Participating DOE Laboratories and Sites
Fermi National Accelerator Laboratory
Since 1976, Fermi National Accelerator Laboratory (Fermilab) has made its 66 MeV clinical neutron beam available for treating advanced, radioresistant cancerous tumors. Between 1976 and 1985, clinical trials involving human subjects were conducted under the auspices of the Radiation Therapy Oncology Group, a division of the National Cancer Institute. These trials were reviewed by an Institutional Review Board (IRB) at each hospital contributing patients to the studies, as well as an IRB that was established for the specific purpose of reviewing trials conducted at Fermilab. That IRB was dissolved in 1985 when the trials terminated.
Since 1985 there have been no clinical trials involving neutron therapy at Fermilab. A clinical trial using microcurrent therapy to alleviate radiation side effects was conducted in 1998-1999 under the supervision of the Provena Saint Joseph Hospital IRB. Provena terminated its relationship with Fermilab in 2003.
The neutron therapy clinic is operated by Northern Illinois University under a Work For Others agreement with Fermilab. Northern Illinois University's IRB has a Federalwide Assurance; however, no clinical trials at the neutron therapy clinic are planned.
Other human subjects research conducted at Fermilab will be reviewed by a new standing IRB to be used by Fermilab.
Also of note is the Former Worker Medical Surveillance Program conducted for interested former workers from Fermilab and sponsored by the DOE Office of Health, Safety and Security (HS-15). Screening for Fermilab former workers is one component of the multi-site National Supplemental Screening Program (NSSP), managed by Oak Ridge Associated Universities in partnership with National Jewish Medical Center, Occupational HealthLink, and Comprehensive Health Services (a nationwide network of occupational health clinics).
Another DOE site IRB, the Oak Ridge Sitewide IRB, serves as the DOE IRB of record for this multi-site program. In this role it conducts initial and ongoing reviews of standard medical screening protocols, informational materials, and consent forms for clarity and consistency.
Content reviewed: November 12, 2013