Human Subject Research at SSRL (Various Handwritten Notes, Reports, and Correspondence)

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Department of Energy San Francisco Operations Office Chairman, Safety Comnittee Stanford Synchrotron Radiation Laboratory Thank you for clarifying the situation at SSRL concerning the use of human assurance that there is no work involving the use of human subjects going on Human Subject Research a t SSRL + subjects.I spoke with Dr. Susan Rose this morning and relayed t o her your For reference, enclosed are copies o f two letters recently sent to Dr. Burton Richter and Eugene Rickansrud and DOE Order 1300.3 (8-23-90) - - Policy on t h e Protection of Human Subjects.’ Additionally, Dr. Rose’s address and telephone number a r e included below. Thank you again f o r your help. I Energy Research Division Enclosures: As stated Radon Program Manager Human Health and Assessments Division Office of Health and Environmental Research U.S. Department of Energy

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Department of Energy San Francisco Operations Office Business Services Division Stanford Linear Accelerator Center Subject: DOE Order 1300.3 - Policy on t h e Proteation of Human Subjects The subject Directive is provided t o you for Information, by authority of SAN If you have questions i n regard to this DOE Order please feel free t o call Joseph Aaron of t h e Energy Research Division on (415) 273-6421. Joann P. van Guillory, Aating Director Contracts i4ana gement D iv i sion

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Stanford Linear Accelerator Department of Energy Some time ago the Office of Energy Research wrote to the Managers of the Department o f Energy (DOE) Operations Offices in reference to draft DOE Order 1300, "Policy on the Protection of Human Subjects." this Office has the responsibility for assuring appropriate implementation and compliance for the entire DOE system. for a point of contact for human subject research related activities, and have subsequently asked a number o f DOE contractors to identify individuals within their organizations who could be similar points of contact. In an effort to reach all DOE and DOE contractor organizations regarding this program, I am writing you to ask that if y o u r organization may be involved in any human subject research, even as a collaborator, you name an individual as a point o f Under the draft Order, We have asked the operations offices - Human subject research responsibi 1 ities in the Department have been assigned Health and Environmental Research. Please provide her, i n writing, the name of a point o f contact for these activities withid your office. If you do not ,have human subject research, according t o the definition provided i n the attached federal Model Policy, please so state in writing to Or- hsp. For your information, I have enclosed the November 10, 1988, Federal Reaister notice o f proposed rulemaking for the "Protection of Human Subjects." The final version of this notice will replace the current DOE CFR Part 745 (enclosed), and will be the policy under which DOE facilities will operate. Also enclosed is a draft of DOE Order 1300, "Policy on t h e Protection o f Human Subjects," which is expected t o be published in the near future. Office o f Energy Research . San Francisco Operations Office

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. US. Department of Energy SUBJECT: POLICY ON THE PROTECTION OF HUMAN SUBJECTS policy set forth in 10 CFR Part 745, Protection of Human Subjects. To establish the Department‘s responsibilities for implementing and a1 1 contractors and subcontractors performing work for the Department, as provided by law and/or contract, and as implemented by the appropriate -leased, or -control 1 ed facil i ties. The provisions o f this Order apply to all Departmental Elements This includes non-DOE funded work at DOE-owned, a. DOE 4300.2A, NON-DEPARTMENT OF ENERGY FUNDED WORK, o f 12-19-86, which establishes the policy, responsibilities, and procedures for authorizing and administering non-DOE funded work performed under DOE contracts. Title 10 CFR Part 600, DOE financial Assistance Regulations, which provides the pol icies and procedures for administration and management o f all DOE financial assistance activities. Title 10 CFR Part 605, Office of Energy Research Special Research Grants Program Regulations, which provides the policies and procedures for the administration and management o f basic and applied research grants awarded by the Office of Energy Research. d . Title 10 CFR Part 745, Protection o f Human Subjects, which sets out DOE’S regulations for protection of human subjects involved in research act i vi ties . e. Chapter 9 o f Title 48 of the Code of Federal Regulations, Department o f Energy Acquisition Regulations (DEAR), which provides the contracting policies established for DOE. Ethical Problems i n Medicine and Biomedical and Behavioral Research recommended and proposed a uniform set o f regulations, based on those o f the Department of Health and Human Services, t o be adopted by all Federal agencies and departments conducting human subject research. A proposed model Federal Policy for the protection of human subjects was published in In December 1981, the President’s Commission for the Study o f A1 1 Departmental Elements INITIATED BY: Office of Energy Research

