Ms. Pamela
S.
Bonee
Oak Ridge Institute for Science and Education/CPD
P.O. Box 117
Oak Ridge, TN 37831-0117
Phone: 865-576-3147
Fax: 865-241-2923
E-mail: Pam.Bonee@orau.org
Number of Human Subjects projects reported: 25
| ORAU-78-96 | "Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals" |
| ORAU-79-63 | "The U.S. Radiation Accident Registry Follow-Up Program" |
| ORAU-80-58 | "Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization" |
| ORAU-80-60 | "Comprehensive Epidemiology Study of Department of Energy Atomic Workers" |
| ORAU-80-61 | "The DTPA Registry Follow-Up Program" |
| ORAU-89-60a | "Amendment - Comprehensive Epidemiology Study of Department of Energy Atomic Workers: National Death Index" |
| ORAU-91-81 | "Use of Prussian Blue for Internal Decontamination of Radiocesium" |
| ORAU-94-106 | "Department of Energy Epidemiologic Surveillance Data Center" |
| ORAU-99-87a | "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." |
| ORAU-00-108 | "Update of a Mortality Study of Titanium Dioxide Workers" |
| ORAU-04-127 | "Survey of Respiratory Symptoms Among Workers in the Forrestal Building" |
| ORAU-05-131 | "DOE National Supplemental Screening Program" |
| ORAU-05-81a | "Amendment: Use of NDA Prussian Blue for Internal Decontamination of Radiocesium (NDA)" |
| ORAU-05-96a | "Amendment: Use of Ca-DTPA and Zn-DTPA (NDA product) for Chelation Therapy of Heavy Metals" |
| ORAU-06-133 | "Extended Research on Detection of Deception Using Volatile Organic Compound (VOC) Emissions" |
| ORAU-06-135 | "Automated Cytogenetic Analysis of Nuclear Workers with Internal Deposits of Plutonium" |
| ORAU-06-136 | "Formative Research: Bird Flu Issues" |
| ORAU-07-137 | "Re-establishment of the Cytogenetics Biodosimetry Laboratory at the Radiation Emergency Assistance Center/Training Site, ORISE/ORAU" |
| ORAU-07-138 | "Adherence to Public Health Directives" |
| ORAU-07-139 | "Pandemic Influenza Message Testing 3 and Pandemic Influenza Vaccine Perception" |
| ORAU-07-140 | "Atomic Nuclear Energy Workers: Pilot Mortality Study of Mound Radiation Workers" |
| ORAU-07-141 | "Assessing Beryllium Control Measures at Rocky Flats" |
| ORAU-07-142 | "Public Engagement on Vaccine and Immunization Efforts White Paper Data Collection Process" |
| ORAU-07-143 | "Factors Influencing Immunization of Health Care Workers" |
| ORAU-07-144 | "Pilot Study: Public Values in Vaccine Planning" |
Other projects of interest associated with this site:
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| NIOSH-95-005 | "Study of Multiple Myeloma among Workers at the Oak Ridge Gaseous Diffusion Plant (K-25)" |
| QC-99-C-7-1-98-02 | "Medical Surveillance of Former and Current Workers at the DOE Gaseous Diffusion Plants, Phase II: Medical Screening" |
| NIOSH-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| UOC-96-DE-FC03-96SF21263 | "Portsmouth GDP & Paducah GDP Building Trades Medical Screening Program, Phase II-LPT" |
| DU-05-30366 | "Former Pantex Worker Medical Surveillance Program" |
"Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals"
Principal Investigator: Dr. Mark S. Jenkins, Oak Ridge Associated Universities
Project started in: 1978
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 96
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/10/07
Explanation of IRB approval:
The renewal was due in October.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Other: 06/01/06 to 05/31/07
Explanation:
U.S. Food and Drug Administration Reporting Year.
Type(s) of Human Subjects Involvement:
Investigational New Drug (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. Radiation Emergency Assistance Center/Training Site (REAC/TS) and co-invesitgators in the study received new DTPA during this reporting period. Both Ca- and Zn-DTPA are approved by both the U.S. Food and Drug Administration (FDA) and DOE/Environment Safety and Health and meet the chemical specifications of the U.S. Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur.). Ca- and Zn-DTPA have recently (late in the reporting period) been classified by the U.S. FDA as New Drug Application (NDA) and are no longer considered investigational drugs (INDs). This project will deal only with IND product, at this point held only by the Strategic National Stockpile (SNS) and REAC/TS, and is expected to be used only in times of national emergency, when NDA product is depleted and can not be rapidly replaced.
