ACHRE Report

Part III

Chapter 18

Recommendations 1 - 6

Recommendations 7-12

Recommendations 13-16

Chapter 18: Footnotes

1 . AEC documents reveal that in order for one researcher to publish a report on his TBI research, he had to respond to the AEC's concerns about potential public relations and legal liability consequences and did so by deleting information that might permit identification of patients. See chapter 8.

2 .These awards included $750,000 in 1976 by Congress to the Olson family, $703,000 in 1987 by court order to the Blauer family, and $750,000 in 1988 by court order to nine Canadians for nonfatal brainwashing experiments. See chapter 3.

3 . For example, based on facts available to the Committee, those Alaskans who were subjects of Air Force-sponsored radioisotope research (see chapter 12) and the pregnant women who were subjects of radioisotope research at Vanderbilt University (see chapter 7) may also be owed an apology. However, the Committee conducted only limited inquiry into these cases. The Advisory Committee did not attempt a full factual inquiry into the Alaskan research, which is the subject of an inquiry by a committee of the Institute of Medicine and the National Research Council, whose report is pending. The Vanderbilt research is currently the subject of litigation that may provide for fuller development of the facts.

4 . Veterans who participated in weapons tests are also eligible for relief under the Radiation Exposure Compensation Act of 1990, which, however, requires claimants to elect the monetary remedy to the exclusion of other benefits to which a veteran may be eligible. We also note the Veterans Exposure Amendments of 1992.

5 . National Cancer Institute, National Institutes of Health, Radon and Lung Cancer Risk: A Joint Analysis of 11 Underground Miner Studies (Washington, D.C.: National Institutes of Health Publication No. 94-3644, January 1994).

6 . The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Washington, D.C.: GPO, 1979).

7 . The convening of a national panel could assist as well with the implementation of Recommendations 10 and 11.

8 . California Health and Safety Code, vol. 40B, sec. 24176 (1995).

9 . For example, in 1994, the Institute of Medicine's Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies recommended that the National Institutes of Health review the area of compensation for research injury. See Women and Health Research (Washington, D.C.: National Academy Press, 1994), 169 and appendix D to that volume titled "Compensation for Research Injuries."

10 . President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, Vol. 1, Report (Washington, D.C.: GPO, June 1982).

11 . Ibid., 50.

12 . While lessons such as those identified above have been learned, by the same token, it seems unlikely that they will be fully taken advantage of unless some individual or entity is designated with responsibility to ensure that this takes place.

13 . The post-World War II records of the Army Office of the Surgeon General are also located primarily either at the Washington National Records Center or with the Office of the Surgeon General. Similarly, very few of the post-World II records of the Chemical Corps and its successors are located at the National Archives but are mostly found at the Washington National Records Center or the successors.

14 . Standard Form 135 (SF-135) is the transmittal form agencies use when shipping records to a federal records center. A folder listing is supposed to accompany all shipments of records, with the exception of the relatively rare classified SF-135, the forms are available for examination by the public.

15 . "Destruction of the U.S. Atomic Energy Commission Division of Intelligence Files," report by the Office of Human Radiation Experiments, 26 August 1994.

16 . As noted in chapter 10, an investigation by the VA concluded that the "confidential Atomic Medicine Division" evidently contemplated was not activated; nonetheless, remaining documents indicate that certain records were kept in anticipation of potential liability claims. As noted further in chapter 10, the precise nature of all records at issue cannot be conclusively determined.

17 . Government contractor records have been found to be beyond the reach of the Freedom of Information Act because contractors are not "agencies" who maintain "agency records," a condition required by the act. However, regulations that govern contractors may bring records that contractors maintain under the act. For example, a recent Department of Energy regulation (10 C.F.R. [[section]] 1004.3[e], 59 Fed. Reg. 63883 [12 December 1994]), provides that even if a contractor-held document fails to qualify as an "agency record" it may be subject to the act if the contract provides that the document in question is the property of DOE. For a discussion of the application of this rule, see Cowles Publishing Company, Decision and Order of the Department of Energy, Case No. VFA-0018, 28 February 1995.

18 . In making this recommendation, the Advisory Committee emphasizes that we do not intend to alter privacy restrictions that currently limit access to records related to biomedical research (such as personal medical records).

19 . 21 October 1994 Addendum to the BNL Task Force-Final Report from John Hogan, Acting Assistant U.S. Attorney, Northern District of Georgia and Counselor to the Attorney General to the Attorney General (ACHRE No. CORP-060595-A), 2-3.

20 . Adapted from U.S. Preventive Services Task Force, Guide to Clinical Preventive Services: An Assessment of the Effectiveness of 169 Interventions (Baltimore: Williams & Wilkins, 1989), xxix- xxxii; and P. S. Frame, "A Critical Review of Adult Health Maintenance," Journal of Family Practice 22 (1986): 341, 417, 511.

21 . National Research Council, Board on Radiation Effects Research, Committee on the Biological Effects of Ionizing Radiations, Health Effects of Exposure to Low Levels of Ionizing Radiation: BEIR V (Washington, D.C.: National Academy Press, 1990), 5, 287-294.

22 . See footnote on testicular risk analysis in chapter 9.

23 . U.S. Preventive Services Task Force, Guide to Clinical Preventive Services, 77.

24 . See footnote on children's risk analysis in chapter 7.

25 . U.S. Preventive Services Task Force, Guide to Clinical Preventive Services.

26 . See "The Basics of Radiation Science" section of the Introduction.

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