Local Considerations. Communicate to the Reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, relevant to the Research (“Local Considerations”) that would affect the conduct or approval of the Research at the Relying Institution. Such communication may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research.
Local Considerations. With respect to Research submitted for Ceded Review, a Relying Institution will identify, interpret (as necessary), and communicate to the Reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews; any federal department- or agency-specific requirements; and the requirements of any applicable federal laws or regulations other than the Federal Policy, other federal human subjects protection regulations or policies, and the FDA Clinical Investigation Regulations that would affect the conduct by or approval of the Research on behalf of the Relying Institution (“Local Considerations”). Such communication may be made through the Reviewing IRB’s designee, if agreed by the relevant Relying Institution(s) in connection with the instance of Research. Notwithstanding anything else in this Section 6.6, for purposes of this Agreement, HIPAA and its requirements are not considered Local Considerations and are addressed separately in Section 4.4 hereof.
Local Considerations. Two Types of PoDIs The Oklahoma Division Office has identified two types of PoDIs, PODIs Emphasized and PoDIs selected based on an Activity/Phase. PoDIs (Emphasized): These are usually projects that have an elevated risk or contain elements of higher risk. For these projects, the Division Office will focus on a large number of preconstruction and construction activities/phases for a given year. The Oklahoma Division Office Area Engineers are responsible for providing oversight on these projects. Each Area Engineer will typically have 3 to 4 emphasized PoDIs (1 to 2 per ODOT field division). These PoDIs are selected by the Area Engineers from the pool of PoDIs identified in the screening process. A PoDI (Emphasized) Project list is developed and provided to the ODOT Project Management Division prior to June 1st. PoDIs (selected based on an Activity/Phase): In a separate process from PoDI selections, the Area Engineers and Program Specialist in the Oklahoma Division Office identify Activities/Phases to review in the upcoming performance year. The activities/phases are typically selected through the Oklahoma Division Office’s annual risk assessment based on the results of past reviews (PoDI and/or CAP), length of time since activity/phase was last reviewed (cyclical approach), and/or other means that the phase/activity was identified as a risk. With the cyclical approach, activities/phases will be rotated through a three to four-year cycle and chosen based on the cycle. The activities/phases are then used to select projects from the pool of PoDIs identified in the screening process. For some activities/phases, the pool of PoDIs may not provide adequate projects to review for a particular activity/phase and therefore, additional projects may need to be added to the PoDI pool. Also, it may be necessary to drop and add projects throughout the year for an activity/phase due to a variety of reasons. As this process is being completed, the PoDI Tracker will be updated to reflect any updates of PoDIs and activities/phases. To make it as simple as possible for ODOT to know what information to provide the Oklahoma Division Office for PoDIs selected based on an activity/phase, the following approach will be taken: • Preconstruction Activities/phases: For these activities/phases, the Oklahoma Division Office will provide Project Management and Local Government Divisions the PoDIs and activities/phases being reviewed that performance year. • Construction Activities/phase...
Local Considerations. Communicate to the Reviewing IACUC the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, relevant to the Research (“Local Considerations”) that would affect the conduct or approval of the Research at the Relying Institution. Such communication may be made through the Reviewing IACUC designee, as determined by the Participating Institutions in connection with the specific Research.
Local Considerations. With respect to Research submitted for Ceded Review, a Relying Institution will identify, interpret (as necessary), and Ccommunicate to the Reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews,; any federal department- or agency-specific requirements; and the requirements of any applicable federal laws or regulations other than the Federal Policy, other federal human subjects protection regulations or policies, and the FDA Clinical Investigation Regulations relevant to the Research that would affect the conduct by or approval of the Research on behalf of the Relying Institution (“Local Considerations”) that would affect the conduct or approval of the Research at the Relying Institution. Such communication may be made through the Reviewing IRB’s designee, as determinedif agreed by the relevant Participating Relying Institution(s) in connection with the specificinstance of Research. Notwithstanding anything else in this Section 6.6, for purposes of this Agreement, HIPAA and its requirements are not considered Local Considerations and are addressed separately in Section 4.4 hereof.