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.
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 ideally should be given within six hours of exposure.
Accidents involving internal contamination with the actinide elements (Pu, Am, Cm) occur in the DOE complex and both Ca-DTPA and Zn-DTPA have proven effectiveness 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 has occured in some reporting periods.
One case involving use of DTPA is recorded on the REAC/TS registry for this reporting time period. This case involved potential internal contamination through a puncture wound to the hand with a radio-contaminant containing radio-isotopes of plutonium and americium (exact radionuclide uncharacterized). Surface contamination was noted to be 25 dpm alpha, but internalized contamination could not be characterized. No adverse effects were reported. Laboratory tests (complete blood count, glucose, blood urea nitrogen, creatinine, and urine) were normal. Urine biodosimetry and/or scan were not reported. After completing the standard consent form, the skin contamination was cleared with go-jo and soap and water. One dose of Zn-DTPA with diluent was administered. No changes in blood pressure or vital signs were noted. No adverse effects were noted.
No serious toxicity in human subjects has been reported as a result of 641 separate patients being administered DTPA (either by slow intravenous push, by intermuscular injection, or by nebulizer) in recommended doses for a total of 4,681 separate doses current through the reporting period (the one case where DTPA was used for external decontamination is not included in the totals). In addition, no serious adverse effects have been noted as a result of over 1,000 doses of Zn-DTPA in the recommended dosage given to individual subjects. The project is approved by the Oak Ridge Site-wide IRB, which also has addressed privacy issues related to this project.
"The U.S. Radiation Accident Registry Follow-Up Program"
Principal Investigator: Dr. Mark S. Jenkins, Oak Ridge Associated Universities
Project started in: 1979
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 63
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/10/07
Explanation of IRB approval:
Renewal due in October.
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 2007
Type(s) of Human Subjects Involvement:
The Radiation Emergency Assistance Center/Training Site (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 were 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 FY2001, 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.
In FY2002 to 2004, the U.S. Food and Drug Administration (FDA) almost exclusively used data from the REAC/TS radiation registry and the DTPA registries as a basis for moving Ca- and Zn-DTPA from an Investigational New Drug (IND) to a New Drug Application (NDA) classification, allowing more general accessability to DTPA for the general medical community.
In FY2005, no radiation accidents were reported to REAC/TS. Up to September 30, 2005 the REAC/TS Accident Registry contained data on 2,177 events involving approximately 133,802 individuals. The U.S. Radiation Accident Registry currently contains medical and health physics data on 134 radiation-related fatalities (26 U.S. accidents, 100 non-U.S. accidents, eight locations of accident not noted, likely due to record error precomputerization), and 428 radiation accidents involving 3,050 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 Nuclear Regulatory Commission (NRC).
An individual's consent to participate in the Radiation Accident Registry/follow-up program is obtained by the co-investigator/physician at the time of the accident. Entry into the Radiation Accident Registry/follow-up program is based on ERDA/NRC/DOE established criteria. ERDA, the Energy Research and Development Administration, was the predecessor of the DOE. All data collected for the Registry will be encoded and entered into the password-protected computerized data bank maintained at Oak Ridge Associated Universities (ORAU) as part of the DOE Record System as described in the Federal Register. The information contained in the Registry is extracted from individual records which are retrievable only by REAC/TS staff by name or other personal identifier. The information, therefore, is included in a DOE Privacy Act system of records and will not be disclosed to third parties without written consent of the participant. Written consent for approved epidemiological research studies using redacted (no identifiers) records is obtained from registry participants at the same time informed consent is obtained.
"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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 11/10/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 44
Reporting period for number of human subjects:
Fiscal Year 2007
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.
The purpose of the lymphocytes drawn on healthy individuals is to provide control cells for beryllium sensitization studies only and are not used as part of any protocol that involves human subjects. The consent form is provided and payment authorization is obtained by laboratory personnel. The results of the tests are stored only under a laboratory identifier code. There is no link between the volunteers and the laboratory codes. Aggregate results are used to set the normal values for each new lot of serum used in the laboratory.
