ࡱ>   bjbj}} O5 --F.F.F.t.../2T.ˢb5;<<<> LlQT,......$JRF.1Wl>>11--<<Zg(```1Wf-8<F.<,`1W,`` ..|<enX:<ˢ&VY|t||F.PST`UtUSSSRR1]SSSˢ1W1W1W1WSSSSSSSSS ,:  SAINT LOUIS UNIVERSITY Central IRB Submission Authorization Form 91Ů approval is required to use a non-91Ů IRB. Complete this form to get the required 91Ů approval. Do not use this form if you are submitting to 91Ů IRB for IRB review. Note: one of the following allowable scenarios must apply to this study:  FORMCHECKBOX  I am using a partner Central IRB [Western IRB (WIRB) including WIRB-Copernicus Group Single Review Service protocols, Quorum Review IRB (Quorum), Advarra, and StrokeNet IRB] and one of the following apply: The central IRB already has the protocol (so we can submit a site application); the 91Ů investigator does not hold the IND/IDE; study procedures occur at 91Ů and SSM sites The 91Ů IRB Director gave authorization to use a partner Central IRB  FORMCHECKBOX  I am using a non-91Ů IRB with prior authorization from the 91Ů IRB Director You may contact the IRB Director at 977-7744 or  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu for pre-authorization If you have questions about whether your study qualifies for external/central IRB review, please email  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu or contact the IRB office at 314-977-7744 prior to completing this form. See 91Ů IRBs Using an External/Central IRB  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb-process/submit-to-non-slu-irb.php" website for details on the submission process and 91Ů requirements for using external/central IRBs. To avoid delays in processing of this form, please note the following: This form should be downloaded for editing in Microsoft Word. Incomplete or incorrectly completed forms, including handwritten forms, will be returned to the investigator. Each member of the research team (investigator and sub-investigators) must have completed human subject protection training, and GCP training if applicable. Refer to the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/training-education.php"Training and Education link on the 91Ů IRB website for instructions. Each member of the research team should have a conflict of interest disclosure form on file. Please refer to 91Ůs HYPERLINK "/research/faculty-resources/research-integrity-safety/conflict-of-interest-coirc.php"conflict of interest policy. Submit the original set of materials to Institutional Review Board, Caroline Building, Room 110, 3556 Caroline Street, St. Louis, MO 63104 OR email to irb@slu.edu. For questions, call 91Ů IRB at 977-7744 or visit the 91Ů IRB Using an External/Central IRB HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb-process/submit-to-non-slu-irb.php"website. *91Ů #:________  SAINT LOUIS UNIVERSITY Central IRB Submission Authorization Form Principal Investigator*: Phone/Pager: Department: Address: E-Mail: Degree: Contact Person: E-mail: Phone: Study Title (sponsors protocol title): *Principal Investigator must be a 91Ů affiliate. IRB INVOICE/eRS INFORMATION (For Industry-Sponsored Studies) Indicate the 91Ů Departmental contact who should receive the invoice for administrative review. 91Ů charges $750 for administrative review of central IRB studies. Also, provide the eRS number for the Clinical Trial Agreement. 91Ů Contact Name:eRS Number: *Note, CTA must be in eRS to avoid review delays*E-Mail: Phone:  Please indicate which IRB you will use:  FORMCHECKBOX  Quorum Review IRB  FORMCHECKBOX  Advarra (formerly Schulman & Chesapeake IRBs)  FORMCHECKBOX  StrokeNet IRB  FORMCHECKBOX  WIRB/WIRB-Copernicus Group  FORMCHECKBOX  Other (provide name of pre-authorized IRB): ________________________ RESEARCH TEAM List names of all members of the research team, their degrees, academic rank or title, department or outside organization (if not affiliated with 91Ů), experience and assigned study duties. In the third column, provide sufficient detail regarding an investigators experience to reflect his/her ability to capably perform the duties listed in the fourth column. Note: the principal investigator (PI) must be a 91Ů affiliate (faculty, staff, student, etc). The research team should include individuals who are directly involved in the performance of procedures required by the protocol, and/or the collection of research data (for investigational drug studies, this would be similar to those listed on the Form FDA 1572). 