Common use of Protection of Human Subjects and Appropriate Care of Laboratory Animals Clause in Contracts

Protection of Human Subjects and Appropriate Care of Laboratory Animals. All human clinical trials performed under this CRADA shall conform to the appropriate Federal law, including, but not limited to all applicable FDA regulations and DHHS regulations relating to the protection of human subjects (see 45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56). NCI and Collaborator also agree to comply with all applicable Federal statutes and Public Health Service policies relating to the use and care of laboratory animals (see 7 U.S.C. 2131 et seq.) Additional information is available from the Office for Human Research Protections, Telephone: 300-000-0000. In accordance with the HHS Office for Human Research Protections guidelines, private patient identifiable information shall only be used by Collaborator for licensing applications to the FDA, if required. All other uses of information under this Agreement shall assure that no private patient identifiable information is disclosed.

Protection of Human Subjects and Appropriate Care of Laboratory Animals. All human clinical trials performed under this CRADA shall conform to the appropriate Federal law, including, but not limited to all applicable FDA regulations and DHHS regulations relating to the protection of human subjects (see 45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56). NCI and Collaborator also agree to comply with all applicable Federal statutes and Public Health Service policies relating to the use and care of laboratory animals (see 7 U.S.C. 2131 et seq.) Additional information is available from the Office for Human Research Protections, Telephone: 300000-000-0000. In accordance with the HHS Office for Human Research Protections guidelines, private patient identifiable information shall only be used by Collaborator for licensing applications to the FDA, if required. All other uses of information under this Agreement shall assure that no private patient identifiable information is disclosed.

Protection of Human Subjects and Appropriate Care of Laboratory Animals. All human clinical trials performed under this CRADA shall conform to the appropriate Federal law, including, but not limited to all applicable FDA regulations and DHHS regulations relating to the protection of human subjects (see 45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56). NCI and Collaborator also agree to comply with all applicable Federal statutes and Public Health Service policies relating to the use and care of laboratory animals (see 7 U.S.C. 2131 et seq.) Additional information is available from the Office for Human Research Protections, Telephone: 300-000-0000. In accordance with the HHS Office for Human Research Protections guidelines, private patient identifiable information shall only be used by Collaborator for licensing applications to the FDA, if required. All other uses of information under this Agreement shall assure that no private patient identifiable information is disclosed.. NCI CRADA 01030