During FY2005, six new serum lots were tested and two were chosen for further use in the laboratory.
"Comprehensive Epidemiology Study of Department of Energy Atomic Workers"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Associated Universities
Project started in: 1980
Status of the Research this Fiscal Year:
Study is no longer enrolling and participants have completed all research-related interventions. The study remains active only for long-term follow-up.
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: 11/10/06
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 2007
Type(s) of Human Subjects Involvement:
The Oak Ridge Institute for Science and Education (ORISE) supports the DOE Office of Health Programs and the National Institute for Occupational Safety and Health (NIOSH) in a number of activities utilizing retrospective occupational records located at various DOE facilities.
These 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.
During FY2007, there was no activity.
"The DTPA Registry Follow-Up Program"
Principal Investigator: Dr. Mark S. Jenkins, Oak Ridge Associated Universities
Project started in: 1980
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 11/10/07
Explanation of IRB approval:
Renewal due in October.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
The purpose of the DTPA Registry Follow-up Program is to document cases where diethylenetriaminepentaacetate (DTPA) is used, both in the DOE complex and elsewhere in the U.S., to document drug safety and efficacy and to maintain a comprehensive registry of medical information in these cases for both the DOE and the U.S. Food and Drug Administration (FDA). Ca-DTPA and Zn-DTPA are distributed by Oak Ridge Associated Universities (ORAU) under contract with the U.S. Department of Energy.
No new supplies of either Investigational New Drug (IND) Ca- or Zn-DTPA for the Radiation Emergency Assistance Center/Training Site (REAC/TS) or its co-investigators have been imported from Heyl, GmbH in Berlin during this reporting period. A shipment of New Drug Application (NDA) DTPA was received and distributed to co-investigators in November 2005. All Ca- and Zn-DTPA held by co-invesitgators are now NDA and are not considered by the FDA as "investigational drugs." They are approved by the FDA, supported by DOE/EH, and meet the chemical specifications of the U.S. 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.
One case involving use of DTPA is recorded on the REAC/TS registry for this reporting time period. This case involved internal contamination through a puncture wound in the hand with a contaminant containing radioisotopes of plutonium and americium. The exact isotopes were not characterized. Skin contamination was noted to be 25 dpm alpha. Estimate of the amount internalized was not included in the report. Urine biodosimetry was not reported. Whole body or focal scan was not reported. After completing the standard consent form, the skin contamination cleared with GoJo Wipes and soap and water. One dose of Zn-DTPA with diluent was administered. No changes in blood pressure or vital signs were noted.
No serious toxicity in human subjects has been reported as a result of 642 separate patients administered DTPA (by slow intravenous push, by intermuscular injection, or by nebulizer) in recommended doses for a total of 4,682 separate doses current through the reporting period (the one case where DTPA was used for external decontamination is not included in the totals). In addition, no serious adverse effects have been noted as a result of over 1,000 doses of Zn-DTPA in the recommended dosage given to individual subjects. The project is approved by the Oak Ridge Site-wide IRB, which also has addressed privacy issues related to this project.
The status of the REAC/TS DTPA Registry through June 2005 shows 27 active co-investigators throughout the country. Since the beginning of the Registry, 642 patients have received 4,682 doses of DTPA with an adverse reaction rate under 1.5 percent, 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 have been modified to meet NDA product according to recommendations of the IRB, DOE/HQ, the FDA, and an independent review committee commissioned by the DOE. The consent form has been modified in FY2005. An individual's consent to participate in the DTPA Registry/follow-up medical program is obtained by the co-investigator/physician at the time of the initial DTPA treatment. All data collected for the Registry will be encoded and entered into the password-protected computerized data bank maintained at ORAU as part of the DOE Record System as described in the Federal Register. The information contained in the Registry is extracted from individual records which are retrievable only by REAC/TS staff by name or other personal identifier. The information, therefore, is included in a DOE Privacy Act system of records and will not be disclosed to third parties without written consent of the participant. Written consent for approved epidemiological research studies using redacted (no identifiers) records is obtained from DTPA registry participants at the same time informed consent is obtained, prior to first DTPA treatment.
"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
Status of the Research this Fiscal Year:
Study is no longer enrolling and participants have completed all research-related interventions. The study remains active only for long-term follow-up.