91Ů IRB considers research team members to have a substantive role in the research, which could include obtaining consent, performing other protocol specific interventions or procedures, or obtaining/analyzing subjects' private, identifiable data. Nurses or residents who provide intermittent care but who do not make a direct and significant contribution to the research do not need to be listed individually on the IRB application. This would include technicians performing standard clinical procedures that may be part of the research protocol. Because it may be difficult to prospectively identify these types of individuals, the names of rotational individuals and the procedures they are expected to perform should be included in the clinical study records rather than be listed on the IRB application. The decision about whether to list a pharmacist on the IRB application is a matter of judgment, dependent upon the contribution that the individual makes to the study. For example, a research pharmacist may prepare test articles and maintain drug accountability for many clinical studies that are ongoing concurrently at an institution. Because the pharmacist would not be making a direct and significant contribution to the data for a particular study, it would not be necessary to list the pharmacist on the IRB application, but he/she should be listed in the investigator's study records. By submitting the protocol, the principal investigator affirms that each individual named has reviewed the protocol and has consented to his or her inclusion. If the research involves a non-91Ů investigator, it is the responsibility of the 91Ů PI to ensure that the non-91Ů investigator has obtained IRB approval from his/her institution (if applicable). A copy of the approval letter from the cooperative institution's IRB must be attached. The PI and sub-investigators must have completed human subjects education and HIPAA training (an online course is available on the 91Ů IRB website). Investigators from other institutions with an IRB may provide their institutions human subjects certification to meet 91Ůs education requirements. This IRB submission will be returned to the PI without review if any of the members of the research team have not completed an acceptable form of human subjects education. GCP training to satisfy NIH Policies will also be verified. Name(s), DegreeAcademic Rank and Department or describe non-91Ů Affiliation Experience (Specify experience which reflects the ability to capably perform study related duties such as other trials conducted, related courses completed, etc.)Duties (see table below for code #)1.  2. 3. 4. 5. 6. 7. 8. 9.10.11.12. You may add members to the table above by expanding as needed (place cursor in the last box of the table, right side, and hit the tab key). Assigned Study Duties (In Column 4 in above table, enter as many numbers as appropriate to describe study duties. For clarification, you may further describe duties within the IRB protocol as needed.)RecruitmentObtains consent Determine Subject Eligibility for Accruala.) Subject Physical Examinations or b.) Follow-up Visits including physical assessmentsPerform study procedures or Specimen Collectiona.) Administer or Dispense Study Drugs, Biologics or Devices (must be licensed) or b.) Receive, Store, Manipulate or Account for Study Drugs, Biologics or DevicesSubject Randomization or RegistryCollection of Subject DataReport Data (CRFs, e-CRFs, Spreadsheets)Data Analysis Review Adverse Events Treat and Classify Adverse EventsOther (Please insert explanation in column 4 after the number. You may further describe within the protocol)  RESEARCH SITE(S) Indicate where the study will be conducted:  FORMCHECKBOX  91Ů/91ŮCare Practice Locations  FORMCHECKBOX  SSM Health 91Ů Hospital  FORMCHECKBOX  SSM Health Cardinal Glennon Childrens Med Ctr  FORMCHECKBOX  SSM Health STL (DePaul, Sts Marys/Joseph/Clare) List any other locations and describe the activities being conducted there. Note: this may disqualify you from use of a central IRB; call the 91Ů IRB at 314-977-7744. Location name and AddressActivities conducted at site1.  Will there be any in-patient SSM Health 91Ů Hospital procedures?  FORMCHECKBOX  No  FORMCHECKBOX  Yes Will the 91Ů site be participating in all parts/procedures/arms of the study?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If no, please outline the procedures that 91Ů will not participate in.  STUDY DESIGN 1. SUBJECTS Number of proposed evaluable subjects you intend to study for the duration of the research 2. DURATION Anticipated Beginning Date of 91Ů Research Project (month/year)  Anticipated End Date of 91Ů Research Project (month/year) FINANCIAL COMPONENTS 1. Will subjects be given remuneration for participation?  