Feasibility of Follow-Up of Human Subjects (Companion to Document 704390)

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FEASIBILITY OF FOLLOW-UP OF HUMAN SUBJECTS For studies funded through RL, a preliminary assessment was made o f the feasibility of identifying, locating, and performing medical follow-up. The study category and project number were taken from the subcommittee staff considerations were addressed: To the extent possible in the time allowed, the following Are t h e subjects identified in study records? Uhat actions are necessary to locate and access such records? Where study records are no longer in existence, can the subjects be identified by recollection o f investigators? Are there confidentiality agreements between investigator and investigating institutions and the subjects? Do such agreements present a potential barrier to identification or location? Information on individual studies i s provided below. Further work would be required to identify and characterize any confidentiality Are the whereabouts o f the subjects known? What methods for locating the subjects might be employed? The location o f very few subjects i s currently known. Use o f the services o f companies that track subjects in epidemiology studies as a principal, ongoing company activity is the most effective means of locating former subjects when identified. a properly identified individual can be located in this manner. Names o f such companies can be provided. Ascertainment o f disease history after locating subjects can be accomplished by the use of standard epidemiologic techniques, such as mailing individuals questionnaires to be completed (with follow-up if necessary) o r conducting interviews with former subjects. o f the accuracy of medical information provided in this manner may be The relationship o f estimated dose incurred as a result o f the study to current annual occupational 1 Imits is addressed in some cases. dfes Conducted bv Onsite Contractors Regarding the feasibility of follow-up for subjects in studies involving

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uncertainty relates t o the identification of the subjects. Locating human subjects many years after the studies can be accomplished in some o f these Cases by contacting currently active former associates o f the subjects. The following pertains to the four relevant studies: Jri t ium Study (11,001, Number 1121 With regard to identification of subjects, about four subjects can be identified readily. For the remaining ten subjects, the General Electric Company can be queried as to the availability o f their research notebooks for 1952 for the Hanford Biology Laboratory. notebooks could be checked t o see whether the names o f subjects were recorded at the time. investigator for the study, who is no longer employed at Hanford, to learn whether he recalls or has records concerning the identity o f subjects. If available, the relevant An alternative would be to contact the principal Regarding the need for such follow-up, the single total body exposure resulted in an intake o f about 3.3 mCi of tritium. The ICRP-recommended annual limit on intake (ALI) for tritium is 3 x IO9 Bq, or about 81 mCi. The subject's exposure, therefore, amounted to about 4 percent o f an annual limit. The dose incurred was probably only about 0.1 rem because o f large intake of water by the subject to speed excretion of the tritium (2 percent o f the annual dose limit for workers). The other subjects had only limited skin exposure on the forearm or abdomen, which would have caused only a small fraction of the dose incurred in the case of the total body exposure. The study involved three groups o f individuals, consisting, respectively, o f three patients at the University of Oregon Medical School, two Hanford volunteers who were injected and studied for calibration purposes at the Swedish Hospital in Seattle, Washington, and five volunteers who ate whitefish from the Columbia River. The three medical school patients have been identified. necessary to access the medical school records to obtain further information. However, the need for follow-up o f the patients is questionable because the radionuclide was administered for medical therapy. The two volunteers administered 32P at the Swedish Hospital are identified. The radiation doses t o the volunteers injected for calibration purposes were 0.025 rem to the bone, 0,009 rem to the liver, and 0.005 rem to the whole body. The respective annual exposure limits are 30 rem to bone, 15 rem to liver, and 5 rem to the whole body. Two o f the ffve volunteers who ate the whitefish have been identified, and there i s a strong possibility that the others can be identified as well. The amounts o f UP in the subjects one day after eating the whitefish were 70, 110, 89, 72, and 93 nCi for an average o f 8 7 nCi, which would give a total radiation dose of .005 rem to the bone, .002 rem to the liver, and It would be

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Promethium St udv (12.001. Number 1101 All subjects can be identified for the promethium project. Estimated doses were 0.036 rem to the liver, 0.008 rem to bone, and 0.005 rem t o the whole body in the case o f injection of the promethium-143. I n the case o f ingestion, the dose to the upper large intestine was 0.038 rem and t o the lower large intestine 0.077 rem. The annual occupational dose limits are 30 rem to bone, 15 rem to liver and intestine, and 5 rem to the Technetium Studv - 12,001. Number 1091 The identity o f the subjects will be available only if contained in University o f Washington records. The isotopes have relatively short half lives (4.3 days for "Tc and 60 days for 9 5 m T ~ )and are rapidly eliminated from the body. The Maximum Permissable Body Burden (MPBB) is not applicable to acute ingested or injected doses; thus, it i s inappropriate to compare administered quantities o f received with the annual occupational dose limit. the subjects were estimated to be about 0.145 rem in comparison to the annual occupational limit o f 5 rem. Testicular Irradiation (2.002 - N o s . 2 and 1891 The feasibility o f any follow-up studies of the Oregon and Washington state penitentiary inmate volunteers who participated in testicular irradiation studies Is diminished by the difficulty of locating a large number o f the Research Foundation of Seattle and by the University of Washington Medical School, and the deliverables required by AEC were the technical reports produced as a result o f the studies. These reports did not include names. I n November o f 1984, RL was requested by Dr. Charles Edington to provide the names and current addresses of these subjects to OHER if they could be That source remains to be explored. It is more appropriate to compare the total dose The whole-body doses to The studies were actually conducted by the Pacific Northwest RL has no record o f the names o f the inmate volunteers at the Washington State Penitentiary. The principal investigator o f the Washington study was unwllllng t o provide the names to RL in 1984. His position was that to do so would be unethical unless he received a formal written request from the person orlginally requiring the Information (at that time the Congressional Inquiry was from Rep. Ottlnger). attorney general about a proper response if Dr. Edington would send a formal request. RL has no knowledge o f whether the information was provided. He did agree to consult with the state

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RL does have access t o inmate subjects. When I provide the last known records which allowed us t o identify the Oregon RL asked the Oregon State Corrections Department to addresses o f these people, the request was refused was unwillinq to violate official state confidentiality policy. The State agreed to tell RL only which individuals were still in the state prison system and to provide the date o f release o f those who were not. memorandum dated November 19, 1984. The following information with regard to follow-up and confidentiality is This information was forwarded t o Dr. Edington with a Page 2 - "To insure complete protection (confidentiality of identity) o f all subjects as required by federal human experimentation policies, all data has been re-coded, SO no reference can be found which will in any manner identify any of the volunteers." Appendix B, Page 10 - From the consent form used: publication o f the results o f the project with the understanding that I shall not be personally identified." withdraw my consent at any time." "I consent to the " I have been advised that I may