Form B: Emory Sign-Off Last Updated: April 26, 2016

EMORY WIRB SIGN-OFF (FORM B)

For all WIRB eligible studies please fill out the following information. You may submit to WIRB prior to sending this form to the Emory WIRB listserve. However, the WIRB submission will be held until the completion of this form is verified by the Emory IRB/WIRB team. The Emory IRB/WIRB team will sign-off on this form once they have verified that all local Institutional requirements have been met (i.e. education, ancillary reviews, etc.) Study Title: WIRB #:

Study Sites Please list all the Emory Sites where the study will take place. (should match the WIRB submission)

EPEX # Number of subjects to be enrolled at Emory (should match the WIRB submission)

Human Subjects Protection Training for Research Team Members Please list all Emory University Research Team Members (include the principal investigator, co- investigators, sub-investigators, research nurses, research coordinators or other individuals who have interactions or interventions with research subjects or their private, identifiable information (including consent and follow-up).) 1.All Emory PI, CO-Is, and Sub-Is need to provide the Key Concepts in Clinical Research for Investigators certificate. Coordinators and study nurses need to have the Introduction to Clinical Research at Emory certificate. 2.Each research team member needs a current Biomedical CITI certification.

Please select the checkboxes that are applicable to each research team member per the instructions above. Documentation of the Key Concepts and Citi requirements should be appropriately labeled and attached with this form to the Emory WIRB listserve. Key Concepts in Biomedical Clinical Research Research Team Member Role CITI for Investigators Certification /Coordinators

Form B: Emory Sign-Off Last updated: April 26, 2016 Ancillary Committee Review

1. Key Points Summary Please attach the Key Points Summary All studies taking place at any EHCEMORY location areWIRB SIGN-OFF (FORMand B) add to Form B Submission Packet required to complete this form. YES Inventory below. Key Points Sensitive study status If this is considered a “sensitive study” (with a stigmatizing condition or factor, i.e. illicit drug use, HIV serostatus, etc), you will need to submit a If the study is not taking place at a Sensitive Studies Summary and Request for N/A EHC site, continue to Question 2. Sensitive Study Status Worksheet instead of the Key Points Summary form Please attach the approved IDS 2. IDS Exemption Request Form (if you do not plan to Exemption Request Form to Form B YES use Investigational Drug Service) Submission Packet Inventory below

N/A Continue to Question 3. 3. Clinical Research Readiness Checklist (OoQ Checklist) Principal Investigators on new research studies All studies taking place at any EHC involving EHC facilities or personnel for clinical location should complete this form and procedures will have to complete the Clinical submit to the Office of Quality per the Research Readiness Checklist (and the Checklist for instructions on the Clinical Research Lab Services and Radiology Checklist if applicable) Readiness form. before the IRB can release validated, approved consent and HIPAA documents. Once the option is determined by OSP, be sure to include the negotiated In- Case of Injury Option in the consent Determined form using the Emory template language and attach the confirmation 4. In-Case of Injury Option from OSP email with the option number. *Please note that the study team may incur a fee from WIRB if the study is Undetermined submitted with the incorrect ICI option.

Once the option is determined by OCR, be sure to include the negotiated Cost Option in the consent form using the Determined Emory template language and attach the confirmation email with the option 5. Cost Option from OCR number. . *Please note that the study team may incur a fee from WIRB if the study is Undetermined submitted with the incorrect cost option.

***Please obtain the following additional required Emory committee approvals prior to submitting your study to WIRB. Emory IRB cannot sign-off on a Form B without these approvals.

6. Is this an oncology study? Please attach a copy of the CTRC a. Please include interventional studies such as YES approval letter and add to Form B pharmacologic, behavioral, surgical (invasive Submission Packet Inventory below. or not) with therapeutic, preventive, or disease Continue to Question 7. management intent as well as non- interventional studies such as epidemiological NO and observational studies. 7. Does this application involve the use of the Please attach a copy of the IHBC following in laboratory or clinical research currently YES approval letter and add to Form B or for future use: Submission Packet Inventory below a. The deliberate transfer of recombinant DNA or Continue to Question 8 RNA, or DNA or RNA derived from recombinant DNA into one or more human subjects; b. live, recombinant, or attenuated NO Formmicroorganisms B: Emory Sign-Off for the purposes of Last updated: April 26, 2016 vaccination of one or more human subjects; or c. investigational vaccine containing EMORY WIRB SIGN-OFF (FORM B)

Form B Submission Packet Inventory

Remember to attach the applicable documents listed below, as well as the Human Subjects Protection Training for Research Team Members documentation to the Emory IRB via the WIRB listserve. Document Type (if applicable)) Document Name(s) Version Date(s) Key Points Summary Key Points- sensitive study CTRC approval IBHC approval Radiation Safety approval IDS Exemption approval Cost Option confirmation (if determined) ICI Option confirmation (if determined) Consent/HIPAA forms

Form B: Emory Sign-Off Last updated: April 26, 2016 EMORY WIRB SIGN-OFF (FORM B)

Investigator Assurance I certify that all information provided in this application represents an accurate description of the intended research project. I agree to follow and abide by all Emory University institutional and IRB policies and procedures, as well as all federal, state and local laws concerning the protection of human research participants, including, but not limited to:  Implementing no changes in the approved protocol or consent form without prior approval of WIRB;  Conducting the research using only the qualified personnel listed on the approved protocol;  Submitting a timely continuing review report as requested by WIRB. If WIRB has not reviewed and approved a research study by the expiration date specified by WIRB, the research must stop unless WIRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. When continuing review of a research protocol does not occur prior to the end of the approval period specified by WIRB, IRB approval expires automatically. Enrollment of new subjects cannot occur after the expiration of IRB approval;  Notifying WIRB within ten (10) working days of any adverse events that are related, unexpected, and place subjects or others at a greater risk of physical or psychological harm than was previously known or recognized; and  Immediately notifying WIRB upon termination of the study or departure of the Principal Investigator from this Institution. I understand that as Principal Investigator, I assume full responsibility for the conduct of the study, and for the protection of the rights and welfare of human participants involved in this research. Signature of PI Date

Departmental Approver Assurances As the Departmental Approver, I assure that the Investigator • Is qualified to conduct the research as described in this application; • Has adequate resources and facilities to conduct the research as described in this application; and • Has available time to oversee and conduct this project.

I also assure that the department will be solely responsible for all costs associated with review by WIRB and coordination of WIRB review by the Emory IRB Office that are not direct billed to or paid for by the study sponsor. Signature of Department Approver Date

Printed Name of Department Approver

For Emory IRB Use Only

Emory WIRB Form B Reviewed by:

Printed Name of Emory IRB Staff Signed Name of Emory IRB Staff

W00000 Date Reviewed and Signed Emory Institutional # (IRB Use Only)

Form B: Emory Sign-Off Last updated: April 26, 2016