FORMCHECKBOX  No  FORMCHECKBOX  Yes, total study amount per subject: .  FORMCHECKBOX  How are payments prorated (what is payment per visit): . Payments greater than $600 per year (or cash equivalent) will be reported to the IRS and are subject to taxation. Please contact HYPERLINK "/busfin/taxes"Tax Compliance for questions related to 1099 forms for non-employees receiving such compensation from the University. HIPAA 1. Type of Health Information to be received:  FORMCHECKBOX  No health information. HIPAA does not apply. Skip to section F.  FORMCHECKBOX  Health information without identifiers. Please complete the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_deidentification_certification_form.doc"De-Identification Certification form (HIPAA identifiers are listed on this form) Skip to section F.  FORMCHECKBOX  Health information with identifiers, including linkable code. This constitutes protected health information (PHI) and HIPAA applies. A HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_authorization_form.doc"HIPAA Authorization Form or a HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_waiver_alteration.doc"waiver of HIPAA authorization is required. 2. Sources of Protected Health Information:  FORMCHECKBOX  Hospital/medical records for in or out patients FORMCHECKBOX  Mental health records FORMCHECKBOX  Physician/clinic records FORMCHECKBOX  Data previously collected for research purposes FORMCHECKBOX  Laboratory, pathology and/or radiology results FORMCHECKBOX  Billing records FORMCHECKBOX  Biological samples FORMCHECKBOX  Other. Please describe:  FORMCHECKBOX  Interviews or questionnaires/health histories If data/specimens will be shared outside the research team, indicate how it will be shared:  FORMCHECKBOX  Linkable code that can link data to the identity of the subject. A HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/code_access_agreement.doc"code access agreement or business associate agreement may be needed.  FORMCHECKBOX  Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies as a Limited Data Set. A HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/dua_external_slu_provider.doc"data use agreement may be needed.  FORMCHECKBOX  With unlimited identifiers, the HIPAA authorization form must describe with whom data/specimens will be shared and for what purpose. CONFLICT OF INTEREST Indicate whether you, your spouse or dependent children, have, or anticipate having, any income from or financial interest in a sponsor, device or drug manufacturer of this protocol, or a company that owns/licenses the technology being studied. Please remember that you are responding for you and any other investigator participating in the study. Financial Interest includes but is not limited to: consulting; speaking or other fees; honoraria; gifts; licensing revenues; and equity interests (including stock, stock options, warrants, partnership and other equitable ownership interests). For questions regarding Conflict of Interest consult the HYPERLINK "/general-counsel/compliance/conflict-of-interest.php" \t "_blank"Conflict of Interest in Research Policy. Check one of the following. Please remember you are answering for yourself, your spouse, dependent children and any investigator on the study, his/her spouse and dependent children. 1.)  FORMCHECKBOX  No Equity Interest and/or Financial Interest less than or equal to $5K2.)  FORMCHECKBOX  Any Equity Interest and/or Financial Interest exceeding $5K but not exceeding $25K in the past year or expected in the current year3. )  FORMCHECKBOX  Financial Interest exceeding $25K in the past year or expected in the current year(Check all those that apply):  FORMCHECKBOX  Consulting  FORMCHECKBOX  Speaking Fees or Honoraria  FORMCHECKBOX  Gifts  FORMCHECKBOX  Licensing agreement or royalty income  FORMCHECKBOX  Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests), or serving on a scientific advisory board or board of directors  FORMCHECKBOX  Other fees/compensation(Check all that apply):  FORMCHECKBOX  Consulting  FORMCHECKBOX  Speaking Fees or Honoraria  FORMCHECKBOX  Gifts  FORMCHECKBOX  Licensing agreement or royalty income  FORMCHECKBOX  Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests), or serving on a scientific advisory board or board of directors  FORMCHECKBOX  Other fees/compensation If you have marked box #2 or #3, please