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: 11/10/06
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 2007
Type(s) of Human Subjects Involvement:
This project uses the National Death Index (NDI) to link death information to worker or special exposure 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.
During FY2007, this data source was not used. It is anticipated that there will be futures uses of the NDI.
"Use of Prussian Blue for Internal Decontamination of Radiocesium"
Principal Investigator: Dr. Mark S. Jenkins, Oak Ridge Institute for Science and Education
Project started in: 1991
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Project funded, but no participants have been enrolled to date.
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: 11/10/07
Explanation of IRB approval:
Renewal due in October.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 06/01/06 to 05/31/07
Explanation:
U.S. Food and Drug Administration reporting period.
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 with high body burdens of radiocesium, radiothallium, or stable thallium. Anyone in the DOE system or with internal contamination with radiocesium, radiothallium, or stable thallium is eligible for treatment with Prussian Blue. Those with internal contamination with radiocesium, radiothallium, or stable thallium elsewhere in the U.S. outside the DOE system are also eligible with DOE approval for treatment if Prussian Blue is not available. Although technically Prussian Blue, under New Drug Application (NDA), should be widely available, there are many locales in the U.S. where it is not immediately available.
There has been no use of Prussian Blue for internal contamination with either radiocesium, radiothalliumin, or stable thallium in the most recent reporting period (6/1/05 to 5/31/06).
ORAU-81, Use of Prussian Blue for Internal Decontamination of Radiocesium and Thallium, has been granted by the Food and Drug Administration's (FDA) Investigational New Drug (IND) 51,700. Despite the approval of an NDA for Prussian Blue to Heyl GmbH, the IND for Prussian Blue is planned at this time to continue but the project remains an inactive. The project will continue in the DOE community using NDA drug (see admendment July 20, 2005). A supply of Prussian Blue, obtained from the German company Heyl GmbH, is currently distributed to six co-investigators in the DOE complex. This product, although manufactured by Heyl under the IND, has been determined to meet NDA standards, and the FDA has authorized ORISE in writing to use the product of Batch # 014082 as NDA quality product. Therefore, all Prussian Blue now with co-investigators is from this batch and so can be treated as NDA product.
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 radiocesium and radiothallium. 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, and CAS Registry No. 14038-43-8. Under the NDA (#58060-00201) Insoluble Prussian Blue is also known as Radioguardase. 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 ORAU's REAC/TS program.
Prussian Blue is distributed by the Oak Ridge Institute for Science and Education (ORISE) to DOE co-investigators for DOE facilities throughout the country. Up until July 20, 2005, Prussian Blue was distributed under the IND. After the amendment for Project 81 of July 20, 2005, it is not available as IND but is as NDA product at DOE facilities participating in the ongoing safety and efficacy study (ORAU 91-81). As an NDA, Prussian Blue is technically available throughout the country from pharmacies with a physician's prescription. However, it is not generally available as yet and ORISE/REAC/TS with DOE approval can also provide limited amounts of Prussian Blue to non-DOE personnel.
ORISE is managed by Oak Ridge Associated Universities (ORAU), under contract with the U.S. Department of Energy (DOE). Insoluble 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 Goiania 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. Additionally, given its widespread availability and its chemical characteristics, it is considered as a prime candidate for use in a terrorist event, such as a dirty bomb. 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.
See amendment of July 20, 2005 for more details.
"Department of Energy Epidemiologic Surveillance Data Center"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 1994
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 11/10/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 79100
Reporting period for number of human subjects:
Fiscal Year 2007
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 are placed in the epidemiological surveillance database where the data are evaluated for quality and completeness. Illness and injury data 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. Oak Ridge Institute for Science and Education does not have access to any of the encryption algorithms. In FY2004, the program was renamed Illness and Injury Surveillance Program with 15 DOE sites participating. In FY2006, one site dropped out of the project due to site closure. In FY2007, there were 13 participating sites. A summary report using data from 1995 to 2004 was completed as well as an abbreviated version of the full report.