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the Federal Reqister on November 10, 1988, establishing this uniform set of regulations as a common rule. currently written, and at such time that it is amended to conform with the This Order implements 10 CFR Part 745, as documentation, satisfactory to the Secretary of Energy, required from the prospective performing institution that assures institutional compliance with and implementation of DOE regulations for the protection o f human b. Certification is the official notification by the institution to DOE i n accordance with the requirements o f 10 CFR Part 745, that a research. project or activity involving human subjects has been reviewed and approved by a n Institutional Review Board in accordance with an approved c. Contractins Officer is a person authorized to enter into, administer, or terminate contracts, financial assistance awards, and sales contracts and to make related determinations and findings. d. DOE Contractors are entities who receive awards from DOE, including management and operating contractors (M&O) , which manage, operate, or provide site services t o DOE research or production facilities that are princiFally engaged i n work for the Department. f. Field Orqanization ! s a general term for any officially established Departmental component (excludes individual duty stations) located outside the Washington, D.C., metropolitan area. Human Subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. "Intervent ion" includes both 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.

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includes communication or interpersonal contact between investigator and subject. "Private information" includes information about 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, Private information must be individuallya medical record). ascertained by the order for obtaining Informed Consent is subject, or the sub the identity of the subject is or may readily be nvestigator or associated with the information) in the information to constitute research involving the legally effective consent by t h e human research ect's legally authorized representative, to participate i n research covered under this policy. after providing t o the subject the basic elements of informed consent as set forth i n 10 CFR Part 745. include disclosure of all potential risks and related consequences or adverse effects, as well as any benefits that may occur as a result of Institution is any public or private entity or agency (including Federal, State, and other agencies). Institutional Review Board (IRBI is a board or committee charged with the responsibility for review o f research activities involving human subjects conducted at, or sponsored by, the institution and approved by the Department o f Health and Human Services (HHS) or.the DOE. The composition of the IRB and details of its procedures and responsibilities are specified in 10 CFR Part 745 and included in the multiple, single, or other project assurance. IRB ADDrOVa'l is the determination of the IRB that the research has been reviewed and may be conducted at an institution or facility within the constraints set forth by the I R B and by other institutional and Minimal Risk means that the probability and magnitude o f harm o r discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or Manasement and Ooerat incl Contractors are those contractors designated by the Secretary in accordance with DOE policies. It is obtained Informed consent documents shall

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n. Non-DOE Entities include other Federal agencies, State, regional , and international bodies; and foreign governments, individuals, firms, or 0. Non-DOE Funded Work is any work performed for non-DOE entities that utilize DOE facilities or contractor personnel and which i s not funded, wholly or in part, by DOE. p . Prosram Secretarial Officer (PSOI is a Secretarial Officer o f the Department who has responsibility for research and development missions and Departmental programs. q. Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to constitute "research" for purposes of this Order, whether or not they are conducted under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. Activities which meet this definition 6. POLICY. It is the policy of the Department of Energy that: a. The rights and welfare o f human subjects involved in research supported or sanctioned by DOE be protected in accordance with 10 CFR 7 4 5 . b . Until the requirements of this Order and 10 CFR 7 4 5 have been met, no research activity involving human subjects shall be initiated. 7. RESPONSIBILITIES AND AUTHORITIES. a . The Secretary establishes Department of Energy policy for the protection of human subjects consistent with 10 CFR 7 4 5 . b . Director of Enerqv Research ( E R - 1 2 i s responsible for the implementation o f 10 CFR 745 within the Department in accordance with policy established by the Secretary. c. Associate Director for Health and Environmental Research (ER-70). ( 3 ) Develops and implements procedures on the protection o f human o f (2) Prepares and updates guidance to be followed for obtaining approval for human subject research.