contact  HYPERLINK "mailto:coi@slu.edu" coi@slu.edu to initiate review of this study and provide the following information: A Conflict of Interest Management Plan has been approved for this study  FORMCHECKBOX ; is pending  FORMCHECKBOX ; has not been initiated  FORMCHECKBOX  Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for each subcategory checked: __________________________________________________________________________________________________________________________________________________________________________________________________ Note to Investigator(s) Reporting a Potential Conflict of Interest Investigator(s) must have: Current, up-to-date Conflict of Interest Disclosure Form on file with the 91Ů Conflict of Interest in Research Committee (COIRC) that describes any financial relationship indicated above. This information must be disclosed on the 91Ů confidential Conflict of Interest Disclosure Form and reviewed by the COIRC before accruing research subjects in this study. If your current Disclosure Form does not contain this information, you are required to submit an updated Disclosure Form to the COIRC. You may not begin your study until your Disclosure Form has been reviewed and any required management plan has been approved by the COIRC for this study. To initiate COIRC review of your study, please contact  HYPERLINK "mailto:coi@slu.edu" coi@slu.edu. In signing this form, the PI certifies that he/she has read the Universitys Conflict of Interest Research Policy and has checked the appropriate boxes above. In addition, the PI certifies that, to the best of his/her knowledge, no person working on this project at 91Ů has a conflict of interest or if a conflict of interest does exist, that an appropriate management plan is in place. By his/her signature, the CHAIR certifies that, to their knowledge, no conflict of interest exists or a conflict does exist for which a management plan has been approved or is under review.  University Radiation Safety Research involving non-standard of care radioactive materials (which includes the terms radioisotopes, radionuclides, radiopharmaceuticals, and nuclear medicine studies, e.g. PET, MUGA, Zevalin, and/or specific radionuclides such as F-18, Tc-99m, Th-201, I-131, Ra-223, Y-90, etc.) will receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). For information on how to submit for radiation safety review, see HYPERLINK "/research/faculty-resources/research-integrity-safety/documents/irb-protocols-requiring-rsc-review-instructions-for-coordinators.pdf"RSC instructions or contact the RSO at 977-6895.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Study involves Nnon SOC Radioactive Material. Per HYPERLINK "/research/faculty-resources/research-integrity-safety/documents/irb-protocols-requiring-rsc-review-instructions-for-coordinators.pdf"instructions, submit to RSC before IRB and complete  HYPERLINK \l "AppendixB" Appendix B  FORMCHECKBOX  Study involves Radiation, but not non SOC Radioactive Materials. Complete  HYPERLINK \l "AppendixB" Appendix B OTHER LEVELS OF REVIEW Institutional Biosafety Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid Molecules (e.g., Gene Transfer), or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid Molecules, or Microorganisms containing Recombinant or Synthetic Nucleic Acid Molecules and/or infectious agents (including select agents and toxins as defined by CDC and/or Animal and Plant Health Inspection Service (APHIS)) into one or more human research participants must be reviewed by the 91Ů Biological Safety Officer. Most of these protocols also require review and approval by the 91Ů Institutional Biosafety Committee (IBC). Please contact the 91Ů Biological Safety Officer at 977-6888 for information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Yes, study requires Institutional Biosafety review. Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee SSM Health 91Ů Hospital requires that all research involving the administration of medications within the hospital (including outpatient areas such as the Emergency Department, etc.) be reviewed and approved by the Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee and that all doses are coordinated, controlled, and dispensed by the hospital's pharmacy department. Please contact the Investigational Drug Services Clinical Pharmacist at 268-7156 or  HYPERLINK "mailto:91ŮH-IDS@ssmsluh.com" 91ŮH-IDS@ssmsluh.com for more information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Yes, study requires PTNT review. SSM Health 91Ů Hospital All research involving SSM Health 91Ů Hospital, including the Emergency Department, inpatient or outpatient services (including outpatient surgery at 91ŮH South Campus and the infusion center at the DOB) and medical record access, requires Research Business Review (RBR) and approval from the Hospital Research Review Committee prior to study initiation. This effort is coordinated through the Clinical Trials Office via eRS. This process is designed to facilitate compliance with state and federal regulations as they pertain to research in hospitals and clinical research billing. While researchers can begin to complete the SSM RBR form at any time, the form should not be submitted until the IRB and the Clinical Trials Office (CTO) have approved the study. Documents should be submitted as soon as possible, or at the latest, concurrently with IRB submission. Please contact  HYPERLINK "mailto:sluh-research@ssmsluh.com" Ssluh-research@ssmsluh.com or the 91Ů Clinical Trials OfficeCTO at 977-6335 or  HYPERLINK "mailto:clinical-trials-office@health.slu.edu" clinical-trials-office@health.slu.edu for more information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Yes, study requires SSM Health 91Ů Hospital review. SSMSL All research involving SSMSL locations (including Cardinal Glennon, excluding 91Ů Hospital), including inpatient or outpatient services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon Research Business Review (RBR) prior to study initiation. This process is designed to facilitate compliance with state and federal regulations as they pertain to research in hospitals and clinical research billing. Please contact the SSMSL Office at 989-2058 or  HYPERLINK "mailto:Marcy_Young@ssmhc.com" Marcy_Young@ssmhc.com for more information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Yes, study requires SSM RBR review. SUBMISSION REQUIREMENTS In addition to this form, complete/submit an original set of all applicable items (check all that apply):  FORMCHECKBOX  Appendix A: IND/IDE Information (attached to this form)  FORMCHECKBOX  Appendix B: Radiation Safety Review form, if study involves radiation (attached to this form)  FORMCHECKBOX  WIRB Submission Form (Initial Review Submission Form)  FORMCHECKBOX  Quorum Review IRB Site Information Questionnaire  FORMCHECKBOX  Advarra Site/Investigator Application  FORMCHECKBOX  Other Central IRB Application (if applicable)  FORMCHECKBOX  Sponsors Protocol   FORMCHECKBOX  Assent Document(s)*  FORMCHECKBOX  Consent Document(s)*  FORMCHECKBOX  Documents used in lieu of a standard consent document * If submitting to an established Central IRB Partner other than StrokeNet, submit consent/assent materials as approved by the Central IRB (without 91Ů customization). If submitting to StrokeNet or received an exception to use on a non-partner IRB, track required 91Ů language into the consent/assent materials and submit the tracked (redlined) version(s). HIPAA documents, if applicable:  FORMCHECKBOX  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_authorization_form.doc"HIPAA Authorization Form  FORMCHECKBOX  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_waiver_alteration.doc"HIPAA Waiver or Alteration of Authorization Form  FORMCHECKBOX  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hipaa_deidentification_certification_form.doc"HIPAA De-Identification Certification Form  FORMCHECKBOX  Other (briefly describe): _______________________________  Supporting documents (only those listed below should be included in submission):  FORMCHECKBOX  Subject Recruitment Material(s)  FORMCHECKBOX  Investigators Drug Brochure (IBs) or Package Insert(s)  FORMCHECKBOX  Investigators Device Manual  FORMCHECKBOX  Copies of IRB training certification if not on file with 91Ů IRB SIGNATURES AND ASSURANCES: I certify that the information provided in this application is complete and accurate, and that this study meets the 91Ů criteria for review by a central IRB. I also understand that the Institution reserves the right to disapprove any study approved by a central IRB. As Principal Investigator, I have ultimate responsibility for the conduct of this research study, its ethical performance, and the protection of the rights and welfare of human subjects. I agree to conduct this research study in accordance with all applicable federal and state regulations, ethical guidelines such as the Belmont Report and Declaration of Helsinki, and 91Ů policies and practices governing human