"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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 11/10/06
IRB approval number: ORAU(99)-87a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 131
Reporting period for number of human subjects:
Fiscal Year 2007
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 FY1999, 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, initial 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 under the BMSP are obtained and appropriate BMSP notification letters and participation forms are sent to persons on these rosters. Individuals indicating a desire to participate in the BMSP are tested for sensitivity to beryllium and may also be given a chest x-ray if they report respiratory symptoms compatible with chronic beryllium disease (CBD). Persons who show sensitization to beryllium on the first test may be scheduled for a second test to confirm the abnormal finding. Further medical evaluation to determine the presence of CBD may be offered to those who have a normal test, but have suspicious lung pathology on chest x-ray examination or symptoms of CBD that cannot be explained by other disease processes. Retesting may be offered once every three to five years to former employees who are found to have normal test results.
Blood is drawn from all study participants for a beryllium lymphocyte proliferation test (Be-LPT). 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.
Any participant who has one abnormal Be-LPT will be mailed an information package explaining the new Department of Labor (DOL) Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) and how to apply for benefits through this program. These participants may receive a second Be-LPT through the Oak Ridge Institute for Science and Education program while waiting to be accepted for benefits from DOL. When accepted into the DOL program, all further medical examinations and benefits for the participant should be coordinated and guaranteed by DOL. The DOL program will cover medical monitoring even if the participant chooses not to have a repeat test or if the repeat test is normal. Through this program, participants will have further diagnostic procedures to determine if they have CBD. The majority of participants who have an abnormal Be-LPT apply and are accepted to the DOL program for further follow-up.
Informed consent is obtained for all participants in the Former Beryllium Worker Medical Surveillance Program. Test results are confidential, but not anonymous, and testing staff will only discuss these results with the participant or persons approved by the participants. Participants are free to withdraw at any time without penalty or loss of benefits.
During FY2005, the emphasis of testing was shifted from former DOE workers to former employees of sites that supplied beryllium to DOE operations (vendors).
"Update of a Mortality Study of Titanium Dioxide Workers"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 2000
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 11/10/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4000
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
The original purpose of the study was to update the cohort mortality study of workers exposed to titanium dioxide. The study is being expanded to include two additional worker cohorts and to include a hazards assessment as part of the analysis. The major components of the new study are computerization of the worker roster and work history; vital status ascertainment using national databases, death certificate retrieval, and cause of death information retrieval; a hazards assessment analysis; comparison of the mortality among the workers to the U.S. general population; and analysis of the risk of mortality related to hazards in the workplace. 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.
"Survey of Respiratory Symptoms Among Workers in the Forrestal Building"
Principal Investigator: Dr. Elizabeth Ellis, Oak Ridge Institute for Science and Education
Project started in: 2004
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 11/09/06
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 2007
Type(s) of Human Subjects Involvement:
The objective of this study was to investigate a health concern among DOE employees in the Forrestal Building in Washington, DC that their recurrent respiratory symptoms are related to their work environment. The study resulted from employee concerns about recurrent respiratory symptoms. Forty-two subjects were enrolled as of 11/8/05, and the study remained open in FY2006 only for long-term follow-up. The study has now been completed in FY2007.
"DOE National Supplemental Screening Program"
Principal Investigator: Dr. John R. McInerney, Oak Ridge Institute for Science and Education
Project started in: 2005
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 06/09/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2505
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
Identify groups of former workers at risk for occupational disease, notify these individuals, and offer them medical screening that can lead to medical tratment. The objective is to provide high quality medical evaluations to former DOE workers so that occupationally related health effects may be identified. Workers who are found to have health conditions requiring further evaluation and treatment will be referred to their private medical physicians and to others in the medical community for follow-up.
The National Supplemental Screening Program (NSSP) will continue to maintain and/or expand its operations to provide medical examination services for six DOE sites, as well as former worker referrals from the DOE Former Worker Programs. No changes are anticipated with regards to NSSP participant enrollment, schedule, or the medical examinations offered/provided by Community Health Systems or the National Jewish Medical and Research Center.
"Amendment: Use of NDA Prussian Blue for Internal Decontamination of Radiocesium (NDA)"
Principal Investigator: Dr. Mark S. Jenkins, Oak Ridge Institute for Science and Education
Project started in: 2005
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Project funded, but no participants have been enrolled to date.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 81a
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/10/07
Explanation of IRB approval:
Renewal due in October.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 06/01/06 to 05/31/07
Explanation:
U.S. Food and Drug Administration project year.
