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MODEL FEDERAL POLICY FOR PROTECTION OF HUMAN RESEARCH SUBJECTS Susan L. Rose, Of fl ce of Hunan Health and Assessments, ER-73, Headquarters, As requested i n the June 20, 1986 letter from Charles DeLIsi t o 306 La Grone Manager, ORO, we have revlewed the subject p o l i c y and are providlng our response t o you. OR0 has no objectlons tothe proposed policy. The request was also sent by OHER t o Oak Ridge Natlonal Laboratory (ORNL) and Oak Ridge Assoclated Unlv ers lt let (ORAU) and they are respondlng separately t o you. It I s our understnndlng that nelther OWL nor ORAU will Interpose objectlons t o the model polfcy. The OSTP plan t o adopt a unlform code o f regulations for hunan research I s based on the present rule of the Department o f Health and Hwn Servlces (DHHS). ORAU and ORNL have conformed t o the DHHS regulatlono for years; thus, It is logical that ORO, ORAU, and OWL have no objectlons t o the Research and Waste Management D lv is lon
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Department of Energy Oak Ridge Operations Office Enclosed please find the recently published Model Federal Policy for Protection of Human Research Subjects. DOE concurred on this policy on October 16, 1984 (Secretary Hodel). It can, therefore,be assumed that barring significant changes, DOE will formally adopt this policy once the final version is released. The new policy will supersede the current 10 CFR Part 745. DOE implementation procedures to carryout this policy will be drafted once the Model Policy becomes law. An identical copy of this letter is also being sent to OHER Laboratory Directors and OHER off - site scientists in vol ved in human subject research. Inasmuch as this document may mean changes inthe way human subject research is reported and evaluated DOE-wide, please review it carefully. Please direct your comments toDr. Susan L. Rose, Human Health & Assessments Division,Office of Energy Research, U.S. Department o f Energy, Washington, At this time, i f you have any concerns or suggestions with respect to the implementation of human subject review mechanisms affecting your areas, please forward these to Dr. Rose also. Please circulate this information to the appropriate staff. Associate Director for Health and Envi ronmental Research Office of Energy Research
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POST OFFICE BOX X OAK RIDGE. TENNESSEE 37831OAK RIDGE NATIONAL LABORATORY OPERATED BY MARTIN MARlEnA ENERGY SYSTEMS, INC Hman Health and Fssessnents Division, ER-73 Office of mergy Research U.S. Department of Energy As per Dr. DeLisi’s request, we have reviewed the Propsed W e 1 Federal Policy for Protection of Human Subjects and have no cunnents or objections to the propsed model. I n general, rn major changes to the Review by markers of the Oak Ridge Associated Ulliversities/Oak Ridge National Lakoratory -ittee on Human Studies (see attachment) indicates that we are currently in ccmpliance w i t h these regulations. current federal regulations are proposed in the model. Thank p u for the opportunity to review and &el. Please call me with any questions. comnent on the proposed Associate Labratory Director for Biomedical and EslvirOnmental Sciences
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Kenneth Flatt, B.S., Oak Ridge Associated Universities Fbward R. Friednun, E%.D., Regional Mental Health Center Karl F. Hubner, M.D., University of Tennessee FWert Lange, M.D., University o f Tennessee Ruby L. Miller, B.S., Yartin Marietta Energy Systems, Inc.
