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Background on SMART IRB Agreement v2.0
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Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement v2.0 necessary?
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Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
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Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?
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Administrative Issues: My institution is not serving as a Reviewing IRB for the NIH nor is it ceding IRB review to the NIH Intramural Research Program IRB. Does my institution need to sign SMART IRB Agreement v2.0?
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Administrative Issues: If my institution serves as a Reviewing IRB for the NIH engaged and for other institutions engaged in the Research, would all of the institutions engaged in that Research need to sign SMART IRB Agreement v2.0?
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Administrative Issues: Does my institution need to re-execute a Joinder Agreement to sign Version 2.0 of the SMART IRB Agreement?
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Administrative Issues: Re-execution of a Joinder Agreement to sign Agreement v2.0 & satisfaction of Section 1.2, HRPP Quality
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Administrative Issues: Does my institution need to document which version of the SMART IRB Agreement covers each of our reliance arrangements in effect?
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Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?
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Non-Interference with Requirements of Law: What must a Participating Institution do if it determines that complying with a provision of the Agreement will cause it to be in violation of applicable law, regulation, or other federal or state requirements?
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Non-Interference with Requirements of Law: What violations or conflicts are addressed in the new Section 8.10?
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Non-Interference with Requirements of Law: What change is effected through the new Section 8.10, No Violation of Law?
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Congruence of Grant Applications/Contract Proposals: Why does SMART IRB Agreement v2.0 retain Section 5.15, Congruence of Grant Applications/Contract Proposals?
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Conflicts of Interest: How do the changes in the conflict of interest provisions reflected in SMART IRB Agreement v2.0 affect institutions that are not collaborating with a federal agency?
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Conflicts of Interest: Is the language in Sections 5.8 and 6.6 of SMART IRB Agreement v2.0 relating to assurance to the Reviewing IRB of satisfaction of investigator conflict of interest policies from the NIH compliant with AAHRPP standards?
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Conflicts of Interest: Single IRB requirements when the Reviewing IRB cannot rely upon the COI assurances from NIH
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Conflicts of Interest: If a Reviewing IRB concludes that it cannot rely upon the conflict of interest assurances from a Relying Institution that is a federal agency, can the Research be withdrawn from Ceded Review with respect to that agency?
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Conflicts of Interest: Under SMART IRB Agreement v2.0, will a Reviewing IRB be able to impose additional, more stringent prohibitions or management plans related to conflicts of interest of federal agency Research Personnel?
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Conflicts of Interest: When a federal agency is a Relying Institution
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Insurance: Can NIH provide additional detail specifying which people affiliated with NIH are (or are not) covered under NIH’s federal liability coverage?
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Insurance: How does the addition of the footnote in SMART IRB Agreeemnt v2.0, Section 4.10, Insurance, affect the Agreement’s insurance provision?
