Ms. Pamela
S. Bonee
ORISE/CPD
P.O. Box 117
Oak Ridge, TN 37831-0117
Phone: 423-576-3147
Fax: 423-241-2923
E-mail: boneep@orau.gov
Number of Human Subjects projects reported: 19
"Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals"
Principal Investigator: Dr. Ronald E. Goans, Oak Ridge Associated Universities
Project started in: 1978
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 96
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Other: 06/19/99 to 05/31/00
Explanation:
FDA Reporting Year
Type(s) of Human Subjects Involvement:
Internal contamination with the actinide elements (Pu, Am, Cm, etc) occur reasonably frequently and both Ca-DTPA and Zn-DTPA have proven efficacy in medical management of these cases. Anyone in the DOE system or elsewhere with internal exposure to actinides (Pu, Am, Cm, etc)is eligible for treatment with Ca-DTPA and Zn-DTPA.
DTPA belongs to the group of synthetic polyamino polycarboxylic acids which form stable complexes (metal chelates) with a large number of metal ions, especially the transuranic elements. The drug effectively exchanges calcium or zinc for another metal of greater binding power and carries it to the kidneys where it is then excreted. Historically, in the DOE laboratory complex, DTPA has been quite successful in promoting urinary excretion of the actinide elements in accident situations where inhalation or systemic uptake through wounds was involved.
IND 4041, Trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA) and IND 14603, Trisodium zinc diethylenetriaminepentaacetate (Zn-DTPA) are investigational new drug applications which are administered by Oak Ridge Associated Universities under contract with the U.S. Department of Energy, Contract No. DE-AC05-76OR00033. Both forms of DTPA have been widely used in the U.S. and in Europe for many years as chelating agents for plutonium and for other heavy elements such as americium, californium, and curium. A new supply of DTPA has been recently imported from Heyl, GmBH in Berlin and distributed to all DTPA co-investigators. This distribution has been approved by both the US FDA and DOE/EH. In addition, the drug meets the chemical specifications of the US Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur).
Ca-DTPA is approximately 10 times more effective than Zn-DTPA for the initial chelation of transuranic elements. Therefore, Ca-DTPA should be used whenever larger body burdens of transuranics are involved. Ca-DTPA is the drug of choice for initial patient management of internal contamination with transuranic elements unless contraindicated. After approximately 24 hours, however, Zn-DTPA is, for all practical purposes, as effective as Ca-DTPA. This comparable efficacy, coupled with its lesser toxicity, makes Zn-DTPA the preferred agent for protracted therapy. The effectiveness of chelation therapy is highly dependent not only on the metal itself, but also on the chemical and physical characteristics of the compound at the time of DTPA administration. Because the efficiency of chelation decreases with time, DTPA should be given within 6 hours of exposure.
No serious toxicity in human subjects has been reported as a result of 625 separate patients administered DTPA (either intravenously by slow IV push or by nebulizer) in recommended doses (for a total of 4565 separate doses). In addition, no serious adverse effects have been noted as a result of over 1000 doses of Zn-DTPA in the recommended dosage given to a single individual.
The project is approved by the current IRB, which also has addressed privacy issues related to this project.
"The U.S. Radiation Accident Registry Follow-Up Program"
Principal Investigator: Dr. Ronald E. Goans, Oak Ridge Associated Universities
Project started in: 1979
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 63
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 70
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The REAC/TS Accident Registry is an invaluable historical resource for research into the mechanisms of radiation accidents as well as a useful compilation of biochemical data collected during medical management of these cases. For each radiation-related accident that either is reported to REAC/TS or for which REAC/TS provides consultation, a case number is assigned and a file begun on this accident. In many cases, we have a complete accident reconstruction, human factors data, medical and laboratory data, patient history transcribed from a live interview at REAC/TS, and multiple kinds of health physics data. This database is an invaluable resource for DOE and other governmental agencies interested in the human factors aspects of radiation-induced injury.