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Office of Science Proposed Model Federal Policy for Protection of Human Subjects; Response to the Flrst Biennial Report of the President’$ Commlssion for the Study of Ethical Problems in Medlclne and Biomedical and Behavioral Research;
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20204 Federal Register / Vol. 51, No. 108 / Tuesday, June 3, 1988 / Notices OFFICE OF SCIENCE AND Proposed Model Federal Pollcy for Protectlon of Human SubJects; Rrr pons e to the First Blennld Report of the Prtsldent'r Commlsslon for the Study of Ethlul Problem8 In Medlclnr and Blomedlcal and Behavloral AOLNCY: Office of Science and Technology Policy. Executive Office of ACTION: Natice of proposed model policy for departmentlagency implementation. SUMMARY: This Notice sets forth the Office of Science and Technology Policy response to the recommendations in the First Biennial Report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. This response, made on behalf of all affected federal departments and agencies, is based on the work of the Ad Hoc Committee for the Protection of Human Research Subjects and further deliberations of the Interagency Human Subjects coordinating Committee. The First Biennial Report was published in the Federal Register on March 29,1982 (47 FR 13272-13305). Responses of the Ad Hoc Committee were reviewed by the Science Advisor to the President and, with some modifications. accepted by affected department and agency heads in May 1985. This Notice inc!udes in response to the first and most important recommendation. a Model Federal Policy for the Protection of Human Research Subjects (Model Policy) involved in research conducted, supported or regulated by federal departments and agencies. The Notice also contains a list of departments and . agencies that intend to adopt the Model Policy and describes what, if any, departures from the Model Policy departments and agencies propose to make a t the time of their policy implementation in order to meet particular statutory requirementr or Public comment and that of the federal departments and agencies is requested on the Proposed Model Policy, proposed department and agency departures, and other aspects of this Notice. Based upon these comments, a Final Model Policy will be published in the Federal Register. Each department and agency will expeditiously and in a coordinated fashion promulgate the Final Model Policy throu h its normal policies, e.g.. through publication of regulations in the Federal Register. procedures for implemen!I'ng such DATES: Comments must be received on or before August 4. 1988. The Interagency Human Subjects Coordinating Committee will consider these comments end refer them to the Office of Science and Technology Policy for use in development of a Final Model Policy and to departments and agencies for use in their policy implementation. iNFomAnoK Comments and requestn for further information should be addressed to: loan P. Porter, Staff Director, Interagency Committee for the Protection of Human Subjects. Building which recommendations or sections of the Model Policy to which the comments Acting Director. Office of Science and Office of Science and Technology Policy Response to the First Biennial Repoti of the Proposed Model Federal Policy for Protection of Human Research Subjcctr Concurrences of Department and Agency Heads and Proposed Departures from the The President's Commission for tlie Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was established on November 9.1978, by Pub. L 95422. One of the charges to the President's Commission was to report biennially to the President the Congress. and appropriate federal departments and agencies on the protection of human subjects of biomedical and behavioral research. In carrying out that charge, the President'r Commission was directed to conduct a review of the adequacy and uniformity (I) of the ruler. policies. guidebe, and regulationa of all federal departments and agencies regarding the protection of human subjects of biomedical or behavioral research which ruch departments and agencier conduct or rupport and (2) of the implementation of such rules. policies, guideliner. md regulations by such agencies, such review to include appropriate recommendations for legislation and In December 1981 the President'e Commission issued itr First Biennial Report on the Adequacy and Uniformity of Fedeml Rules and Policies, and their Implementation. for the Protection of Human Subjects in Biomedical and ADDRESSES FOR COMMENT AND FURTHER Behavioml Research. Protecting Human Subjects. In transmitting the Report to the President. Morris B. Abram. Chairman of the Commission noted The Commission doe8 not propose m y major changes in the substance of the ruler on human research. although a number of adjustments are recommended to recognize the fledbiiity needed by research institutions. particular!y in responding to allegations of mongdoing or other problems. We a180 propose a simple improvement in :he reports filed by researchers. to provide information on the number of subjects and on any that are adversely affected by participation in a research project. T h e Commission does recommend one major organizational change. namely that a uniform core of regulations be adopted. based upon the present rules of the Department of become the lead agency in this field. This consolidation would eliminate needless duplication in the rules of the 23 other Federal entities that support or regulate research. thereby simplifying both local compliance with the ruler, and Federal 'oversight of the system. Copies of this report are being sent to all affected Federal agencies. with a request for action, purauant to the Commission's enabling leginlation. In accord with Pub. L 95-822. each federal department or agency which receives recommendations from the President's Commission with respect to its rules, policies. guidelines or regulations, must publish the recommendations in the Federal Register and provide an opportunity for interested persons to submit written data, views and arguments with respect to adoption of the recommendations. On Secretary, HHS. published the report on behalf of all the departments and agencies affected by the In May 1982 the Chairman of the Federal Coordinating Council for Science. Engineering and Technology (FCCSET). appointed an Ad Hoc Committee for the Protection of Human Research Subjects under the auspices of -the FCCSET. The Committee. chaired by Secretary for Health. HHS. was composed of the representatives and Ex Officiomembera of affected departments and agencies. In consultation with the Office of Science and Technology Policy (OSTP) and the Office of Management and Budget, the Ad Hoc Committee, after considering all public comments, developed responses to the recommendations of the President's Commission. After further review and refmement. OSTP responded on behalf of all affected department and agency heads to the recommendationr of the Resident's Commission.
