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B U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50) TITLE 42âPUBLIC HEALTH CHAPTER IâPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER DâGRANTS PART 50âPOLICIES OF GENERAL APPLICABILITY Subpart FâResponsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought Sec. 50.601 â Purpose. 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. Sec. 50.602 â Applicability. This subpart is applicable to each Institution that applies for PHS grants or cooperative agreements for research and, through the implementation of this subpart by each Institution, to each Investigator participating in such research (see Sec. 50.604(a)); provided that this subpart does not apply to SBIR [Small Business Innovation Research] Program Phase I applications. In those few cases where an individual, rather than an institution, is an appli- 295
296 CONFLICT OF INTEREST cant for PHS grants or cooperative agreements for research, PHS Awarding Components will make case-by-case determinations on the steps to be taken to ensure that the design, conduct, and reporting of the research will not be biased by any conflicting financial interest of the individual. [p35816] Sec. 50.603 â 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 or- ganization (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 sub- part relating to financial interests, âInvestigatorâ includes the Investigatorâs spouse and dependent children. PHS means the Public Health Service, an operating division of the U.S. De- partment 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 contrib- ute 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., stocks, stock options or other own-
APPENDIX B 297 ership 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 ap- plicant 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 Investigatorâs 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 Inves- tigator and the Investigatorâs 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 es- tablished by Pub. L. 102-564. Sec. 50.604 â Institutional responsibility regarding conflicting interests of investigators. Each Institution must: (a) Maintain an appropriate written, enforced policy on conflict of interest that complies with this subpart and inform each Investigator of that policy, the Investigatorâs reporting responsibilities, and of these regulations. If the Institution carries out the PHS-funded research through subgrantees, contractors, or collaborators, the Institution must take reasonable steps to
298 CONFLICT OF INTEREST ensure that Investigators working for such entities comply with this sub- part, either by requiring those Investigators to comply with the Institutionâs policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with this subpart. (b) Designate an institutional official(s) to solicit and review financial dis- closure statements from each Investigator who is planning to participate in PHS-funded research. (c)(1) Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) That would reasonably appear to be affected by the research for which PHS funding is sought; and (ii) In entities whose financial interests would reasonably appear to be af- fected by the research. (2) All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. (d) Provide guidelines consistent with this subpart for the designated official(s) to identify conflicting interests and take such actions as neces- sary to ensure that such conflicting interests will be managed, reduced, or eliminated. (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) for different situations. (f) Establish adequate enforcement mechanisms and provide for sanctions where appropriate. (g) Certify, in each application for the funding to which this subpart ap- plies, that: (1) There is an effect at that Institution a written and enforced administra- tive process to identify and manage, reduce or eliminate conflicting interests
APPENDIX B 299 with respect to all research projects for which funding is sought from the PHS, (2) Prior to the Institutionâs expenditure of any funds under the award, the Institution will report to the PHS Awarding Component the existence of a conflicting interest (but not the nature of the interest or other details) 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 Institutionâs 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) The Institution will otherwise comply with this subpart. [p35817] Sec. 50.605 â Management of conflicting interests. (a) The designated official(s) must: Review all financial disclosures; and determine whether a conflict of interest exists and, if so, determine what actions should be taken by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) Public disclosure of significant financial interests; (2) Monitoring of research by independent reviewers; (3) Modification of the research plan; (4) Disqualification from participation in all or a portion of the research funded by the PHS; (5) Divestiture of significant financial interests; or (6) Severance of relationships that create actual or potential conflicts.
300 CONFLICT OF INTEREST (b) In addition to the types of conflicting financial interests described in this paragraph that must be managed, reduced, or eliminated, an Institution may require the management of other conflicting financial interests, as the Institution deems appropriate. Sec. 50.606 â Remedies. (a) If the failure of an Investigator to comply with the conflict of interest policy of the Institution has biased the design, conduct, or reporting of the PHS-funded research, the Institution must promptly notify the PHS Awarding Component of the corrective action taken or to be taken. 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. (b) The HHS may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in PHS-funded research, including a requirement for submission of, or review on site, all records pertinent to compliance with this subpart. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records and/or other information that may be available, the PHS Awarding Component may decide that a particular con- flict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict of interest in accordance with this subpart. The PHS Awarding Component may determine that suspension of funding under 45 CFR 74.62 is necessary until the matter is resolved. (c) In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or re- ported by an Investigator with a conflicting interest that was not disclosed or managed as required by this subpart, the Institution must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research. Sec. 50.607 â Other HHS regulations that apply. Several other regulations and policies apply to this subpart. They include, but are not necessarily limited to:
APPENDIX B 301 42 CFR Part 50, Subpart DâPublic Health Service grant appeals procedure 45 CFR Part 16âProcedures of the Departmental Grant Appeals Board 45 CFR Part 74âUniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non- Profit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments 45 CFR Part 76âGovernment-wide debarment and suspension (non-procurement) 45 CFR Part 79âProgram Fraud Civil Remedies 45 CFR Part 92âUniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments