A short paper on the radiation experiments by M.I.T. at Fernald and current oversight of radiation research. I wrote this prior to the current headlines.

1. Bodeker
Generalized Summary
In 1994, President Clinton declassified documents to create “an initiative for openness”
(Department of Defense, 1997), p. ix). Declassified documents revealed over 2,300 human
experiments involving ionizing radiation. Amongst these experiments were the Fernald School
experiments, jointly performed by the Massachusetts Institute of Technology (MIT) and the
Atomic Energy Commission (AEC).
The Fernald School was an institution designed to warehouse children deemed ‘feeble-minded’
(Leung, 200). It was there in the 1950s that 19 mentally retarded boys were fed radioactive iron
and/or calcium without informed consent from the parents (McCally, Cassel, & Kimball, 1994;
Vaishnav, 1994). Both Downs-syndrome patients and their parents received radioactive iodine
in a subtherapeutic dose (0.1 mCi; a therapeutic dose is 30 to 80 mCi).(Department of Energy,
1994; Zidan, et al., 2004) One source stated the studies occurred from the 1940s through 1961
and had some elements of consent but acknowledges that most parents did not realize the level
of risk until the story was released in the 1990s.(West, 1998) These children and adolescents did
not realize they were taking part in a research study, but thought they were participating in a
‘science club’ and were happy to receive extra attention, as they were often bereft of parental
attention.(Egilman, Wallace, Stubbs, & Mora-Corrasco, 1998)
After final analysis, it was determined that the maximum dose of radiation received by a
research subject was 330 mrem, which is 3 times higher than the recommended dose for
background radiation in one year (United States Nuclear Regulatory Commission, 2008). This
was decided to be non-harmful to the participants (Blau, 1995; Department of Defense, 1997)
Abuse
Several facts lead to the disconcerting nature of the human radiation experimentation taking
place at Fernald School. Most significantly was a lack of informed consent. The Nuremberg Code
was being developed in the 1940s and published in 1949; the first declaration therein states
informed consent must be voluntary, without coercion or deceit.(National Institutes of Health,
1949) Secondly, the Nuremberg Code states the experiment should yield, “…fruitful results for
the good of society…” but these results were not published or utilized for biological
research.(McCally, et al., 1994). The Belmont Report and the Declaration of Helsinki were not
yet implemented, but the Nuremberg trial would have been making sensational headlines.
Outcome
The information regarding these experiments (Robert S. Harris, PI) was published in peer-
reviewed journals.(Sharpe, Harris, & et al., 1948a, 1948b; Sharpe, Peacock, Cooke, & Harris,
1950), however the studies became most notorious when all the documents were declassified in
1994 and sensationalized in the modern news media.(Egilman, et al., 1998). These documents
were released due to the President’s order in 1994 to investigation the ‘human radiation
experiments’ and conclude if they were robust and obtained under appropriate ethical
guidelines. Additionally, the newly created Human Radiation Intra-agency Working Group
would provide new recommendations for further human radiation experiments to be carried

2. Bodeker
out.(Clinton, 1994) While a national radiation research oversight has been established by the
National Cancer Institute, one does not exist within OHRP. Local oversight committees include
the FDA-approved radioactive drug research committee (RDRC) and most institutions have an
oversight committee for the use of radiation in research.(Office for Human Research
Protections, 2009)
Evaluation of the Present Process
Current regulations require robust consent to be obtained from both the child and the legally
authorized representative. This may or may not be a parent. Research utilizing individuals with
dubious mental capabilities and ability to consent may be required to have a patient advocate
represent the patient, providing another opportunity for oversight. However, the discussion
during the consent process and the text of the informed consent document all stem from a
robust thorough review performed by the local oversight committees. This is the problem with
the current process in research.
It will be a rare institutional review board that maintains a therapeutic radiation oncologist no
less a nuclear medicine physician. These two medical physician differ from their radiological
colleagues, as they specialize in high doses of ionizing radiation through external and solid
(radiation oncology) and liquid (nuclear medicine) sources. Due to these limitations, the IRB
will defer to a specialized board, such as a Medical Radiation Protection Committee or
Independent Radiation Advisory Committee, to provide the appropriate risk assessment for a
study utilizing ionizing radiation. Indeed, the IRB is entirely dependent upon this committee to
truly assess hazards.
The radiological staff at an institution is most likely small and incestuous. Given a lack of
national oversight, this can lead to improper friendships among reviewing committees and rules
being bent. Documentation will vary greatly across institutions as well as procedures. In fact, the
OHRP’s IRB guidebook does not even offer CFR regulations that must be reviewed or answered
for radiological research examination. For this reason, it would be best for national regulations
to be implemented, requiring a national authority to review and investigate research oversight
by local radiation research committees. The threat, rather than the occurrence, may provide
necessary motivation to reduce conflicts of interest, keep the local oversight robust, and the
radiological research meaningful.
References
Blau, S. E. (1995). Institute charged in Fernald radiation experiment lawsuit. The Tech, 115(49).
Clinton, W. J. (1994, January 20). Advisory committee on human radiation experiments
Retrieved June 2, 2009, from http://www.hhs.gov/ohrp/documents/19940120.pdf
Department of Defense (1997). Report on search for human radiation experiment records.
Springfield, VA.

3. Bodeker
Department of Energy (1994). Experiments list: OT-19 Radioisotope studies at the Fernald State
School, Massachusetts Retrieved June 2, 2009, from
http://www.hss.energy.gov/healthsafety/ohre/roadmap/experiments/0491doc.html#0491_Oth
er
Egilman, D., Wallace, W., Stubbs, C., & Mora-Corrasco, F. (1998). Ethical aerobics: ACHRE's
flight from responsibility. Account Res, 6(1-2), 15-61.
Leung, R. (200, May 4). America's deep, dark secret Retrieved June 2, 2009, from
http://www.cbsnews.com/stories/2004/04/29/60minutes/main614728.shtml
McCally, M., Cassel, C., & Kimball, D. G. (1994). U.S. government-sponsored radiation research
on humans 1945-1975. Med Glob Surviv, 1(1), 4-17.
National Institutes of Health (1949). Regulations and ethical guidelines: The Nuremberg code
Retrieved June 2, 2009, from http://ohsr.od.nih.gov/guidelines/nuremberg.html
Office for Human Research Protections (2009). Institutional review board guidebook: Chapter
V, E. Use of radioactive materials and X-rays Retrieved June 2, 2009, from
http://www.hhs.gov/ohrp/irb/irb_chapter5.htm
Sharpe, L. M., Harris, R. S., & et al. (1948a). Effect of phytate and other food ingredients on the
absorption of radioactive iron. Fed Proc, 7(1 Pt), 112.
Sharpe, L. M., Harris, R. S., & et al. (1948b). Effect of phytate and other food ingredients on the
absorption of radioactive iron. Fed Proc, 7(1 Pt 1), 298.
Sharpe, L. M., Peacock, W. C., Cooke, R., & Harris, R. S. (1950). The effect of phytate and other
food factors on iron absorption. J Nutr, 41(3), 433-446.
United States Nuclear Regulatory Commission (2008, May 6). Personal annual radiation dose
calculator Retrieved June 2, 2009, from http://www.nrc.gov/about-nrc/radiation/around-
us/calculator.html
Vaishnav, A. R. (1994). Task force reports on Fernald studies. The Tech, 114(28).
West, D. (1998). Radiation experiments on children at the Fernald and Wrentham schools:
lessons for protocols in human subject research. Account Res, 6(1-2), 103-125.
Zidan, J., Hefer, E., Iosilevski, G., Drumea, K., Stein, M. E., Kuten, A., et al. (2004). Efficacy of
I131 ablation therapy using different doses as determined by postoperative thyroid scan uptake
in patients with differentiated thyroid cancer. Int J Radiat Oncol Biol Phys, 59(5), 1330-1336.