your packet are needed to facilitate IRB review, as follows: • As applicable, submit a copy of the following: • Documentation of Completion of CITI or Equivalent Program • Investigator’s Brochure • Clinical Engineering Approval Letter • 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 for a multi-site study • FDA Form 1572

7. 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)

8. Response to IRB Request • Include the following in the order indicated: • Cover Memo that Addresses the Children’s IRB’s Comments Point-by-Point • Copy of Any Amended Document(s) with Changes Highlighted • Clean Copy of Any Amended Document(s)

9. 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

10. Amendment • Include the following in the order indicated: • Request for Modification Form • Copy of Any Amended Document(s) with Changes Highlighted • Clean Copy of Any Amended Document(s) • Two copies of your packet are needed to facilitate IRB review

11. 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., it involves minor changes to an approved study) • Full Board Review – required if the amendment does not qualify for an expedited review

12. Serious Adverse Event Report • Include the following in the order indicated: • Serious Adverse Event Report Form • Use the appropriate type, either: Report of Serious Adverse Event (SAE) at a Children’s Location or Report of Serious Adverse Event (SAE) at a Non-Children’s Location • Written Narrative Describing the Serious Adverse Event • Any Supporting Documentation • Copy of Any Resulting Amended Document(s) with Changes Highlighted • Clean Copy of Any Resulting Amended Document(s) • Two copies of your packet are needed to facilitate IRB review, as follows:

13. Serious Adverse Event Report (Continued) • Determining Type of Review Required: • Expedited Review – types of reports that qualify: • Event did not affect the risk/benefit ratio • Full Board Review – required if: • Event affected the risk/benefit ratio and/or resulted in more than minor changes to the study

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

15. Continuing Study • Include the following, in the order indicated: • Request for Continuing Renewal Form • Any Relevant Multi-Center Trial Reports or Other Information about the Study’s Findings • Protocol Summary in IRB template (not applicable if expedited review will be conducted and (1) all elements are in the protocol or (2) study closed to enrollment with no treatment procedures taking place (i.e., only open for long-term follow-up or data analysis)) • Currently Approved Informed Consent Document (not applicable if a waiver has been granted)

16. Continuing Study (Continued) (list of items to include, continued) • Newly Proposed Informed Consent Document (if requesting changes) • Newly Proposed Versions of Other Study Materials (if requesting changes) • Adverse Event Reports Not Previously Submitted (use Children’s IRB report forms and attach supplementary information) • Copy of Collaborating Institutions’ IRB Approval Notices if Children’s staff runs the operations, coordinating or statistical center

17. 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)

18. Where to Send Submissions • Send Children’s IRB Submissions to: Children’s IRB Office Clinical Research Department Children’s Healthcare of Atlanta 1920 Briarcliff Road - Atlanta, GA 30329 3rd Floor, Room 371 • If responding to an IRB Request that may be emailed as indicated in the letter you received, send submission to: serrena.slaton@choa.org

19. Resources • 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. Sarah Marie Huban, IRB Manager (404) 785-7477, sarahmarie.huban@choa.org Serrena Slaton, IRB Coordinator (404) 785-7555, serrena.slaton@choa.org

20. 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. • Outside the Children’s system, log onto www.choa.org, then select For Professionals, then Clinical Research, then Institutional Review Board.

21. Resources(Continued) • The Office for Human Subjects Protections (OHRP) website is www.hhs.gov/ohrp. Here you will find a host of information about the IRB process. HHS regulations found at: www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm • The United States Federal Drug Administration (FDA) website is www.fda.gov. Here you will find a host of information that pertains to the agency’s oversight of and guidance for clinical trials. FDA regulations found at: www.fda.gov/oc/ohrt/irbs/appendixb.html www.fda.gov/oc/ohrt/irbs/appendixc.html

22. Resources(Continued) • FDA Information Sheets • These provide helpful guidelines for Clinical Researchers. They are found at 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 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.