ࡱ>  }bjbj }c}ctFF!!e/e////d00002 05<<<<}? %MQDUWWWWWW$\{/S?^}?SS{e/e/<<Z[[[Se/8</<U[SU[[^ŷ4/<pFT*hA0aTU/e SS[SSSSS{{XSSSSSSSSSSSSSSSS! +.:  SAINT LOUIS UNIVERSITY NCI Central IRB (CIRB) Submission Authorization Form INSTRUCTIONS FOR INVESTIGATORS REQUESTING USE OF CIRB This form should be used by investigators wanting to submit to CIRB for IRB review. Submission to the CIRB cannot occur without prior 91Ů authorization; complete this form to pursue the required 91Ů approval. Do not use this form if you are submitting to 91Ů IRB for IRB review. Answer the following questions to determine whether you are eligible to use CIRB: Y N  FORMCHECKBOX   FORMCHECKBOX  Proposed research has active CIRB approval ( HYPERLINK "https://ncicirb.org/" https://ncicirb.org/)?  FORMCHECKBOX   FORMCHECKBOX  Proposed research will be conducted by a CIRB-approved PI?  FORMCHECKBOX   FORMCHECKBOX  Proposed research does not involve prisoners? All answers to the above must be Y (yes) to be eligible for submission to CIRB; if not eligible, submit to 91Ů IRB. If you have questions about whether your study qualifies for CIRB 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. Please see 91Ůs HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/nci_cirb_pi_guidelines.docx"Guidelines for use of CIRB for details about the CIRB submission process and 91Ů requirements for using CIRB. 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. Please 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 "/general-counsel/compliance/conflict-of-interest.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 E-mail to  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu. For questions about 91Ů policies and procedures, call 91Ů IRB at 977-7744 or visit the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/training-education.php"website. For questions about CIRB policies and procedures, go to  HYPERLINK "https://ncicirb.org/" https://ncicirb.org/. *IRB #:________  SAINT LOUIS UNIVERSITY Institutional Review Board (IRB) NCI-CIRB 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 and must be a registered PI with CIRB (requires completion and submission of Annual PI Worksheet). Call 977-7744 with questions. PROJECT INFORMATION:  FORMCHECKBOX   FORMCHECKBOX Cooperative Group - Childrens Oncology Group Other (Please list):__________________________  91Ů eRS Number*: __________ *Note, study must be in eRS to avoid review delays.  DOCUMENT CHECKLIST Please complete and submit all applicable items along with this application (check all that apply):  FORMCHECKBOX  NCI Application, Protocol, Consent/Assent: most recent version date:________________  FORMCHECKBOX  CIRB Study Specific Worksheet (complete in CIRB system, save, print PDF, do not yet submit to CIRB)  FORMCHECKBOX  CIRB Approval Letter  FORMCHECKBOX  Other NCI-CIRB documents if applicable (SAE Reports, etc.)   FORMCHECKBOX  Assent Document(s), prepared using 91Ů Template Assent documents _____ Number of assent documents submitted  FORMCHECKBOX  Consent Document(s), prepared in accordance with required HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/nci_cirb_slu_boilerplate_language.doc"91Ů Boilerplate Consent language _____ Number of consent documents submitted Submit any documents used in lieu of a standard consent document:  FORMCHECKBOX  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_recruitment_statement_template.doc"Recruitment statement or letter  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "46.117"Short form (45CFR46.117(b)2)  FORMCHECKBOX  Translated consent documents if the study involves subjects whose first language is not English (these may be submitted after the English version is approved by the IRB). See the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_nonenglish_speaking.doc"Guidelines for Studies Involving Non-English Speaking Subjects 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): _______________________________  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. 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, administering an investigational agent (such as chemo nurse), 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 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. 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.  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.)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 a.) Review Adverse Events or b.) Treat and Classify Adverse EventsOther (Please insert explanation in column 4 after the number.)  RESEARCH SITE(S) 1. Indicate where the study will be conducted:  FORMCHECKBOX  91Ů, Medical Center Campus  FORMCHECKBOX  Cardinal Glennon Childrens Medical Center  FORMCHECKBOX  91Ů UMG Practice Locations  FORMCHECKBOX  91Ů Hospital (Tenet) 2. Will there be any in-patient 91Ů Hospital procedures?  