DECEMBER 2023 COGR UPDATE President’s Message - Reflections, Updates, & Gratitude

Other issues we raised in our feedback included: • the use of many undefined terms; • the extraordinary degree of due diligence required in the intermediary certification requirement; • the designation of institution Authorized Organization Representatives (AORs) as responsible officials for disclosures; • the reporting of multiyear gifts and contracts; • the lack of explicit exemption of tuition. [...] Whether action may be needed to meet the needs of the Government or protect the public against nonuse or unreasonable use of the subject invention may include consideration of factors that unreasonably limit availability of the invention to the public, including the reasonableness of the price and other terms at which the product is made available to end-users5.” As noted in COGR’s June 2023 updat. [...] The applicability of the requirements to research contracts where ICT may be used in the performance of the research is uncertain. [...] In addition, both the June and October COGR Meetings featured updates on the results of the F&A survey, and both the June presentation and the October presentation include analyses that may of interest to the COGR membership. [...] 495, and the PHS Policy on the Human Care and Use of Laboratory Animals.” COGR submitted comments objecting to the proposed disclaimer because it incorrectly suggests that OLAW, through guidance, can add to or increase the requirements of its underlying statutory/policy authority (i.e., the Health Research Extension Act of 1985 and the PHS Policy on the Humane Care and Use of Laboratory Animals).