DOE Policy on the Protection of Human Subjects

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DOE POLICY ON THE PROTECTION OF HUMAN SUBJECTS for implementing policy set forth in 10 CFR Part 745 (as amended), Protection of Human Subjects. SCOPE. The provisions o f this Order apply to all Departmental Elements and all contractors and financial assistance recipients performing work for the Department, as provided by law and/or contract, and as implemented by the appropriate contracting officer. This includes non-DOE funded work at DOE owned, leased, or controlled facilities. To establish the Department’s responsibilities and authorities DOE 4300.2A, NON-DEPARTMENT OF ENERGY FUNDED WORK, o f 12/19/86, which establishes the pol icy, responsibilities, and procedures for authorizing and administering non-DOE funded work performed under 10 CFR Part 600, DOE Financial Assistance Regulations, which provides the policies and procedures for administration and management o f all DOE f inanci a1 assistance activities. 10 CFR Part 605, Office of Energy ,Research Special Research Grants Program Regulations, which provides the policies and procedures for the administration and management of basic and applied research grants awarded by the Office of Energy Research. -. agencies and departments conducting human subject research. This order BACKGROUND. In December, 1981, the President’s Comnission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended and proposed a uniform set of regulations, based on those of the Department of Health and Human Services, to be adopted by all Federal implements that model policy within the Department.n 10 CFR Part 745, (to be amended), Protection of Human Subjects, which sets out DOE’S regulations for protection o f human subjects involved in research activities. Chapter 9 o f Title 4 8 o f the Code o f Federal Regulations entitled the Department of Energy Acquisition Regulations (DEAR), which provides the contracting policies established for DOE. Report o f the National Commission for the Protection o f Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”), which recommended that a national pol icy be established for the protection of human subjects involved in Federally sponsored or sanctioned research.

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a . Assurance (Multiple Projects, Single Project o r Other Types o f projects) means the written documentation, satisfactory to the DOE Secretary, required from the prospective performing institution that assures institutional compliance with and implementation of DOE regulations for the protection o f human research subjects. Certification the official notification by the institution t o the Department o f Energy that a research project or activity involving human subjects has been reviewed and approved by an Institutional Review Board in accordance with an approved assurance. c. Cognizant Contracting Officer is a person designated by DOE to enter into and/or review, modify, or terminate contracts, financial assistance awards, and sales contracts and make related determinations and findings. d. DOE Contractors are entities who receive awards from DOE including MbO (managing and operating) contractors, which manage, operate or provide site services to DOE research or production facilities that are principally engaged in work for the Department. e. DOE Facilities are any o f the DOE-owned, leased or controlled f. Field Orqanization is a general term for any officially established Departmental component (excludes individual duty stations) located outside the Washington, D.C. metropolitan area. g. Human Sub'ect a living individual about whom an investigator -essional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) ident if iabl e private information. physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. "Interaction" includes comnunication or interpersonal contact between investigator behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity o f the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. h. Informed Consent Documents are the legally effective informed consents obtained by the investigator from the human subjects in the research covered by this policy. The requirements for informed consent are contained in 10 CFR Part 745 (as amended).

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Institution is any public or private entity or agency (including Federal, state, and other agencies). Institutional Review Board (IRB) i s a board or committee charged with the responsibility for review of research activities involving human subjects conducted at, or sponsored by, the institution and approved by the Health and Human Services (HHS) or the DOE. The composition of the IRB and details o f its procedures and responsibilities are specified in 10 CFR Part 745 (as amended) and included in the multiple, single, or other project assurance. k. IRB a roval is the determination o f the IRB that the research has &d and may be conducted at an institution or facility within the constraints set forth by the I R B and by other institutional and Federal requirements. 1. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance o f routine physical or psychological examinations or tests. m. Manaqement and Operatinq Contractors are those contractors designated by the Secretary in accordance with DOE policies. Non-DOE Entities include other Federal agencies, State, regional and local governments; educational institutions; private individuals, commercial firms, non or not-for-profit organizations; international bodi es ; and, foreign governments, individual s , firms, 0 . Non-DOE Funded Work is any work performed for non-DOE entities that utilizes DOE facilities or contractor personnel and which is not funded, wholly or in part, by DOE. p. Program Secretarial Officer is a Secretarial Officer o f the c Department who has responsibility for R&D missions and q. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for purposes o f this order, whether or not they are conducted under a program which is considered research for other purposes. "service" programs may include research activities. For example, some "demonstration" and 6. POLICY. It is the policy of the Department o f Energy that: a. The rights and welfare of human subjects involved in research supported or sanctioned by D O E be protected in accordance

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b. Until the requirements o f this order and 10 CFR 745 (as amended) have been met, no research activity involving human subjects shall be i ni ti ated . 7. RESPONSIBILITIES AND AUTHORITIES. a. The Secretary. Establishes Department o f Energy policy for the protection o f human subjects in accordance with 10 CFR 745 (as b. The Director of Energy Research (ER-11 is responsible for the implementation of 10 CFR 745 (as amended) within the Department. c. The Associate Director for Health and Environmental Research (ER-70). I) Developes, and assures the implementation of, procedures on the protection of human subjects. 2) Prepares and updates guidance to be followed for obtaining approval for human subject research. 3) Approves all human subject assurances, negotiatbn, and -y evaluation processes. ER-70 may delegate authority for the evaluation and negotiation processes to the Heads o f .-*..-..b4) Reviews all research with human subjects to ascertain compliance I,/ with WE regul at i ons and orders and appl i cab1 e Federal regul at ions. In a timely fashion, approves, rejects, or requests additional information on proposed work and provides written determination of human subject compliance to the Program Secretarial Officer or appropriate Head of Field Organization. 5) Investigates allegations of noncompliance with 10 CFR 745 (as amended) and this order, and recommends t o the Program Secretarial Office (PSO) or Head of Field organization appropriate action required. 6) Serves as the official DOE representative on the Interagency Human Subjects Coordinating Committee. d . Program Secretarial Officers or their Desiqnees. 1) Implement the procedures established by ER-70. 2) Review all proposals and applications to identify research involving human subjects. 3) In accordance with procedures developed by ER-70, request 4) Supply ER-70's determination of compliance with 10 CFR 745 (as amended) t o the Cognizant Contracting Officer.

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5) Review annual progress reports f o r human subject activities and review for acceptance/disapproval annual certification o f 6) Promptly notify ER-70 o f known or potential adverse human 7) Require all progress reports from entities performing research t o address human subject activities. e. Heads of DOE Field Organizations. 1) Fulfill responsibilities o f PSO for non-DOE funded work at DOE owned o r leased facilities. 2) Fulfill all responsibilities o f PSO for DOE-funded work originating in the field office or Government-owned Government-operated faci 1 it i es . f . Cognizant Contracting Officers. 1) Include in all solicitations a provision requiring human subject research information in accordance with 10 CFR 745 (as amended). 2) Assure that all Departmental human subjects requirements as stated in this order and in 10 CFR 745 (as amended) have been met prior to t o the execution o f each award identified as involving human in all awards. 3) Incorporate the requirement to comply with 10 CFR 745 (as amended)