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: 20
"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: 12/01/00
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: 06/19/00 to 05/31/01
Explanation:
FDA Reporting Year
Type(s) of Human Subjects Involvement:
Accidents involving internal contamination with the actinide elements (Pu, Am, Cm, etc) occur in the DOE complex and both Ca-DTPA and Zn-DTPA have proven efficacy in the 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. Most cases of internal contamination involve inhalation of the material, but uptake through wounds usually occurs at least once each reporting period.
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. A new supply of DTPA has been recently imported from Heyl, GmBH in Berlin and distributed to all 40 current 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 635 separate patients administered DTPA (either intravenously by slow IV push or by nebulizer) in recommended doses (for a total of 4675 separate doses; current through 10/2001). 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: 12/01/00
IRB approval number: 63
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 169
Reporting period for number of human subjects:
Fiscal Year 2001
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. In many cases, we have 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. In FY 2001, this work was extended to encompass criticality accidents (Goans, et al, health Physics 81(4): 446-449, 2001). These papers represent excellent examples where retrospective analysis of accidents has been used to further the medical treatment of future cases.
Through June, 2001, the REAC/TS Central Registry contained data on 2065 cases involving approximately 133,789 individuals. The US Radiation Accident Registry currently contains medical and health physics data on 134 radiation-related fatalities (30 US accidents; 104 non-US accidents), and 418 radiation accidents involving 3041 significant exposures. 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: 12/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 23
Reporting period for number of human subjects:
Fiscal Year 2001
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. The results from this testing are used to establish the range of values for a normal test and to identify the cut-off values to be used in identifying abnormal tests in beryllium-exposed workers. 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: 12/01/00
IRB approval number: 60
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2069
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
ORISE supports the DOE Office of Health Programs 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. Scanning original facility documents for NIOSH use in worker studies.
4. Analyzing cause of death data with respect to exposure level using standard dose-response methodology.
5. 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: 12/01/00
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 2001
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.
Recently, a new supply of Ca-DTPA and Zn-DTPA was imported from Heyl, GmBH in Berlin and distributed to all 40 current co-investigators. This drug is approved by both the US FDA and DOE/EH, and 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, 2000, to May 31, 2001, 6 patients received DTPA for a total of 7 doses. The status of the Radiation Emergency Assistance Center/Training Site (REAC/TS) DTPA Registry through June, 2001 shows 40 active co-investigators throughout the country. Since the beginning of the Registry, 635 patients have received 4675 doses of DTPA with an adverse reaction rate under 1.5%, mostly very minor. Our extensive documentation of DTPA usage therefore demonstrates 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 are modified periodically according to 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: 12/01/00
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 2001
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 FY01.
"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: 12/01/00
IRB approval number: 81
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2001
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 in the US with internal contamination with radiocesium or radiothallium is eligible for treatment with Prussian Blue. Interestingly, the most recent use of Prussian Blue has been in medical treatment of intentional poisoning with thallium. In the last three years, DOE has made Prussian Blue available to three patients in the US with severe thallium poisoning. Without this compassionate gesture, at least one patient would likely have died.
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, obtained from the German company Heyl GMBH, is currently distributed to four co-investigators in the DOE complex.
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).
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. In the normal course of DOE operations, internal contamination with radioactive cesium is thought to be more likely than with radiothallium.
Of the various radioisotopes of cesium, Cs-137 is the most important. Cs-137 is a common fission by-product material, a frequent active component of sealed sources, and an important radionuclide in radiation oncology. The use of Cs-137 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 Cs-137 in the 1987 Goiania, 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: 12/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 447
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The objective is to retrieve hard-copy death certificates 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"
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: 01/17/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 203
Reporting period for number of human subjects:
Fiscal Year 2001
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, 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, or if they request to participate.
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, for selected repeat participants, 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 one or 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.
"Y12 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: 12/01/00
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 2001
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. A chest x-ray is offered if the individual reports any symptoms that are compatible with chronic beryllium disease. 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: 12/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 69290
Reporting period for number of human subjects:
Fiscal Year 2001
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 UOC-96-DE-FC03-96SF21263.
Project Identifier: ORAU-97-UC1_IRB
Project Title: "Medical Surveillance Program for Construction Workers at Oak Ridge, TN : Phase II-LPT"
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"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: 12/01/00
IRB approval number: ORAU(99)-87a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5058
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
See abstract for ORAU-92-87
See project NIOSH-97-007.
Project Identifier: ORAU-99-NIOSH2_IRB
Project Title: "Cohort Mortality Study of DOE Chemical Laboratory Workers"
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"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
This project ended in fiscal year 2001.
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: 12/01/00
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 2001
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.
During this reporting period no additional data was collected. Draft report has been submitted to DOE for approval. Final report will be published and project closed as soon as DOE approval received.
"Infrared Thermography to Detect Intentional Deception"
Principal Investigator: Dr. G. R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2000
This project ended in fiscal year 2001.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 105
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 04/23/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 22
Reporting period for number of human subjects:
Fiscal Year 2001
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.
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 IR thermal responses
-Phase II determines characteristics of IR responses in simulated interviews involving deception
-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 IR imaging system, thus incurring no up-front equipment procurement costs. An advantage of the system is that test subjects can be observed and IR images displayed and recorded in real-time as data collection proceeds. Study participants are volunteers (with informed consent) recruited from the local community, including students from local colleges, the regional medical center, and general population. There are no known risks of any harmful exposure, since this is strictly a passive thermal system. Participant privacy and confidentiality were preserved with use of approved informed consent forms, one for Phase I and one for Phase II testing.
Details of the test protocols for Phase I and Phase II were different and are reflected in the individual consent forms. In both phases, however, individual participants were asked to provide data under similar circumstances that involved sitting in front of IR camera equipment and having their IR images recorded for analysis. The difference in Phase II involved the introduction of deception in questions. Data in Phase I were obtained under neutral conditions.