One of the most important aspects of medical management of a radiation accident is early dosimetry information. However, in many cases, both the magnitude of the accident and the dosimetry profile(s) of the victim(s) are not known for days to weeks. Data from the REAC/TS Accident Registry was recently used to develop an early dose assessment algorithm for high level gamma accidents. This algorithm (Goans, et al, Health Physics 72(4): 513-518, 1997) provides a simple dose-estimation algorithm based on lymphocyte kinetics from prior radiation accidents. This is an excellent example where retrospective analysis of accidents has been used to further the medical treatment of future cases.
In September, 1999, a significant criticality accident occurred at the Tokai fuel reprocessing facility in Japan. This accident involved 49 individuals, 3 of whom had medically significant doses. Because of the similarity of this accident to the 1958 Y-12 criticality accident, extrapolation of that data and revised algorithms (such as those mentioned above) were used to transmit early dosimetry information to Japanese treating physicians. REAC/TS is continuing to follow the case extensively and a large data file has been accumulated.
In March, 1999, the US Accident Registry was again put to medical use when a severe accident occurred in Lima, Peru involving an 192Ir industrial radiography source. This case was quite similar to one that occurred in Los Angeles in 1979 and the health physics dosimetry was well worked out for that accident. This data from the Registry was invaluable in providing early dosimetry to the Peruvian medical team.
Through September, 1999, the REAC/TS Central Registry contained data on 1769 cases involving approximately 142,488 individuals. The US Radiation Accident Registry currently contains 243 cases involving 1342 patients and the Non-US Radiation Accident Registry contains 164 cases, involving approximately 132,283 individuals (Chernobyl: 116,500; Brazil: 249; Mexico: 4000; Kyshtym: 10,180; Spain: 27). As usual, the response from REAC/TS continues to occur through interaction directly with the private sector, through all aspects of the DOE system, various state and foreign agencies, and with the NRC.
"Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Institute for Science and Education
Project started in: 1980
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objectives are to define the range and variability in the proliferative response of human lymphocytes to in vitro exposure to beryllium salts. This specific study involves blood samples from control persons who have never been at risk for exposure to beryllium in the workplace. Standard laboratory methods for separating and culturing cells are used. The only procedure that directly involves the blood donor is the venipuncture that is used to collect the blood sample. The only risks anticipated are the minor bleeding at the site of the venipuncture.
"Comprehensive Epidemiology Study of Department of Energy Atomic Workers"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Associated Universities
Project started in: 1980
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 60
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 13719
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
ORISE supports the DOE Office of Environmental Safety and Health in a number of technical areas. The principal area is to serve as the Epidemiologic Surveillance Data Center. In this capacity the following tasks are performed:
1. Receive data transmissions from epidemiologic surveillance sites and provide data management and quality assurance on the data received,
2. Provide quality assured nosologic coding for epidemiologic surveillance data,
3. Analyze data and construct reports for epidemiologic surveillance, and
4. Perform required Quick Response epidemiologic reviews and studies.
Other tasks involve rapid response and investigation of worker health concerns. In this capacity, the following activities may be performed:
1. Interviews of present and former workers to gather data about specific workplace hazards.
2. Submission of lists of workers who have unique exposures to the statewide tumor registry in order to monitor cancer incidence in the group.
The National Institute for Occupational Safety and Health (NIOSH) and DOE activities include:
1. Compiling rosters of workers from hard copy records.
2. Collecting death certificates for DOE worker populations; coding causes of death and entering codes to computer files.
3. Analyzing cause of death data with respect to exposure level using standard dose-response methodology.
4. Analyzing cause of death data in a descriptive manner.
"The DTPA Registry Follow-Up Program"
Principal Investigator: Dr. Ronald E. Goans, Oak Ridge Associated Universities
Project started in: 1980
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 61
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose of the DTPA Registry Follow-up Program is to document cases where DTPA is used, both in the DOE complex and elsewhere in the US, to document drug efficacy and to maintain a comprehensive registry of medical information in these cases for both the DOE and the FDA. Ca-DTPA and Zn-DTPA are distributed by Oak Ridge Associated Universities (ORAU) under contract with the US Department of Energy (DOE) Contract No. DE-AC05-76OR00033. ORAU manages the FDA Investigational New Drug (IND) authorizations for Ca-DTPA and the analogous Zn-DTPA for DOE.
