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Investigators and their research staff may only perform those activities in a research study for which they have the relevant credentials and privileges.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"702","RUN_ID":"1894"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[51],"coordinatesList":[[144.10000610351562,694.4000244140625,391.0941467285156,79.5880126953125]]},{"pageNumber":0,"geomIndex":106582,"lastGeomIndex":106761,"textElement":"Investigators and co-investigators must be identified on the IRB application and must provide credentials, conflict of interest statements or other documentation required by VA and local facility policies.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"703","RUN_ID":"1895"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,116.5999755859375,385.0110168457031,36.08795166015625]]},{"pageNumber":0,"geomIndex":106761,"lastGeomIndex":107118,"textElement":"All individuals involved in conducting VA human subjects research are required to complete training in ethical principles on which human subjects research is to be conducted. Specific requirements regarding the type and frequency of training are found on ORD’s website. All other applicable VA and VHA training requirements at the local and national level must be met (e.g., privacy and information security training).","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"704","RUN_ID":"1896"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,204.54998779296875,393.5692443847656,79.5880126953125]]},{"pageNumber":0,"geomIndex":107118,"lastGeomIndex":107199,"textElement":"Investigators must prospectively document their research with their supervisor in writing.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"705","RUN_ID":"1899"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,234.5,390.4450988769531,21.5880126953125]]},{"pageNumber":0,"geomIndex":107199,"lastGeomIndex":107302,"textElement":"Investigators must submit exempt protocols that require limited IRB review to the IRB for limited IRB review/approval.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"706","RUN_ID":"1900"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,264.45001220703125,391.6329650878906,21.5880126953125]]},{"pageNumber":0,"geomIndex":107302,"lastGeomIndex":107753,"textElement":"Research Protocol. The investigator must develop and submit a research protocol that is scientifically valid, describes the research objectives, background and methodology, provides for fair and equitable recruitment and selection of subjects, minimizes risks to subjects and others, and describes a data and safety monitoring plan consistent with the nature of the study. The research must be relevant to the health or welfare of the Veteran population. When relevant, the protocol must include the following safety measures:","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"707","RUN_ID":"1901"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[126.0999984741211,366.8999938964844,412.5000991821289,94.08798217773438]]},{"pageNumber":0,"geomIndex":107753,"lastGeomIndex":107806,"textElement":"The type of safety information to be collected including AEs;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"708","RUN_ID":"1903"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,381.3999938964844,291.4559020996094,6.13800048828125]]},{"pageNumber":0,"geomIndex":107806,"lastGeomIndex":107839,"textElement":"Frequency of safety data collection;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"709","RUN_ID":"1905"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,397.0,172.95297241210938,6.13800048828125]]},{"pageNumber":0,"geomIndex":107839,"lastGeomIndex":107893,"textElement":"Frequency or periodicity of review of cumulative safety data;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"710","RUN_ID":"1907"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,412.6000061035156,292.0499572753906,6.13800048828125]]},{"pageNumber":0,"geomIndex":107893,"lastGeomIndex":107967,"textElement":"Statistical tests for analyzing the safety data to determine if harm is occurring; and","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"711","RUN_ID":"1909"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,443.6499938964844,376.9590148925781,21.587982177734375]]},{"pageNumber":0,"geomIndex":107967,"lastGeomIndex":108037,"textElement":"Conditions that trigger an immediate suspension of the research, if applicable.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"712","RUN_ID":"1910"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,458.1499938964844,378.8400573730469,6.13800048828125]]},{"pageNumber":0,"geomIndex":108037,"lastGeomIndex":108304,"textElement":"Approvals. The investigator must submit the protocol for initial review and obtain written approvals from the IRB, other applicable committees, and from the R\u0026D Committee. In addition, the investigator must receive written notice from the ACOS/R\u0026D that the research may commence before initiating the research.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"713","RUN_ID":"1911"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[126.0999984741211,518.2000122070312,389.2070083618164,50.5880126953125]]},{"pageNumber":0,"geomIndex":108304,"lastGeomIndex":108356,"textElement":"An investigator may not self-certify that a study is exempt.