Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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Appendix B: U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50)
Appendix B: U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50)
Pages 295-301
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This subpart promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS [Public Health Service] grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator.
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Public Health Service Act or PHS Act means the statute codified at 42 U.S.C.
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Small Business Innovation Research (SBIR) Program means the extramural research program for small business that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Pub.
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(e) Maintain records of all financial disclosures and all actions taken by the Institution with respect to each conflicting interest for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 74.53(b)
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found by the institution and assure that the interest has been managed, reduced or eliminated in accordance with this subpart; and, for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification; (3) The Institution agrees to make information available, upon request, to the HHS regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias; and (4)
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The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project.
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APPENDIX B 301 42 CFR Part 50, Subpart D–Public Health Service grant appeals procedure 45 CFR Part 16–Procedures of the Departmental Grant Appeals Board 45 CFR Part 74–Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other NonProfit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments 45 CFR Part 76–Government-wide debarment and suspension (non-procurement) 45 CFR Part 79–Program Fraud Civil Remedies 45 CFR Part 92–Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments
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