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JH Jarre t tOate March 29, 1974 RE Nightingale Bill Bair, Chairman WF Riemath Human Subjects Comrni ttee (HSC) From Dave Lester ,y OF SEMI-PORTABLE IRRADIATOR PROGRAM Battelle may be requested by AEC-DBER t o develop and prepare a blood ir radiator t o be used on human subjects by another AEC contractor (Dr. James Wolf, Veterans Hospital, Richmond, Virginia). - The following HSC action is desired : 0Consideration and Approval o f Completed - late - June di at or Design Ir radiator and Operating Procedures Refs: (1) Corporate Policy / Procedure,Section 0.2.1.5. (2) Program plan recommended t o AEC-DBER: " Alternatives for the AEC Providing a Blood Ir radiator to Veterans Hospital, Richmond, At the request of AEC-HQ staff, we have evaluated alternative means by which the AEC could supply a blood ir radiator to Dr. Wolf. As a result o f this evaluation, we have recommended (Reference 2)that Bat tell e design and fabricate the needed ir radiator subject to the following approvals by Bat tell e HSC: Approval o f Program Work Plan 0 0 Approval of Blood Ir radiator Design cr 0 Approval ofthe Completed Ir radiator and Operating Procedures Recent. indications are that the AEC will request Bat tell e to perform the work we have recommended. The remaining paragraphs i n this letter provide.information that summarize and supp1emen.t material in References 1 and 2.
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We estimate that the non-portable irradiator can be supplied ata cost of about $15,000 within four months after the effort is authorized by the AEC - DBER. description of the work i s summarized i n a program plan section of Reference 2. We have recommended that an addition t o the existing program funds (RX-01-03) be made for this effort. gested t h a t funds be transferred from the nitrogen-13 generator program (also However, we expect this will not be possible and have sugRiemath) w i accompany the unit to Richmond and proceed with a training program for hospital personnel i n the technical/mechanical handling of the u n i t and suitable radiation control procedures. The medical protocol for using the u n i t will be determined by Dr. Wolf i n conjunction w i t h the hospital medical advisory committee for evaluation of kidney transplant and dialysis cases. patients i n regard t o kidney transplant and immuno-supressant procedures are subject t o the review of this Veterans Hospital Committee. All work with This work appears t o f a l l i n Category 4 on Page 2 of the reference policy procedure. Testing o f human subjects is essentially subcontracted t o the team a t Veterans Hospital; but the contract i s separate through the AEC. Battelle's responsibility i s to release t o the AEC a u n i t suitable for use by Dr. Wolf under the separate contract. understanding t h a t existing legal arrangements between BNW and the AEC would indemnify Battelle from financial liability related t o use o f the unit. Further evaluation o f this by the Human Subjects Committee is, of course, necessar I t should be reiterated that Battelle's role i n providing this unit is in thkgi - neering design and fabrication of the unit and that all medical protocol i s the responsibility of Dr. lblf and his team under t h e i r AEC contract. responsibility i s insuring that the proper radiation control procedures and technical operation of the unit is observed. the technical operating procedures and seeing t h a t they are implemented with the Under the norma7 controls of the Veterans Hospital and the control o f the medical protocol i n Dr. Wolf's programs, itis understood thata basic mechanism for the protection o f the rights and welfare of the individuals involved is in place. This i s evidenced by the regular review procedures of the kidney transplant and dialysis committees a t the Veterans Hospital i n addition to their normal hospital administrative controls which cover informed, written consent o f subjects and adequate education of the individuals w i t h regard t o the risks and effects of the experimental clinical applications. welfare of the patients and the implementation o f proper written consents and informd status o f the individuals lies with the Veterans Hospital administrative procedures and with Dr. Wolf. The medical staff involved recognize the state of that such techniques as blood irradiation induce i n the form the patient as such while also t a k i n g the necessary precautions for protection of the immune suppressed patient. Final classification is up to the Committee. It is our We will be responsible f o r preparing The primary responsibility for the All work on this program will be held i n compliance w i t h applicable government regulations, both with respect t o shipment and control of radiation sources and
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with regard t o the use of such sources i n the medical environment under the AEC: regulation of the Veterans Hospital contract. the portable irradiator program, Battelle is i n a unique position t o provide, on a timely basis, a semi-portable u n i t for use by the Veterans Hospital. To date we have determined that no other imnediate route t o this application i s available. I t is important to the overall blood irradiator program that data with regard t o short-term exposures be obtained on a timely basis so that information can be compared with the results obtained i n the case of chronic, long-term exposures which are apart of the animal testing i n the portable blood ir radiator Because of our involvement with c t potential for saving gram, the use of the ir radiator would require, on this particular patient,a separate evaluation by the Committee. bil it y that such an occurrence will be involved i n this program. Itis presently deemed a very low probaI t is important t o note that this program is separate from the portable blood ir radiator program which i s presently i n the animal testing phase. The types of irradiators being used i n the portable program are very different and presently lack many of the controls that will be involved i n the semi-portable ir radiator. ed with this program will be received i n the near future, probably on o r about April 1. 17 of Reference 2 , April would be "Month 1." The Human Subjects Committee review has four identified milestones on the reference schedule. The f i r s t milestone entitled "Contact with the Human Subjects Committee to Initiate a Review" i s designated as the middle of the first month(about April 15). Formal unit design submittal t o the Committee for review occurs i n the middle of the second month (May 15). The formal submittal would take the form of the detailed design i n terms o f shop drawings for review by the Committee, along w i t h a review of the general procedures by which the u n i t will be operated, the Committee i s needed by the end of the second month (late May). The final approval identified i n the middle of the third month involves approval o f the u n i t as described by the final design and approval of the protocol procedures and training method t o be used i n introducing the unit to the hospital. Pursuant to this requirement, i t is deemed desirable that the Committee meet i n the very near future to consider t h i s program. to April 15 is highly desirable i n the light o f the projected schedule. be happy t o provide the Committee w i t h any additional information which they require that is not covered in this letter or the attached document. We would consider i t desirable t o make a brief presentation t o the Comnittee t o outline the principal aspects o f this program and respond t o questions from the Committee. In reference t o Page Fabrication release from Some initial deliberation prior Your continued interest in this program will be greatly appreciated.