The study yielded a body of data that was analyzed using appropriate statistical techniques. Phase II test work was completed in FY 2001, data were analyzed, and the project report is in final stages of preparation.
For continuation of this project, there are two amendments: 00-105a and 00-105b. The first is to develop a device to monitor heart rates and the other is to perform extended research in thermography, both for enhanced deception detection.
"Vaccine Safety Focus Groups"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2000
This project ended in fiscal year 2001.
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: 12/01/00
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 2001
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.
See project NIOSH-95-005.
Project Identifier: ORAU-00-NIOSH1_IRB
Project Title: "Study of Multiple Myeloma among Workers at the Oak Ridge Gaseous Diffusion Plant (K-25)"
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See project NIOSH-97-009.
Project Identifier: ORAU-00-NIOSH3_IRB
Project Title: "Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation"
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See project NIOSH-95-004.
Project Identifier: ORAU-00-NIOSH4_IRB
Project Title: "Leukemia Case-Control Study"
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"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: 12/01/00
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 2001
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.
"Measurements of DU in Gulf War Veterans"
Principal Investigator: Dr. Richard E. Toohey, Oak Ridge Institute for Science and Education
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 08/24/01
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 2001
Type(s) of Human Subjects Involvement:
The objective of this study is to determine if field-portable gamma-ray spectrometers used by REAC/TS for measurements of radioactive materials in radiation accident victims can quantify the activity of depleted uranium (DU) fragments embedded in the extremity tissues of Gulf War veterans.
Field-portable gamma-ray spectrometers will be placed over the locations of known DU shrapnel deposits in from three to six selected veterans of the Gulf war who were wounded by DU munitions in "friendly fire" incidents. Each measurement will last approximately 30 minutes. Data will be analyzed to determine the sensitivity of the method and compared with results obtained on the same subjects at the Boston VAMC. These measurements are completely passive; the detectors measure radiation coming from radioactive materials in the subject.
"Testing of Environmental Health Calendar"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2001
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: 09/13/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Oak Ridge Institution for Science and Education (ORISE) provides technical assistance in health communication to the Agency for Toxic Substances and Disease Registry (ATSDR). ORISE is working with ATSDR to test the draft version of a calendar that is to provide information to parents on various environmental health issues. Data is to be collected by means of focus groups. 8-10 people will be selected as being the target audience and will be gathered at a facility. A moderator will lead a discussion based on a series of questions designed to prompt discussion of the subject of interest.
ORISE will maintain no identifiers connecting any data collected to any particular participant, neither will it provide any personal identifiers to ATSDR. Firms that conduct recruiting and host the sessions will be required to assign a random digital code to each participant's information and keep the key to the code. Informed consent will be obtained from all focus group participants.
"Enhanced Latent Fingerprint Detection in Missing Exploited Children"
Principal Investigator: Dr. Linda A. Lewis, BWXT-Y-12
Project started in: 2001
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: 04/20/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The latent fingerprints of young children are significantly more difficult to develop as the prints age compared to the prints of adults. In criminal cases involving children, evidence known to contain a latent print has been processed without successfully developing a print.
During the past two years, researchers at Oak Ridge have been studying the fundamental chemistry involved in fuming latent fingerprints with superglue (ethyl cyanoacrylate). Researchers have found that the quality of a cyanoacrylate-developed fingerprint is significantly dependent upon the condition and composition of the latent print prior to fuming. Two major types of latent prints have been investigated--clean and oily prints. Clean prints (obtained by thoroughly washing and rinsing the hands) were purely eccrine in nature, closely mimicking the expected composition of a prepubescent children's print. Findings clearly demonstrated that clean prints were not developed by cyanoacrylate fuming after aging over 24 hours. Oily prints (obtained by swiping fingers over the forehead region) were a mixture of sebaceous and eccrine secretions. It was determined that oily prints could be successfully developed by cyanoacrylate fuming up to and possibly beyond 18 months.
Literature will be distributed requesting the assistance of children by donating fingerprints at a daycare center. Ten fingerprints will be collected from each child whose parent or guardian has signed the consent form to allow their child to participate in the fingerprinting activity. The child will be asked if they wish to participate in the fingerprinting activity. The child will press a finger/thumb on a disk that has been pre-glued into a petri dish. The collected fingerprints will be transported back to the laboratory and aged prior to development with superglue. During the study, no child will be exposed to any chemicals or other agents. The petri dish will labeled with only the child's age, gender, and a unique number. No link between the child and the print will exist.
"National Digital Mammography Archive (NDMA), Phase II"
Principal Investigator: Ms. Barbara Beckerman, BWXT
Project started in: 2001
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: 05/08/01
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 2001
Type(s) of Human Subjects Involvement:
This is an R&D project to develop and implement an integrated scalable testbed of a system that can be used as a national breast imaging archive and network infrastructure to support telemammography using Next Generation Internet technologies. There are four participating clinical centers participating in this research. All patients will have their imaging performed and digitized at the institution at which they are seeking clinical care. Each site will be responsible for consenting their own patients to participate. Images and data will be encrypted when transmitted over high-speed virtual private networks (VPNs), to ensure security to and from an archive that is being developed and maintained at the University of Pennsylvania.
Adequate security is critical to maintain patient confidentiality and the integrity of records. The combination of security layers will secure data from the local site to the archive. Although patient consent will not be required for clinical operation of the archive, patient consent will be obtained prospectively from patients contributing data to the testbed project.
See project CUHSC-96-DE-FC03-96SF21259.
Project Identifier: ORAU-01-CUHSC_IRB
Project Title: "Medical Monitoring Program for Former Rocky Flats Workers"
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