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Federal Register I Vol. 51, No. 106 / Tuesday. June 3, 1988 / Notices 20205 The first and most far-reaching recommendation of the Resident's Commission resulted in the development of a Propcced Model Federal Policy for the Protection of Human Research regulations for the protection of human T h e President should, through appropriate action. require that aU federal departments and sgzncias adopt as a common core the qu lat ions governing research with human rubjects issued by the Department of Health and Human Services (cobfied at 45 CFR Part M).as periodically amended or revised while permitting additions needed by any department or ageccy that are not inconsistent with these core provisions. The Ad HJC Committee agreed that uniformity is desirable among departments and agencies to eliminate urfiecessary regulation and to promote increased understanding and ease of compliance by institutions that conduct federaDy supported or regulated resesrch involving human subjects. Therefore. the Ad Hoc Committee developed a Model Policy. which applies to research involving human subjects that is conducted supported or regulated by federal departments and agencies. In accordance with the Model Pclicy is based on Subpart A of the regu1aiior.s of the Department of Health and Huan Services (HHS) for the protection of human research subjects (45 CFR Part 48). The hoposed Model Policy developed by the Ad EOC Committee was later modified by OSTP to enhsnce uniformity of implementation among t!!c affected federal departments and agencies and to provide consistency with o!her related policies. The revised Folicy was ccncmcd in by all affected federal departments and agencies heads The Resident's Commission also recommended tha: the President authorize and direct the Secretary. HHS. to designate an office with gcvenmeniwide jurisdiction to coordina?, monitor and evaluate the implerneztationof all federal regulations governing research with human subjects. For the reasons set forth in its response, the Ad Hoc Committee recommended tkat the Office for Protection from Research Risks (OPRR). National Institutes of Health. serve in a federal coordinating role for the protection of human subjects. The Director. OPRR chairs tfe Interagency Human Subjects Coordinating Committee described " h a Proposed Model Policy and the other responses to the President's Commission accepted by OSTP and the affected department and agency heads, are set forth below. After a public comment period and publication of a Final Model Policy, each department and agency will promulgate the Model Policy expeditiously through whatever procedures are normally utilized for the implementation of policies or regulationn, e.g. through publication 88 regulations in the Federal Register. hstancei in which the policies of certain departments and agencies propore to depart &om the Model Policy during their rulemaking or other implementation processea to accommodate statutory or program requirements are also described herein. The Interagency Human Subjects Coordinating Committee chartered in October 1983 under the auspices of FCCS€I', is composed of representatives of all federal departments and agencier that conduct, support or regdate research in vol va human subjects. The Committee is advirory to department and agency heads, and among other responsibilities, evaluates the implementation of the Model Policy and recommends changes a8 necessary. OSTP rerponres to the recommendations of the President'r Commission based on the report of the Ad Hoc Committee: the Propored Model Policy; and the ConCurrenCes and intended departures of each affected federal department or agency head are Response to Recommendations of the Technology Policy (OSTP]to the recommendations of the President'r Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in Protecting Human Subjects: the First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies. and their Implementation for the Protection of Human Subjects in Biomedical and This response is based on the work of the Ad Hoc Committee for the Protection of Human Research Subjects of the Federal Coordinatirig Cound for Science, Engineering, and Technology which was modified to incorporate OSTP policy ccnsideratiom in and accepted by affected Federal department and agency headr in June The Pmsident should, through appropriate action. requirs that all fedeml departments or agencies adopt as a common core the regulations governing reseaxh with human subjectp issued by the Department of Health and Response of the Office of Science and Hucrioii Senices (codi?ieJ ot 45 CFA Parr 46), as periodiccllly amended or revised. while permitting additrocs needed by a1;y department or agency tno: ore nr;&inconsiztent with these core [A timetable of 180 days should be established by the President to provide an incentive for the interagency group to resolve any remaining questions about the HHS core regulations and identify an initial set of special rules beyond the core that are needed by various departments and agencies. If action i s not pronpt. the Commission sugges:s that Congress enact legislation drecting the Executive branch to establish by a specified date a uniform set of regulations under a lead agency.) The Ad Hoc Committee agreed in principle with this recommendation and developed a Model Federal Policy adaptations of HHS regulations for the protection of human subjects involved in research (45 CFR Part 46). The Office of Science and Technology Policy has made reveral modifications to increase uniformity of procedures among the federal departments and agencies and to increase compatibility with other current federal policies. Hoc Committee's attempt to meet …
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