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"714","RUN_ID":"1913"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,532.7000122070312,281.0830078125,6.13800048828125]]},{"pageNumber":0,"geomIndex":108356,"lastGeomIndex":108591,"textElement":"Once approved by the IRB, the protocol must be implemented as approved. All modifications to the approved research protocol or consent form must be approved by the IRB prior to initiating the changes except when necessary to eliminate apparent immediate hazards to the subject.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"715","RUN_ID":"1914"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,592.75,383.1741027832031,50.5880126953125]]},{"pageNumber":0,"geomIndex":108591,"lastGeomIndex":108982,"textElement":"The investigator must also obtain continuing review and approval at a frequency established by the IRB, but not less than once every year (except for research subject to the 2018 Requirements where continuing review is not required) and is expected to submit all materials required for continuing review in sufficient time to assure approval prior to the expiration date. No research activities may be conducted at any time without a currently valid IRB approval.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"716","RUN_ID":"1915"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[144.10000610351562,680.7000122070312,395.3180236816406,79.5880126953125]]},{"pageNumber":0,"geomIndex":108982,"lastGeomIndex":109256,"textElement":"Conflict Of Interest. The investigator must disclose to the IRB any potential, actual, apparent, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and comply with all applicable VA and other federal requirements regarding conflict of interest.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"717","RUN_ID":"1918"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[52],"coordinatesList":[[126.0999984741211,754.0999755859375,400.8210220336914,65.0379638671875]]},{"pageNumber":0,"geomIndex":109256,"lastGeomIndex":109836,"textElement":"Initial Contact. During the recruitment process, members of the research team must make initial contact with potential subjects in person or by letter prior to initiating any telephone contact, unless there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study. (NOTE: This does not apply to situations where a Veteran calls in response to an advertisement. If existing information from sources such as a medical record or database, research or non-research, are used to identify human subjects, there must be an IRB approved HIPAA waiver for this activity in the new protocol.)","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"718","RUN_ID":"1921"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[126.0999984741211,232.5999755859375,411.26810455322266,123.08795166015625]]},{"pageNumber":0,"geomIndex":109836,"lastGeomIndex":109983,"textElement":"Any initial contact by letter or telephone must provide a telephone number or other means that the potential subject can use to verify that the study constitutes VA research.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"719","RUN_ID":"1923"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[144.10000610351562,277.04998779296875,391.1711120605469,36.0880126953125]]},{"pageNumber":0,"geomIndex":109983,"lastGeomIndex":110063,"textElement":"If a contractor makes the initial contact by letter, the VA investigator must sign the letter.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"720","RUN_ID":"1926"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[144.10000610351562,307.0,378.2129821777344,21.5880126953125]]},{"pageNumber":0,"geomIndex":110063,"lastGeomIndex":110573,"textElement":"Informed Consent for Research. The investigator must obtain and document legally effective informed consent of the subject or the subject\u0027s LAR prospectively (i.e., no screening or other interaction or intervention involving a human subject can occur until after the IRB-approved informed consent requirements have been met) that is in alignment with ethical principles that govern informed consent for research. The only exceptions are if the IRB determines the research is exempt, or approves a waiver of the informed consent process, or approves a waiver of the signed informed consent document.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"721","RUN_ID":"1927"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[126.0999984741211,423.95001220703125,412.53324127197266,108.5880126953125]]},{"pageNumber":0,"geomIndex":110573,"lastGeomIndex":110892,"textElement":"If the investigator does not personally obtain informed consent, the investigator must delegate this responsibility in writing (e.g., by use of a delegation letter) to research staff sufficiently knowledgeable about the protocol and related concerns to answer questions from prospective subjects, and about the ethical basis of the informed consent process and protocol.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"722","RUN_ID":"1931"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[144.10000610351562,497.3999938964844,394.2401428222656,65.08798217773438]]},{"pageNumber":0,"geomIndex":110892,"lastGeomIndex":111318,"textElement":"If the investigator contracts with a firm, e.g., a survey research firm, to obtain consent from subjects, collect private individually identifiable information from human subjects, or are involved in activities that would institutionally engage the firm in human subjects research, the firm must have its own IRB oversight of the activity. In addition, the PO must determine that there is appropriate authority to allow the disclosure of individual names and other information to the contracted firm.