During the last FY, a new supply of Ca-DTPA and Zn-DTPA was imported from Heyl, GmBH in Berlin and distributed to all co-investigators. This drug is approved by both the US FDA and DOE/EH. It meets the chemical specifications of the US Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur.)
DTPA belongs to the group of synthetic polyamino polycarboxylic acids which form stable complexes (metal chelates) with a large number of metal ions, especially the transuranic elements. The drug effectively exchanges calcium or zinc for another metal of greater binding power and carries it to the kidneys where it is then excreted. Historically, in the DOE laboratory complex, DTPA has been quite successful in promoting urinary excretion of the actinide elements in accident situations where inhalation or systemic uptake through wounds was involved.
In the last reporting period, June 1, 1998, to May 31, 1999, 3 patients received DTPA for a total of 4 doses. The status of the Radiation Emergency Assistance Center/Training Site (REAC/TS) DTPA Registry through June 1997 shows 47 active co-investigators throughout the country. Since the beginning of the Registry, 622 patients have received 4565 doses of DTPA with a drug adverse reaction rate of approximately 2.7%, mostly very minor. Our extensive documentation of DTPA usage therefore shows the inherent safety of the drug.
We feel that the REAC/TS DTPA Registry is a valuable resource for the medical follow-up of workers involved in accidents involving the transuranic elements.
The DTPA package inserts and the consent form have been modified according to recent recommendations of the IRB, DOE/HQ, the FDA, and an independent review committee commissioned by the DOE.
"Amendment - Comprehensive Epidemiology Study of Department of Energy Atomic Workers: National Death Index"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Institute for Science and Education
Project started in: 1989
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 60a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This project uses the National Death Index (NDI) to link death information to worker populations. The NDI is a specialized source of death data. Death certificates retrieved under this protocol are maintained and shared under a restrictive set of rules set forth by the NDI. The NDI was not used in FY99.
"Use of Prussian Blue for Internal Decontamination of Radiocesium"
Principal Investigator: Dr. Ronald E. Goans, Oak Ridge Institute for Science and Education
Project started in: 1991
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 81
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Prussian Blue (ferric ferrocynate) is well-studied as an ion-exchange resin which is quite efficacious in the decorporation therapy required for patients high body burdens of radiocesium or radiothallium. Anyone in the DOE system or elsewhere with internal contamination with radiocesium or radiothallium is eligible for treatment with Prussian Blue.
ORAU-81, Use of Prussian Blue for Internal decontamination of Radiocesium and Thallium has been granted FDA IND 51,700. A supply of Prussian Blue has been obtained from the German company Heyl GMBH. A Prussian Blue Registry has also been instituted at REAC/TS and currently has four co-investigators.
Prussian Blue, is to be used in the U.S.DOE complex as a decorporation agent for patients internally contaminated with medically significant amounts of cesium and thallium. In this document, the name Insoluble Prussian Blue (PB) without further specification indicates the following compound:
Ferric(III) hexacyanoferrate(II) "insoluble PB"
Fe4 [Fe (CN)6]3
Molecular weight: 859.3
Color Index No. 77.510
CAS Registry No. 14038-43-8
Prussian Blue is distributed by Oak Ridge Institute for Science and Education (ORISE). ORISE is managed by Oak Ridge Associated Universities (ORAU), under contract with the U.S. Department of Energy (DOE), Contract No. DE-AC05-76OR00033.
Insoluble Prussian Blue (PB), ferric hexacyanoferrate, Fe4[Fe(CN)6]3 is a drug that enhances excretion of isotopes of cesium and thallium from the body by means of ion exchange. It has had a long and successful history in the treatment of internal contamination with radiocesium. The Oak Ridge Institute for Science and Education (ORISE) undertaking for this IND will: (1) make Insoluble Prussian Blue more widely available at Department of Energy (DOE) facilities for physicians to treat individuals with significant radiocesium and radiothallium contamination and (2) quantitate efficacy and establish a drug profile based on wider experience. In the DOE system, internal contamination with radiocesium is expected to be much more important than with thallium.