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 with high body burdens of radiocesium, radiothallium, or stable thallium. Anyone in the DOE system or with internal contamination with radiocesium, radiothallium, or stable thallium is eligible for treatment with Prussian Blue. Those with internal contamination with radiocesium, radiothallium, or stable thallium elsewhere in the U.S. outside the DOE system are also eligible with DOE approval for treatment if Prussian Blue is not available. Prussian Blue is manufactured under its New Drug Application (NDA) by Heyl GmbH of Germany and is not considered investigational. Physicians can write prescriptions for Prussian Blue and pharmacies can carry Prussian Blue. Prussian Blue, under the NDA, should be widely available, but there are many locales in the U.S. where it is not immediately available.
There has been no use of Prussian Blue for internal contamination with either radiocesium, radiothalliumin, or stable thallium in the most recent reporting period (6/1/05 to 5/31/06).
ORAU-81, Use of Prussian Blue for Internal Decontamination of Radiocesium and Thallium, has been granted by the Food and Drug Administration's (FDA) Investigational New Drug (IND) 51,700. Despite the approval of an NDA for Prussian Blue to Heyl GmbH, the IND for Prussian Blue is planned at this time to continue but the project remains an inactive (see Project 91-81). The project will continue in the DOE community using NDA drug product and called project ORAU 81a (see admendment of July 20, 2005). A supply of Prussian Blue, obtained from the German company Heyl GmbH, is currently distributed to six co-investigators in the DOE complex. This product, although manufactured by Heyl under the IND, has been determined to meet NDA standards, and the FDA has authorized the Oak Ridge Institute for Science and Education (ORISE) in writing to use the product of Batch # 014082 as NDA quality product. Therefore, all Prussian Blue now with co-investigators is from this batch and so can be treated as NDA product. ORISE is managed by Oak Ridge Associated Universities (ORAU), under contract with the DOE.
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 radiocesium and radiothallium. 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, and CAS Registry No. 14038-43-8. Under the NDA (#58060-00201) Insoluble Prussian Blue is also known as Radioguardase. 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 ORAU's REAC/TS program.
Prussian Blue is distributed by ORISE to DOE co-investigators for DOE facilities throughout the country. Up until July 20, 2005, prussian blue was distributed under the IND. After the amendment for Project 81 of July 20, 2005, it is not available as IND but is as NDA product at DOE facilities participating in the ongoing safety and efficacy study (ORAU 91-81a). As an NDA, Prussian Blue is technically available throughout the country from pharmacies with a physician's prescription. However, it is not generally available as yet and ORISE/REAC/TS with DOE approval can also provide limited amounts of Prussian Blue to non-DOE personnel.
Insoluble Prussian Blue, 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 Goiania 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. Additionally, given its widespread availability and its chemical characteristics, it is considered a prime candidate for use in a terrorist event, such as a dirty bomb. 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.
See amendment of July 20, 2005 for more details.
"Amendment: Use of Ca-DTPA and Zn-DTPA (NDA product) for Chelation Therapy of Heavy Metals"
Principal Investigator: Dr. Mark S. Jenkins, Oak Ridge Institute for Science and Education
Project started in: 2005
This is an international project.
Foreign Subjects Yes
Foreign Data Yes
Foreign Specimens Yes
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Project funded, but no participants have been enrolled to date.
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: 11/10/07
Explanation of IRB approval:
Renewal due in October.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 06/01/06 to 05/31/07
Explanation:
U.S. Food and Drug Administration project year.
Type(s) of Human Subjects Involvement:
Investigational New Drug (IND) 4041, trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA), and IND 14603, trisodium zinc diethylenetriaminepentaacetate (Zn-DTPA) formerly used in this study has been replaced by New Drug Application (NDA) product and as a result are no longer considered investigational. Because the Food and Drug Administration (FDA) awarded NDA approval of Ca- and Zn-DTPA based predominently on the animal studies and the "animal rule," and the limited human study based on the Radiation Emergency Assistance Center/Training Site (REAC/TS) DTPA registry, the U.S. Department of Energy (DOE) and project co-investigators desired to continue safety and efficacy studies on these chelators and to continue the study at Oak Ridge Associated Universities (ORAU) under contract with the DOE. New supplies of NDA product for both DTPAs have been imported from Hamelm of Germany and distributed to co-investigators in July 2005. All IND product except that at the Strategic National Stockpile (SNS), Centers for Disease Control, and REAC/TS was recalled and has been stored at the Oak Ridge Institute for Science and Education (ORISE)/ORAU under management of REAC/TS. Ca- and Zn-DTPA have recently (2004 reporting period) been classified by the U.S. FDA as New Drug Application and product manafactured under the NDA are no longer considered investigational. Both Ca- and Zn-DTPA manufactured under the NDA are approved by both the U.S. FDA and DOE/Environment Safety and Health and meet the chemical specifications of the U.S. Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur.). This project will deal only with NDA product, now available by prescription by physicians throughout the U.S. but limited by availability. This study focuses mainly on NDA product use at DOE facilities and with existing co-investigators.