FORMCHECKBOX  No  FORMCHECKBOX  Yes SPECIAL POPULATIONS Research involving pregnant women, human fetuses, neonates of uncertain viability, nonviable neonates, prisoners, or children as subjects requires additional protections set forth by the Department of Health and Human Services (DHHS). Please see the Code of Federal Regulations (45 CFR part 46) for specific regulations or click on the applicable population below: For this research protocol, please check all that apply:  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "subpartb"Pregnant subjects or fetuses  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "subpartb"Neonates  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "subpartc"Prisoners, incarcerated subjects Note: CIRB does not review research involving prisoners. If you wish to enroll prisoners in a study, 91Ů IRB must conduct the IRB review.  FORMCHECKBOX  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "subpartd"Subjects less than 18 years old CONFIDENTIALITY 1. Protected Health Information (PHI) (Protected Health Information = health information + identifiers) a. Type of Health Information to be received:  FORMCHECKBOX  No health information. HIPAA does not apply. (Please skip to question D2)  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 (and then skip to question D2)  FORMCHECKBOX  Health information with identifiers, including linkable code. This constitutes protected health information (PHI) and HIPAA applies. A consent/HIPAA document 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. b. 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 2. Data Sharing Indicate entities or individuals other than the listed research team who will have access to the research study data. (mark all that apply)  FORMCHECKBOX  No one else/not applicable (skip to section E) FORMCHECKBOX  Data Safety Monitoring Committee  FORMCHECKBOX  Statistician  FORMCHECKBOX  Consultants FORMCHECKBOX  Colleague(s)  FORMCHECKBOX   HYPERLINK "http://grants2.nih.gov/grants/policy/data_sharing" NIH data sharing requirements are applicable FORMCHECKBOX  Data, Tissue, Specimen Registry(s) FORMCHECKBOX  Other Research Laboratory (s) FORMCHECKBOX  Coordinating Center FORMCHECKBOX  Other. Please specify. FORMCHECKBOX  Sponsor FORMCHECKBOX  Transcription servicePlease note: If using a consent document, the level of study participant access to the study data must be discussed in the consent document even if no access is granted to the participant. Please list where or to whom data or specimens (blood/tissue) will be sent outside of 91Ů. Examples include: external collaborators listed above, a study sponsor, outside labs. NameData (D) or Specimen (S)?1.2.3.4. 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 how information will be disclosed. E. CONFLICT OF INTEREST Indicate whether the PI, study staff, or immediate family of the PI or study staff have, or anticipate having, any income from or financial interest in a sponsor of this protocol, or a company that owns/licenses the technology being studied. Financial Interest includes but is not limited to: consulting, speaking or other fees; honoraria; gifts; licensing revenues; other research agreements; 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"Conflict of Interest in Research Policy. Check one of the following: 1.)  FORMCHECKBOX  No Financial Interest or financial interest less than or equal to $5K2.)  FORMCHECKBOX  Financial Interest exceeding $5K or more but not exceeding $25K, and/or any equity interest3. )  FORMCHECKBOX  Financial Interest exceeding $25K (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 provide the following information: A Conflict of Interest Management Plan has been approved for all investigators  FORMCHECKBOX ; is pending  FORMCHECKBOX ; has not been initiated  FORMCHECKBOX  Describe who, 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 Committee (COIC) that describes any financial relationship indicated above. Financial disclosure statement incorporated into the consent document. In signing this form, the INVESTIGATOR certifies that he/she has read the Universitys Conflict of Interest Research Policy and has checked the appropriate box above. In addition, the INVESTIGATOR 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.  F. OTHER LEVELS OF 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 (no ionizing radiation)  FORMCHECKBOX  Study involves ionizing radiation. (Complete Appendix A)  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 more information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Request is Pending  FORMCHECKBOX  Review Completed/Approval __________(attach documentation to this submission) Date  Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee 91Ů Hospital requires that all research involving the administration of medications within the hospital (including outpatient areas such as the Emergency Department, TenetCare, Anheuser-Busch Institute, 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@tenethealth.com" 91ŮH-IDS@tenethealth.com for more information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Request is Pending  FORMCHECKBOX  Approval Received _________________ Date of Approval 91Ů Hospital All research involving 91Ů Hospital, including inpatient or outpatient services and medical record access, requires approval from the 91Ů 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. Documents should be submitted as soon as possible, or at the latest, concurrently with IRB submission. Please contact the Research Compliance Office at 577-8113 or  HYPERLINK "mailto:sluh.research@tenethealth.com" sluh.research@tenethealth.com or the 91Ů Clinical Trials Office at 977-6335 or  HYPERLINK "mailto:clinical-trials-office@slu.edu" clinical-trials-office@slu.edu for more information.  FORMCHECKBOX  Not Applicable  FORMCHECKBOX  Request is Pending  FORMCHECKBOX  Approval Received _________________ Date of Approval SSMSL All research involving SSMSL locations (including Cardinal Glennon), including inpatient or outpatient services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon Research Business Review 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. The RBR process should be initiated as soon as possible, or at the latest, concurrently with IRB submission. 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  Request is Pending  FORMCHECKBOX  Approval Received _________________ Date of Approval 91ŮCare Marketing To list your clinical trial on the 91ŮCare Marketing website, please complete the Clinical Trials Information Form on  HYPERLINK "http://www.slu.edu/Documents/91ŮCare/Clinical_Trials_Information_Form.pdf" \t "_blank" PDF or  HYPERLINK "http://slucare.edu/clinical_trials/trials_info_form.php" \t "_blank" online.  SIGNATURES AND ASSURANCES: I certify that I have read and understand 91Ůs HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/nci_cirb_pi_guidelines.docx"Guidelines for use of NCI-CIRB and have reviewed the information with the research team. I certify that the information provided in this application is complete and accurate, and that this study meets the 91Ů criteria for review by NCI-CIRB. I also understand that the Institution reserves the right to disapprove any study approved by NCI-CIRB. 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. I understand that no research involving human subjects will convene until CIRB 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 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. _________________________________________________________ __________________ 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 NCI-CIRB for review: _________________________________________________________ __________________ Signature of 91Ů designated personnel Date _________________________________________________________ Printed name of 91Ů designated personnel Please refer to Appendix B for Review Comments and Consent/Assent Instructions APPENDIX A 91Ů Radiation Safety Review of Research Involving Human Subjects Important: (1) It is the responsibility of the PI to assure the accuracy and completeness of the data submitted in this section, consistent with guidelines provided below. (2) The 91Ů IRB will determine if this study requires radiation safety review by the Radiation Safety Officer and/or the Radiation Safety Committee. (3) For projects requiring radiation procedures, please refer to the following guidance: HYPERLINK "http://oess.slu.edu/index.php?page=irb-instruction-sheet"http://oess.slu.edu/index.php?page=irb-instruction-sheet If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with this protocol in Table 1 below. (Includes X-ray, 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 DUKE Radiation Safety Committee Website, available at the following links: Adult Patients: HYPERLINK "http://www.safety.duke.edu/RadSafety/consents/irbcf_asp/adults/default.asp"http://www.safety.duke.edu/RadSafety/consents/irbcf_asp/adults/default.asp Pediatric Patients: HYPERLINK "http://www.safety.duke.edu/RadSafety/consents/irbcf_asp/peds/default.asp"http://www.safety.duke.edu/RadSafety/consents/irbcf_asp/peds/default.asp 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 APPENDIX B 91Ů Administrative Review Comments For Inclusion in CIRB Study-Specific Worksheet (TO BE COMPLETED BY 91Ů ADMINISTRATIVE REVIEWERS/IRB ONLY) NOTE: Items included on this Appendix must be incorporated into the Study-Specific Worksheet to be submitted to CIRB by the 91Ů PI. General Comments: Study-Specific Informed Consent Document Requirements (Additions to or Deviations from Boilerplate Language): Radiation Risk Language: Pregnancy Language (if deviates from template language): Cost Language: Payment Language: Compensation for Injury Language: Investigator Conflict of Interest Language: Other: Protocol Specific Assent Document Requirements (Additions to or Deviations from Template):      Version Date: 3/2014 PAGE  Version Date: 3/2014 *An IRB number will be assigned to your protocol by the IRB office. 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