Of the various radioisotopes of cesium, 137Cs is the most important. 137Cs is a common fission by-product material, a frequent active component of sealed sources, and an important radionuclide in radiation oncology. The use of 137Cs falls under the jurisdiction of the Nuclear Regulatory Commission (NRC). It is a ubiquitous radionuclide found throughout the DOE system and in hospitals performing either gynecological brachytherapy or interstitial therapy for solid tumors. Until the GoiGnia incident in Brazil, there were very few cases of radiocesium contamination requiring decorporation therapy. However, there is an increasing potential for such contamination to occur and a need for specific therapy. The recent increase in workers performing remediation work at hazardous waste sites also requires that clinicians have Insoluble Prussian Blue available and understand the nature of its pharmacodynamics.
Insoluble Prussian Blue has been recommended for years as the drug of choice by national and international radiation protection societies for use in treating internal contamination with radiocesium. It was effectively used in the treatment of patients contaminated with 137Cs in the 1987 GoiGnia, Brazil accident under temporary clearance by FDA for "compassionate use" by the Oak Ridge Associated Universities' Radiation Emergency Assistance Center/Training Site (REAC/TS) program.
"Identification and Abstraction of Death Certificates for National Registry of Persons Exposed to Hazardous Substances"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 1991
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 09/20/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objective is to retrieve hard-copy death certicates from states' vital records offices and electronic death information from the National Death Index (NDI) for individuals included in ATSDR disease registries. ATSDR provides identifying information and date and state of death information for individuals included in its registries. ORISE matches this information against the NDI to retrieve death certificate and cause of death information. Based on data received from the NDI, requests are made to the states in which the deaths occurred for hard-copies of the death certificates. All electronic and hard-copy records are returned to ATSDR at the completion of project. Access to ATSDR data at ORISE is on a need to know basis. All research staff have signed confidentiality agreements as a condition of employment. All hard-copy records are kept in locked cabinets when no being used. Electronic files are accessed using a password.
"Former Radiation Worker Medical Surveillance Program at Rocky Flats (Formerly, Medical Monitoring Program for Former Radiation Workers at Rocky Flats""
Principal Investigator: Mr. Joe M. Aldrich, Oak Ridge Institute for Science and Education
Project started in: 1992
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/14/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 133
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
ABSTRACT
OBJECTIVES
The objective of this program is to provide selected former radiation workers of the Rocky Flats Environmental Technology Site (formerly, Rocky Flats Plant) an opportunity to receive follow-up medical monitoring and to have their lifetime radiation dose updated. Additionally, this program will provide information on long-term health following exposure to radiation as a result of work at Rocky Flats.
Former radiation workers are invited to participate in the program if they meet specific criteria for radiation exposure received while they worked at Rocky Flats or if a review of their exposure record indicates a significant likelihood that an internal deposition or external dose may have occurred that was not well evaluated in the past.
Those participants for whom there is the potential for unrecorded dose or whose updated total effective dose equivalent (TEDE) is 20 rem or more may be invited to return for subsequent medical examinations and dose evaluation on a periodic basis, currently about every three years. These eligibility criteria are subject to change as a result of program funding and DOE directive.
Participation in the program is completely voluntary. Consent is documented by participant and witness signatures on a consent form. Individuals can withdraw from the program at any time.
METHODOLOGY AND INVOLVEMENT OF HUMAN SUBJECTS
Participants are asked to complete a Health and Exposure History questionnaire that summarizes their work, health, and family medical history. A medical examination and radiation exposure history review are scheduled, and a letter is sent to them with information about their trip, examination times, locations, and pre-authorized travel and lodging reimbursements.
