IRB Review Considerations for Cooperative Research Sample Clauses

IRB Review Considerations for Cooperative Research. OHRP notes that multiple institutions may be engaged in the same non-exempt human subjects research project. For such cooperative research projects, institutions may enter into joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements to avoid duplication of effort, in accordance with HHS regulations at 45 CFR 46.114.
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Related to IRB Review Considerations for Cooperative Research

  • Scope of Cooperation 1. The Authorities recognise the importance of close communication concerning the Covered CCPs and intend to cooperate regarding: a) general issues, including with respect to regulatory, supervisory, enforcement or other developments concerning the Covered CCPs and Australia; b) issues relevant to the operations, activities and services of the Covered CCPs; c) the coordination of supervisory activities and, where appropriate and consistent with applicable laws and each Authority’s mandate, providing assistance in the implementation of enforcement decisions; d) any other areas of mutual interest. 2. The Authorities recognise in particular the importance of close cooperation in the event that a Covered CCP, particularly one whose failure likely would be systemically important to an Authority, experiences, or is threatened by, a potential financial crisis or other Emergency Situation. One or both of the Local Authorities should provide notification to ESMA, and ESMA should provide notification to the Local Authorities, consistent with Article 3(4) below and each Authority should keep the other Authorities appropriately informed throughout the Emergency Situation. The Local Authorities should coordinate and lead in an Emergency Situation and should consult with and take account of the views of ESMA to the greatest extent practicable. ESMA should coordinate with the relevant CBI(s) regarding an Emergency Situation of a Covered CCP and any emergency measures that the CBI may consider appropriate. 3. Cooperation will be most useful in circumstances where issues of regulatory, supervisory or enforcement concern may arise, including but not limited to: a) the initial application of a Covered CCP for recognition in the European Union pursuant to Article 25 of EMIR and the periodic reviews of its recognition pursuant to Article 25(5) of EMIR; b) ESMA’s assessment of compliance and monitoring of the ongoing compliance by a Covered CCP with the Recognition Conditions; c) the tiering determination of a Covered CCP by ESMA pursuant to Article 25(2a) of EMIR; d) changes in a Covered CCP's internal rules, policies and procedures that could affect the way in which the Covered CCP complies with any Recognition Conditions; e) regulatory, supervisory or enforcement actions or approvals taken by a Local Authority or ESMA in relation to a Covered CCP, including changes to the relevant obligations and requirements to which the Covered CCPs are subject that may impact the Covered CCPs' continued compliance with the Recognition Conditions; and f) changes to regulatory status or requirements that could result in a change in the regulatory status of, relief granted to, or supervisory treatment of a Covered CCP and potentially could disrupt cross-border clearing arrangements.

  • Considerations on Review In considering the review, the Plan Administrator shall take into account all materials and information the claimant submits relating to the claim, without regard to whether such information was submitted or considered in the initial benefit determination.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Cooperation with Inspector General Grantee understands its duty, pursuant to Section 20.055(5), Fla. Stat., to cooperate with Florida Housing’s Inspector General in any investigation, audit, inspection, review, or hearing. Grantee will comply with this duty and ensure that any contracts issued under this Agreement impose this requirement, in writing, on its subcontractors.

  • Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

  • Procurement Related Complaints and Administrative Review 49.1 The procedures for making a Procurement-related Complaint are as specified in the TDS. 49.2 A request for administrative review shall be made in the form provided under contract forms.

  • Labor Cooperation The Parties shall enhance their communication and cooperation on labor, social security and environment issues through Memorandum of Understanding on Labor Cooperation between the Government of the People's Republic of China and the Government of the Republic of Peru.

  • Assistance and Cooperation (a) Each of the Companies shall provide (and shall cause its Affiliates to provide) the other Companies and their respective agents, including accounting firms and legal counsel, with such cooperation or information as they may reasonably request in connection with (i) preparing and filing Tax Returns, (ii) determining the liability for and amount of any Taxes due (including estimated Taxes) or the right to and amount of any refund of Taxes, (iii) examinations of Tax Returns, and (iv) any administrative or judicial proceeding in respect of Taxes assessed or proposed to be assessed. Such cooperation shall include making available, upon reasonable notice, all information and documents in their possession relating to the other Companies and their respective Affiliates as provided in Section 9. Each of the Companies shall also make available to the other Companies, as reasonably requested and available, personnel (including employees and agents of the Companies or their respective Affiliates) responsible for preparing, maintaining, and interpreting information and documents relevant to Taxes. (b) Any information or documents provided under this Section 8 or Section 9 shall be kept confidential by the Company or Companies receiving the information or documents, except as may otherwise be necessary in connection with the filing of Tax Returns or in connection with any administrative or judicial proceedings relating to Taxes. Notwithstanding any other provision of this Agreement or any other agreement, in no event shall any of the Companies or any of their respective Affiliates be required to provide the other Companies or any of their respective Affiliates or any other Person access to or copies of any information if such action could reasonably be expected to result in the waiver of any Privilege. In addition, in the event that any of the Companies determine that the provision of any information to the other Companies or their respective Affiliates could be commercially detrimental, violate any law or agreement or waive any Privilege, the Parties shall use reasonable best efforts to permit compliance with their obligations under this Section 8 or Section 9 in a manner that avoids any such harm or consequence.

  • Labor-Management Cooperation When an Appointing Authority initiates a planning process or management study which is anticipated to result in layoff, the Appointing Authority will meet and confer with the Local Union during the decision planning phase and again during the implementation planning phase. The Appointing Authority and the Local Union shall enter into negotiations regarding a Memoranda of Understanding upon request of either party to modify this Agreement regarding the implementation plans which shall include, but are not limited to, the following: • Length of layoff notice; • Job and retraining opportunities; • Alternative placement methods; • Early retirement options pursuant to M.S. 43A.24, Subd. 2(i); • Bumping/vacancy options for part-time employees to preserve their insurance eligibility or contribution; and • Other methods of mitigating layoff or their effect on employees.

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