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Department of Energy Office f o r Protection from Research Risks Office of the Director Department of Health and Human Services This isin response t o your letter of June 17, 1980, t o Dr. C.C. Lushbaugh, Oak Ridge Associated Universities (ORAU), and our subsequent telephone conversation requesting an investigation and report concerning involvement of individuals as subjects of research a t the Oak Ridge National Laboratory Before discussing the results o f our investigation, i t may be helpful t o clarify the role of the two institutions referred i n your letter. The Oak Ridge National Laboratory isa Federally owned facility operated for Division.. Research at CR NL for other government agencies i s conducted under the DOE contract with Union Carbide Corporation. Oak Ridge Associated Universities i s also a prime operating contractor of DOE. Since there are two DOE research centers i n Oak Ridge, both of whom have work funded by NIH, a bi-institutional General Assurance was sought and granted by NIH with both institutions sharing the General Asstirance (G01716). on Human Studies is chaired by Dr. Robert Lange of the University of Tennessee Memorial Research Center i n Knoxville, Tennessee. For continuity, Or. Lushbaugh has agreed t o have all matters relating t o the Committee be addressed tohim. The fact that Dr. Lushbaugh is listed as the Institutional Officer t o whom correspondence concerning Board affairs should be addressed does not change the bi-institutional nature of the Cormnittee as shown i n Enclosure 1 . For ORNL, Dr. John Storer i s the This block diagram was included a s Annex 6 Human Subjects Project
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inth1ettr of Ja uary 17,1977, from Dr. C.C. Lushbaugh t o Dr. Roy Kinard. I n view of the somewhat complex bi-institutional involvement, we determined that the best method t o obtain the information you requested was for DOE to undertake t h i s investigation and report the results directly t o you. I will address your questions i n the order i n which they appear i n your letter of June 17, 1980. 1 . "confirmation from the institution of the reported incidents, including whether or not IRB review o f the activities took place and,if so, minutes o f the review": I n the Spring of 1979, Dr. Thomas Slaga, a member o f the Senior Staff at the Oak Ridge National Laboratory, did small area of his skin as did four other members o f Dr. Slaga's research group. The application occurred only once, away from the Laboratory and during off-duty Prior to this exposure, no IRB review had occurred. Unfortunately, a formal investigation and report were not made a t the time ORNL first learned of the exposure. We have already informed ORNL of our position t h a t such a n investigation should have been made immediately and the results reported t o us promptly. Subsequently, Dr. Slaga did submit an application t o the ORAU/ORNL Commi'ttee on Human Studies and the application was disapproved. Dr. Slaga's application and the Minutes of the Commi tte e Is review and re1 a ted correspondence i s 2. " i n the event that there had been no prior I R B approval, a report o f any follow-up or corrective action taken by the institution including measures t o prevent the recurrence of similar incidents": Following a determination by the Director o f the ORNL Biology Division that exposure t o TPA had occurred without
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prior IRB or Laboratory approval, Dr. Slaga was informed i n the strongest possible terms that this was an unacceptable practice and its occurrence away from the Laboratory did not relieve Dr. Slaga of his professional responsibility. Dr. Slaga was again informed of ORNL policies with regard t o human use experimental procedures which require that any proposed research involving human subjects be approved i n advance by the ORAU/ORNL Committee o n Human Studies. indicated previously, Dr. Slag a did subsequently submit a n application which was n o t approved. As a result of this incident, a l l ORNL policies and procedures regarding human use experiments have been reviewed t o insure that they could be reasonably expected t o prevent any such future occurrence. Following this review, i t has been emphasized t o all ORNL Senior Research staff the importance of these procedures and their individual responsibility t o see that all investigators and staff under their supervision are fully aware of the policies and adhere i o them. Further, a n additional administrative check has been introduced i n t o the 3 . "a statement of the institutional policy regarding IRB review of such activities and what is being done administratively t o insure understanding of, and compliance with, the policy on the part of researchers": As indicated above, the Oak Ridge National Laboratory i s a Federally owned facility of the Department of Energy and must observe all regulations of the DOE and the other Federal agencies where they apply, Subjects'' (10 CFR, Part 745) conform t o the Department of Health a n d Human Services' regulations and clearly require the Institutional Review Board review and approval of any activity involving human subjects. ORNL and ORAU by the "Implementing Guidelines for Research on Human Subjects", Enclosure 3. These guidelines are being updated to reflect the change from DHEW t o HHS and from ERDA t o review and approval of the Committee on Human Studies. When approved by the Commi.ttee, the revised guidelines will be promptly forwarded t o you for your review. The DOE regulations f o r "Protection of Human These regulations are covered a t Some other minor changes may also be made subject t o
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We have emphasized t o ORNL Senior Management the impcrtance of these regulations and their responsibiiity t o see that they are fully complied with. Subsequently, one additional administrative check has been added t o the ORNL procedures. All proposed research which has been reviewed and approved by the IRB must still such research activity can actually be initiated. We believe this additional decision point is administratively very useful ina Laboratory as large as ORNL. 4 . "how the current institutional policies regarding use and handling of know carcinogenic and other hazardous materials adequately cover research involving human subject": Prior t o obtaining permission t o work with any known carcinogenic or other hazardous materials, a research protocol must be submitted t o the ORNL Eiohazards Review Cornittee. This Committee functions similar t o the Institutional Review Board and must review and approve the research proposed, determine that the Laboratory i n which the material will be used meets a l l applicable safety standards and t h a t the protocol clearly contains a1 1 procedures for handling, storage and disposal of the materials. Review and approval of the proposal for scientific merit must precede submission t o the Biohazards Review Cornittee. The Minutes of the Biohazards Review Committee are reviewed Sy a professional member of the M)E staff. periodic occupational safety audits of the facilities used for such research t o insure full compliance with all Federal The DOE-Oak Ridge staff also conducts If the Biohazards Review Committee approves the proposed research, i t would then be submitted t o the ORAU/ORNL Committee on Human Studies i f human subjects were t o be involved. We have devoted considerable effort to providing the fullest possible answers t o your letter request. and appreciate your patience. I f you have suggestions or coments t o improve these procedures, we would be most glad to receive them or t o provide other information you might require. I regret that it has taken so long 1 . Committee Block Diagram William R. Bibb, Director