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"723","RUN_ID":"1932"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[162.10000610351562,599.8499755859375,377.0030822753906,94.08798217773438]]},{"pageNumber":0,"geomIndex":111318,"lastGeomIndex":111472,"textElement":"The investigator must ensure that all original signed and dated informed consent documents are maintained in the investigator’s research files, readily retrievable, and secure.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"724","RUN_ID":"1933"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[162.10000610351562,644.2999877929688,375.2210998535156,36.0880126953125]]},{"pageNumber":0,"geomIndex":111472,"lastGeomIndex":111999,"textElement":"HIPAA Authorization. The investigator or designee must obtain HIPAA authorization for the use and disclosure of the subject’s PHI, or obtain an IRB-approved waiver of HIPAA authorization unless there is a limited data set and appropriate DUA. The written HIPAA authorization may either be a standalone document or combined with the research informed consent approved by the IRB. If a standalone document is used as the written HIPAA authorization, VA Form 10-0493: Authorization for Use and Release of Individually Identifiable Health Information Collected for VHA Research, must be used to document the authorization.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"725","RUN_ID":"1934"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[53],"coordinatesList":[[144.10000610351562,754.0999755859375,383.1410217285156,101.43798828125]]},{"pageNumber":0,"geomIndex":111999,"lastGeomIndex":112534,"textElement":"Reporting. The investigator is responsible for reporting unanticipated problems involving risks to subjects or others, serious unanticipated problems involving risks to subjects or others, apparent serious or continuing noncompliance, any termination or suspension of research; and privacy or information security incidents related to VA research, including: any inappropriate access, loss, or theft of PHI; noncompliant storage, transmission, removal, or destruction of PHI; or theft, loss, or noncompliant destruction of equipment containing PHI, in accordance with local facility or IRB SOPs and VHA Handbook 1058.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"726","RUN_ID":"1939"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[54],"coordinatesList":[[126.0999984741211,261.5999755859375,412.48905181884766,108.58795166015625]]},{"pageNumber":0,"geomIndex":112534,"lastGeomIndex":112849,"textElement":"VA personnel who become aware of the occurrence of research-related events (as described above) are responsible for following VA medical facility established processes and timelines for promptly reporting the events to the appropriate VA medical facility point(s)-of-contact designated to receive such reports at the VA medical facility that approved the research.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"727","RUN_ID":"1941"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[54],"coordinatesList":[[162.10000610351562,335.04998779296875,373.4060974121094,65.0880126953125]]},{"pageNumber":0,"geomIndex":112849,"lastGeomIndex":113384,"textElement":"Research Records. All written information given to subjects must be in the investigator’s research file along with the consent form(s). All records regardless of format (paper, electronic, electronic systems) must be managed per NARA approved records schedules found in VHA RCS 10-1 and therefore must be retained until disposition instructions, as approved by NARA, are published in VHA RCS 10-1. NOTE: Once the disposition schedule is determined, records should be disposed in accordance with VHA RCS 10-1. If the investigator leaves VA, all research records must be retained by the VA facility where the research was conducted.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"728","RUN_ID":"1946"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[54],"coordinatesList":[[126.0999984741211,452.0,411.8951187133789,108.5880126953125]]},{"pageNumber":0,"geomIndex":113384,"lastGeomIndex":113951,"textElement":"VHA Health Record. A VHA health record must be created or updated, and a progress note created, for all research subjects (Veterans or Non-Veterans) who receive research procedures or interventions as inpatients or outpatients at VA medical facilities that are either used in or may impact the medical care of the research subject at a VA medical facility or at facilities contracted by VA to provide services to Veterans (e.g., Community-Based Outpatient Clinics or nursing homes). Informed consent and HIPAA authorization documents are not required to be in the health record. The name and contact information of the researcher conducting the study should be included.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"729","RUN_ID":"1950"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[54],"coordinatesList":[[126.0999984741211,583.4500122070312,405.0970230102539,123.0880126953125]]},{"pageNumber":0,"geomIndex":113951,"lastGeomIndex":114361,"textElement":"Investigational Drugs and Devices. The investigator must conduct VA human subjects research involving investigational drugs and devices in accordance with all applicable VA policies and other federal requirements including, but not limited to: VHA Directive 1200.05 (3), VHA Handbook 1108.04, and applicable FDA regulations. The storage and security procedures for test articles used in research must be reviewed and approved by the IRB and follow all applicable federal rules.