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(3) Approves all human subject as swan ces, negotiations, and evaluation and negotiation processes to the Heads of Field ER-70 may delegate authority for the ( 4 ) Reviews all research with human subjects for compliance with DOE regulations and Orders and applicable Federal regulations. In a timely fashion, approves, rejects, or requests additional information on proposed work and provides written determination of human subject compliance to the PSO or appropriate Head o f Field Investigates allegations of noncompliance with 10 CFR 745 and this Order, and recommends to the PSO or Head of Field Organization appropriate action required. (6) Serves as the official DOE representative on the Interagency Human Subjects Coord i nat i ng Commi t tee. d. Proqram Secretarial Officers or their Desiqnees. Implement the procedures establ i shed by ER-70. Review all proposals and applications to identify research involving human subjects. (3) In accordance with procedures developed by ER-70, request determination of compliance by ER-70. ( 4 ) Supply ER-70's determination o f compliance with 10 CFR 745 to the cognizant contracting officer. (5) Promptly notify ER-70 o f known or potential adverse human health effects and issues o f non-compliance in 10 CFR Part 745. e. Heads of Field Oraanizations or their Desianees. (1) Fulfill responsibilities of PSO's under paragraph 7d for non-DOE funded work at DOE-owned or -leased facilities. funded work originating in the field office o r Government-owned

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(1) Include in appropriate solicitations a provision requiring human subject research information in accordance with 10 C F R 745. (2) Require receipt o f complete assurance, certification, and ER-70 human subject approval documents, prior to initiation o f research involving human subjects. BY ORDER OF THE SECRETARY OF ENERGY : Director o f Administration and Human Resource Management

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CERTIFICATION OF HUMAN SUBJECTS APPROVAL Department of Medicine FROM: Chairman, Administrative Panel o n Human Subjects in Medical Research T h e Panel approved human subjects involvement in your research project on T h e expiration date of this approval is January 2, 1990. I f this project is t o continue beyond that date, please submit a n updated proposal in advance for the Panel's re-approval. I f this proposal is used in conjunction with any other human txpcrimentation or if it is modified in any way, i t must b e reapproved for these special circumstances. In addition, the Panel reguests prompt notification of any complications which may occur during any experiA l l continuing projects and activities must b e reviewed and re-approved at least annually by the Panel. Panel approval o f any project is f o r a maximum period of one year. I t is the responsibility ofthe investigator t o resubmit the project to the Panel for annual review. Period of Time : 01/03/89 throuph 01/02/90 Full Board Review

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Protocol: K-Edge Subtraction Angiography with Synchrotron Grant: K-Edge Subtraction Angiography with Synchrotron Chair, Administrative danel on Laboratory Animal Care Protocol Approved for Period: 12/21/88 - 12/20/89 I am pleased to inform you that the Administrative Panel on Laboratory Animal Care has reviewed this protocol and that it was approved at their meeting on 12/21/88. The expiration date of this approval is 12/20/89. If it is your intention t o continue beyond that date, please submit an updated protocol thirty days before the expiration date for the Panel's re-approval. Requests for any changes t o this protocol during the approval period must be filed with the Panel. A copy of this memo and protocol should accompany any request for changes. The Panel requests prompt notification of any complication which may occur during an experimental procedure involving animals. cc: Sponsored Projects Office

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TO: WILLIAM GOUGH SUBJECT: PLANNED HUMAN ANGIOGRAPHY EXPERIMENT This memo is to inform you of the planned second series of "Iodine Dichromography" experiments with human subjects to be carried out The experiments will be carried out by the same reseach team which performed the original experiments last year. The exposure control hardware and the medical and experimental protocols are unchanged. The medical protocols and informed consent material have been reviewed and re-approved by the Stanford University Human Subjects Committee. A copy of the approval is included herewith. The present plan is to use four subjects, one of whom participated in the first experiment, commencing Friday, April 2 4 , and at the rate of one per day …