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.
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 ideally should be given within six hours of exposure.
Accidents involving internal contamination with the actinide elements (Pu, Am, and Cm) occur in the DOE complex and both Ca-DTPA and Zn-DTPA have proven effectiveness 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 has occured in some reporting periods.
There have been no cases of administration of either Ca- or Zn-DTPA since distribution of the NDA product.
"Extended Research on Detection of Deception Using Volatile Organic Compound (VOC) Emissions"
Principal Investigator: Dr. Gerhard R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2006
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 10/24/05
Explanation of IRB approval:
The IRB approval period was for 12 months starting on 10/24/2005 and extending through 10/23/2006 that included the participant testing period.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This is the continuation of research initiated under a previous project in FY2004 that ended in FY2005 (Project ID: ORAU-04-126, "Remote Deception Detection Using Volatile Chemical Emissions Research Project"). The new project was ID: ORAU-06-133, "Extended Research on Detection of Deception Using Volatile Organic Compound (VOC) Emissions."
A.) Objective: The objective of this research was to obtain additional data to investigate the feasibility of developing a system to detect intentional deception in individuals by monitoring small changes in natural volatile organic compound (VOC) emissions from skin surfaces.
B.) Methodology: Data collection involved obtaining air samples drawn from the headspace over a person's hand and forearm placed in a soft plastic sleeve. The air flowpath included passing through special sampling tubes intended to adsorb and capture natural VOCs emitted by the subject. After sampling, the tubes were analyzed in the laboratory using gas chromatography/mass spectrometry to separate the VOCs by type and determine their concentration in the air samples. The resulting data were then analyzed and interpreted using statistical methods to determine if the variations in VOCs detected could indicate the stress levels associated with deceptive behavior.
C.) Ionizing radiation, radioactive substances, chemical substances: None used in this project.
D.) Involvement of Human Subjects: Following completion of the strictly voluntary consenting process, study participants were asked to take a piece of contraband material into the nearby testing facility and intentionally lie about possessing it. In the testing facility, the participant was seated comfortably at a table with the hand and forearm in a loose-fitting, flexible plastic sleeve to enable the collection of VOC samples for analysis. In this situation, each participant was asked to lie intentionally when answering several questions about possessing the particular item.
Privacy of project participants was protected and confidentiality maintained to the extent allowed by law. All materials, equipment, and instrumentation used in the study were innocuous and nontoxic to human skin surfaces.
"Automated Cytogenetic Analysis of Nuclear Workers with Internal Deposits of Plutonium"
Principal Investigator: Dr. Gordon K. Livingston, Oak Ridge Institute for Science and Education
Project started in: 2006
Status of the Research this Fiscal Year:
Project funded, but no participants have been enrolled to date.
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: 04/18/07
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 2007
Type(s) of Human Subjects Involvement:
The objective of this study is to evaluate the sensitivity and usefulness of a simple and low-cost Giemsa staining protocol which combines digital imaging and automated karyotyping as a novel method to qualify the frequency of chromosome aberrations in lymphocytes of former radiation workers with known internal deposits of plutonium. A secondary objective is to compare the resulting data with cytogenetic data already in hand from an earlier study that was performed based on replicate samples of the same specimens using a fluorescence in situ hybridization (FISH) molecular technique.