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"730","RUN_ID":"1953"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[54],"coordinatesList":[[126.0999984741211,671.4000244140625,405.15201568603516,79.5880126953125]]},{"pageNumber":0,"geomIndex":114361,"lastGeomIndex":114441,"textElement":"The PI or Local Site Investigator (LSI) must provide the Pharmacy Service with the following:","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"731","RUN_ID":"1957"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[54],"coordinatesList":[[144.10000610351562,701.3499755859375,382.4700622558594,21.58795166015625]]},{"pageNumber":0,"geomIndex":114441,"lastGeomIndex":114584,"textElement":"Written approval letter signed by the ACOS for R\u0026D that all relevant approvals have been obtained and that the study may be initiated at the site (VHA Directive 1200.01);","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"732","RUN_ID":"1958"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[55],"coordinatesList":[[162.10000610351562,116.5999755859375,368.5331115722656,36.08795166015625]]},{"pageNumber":0,"geomIndex":114584,"lastGeomIndex":114605,"textElement":"An IRB approval letter;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"733","RUN_ID":"1960"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[55],"coordinatesList":[[162.10000610351562,131.0999755859375,110.57199096679688,6.13800048828125]]},{"pageNumber":0,"geomIndex":114605,"lastGeomIndex":114638,"textElement":"A copy of the approved study protocol;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"734","RUN_ID":"1962"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[55],"coordinatesList":[[162.10000610351562,146.70001220703125,187.61599731445312,6.13800048828125]]},{"pageNumber":0,"geomIndex":114638,"lastGeomIndex":114676,"textElement":"A copy of VA Form 10-9012, when appropriate;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"735","RUN_ID":"1964"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[55],"coordinatesList":[[162.10000610351562,162.29998779296875,229.74609375,6.13800048828125]]},{"pageNumber":0,"geomIndex":114676,"lastGeomIndex":114698,"textElement":"An IB, when 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The informed consent document may contain information on the project as a whole as long as the document clearly describes which procedures will be performed at VA and which will be performed at other institutions.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"805","RUN_ID":"2068"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[144.10000610351562,470.29998779296875,391.6439514160156,94.08798217773438]]},{"pageNumber":0,"geomIndex":125422,"lastGeomIndex":125543,"textElement":"The VA informed consent document must clearly state when procedures mentioned at other institutions are part of the VA’s portion of the study.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"806","RUN_ID":"2069"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[162.10000610351562,499.29998779296875,351.3951110839844,20.63800048828125]]},{"pageNumber":0,"geomIndex":125543,"lastGeomIndex":125651,"textElement":"The informed consent document and HIPAA authorization must be consistent and include information describing the following:","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"807","RUN_ID":"2070"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[162.10000610351562,528.2999877929688,375.8260192871094,20.63800048828125]]},{"pageNumber":0,"geomIndex":125651,"lastGeomIndex":125698,"textElement":"PHI to be collected and/or used by the VA research team;","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"808","RUN_ID":"2071"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[180.10000610351562,542.7999877929688,280.467041015625,6.13800048828125]]},{"pageNumber":0,"geomIndex":125698,"lastGeomIndex":125741,"textElement":"PHI to be disclosed to the other institutions; and","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"809","RUN_ID":"2073"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[180.10000610351562,557.2999877929688,232.82601928710938,6.13800048828125]]},{"pageNumber":0,"geomIndex":125741,"lastGeomIndex":125773,"textElement":"Purpose for which the PHI may be used.","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"810","RUN_ID":"2074"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[180.10000610351562,571.7999877929688,196.75698852539062,6.13800048828125]]},{"pageNumber":0,"geomIndex":125773,"lastGeomIndex":126177,"textElement":"Waivers. PHI obtained in research for which the IRB of Record has waived the requirements to obtain a HIPAA authorization and a signed informed consent document may not be disclosed outside VA unless the VA facility Privacy Officer ensures and documents VA’s authority to disclose the PHI to another institution. A waiver of HIPAA authorization is not sufficient to fulfill the requirements of other applicable privacy regulations such as the Privacy Act of 1974 (5 U.S.C. 552a).","tableIndex":-1,"rowIndex":-1,"cellIndex":-1,"fontColor":"#6767af","identifiers":{"PARAGRAPH_ID":"811","RUN_ID":"2075"},"issueDetails":{"backgroundColor":"FFFFFF","isHeader":"false","textColor":"F898A6"},"issueTypeId":"LowContrastIssue:DOCX","dismiss":false,"pageNumbers":[59],"coordinatesList":[[126.0999984741211,659.75,398.4089126586914,79.5880126953125]]},{"pageNumber":0,"geomIndex":126177,"lastGeomIndex":126487,"textElement":"Research Data. 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