subject research and research involving the use of a central IRB as described on the 91Ů IRB website. I understand that no research involving human subjects will convene until central IRB approval and all necessary 91Ů approvals are in place. As PI, I assure that if members of the 91Ů research team access protected health information from a 91Ů covered entity in order to seek consent/authorization for research, such access is necessary for the research, is solely for that purpose, and the information will not be removed from the covered entity without authorization or an approved waiver. _________________________________________________________ __________________ PI Signature Date _________________________________________________________ PI Printed name I affirm that the enclosed application is within the academic and/or clinical scope of this Department/Division. In addition, I certify that adequate space and resources are available to conduct this research. I understand that, if applicable, the industry sponsor of the above-referenced research study will receive an invoice for central IRB review fee(s). I understand that if this fee is not paid within the allowable number of days, my department/division will be asked to pay this fee. I will assure that this fee is paid in a timely manner if this situation arises. _________________________________________________________ __________________ Department Chair Signature Date _________________________________________________________ Printed name of Department Chair Based on the information provided by the PI for this study, this study may be submitted to central IRB for review: _________________________________________________________ __________________ Signature of 91Ů designated personnel Date _________________________________________________________ Printed name of 91Ů designated personnel WIRB: Refer to Appendix C for 91Ů Comments and Consent Instructions Quorum: Refer to Institution Cover Page for Protocol-Specific Instructions APPENDIX A Complete this section if the study involves drugs, devices and/or biologics. Check and/or complete the following information (repeat for each drug/device as needed):  FORMCHECKBOX  Investigational New Drug or Biologic Product Name: _______________________________________________ IND Number: ___________________________________________ Name of sponsor who holds the IND: ______________________________________  FORMCHECKBOX  Investigational use of FDA Approved drug (See HYPERLINK "http://www.fda.gov/oc/ohrt/irbs/default.htm"FDA Guidance for more information regarding off-label and investigational use of marketed drugs, biologics). Name: _______________________________________________ IND Number: ___________________________________________ Name of sponsor who holds the IND: _______________________________________  FORMCHECKBOX  Investigational Device Name: _______________________________________________ IDE Number (or indicate exempt from IDE requirements): ___________________________ Name of sponsor who holds the IDE: ________________________________________ Indicate level of risk per FDA regulations:  FORMCHECKBOX Significant risk  FORMCHECKBOX Non-significant risk See HYPERLINK "http://www.fda.gov/oc/ohrt/irbs/devices.html"level of risk per FDA regulations and guidance and attach supporting documentation (device information or documentation from FDA indicating it is exempt from IDE requirements). The risk determination should be based on the proposed use of a device in an investigation, not on the device alone.  FORMCHECKBOX  FDA Approved device Name: _______________________________________________ IDE Number (or indicate exempt from IDE requirements):_________________________________ Name of sponsor who holds the IDE: _______________________________________ Complete the boxes below as appropriate: For FDA approved Drugs: Are any classified as **Category X ? If yes, indicate drug name(s): **Category X drugs are products that demonstrated positive evidence of fetal abnormalities or risks in well-controlled trials. Category X drugs are contraindicated in women who are or may become pregnant. If you are unsure of the classification of the drug, check package insert or PDR, or call the manufacturer or Pharmacy Services Study Phase: (check as appropriate)  FORMCHECKBOX  Pilot  FORMCHECKBOX  Phase I FORMCHECKBOX  Phase II FORMCHECKBOX  Phase III FORMCHECKBOX  Phase IV FORMCHECKBOX  Not Phased APPENDIX B 91Ů Radiation Safety Review of Research Involving Human Subjects For projects involving radiation procedures, please refer to this HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_radiation_safety.doc"guidance. 