"Formative Research: Bird Flu Issues"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2006
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 12/05/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 146
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
Given the likely occurrence, possible consequences, and uncertainties of human pandemic influenza, the U.S. Government has deemed planning and preparedness to be prudent, and numerous efforts are in progress at the federal, state, tribal, and local levels. Materials to inform the public and stakeholders about pandemic influenza and issues associated with it have been prepared and tested by health care profesionals and the public. New draft educational materials have been developed, and this study will assess current knowledge, attitudes, and beliefs regarding bird flu and pandemic influenza, identify factors which determine why people have or have not taken actions to prepare for pandemic influenza, and test draft communication materials.
"Re-establishment of the Cytogenetics Biodosimetry Laboratory at the Radiation Emergency Assistance Center/Training Site, ORISE/ORAU"
Principal Investigator: Dr. Gordon Livingston, Oak Ridge Institute for Science and Education
Project started in: 2007
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 10/02/07
Explanation of IRB approval:
Renewal due by October.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
The goal of this study is to re-establish the Cytogenetics Biosimetry Laboratory at REAC/TS so that it may serve as a national medical emergency response resource capable of providing radiation dose estimates upon request.
Peripheral blood samples are collected from the subjects and are irradiated in the collection tubes to known amounts of radiation. The samples are then cultured to collect lymphocytes in metaphase for analysis of dicentric chromosomes, markers of radiation induced damage. The number of dicentrics can then be plotted versus dose to develop a calibration curve.
"Adherence to Public Health Directives"
Principal Investigator: Dr. Richard Tardif, Oak Ridge Institute for Science and Education
Project started in: 2007
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 01/30/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 59
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
The proposed research involves interviews with emergency and public health personnel, opinion-leaders in the community, and selected members of the public. A hypothetical bioterrorist incident involving plague will be the situation used to guide discussion about likely responses to public health directives and the factors influencing those responses. The research is to be conducted in St. Louis, Missouri.
"Pandemic Influenza Message Testing 3 and Pandemic Influenza Vaccine Perception"
Principal Investigator: Dr. Richard Tardif, Oak Ridge Institute for Science and Education
Project started in: 2007
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 02/07/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 67
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
Given the presence of new materials to be tested and the changes in the social environment, Department of Health and Human Services / Centers for Disease Control and Prevention (HHS/CDC) desires to conduct another investigation to assess changes in knowledge attitudes and beliefs regarding bird flu and public perception of the availability and need for a vaccine, and test new informational messages.
"Atomic Nuclear Energy Workers: Pilot Mortality Study of Mound Radiation Workers"
Principal Investigator: Dr. Elizabeth Ellis, Oak Ridge Institute for Science and Education
Project started in: 2007
Status of the Research this Fiscal Year:
Protocol approved, but no funding and no human participants
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: ORAU-07-140
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 04/03/07
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 2007
Type(s) of Human Subjects Involvement:
A pilot study was conducted in preparation of a National Institutes of Health R01 grant application to assess the risk of cancer among workers employed early in the atomic energy era in the development of nuclear power and weapons and the handling and processing of nuclear materials. The pilot demonstration project involved a follow-up study of workers at the Mound radiation facility. The cohort had been identified and followed for mortality through 1983 (Wiggs et al. 1991, 1994). Mound workers were followed through 2005 and new deaths over the past 22 years were identified, the status and availability of existing dosimetry was evaluated, and issues to address in the full-scale study delineated. The Mound facility is unique in that workers were exposed to polonium (Po), a radionuclide that has received much attention recently and for which health effects studies are few (Harrison et al. 2007).
After approval was received 23 March 2007 from the Department of Energy for the Mound pilot study, we obtained access to the Mound worker data, obtained IRB approval to conduct the pilot study, linked the roster of workers to mortality files and obtained fact of death, conducted standardized mortality analyses, and presented preliminary results at an Oak Ridge workshop, including crude dose-response analyses. The pilot study demonstrated the ease and feasibility in accessing prior DOE worker populations, conducting the mortality follow-up, addressing issues of dosimetry (both internal and external), and other practical matters that will have to address in the expanded effort. Although it will take several months to finalize the Mound worker evaluation, the capability of the proposed consortium of investigators to conduct a larger investigation of previous DOE worker studies was demonstrated.
"Assessing Beryllium Control Measures at Rocky Flats"
Principal Investigator: Dr. Arthur W. Stange, Oak Ridge Institute for Science and Education
Project started in: 2007
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Study protocol is inactive.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Re