The medical exam, will typically include the following:
* blood and urine samples to be analyzed by a clinical laboratory for a panel of health indicators, such as liver, kidney and thyroid function, cholesterol and glucose levels, and prostate-specific antigen (PSA), if requested by male participants,
* a chest x ray, with associated external exposure to ionizing radiation,
* a respiratory function test,
* vision and hearing tests,
* height, weight, and vital signs measurements,
* a test for occult blood in a stool sample,
* an electrocardiogram, and
* a physical examination.
The blood samples are taken from a vein in the participant’s arm. There is little physical risk in drawing the blood. In a few people, slight pain and bruising occur. Rarely, an infection from the needle puncture results from the procedure.
Participants may be asked to provide two separate 24-hour urine excretion samples for analysis for plutonium and/or americium. A lung count for americium-241 and, by inference, plutonium, may be performed at Rocky Flats. Occasionally, counts are made also on former contaminated wound sites and the skull and/or liver. None of these counts is invasive or painful; the detector is simply placed on the outer surface of the location being counted.
Radiation exposure history and lung count and urine analysis results are used to further refine participants’ calculated radiation doses, using the internal dosimetry computer code, CINDY, and individual retention and excretion patterns for plutonium and americium.
There is minimal financial cost to the participant for program activities. The program pays for pre-authorized travel and lodging costs for the medical examination and lung count, as well as shipping expenses for return of the urine samples.
Participants receive the results of medical and dosimetry tests and measurements, with a recommendation that participants provide the medical information to their personal physicians for inclusion in their medical files and for any appropriate follow-up. The program does not contact their physicians directly except in cases of emergency or participant request.
Personally-identifiable medical examination and dose assessment results are maintained as confidential information and are not released to anyone outside the program without the participants’ written permission, as required by law or DOE directive, or as indicated on the consent form. Individuals involved with the program have access to participants’ records only after having signed a document acknowledging their understanding of record confidentiality.
Records also will be used in the program database - a list of participants in the program and information summarized from their employment history and medical and dose assessment records. Personal identifiers are not published in any reports generated from the DOE former radiation worker database. However, privacy and confidentiality of medical records cannot be guaranteed. Access to or release of records could be required under court order or DOE directive.
"Y-12 Beryllium Workers Follow-up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Associated Universities
Project started in: 1992
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: 87
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This project began as a research effort for screening current and former workers at the Y-12 Plant in Oak Ridge, Tennessee. At the beginning of FY99, the scope was expanded to include former workers at all DOE facilities where beryllium was used.
The Former Beryllium Workers Medical Surveillance Program (BMSP) is composed of five interrelated tasks and includes the identification, notification, scheduling, testing, and retesting of former employees of DOE sites who believe they were exposed to beryllium during their employment. Rosters of former employees from DOE sites falling under the BMSP are obtained and appropriate notification letters and participation forms are sent to former employees designated as having had the opportunity for exposure to beryllium. All individuals indicating a desire to participate are tested for sensitivity to beryllium, and offered a chest x-ray. Retesting is offered once every three years to former employees previously tested who were found to have normal test results. In addition, retesting is offered every year to former employees who had a positive blood test for sensitivity to beryllium that was not confirmed or who had an abnormal chest x-ray possibly associated with CBD. A BMSP Registry is maintained for all individuals tested. The deidentified registry contains relevant demographic information for each participant, along with the results of beryllium sensitivity screening and/or CBD medical evaluations, occupational work histories, and other information pertinent to the identification of high risk jobs and work areas.
Blood is drawn from all study participants for a lymphocyte transformation test (LTT). There is little physical risk in drawing the blood. In a few people slight pain and bruising may occur. Rarely is an infection from the needle puncture possible.
