[Code of Federal Regulations] [Title 42, Volume 1] [Revised as of October 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR50.603] [Page 152-153] TITLE 42--PUBLIC HEALTH CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents Subpart F_Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought Sec. 50.603 Definitions. As used in this subpart: HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated. Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency). Investigator means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. For purposes of the requirements of this subpart relating to financial interests, ``Investigator'' includes the Investigator's spouse and dependent children. PHS means the Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated. PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart. Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq. Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development. As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority. Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., [[Page 153]] stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include: (1) Salary, royalties, or other remuneration from the applicant institution; (2) Any ownership interests in the institution, if the institution is an applicant under the SBIR Program; (3) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; (4) Income from service on advisory committees or review panels for public or nonprofit entities; (5) An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or (6) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000. 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. L. 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program includes the Small Business Technology Transfer (STTR) Program, which was established by Pub. L. 102-564.