91Ů template consent radiation risk language should be used in the 91Ů consents (see item #3 for more information). Note: protocols that involve non-standard of care radioactive materials (which includes the terms "radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", "MUGA", "Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-233", "Y-90", etc.) will receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases, submission to the RSO/RSC should occur first, even before submission to IRB. For more information on how to submit for radiation safety review, see RSC HYPERLINK "/research/faculty-resources/research-integrity-safety/documents/irb-protocols-requiring-rsc-review-instructions-for-coordinators.pdf" \t "_blank"instructions or contact the Radiation Safety Officer at 977-6895. List and quantify the radiographic diagnostic and therapeutic procedures associated with this protocol in Table 1 below. (Includes fluoroscopy, CT, radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife procedures, etc.) TABLE 1 - PROCEDURES(1)(2)(3)(4)(5)(6)Radiation ProcedureTotal No. of ExamsNumber that are SOCNumber that are NOT SOCEstimated Effective Dose per Procedure (mrems)Effective Dose Subtotal (mrems)TOTAL ESTIMATED RESEARCH RADIATION DOSE: TABLE DEFINITIONS/INSTRUCTIONS: STANDARD OF CARE (SOC): Are the procedures being performed a normal part of the clinical management for the medical condition that is under study? If yes, specify the number of exams for each listed procedure that are SOC in column 3. NOT SOC: Are the procedures being performed because the research subject is participating in this project (e.g. extra CT scans, more fluoroscopy time, additional Nuclear Medicine Studies, etc.)? If yes, specify the number of exams for each listed procedure that are NOT SOC in column 4. Note: If all listed procedures are SOC (i.e. all column 4 entries are zero only), then this section of the application is complete. If there are procedures that are NOT SOC, proceed as outlined below. DOSE ESTIMATE: In column 5, specify the estimated effective dose for each procedure that is NOT SOC. You may use data from the  HYPERLINK "https://vmw-oesoapps.duhs.duke.edu/radsafety/consents/irbcf_asp/default.asp" DUKE Radiation Safety Committee Website. Use of additional references that may provide a higher degree of accuracy of radiation dose estimates for procedures at 91Ů are encouraged. All references, including use of the Duke website, must be specified below. EFFECTIVE DOSE SUBTOTAL: For each line item, complete column 6 by multiplying the Number of procedures that are NOT SOC (Column 4) by the Estimated Dose per Procedure (Column 5). Enter the result for each procedure (line item) in column 6. TOTAL ESTIMATED RESEARCH RADIATION DOSE: Add the Effective Dose Subtotals for all procedures (line items) in Column 6, and enter on the bottom line of Table 1. In Table 2 below, specify the resource/reference used for estimating the dose for each procedure (line item) listed in column 1 (copy column 1 from Table 1 into column 1 of Table 2). TABLE 2 REFERENCES(1)(2)Radiation ProcedureReferences used for Estimating Dose 91Ů Radiation Risk language must be incorporated into the 91Ů consents. Please refer to the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_radiation_language.docx"91Ů Informed Consent Radiation Risk Template Language to identify the appropriate language based on the radiation dose estimate, whether exposure is SOC/Not SOC and depending on the population (adult/pediatric). Enter the appropriate 91Ů template language below (the IRB will ultimately request this language be incorporated by the central IRB).  APPENDIX C 91Ů Administrative Review Comments & Consent Instructions (FOR IRB USE ONLY) General Comments: Protocol Specific Informed Consent Document Requirements (Additions to or Deviations from Template): Radiation Risk Language: Pregnancy Language (if deviates from template language): Cost Language: Payment Language: Compensation for Injury Language (if deviates from template language): Investigator Conflict of Interest Language: Other: Protocol Specific Assent Document Requirements (Additions to or Deviations from Template):      IRB Form Version: 7/2018 PAGE  IRB Form Version: 7/2018 PAGE  IRB Form Version: 7/2018 *A 91Ů number will be assigned to your submission. 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