A small number of participants (2-5%) are referred for a definitive diagnosis, including bronchoscopy, bronchial alveolar lavage and lung biopsy. Prior to the definitive diagnosis, they receive a physical examination, chest x-ray, complete blood count, and breathing test. Discomfort from the bronchoscopy is modest and consists mainly of pressure in the nose and some coughing until the bronchial tubes are numbed. An intravenous tube is in place during the procedure. A minor risk from the IV may occur if it slips out of the vein and fluid enters the tissues possibly causing pain or allowing medication that is being injected through the tubing to leak and cause inflammation. Before the procedure, the study participant is sedated. If a person is extremely sensitive to the medication, they may enter a deep sleep, in which case medication to counteract narcotics are required.
Bronchoscopy with biopsy may occasionally result in bleeding in some people, possibly requiring hospitalization for observation. An additional risk of the bronchoscopy with the biopsy procedure is rupture of the outer lining of the lung resulting in an air leak, requiring the insertion of a small tube to remove the air that escapes into the chest cavity. Other possible risks are the development of fever, or rarely, development of pneumonia.
Extremely rarely, a very sensitive individual could die from a complication from the procedure (much less than 1%). These risks are discussed with the individuals prior to their undergoing the definitive diagnosis procedures.
"Department of Energy Epidemiologic Surveillance Data Center"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 02/10/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 61538
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose is to undertake regular and systematic collection, analysis, and interpretation of data on illness and injury in the DOE work force. The objectives are: determine rates of illness and injury among workers; identify increases in the risk of disease among workers; provide data in response to questions from workers, physicians and others about possible occupational health effects; and identify areas in which further investigation or analytic studies should be initiated. This ongoing surveillance requires regular collection, maintenance, and interpretation of illness and injury, demographic and job-related data. Electronic data submissions are received at regular intervals from the participating DOE sites. The data is placed in the epidemiological surveillance database where the data are evaluated for quality and completeness. The illness and injury are nosologically coded. The data are processed into annual reports for each site that include characterization of the work force included in the epidemiological surveillance program at the site and an evaluation of the observed illness and injury trends at each site. All data used for epidemiological surveillance are routinely collected for other purposes. Data for individual workers are identifiable only by an encrypted number. Each participating site uses its own encryption algorithm. ORISE does not have access to any of the encryption algorithms.
See project NIOSH-95-015.
Project Identifier: ORAU-97-BU-1_V
Project Title: "Prevention of Stress and Health Consequences of Workplace Downsizing and Reorganization: Oak Ridge Review"
Go to list of projects at Oak Ridge Institute for Science and Education
See project UOC-96-DE-FC03-96SF21263.
Project Identifier: ORAU-97-UC1_V
Project Title: "Medical Surveillance Program for Construction Workers at Oak Ridge, TN : Phase II-LPT"
Go to list of projects at Oak Ridge Institute for Science and Education
"Beryllium Workers Follow-up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease. Amendment - to add Former Beryllium Workers at all DOE sites where Beryllium was used."
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Institute for Science and Education
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/99
IRB approval number: ORAU(99)-87a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2747
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
See abstract for ORAU-92-87
See project LANL-96-05.
Project Identifier: ORAU-99-LANL-1_V
Project Title: "Development of Improved Methods for the Detection of Individual Sensitivity to Beryllium 9"
Go to list of projects at Oak Ridge Institute for Science and Education
"Updated Study of the Accelerated Access Authorization Process"
Principal Investigator: Dr. G. R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/17/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Introduction
In a 1996 study the Center for Human Reliability Studies (CHRS) conducted a research study on 725 subjects applying for security clearances between 1991 and 1993, who participated in the voluntary Accelerated Access Authorization Process (AAAP). Successful completion of the AAAP allowed participants interim access to begin work activities while awaiting approval through the standard access authorization process. The study compared the number of derogatory issues uncovered by the AAAP and by the Background Investigation (BI) for each subject.
The AAAP has continued to run in parallel to the standard BI for nearly six years since the end of the original study period. The purpose of the current study is to update the data and investigate whether the AAAP process continues to reveal a greater number of derogatory issues than the BI, and if so, in what derogatory areas.
Methods
Data Collection
CHRS researchers will obtain data on all AAAP participants from the years 1995 to 1999 by going on site and abstracting from hardcopy records in secured areas. Collected information will include a year of participation, specific issues raised through the AAAP, specific issues raised through the BI, interim access granted (yes/no), security clearance granted (yes/no), and other information deemed relevant. The de-identified data will be entered into a database with only a pseudoidentifier.
Conclusions
The updated study will determine whether or not the AAAP has continued to function well in identifying individuals who do not pose a security risk. Conclusions will be based on well-documented data of high quality covering a five-year time period during which the AAAP has been well established.
"Infrared Thermography to Detect Intentional Deception"
Principal Investigator: Dr. G. R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 02/10/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 39
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose of this study done by the Center for Human Reliability Studies at ORISE is to assess the utility of infrared (IR) thermography to provide a non-intrusive adjunct to the polygraph for determining trustworthiness and reliability of personnel with security access authorizations. This study represents the first known systematic investigation devoted to evaluating this new technology to bolster capabilities to detect intentional deception.
The complete study consists of three phases. Phase I and Phase II are part of the current study. Objectives include the following:
-Phase I establishes the baseline for human infrared thermal response thresholds
-Phase II determines characteristics of infrared responses in simulated interviews
-Phase III (to be detailed, proposed, and performed at a later time) will demonstrate the effectiveness of IR thermography as an adjunct to the polygraph under actual field operating conditions
Cost effectiveness is an important consideration in this project. For this reason, a teaming arrangement was formed with the Oak Ridge National Laboratory to provide the infrared imaging system; thus incurring no up-front equipment costs. An advantage of the system is that subjects can be observed and infrared images displayed and recorded in real-time as data collection proceeds. Study participants are volunteers (informed consent) recruited from the community including students from local colleges, the regional medical center, and other sources. There are no known risks of any exposure since this is strictly a passive thermal system.
The study is designed to yield a body of data analyzed using appropriate statistical techniques. Reported data will be organized and interpreted to highlight confidence and reliability of results.
"Vaccine Safety Focus Groups"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 05/10/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 124
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Parents with children of initial vaccination age (defined as less than two years of age) that reside in geographic areas earmarked as target PRIZM Cluster area (clusters that have a high probability to have seen or read recent stories on vaccine safety) will be invited to participate in voluntary focus groups. These focus groups will be composed of parents from both first time and multiple child families. These participants will be asked to recall their feelings and concerns about initial vaccine administration.
Additionally, the moderator of the focus group will ask the focus group participants in-depth questions to assess parental perception of vaccine safety to determine questions and concerns among parents of initial vaccine age children. The moderator will also present several current or proposed vaccine communication products to assess the efficacy and effectiveness of these products to address parental vaccine safety concerns.
These focus groups will be conducted in three metropolitan areas: Houston, Texas; Kansas City, Missouri; and, San Jose, California. In Houston, focus group participants will be recruited from pediatric clinics located in the targeted PRIZM cluster areas. Focus group participants in the Kansas City areas will be recruited from family practice clinics in the targeted PRIZM cluster areas. Focus group candidates in the San Jose area will be recruited from a prepaid managed care provider with immunization clinics located in the targeted PRIZM cluster areas. The use of different types of clinical practices in these geographically diverse locations is an effort to allow for differences in primary care practice type and capture potentially diverse responses.
"Update of a Mortality Study of Titanium Dioxide Workers"
Principal Investigator: Dr. Elizabeth D. Elllis, Oak Ridge Institute for Science and Education
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 04/04/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3838
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose of the study is to update the cohort mortality study of workers exposed to titanium dioxide. The major components of the update will be computerization of data from the original study; vital status ascertainment using national databases; death certificate retrieval and cause of death information retrieval using the states' vital records offices and the National Death Index; and comparison of the mortality among the workers to the US general population. Since this study will be carried out using existing records, the risks to the study participants originate from loss of privacy of the workers or their survivors. To minimize this risk, access to records is on a need to know basis only. All research staff who have access to the records have signed a confidentiality agreement. When not in use, records are kept in locked cabinets. Access to electronic data is password protected.