Ms. Pamela S. Bonee
ORISE/CPD
P.O. Box 117
Oak Ridge, TN 37831-0117
Phone: 423-576-3147
Fax: 423-241-2923
Email: boneep@orau.gov
Projects are approved by an IRB located at: Oak Ridge Institute for Science and Education.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1394
Number of Human Subjects Projects reported: 12
Project Identifier: ORAU-78-96
Project Title:
Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals
Principal Investigator:
Dr. Ronald E. Goans
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1978
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 96
Number of Human Subjects who participated in this project/protocol during
06/19/07 - 05/31/98: 2
FDA Reporting Year
Type of Human Subjects Involvement:
Chelation therapy for internal contamination of heavy elements in radiation accidents. Radioactive materials are not administered internally.
Anyone in the DOE system or elsewhere with internal exposure to actinides (Pu, Am, Cm, etc) are eligible for treatment with Ca-DTPA and Zn-DTPA.
DTPA belongs to the group of synthetic polyamino polycarboxylic acids which form stable complexes (metal chelates) with a large number of metal ions, especially the transuranic elements. The drug effectively exchanges calcium or zinc for another metal of greater binding power and carries it to the kidneys where it is then excreted. Historically, in the DOE laboratory complex, DTPA has been quite successful in promoting urinary excretion of the actinide elements in accident situations where inhalation or systemic uptake through wounds was involved.
IND 4041, Trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA) and IND 14603, Trisodium zinc diethylenetriaminepentaacetate (Zn-DTPA) are investigational new drug applications which are administered by Oak Ridge Associated Universities under contract with the U.S. Department of Energy, Contract No. DE-AC05-76OR00033. Both forms of DTPA have been widely used in the U.S. and in Europe for many years as chelating agents for plutonium and for other heavy elements such as americium, californium, and curium.
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 of 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 617 separate patients administered DTPA (either intravenously by slow IV push or by nebulizer) in recommended doses (for a total of 4560 separate doses). In addition, no serious adverse effects have been noted as a result of over 1000 doses of Zn-DTPA in the recommended dosage given to a single individual.
One significant issue with the current ORISE supply of DTPA is the fact that both forms are in excess of 20 years old. Yearly testing indicates that the supply is stable, but a public perception issue exists in prescribing a drug of this age to a DOE worker. For 3 years, we have been in discussions with the DOE and the FDA to purchase a new batch of DTPA from Heyl GmBH in Berlin, Germany, and rotate this out to the current group of co-investigators. We now have FDA approval to buy a new stock from Heyl in Germany and delivery is expected by 1/99.
The project is approved by the current IRB, which also has addressed privacy issues related to this project.
Project Identifier: ORAU-79-63
Project Title:
The U.S. Radiation Accident Registry Follow-Up Program (formally ORAU-80-63 in FY97 database)
Principal Investigator:
Dr. Ronald E. Goans
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1979
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 63
Number of Human Subjects who participated in this project/protocol during
06/01/97 - 05/31/98: 305
FDA Reporting Period
Type of Human Subjects Involvement:
The REAC/TS Accident Registry is an invaluable resource for research into the mechanisms of radiation accidents as well as a useful compilation of biochemical data collected during medical management of these cases. For each radiation-related accident that either is reported to REAC/TS or for which REAC/TS provides consultation, a case number is assigned and a file begun on this accident. In many cases, we have a complete accident reconstruction, human factors data, medical and laboratory data, patient history transcribed from a live interview at REAC/TS, and multiple kinds of health physics data. This database is an invaluable resource for DOE and other governmental agencies interested in the human factors aspects of radiation-induced injury.
One of the most important aspects of medical management of a radiation accident is early dosimetry information. However, in many cases, both the magnitude of the accident and the dosimetry profile(s) of the victim(s) are not known for days to weeks. Data from the REAC/TS Accident Registry was recently used to develop an early dose assessment algorithm for high level gamma accidents. This algorithm (Goans, et al, Health Physics 72(4): 513-518, 1997) provides a simple dose-estimation algorithm based on lymphocyte kinetics from prior radiation accidents. This is an excellent example where retrospective analysis of accidents has been used to further the medical treatment of future cases.
Through June 1998, the REAC/TS Central Registry contained data on 1701 cases involving approximately 142,331 individuals. The US Radiation Accident Registry currently contains 239 cases involving 1336 patients and the Non-US Radiation Accident Registry contains 155 cases, involving approximately 132,168 individuals (Chernobyl: 116,500; Brazil: 249; Mexico: 4000; Kyshtym: 10,180; Spain: 27). As usual, the response from REAC/TS continues to occur through interaction directly with the private sector, through all aspects of the DOE system, various state and foreign agencies, and with the NRC.
Project Identifier: ORAU-80-58
Project Title:
Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization
Principal Investigator:
Dr. Donna L. Cragle
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 8
Type of Human Subjects Involvement:
Objectives are to define the range and variability in proliferative response of human lymphocytes to in vitro exposures to beryllium salts. This specific study involves blood samples from control persons who have never been at risk for exposure to beryllium in the workplace. Standard laboratory methods for separating and culturing cells are used. The only procedure that directly involves the blood donor is the venipuncture that is used to collect the blood sample. The only risks anticipated are the minor bleeding at the site of the venipuncture.
Project Identifier: ORAU-80-60
Project Title:
Comprehensive Epidemiology Study of Department of Energy Atomic Workers
Principal Investigator:
Dr. Donna L. Cragle
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $66,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 60
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 22,625
Type of Human Subjects Involvement:
ORISE supports the DOE Office of Environmental Safety and Health in a number of technical areas. The principal area is to serve as the Epidemiologic Surveillance Data Center. In this capacity the following tasks are performed:
1. Receive data transmissions from epidemiologic surveillance sites and provide data management and quality assurance on the data received,
2. Provide quality assured nosologic coding for epidemiologic surveillance data,
3. Analyze data and construct reports for epidemiologic surveillance,
4. Perform required Quick Response epidemiologic reviews and studies, and
5. Analyze data covering a 10-year period generated from return-to-work clearances and other illness and injury records from the Sandia National Laboratory.
Other tasks involve rapid response and investigation of worker health concerns. In this capacity, the following activities may be performed:
1. Interviews of present and former workers to gather data about specific workplace hazards.
2. Submission of lists of workers who have unique exposures to the statewide tumor registry in order to monitor cancer incidence in the group.
The National Institute for Occupational Safety and Health (NIOSH) and DOE activities include:
1. Compiling rosters of workers from hard copy records.
2. Collecting death certificates for DOE worker populations; coding causes of death and entering codes to computer files.
3. Analyzing cause of death data with respect to exposure level using standard dose-response methodology.
4. Analyzing cause of death data in a descriptive manner.
Project Identifier: ORAU-80-61
Project Title:
The DTPA Registry Follow-Up Program
Principal Investigator:
Dr. Ronald E. Goans
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Included in EHW 1307 funding (Radiation, Medicine and Cytogenetics Program Funding)
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 61
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 2
Type of Human Subjects Involvement:
The purpose of the DTPA Registry Follow-up Program is to document cases where DTPA is used, both in the DOE complex and elsewhere in the US, to document drug efficacy and to maintain a comprehensive registry of medical information in these cases for both the DOE and the FDA. Ca-DTPA and Zn-DTPA are distributed by Oak Ridge Associated Universities (ORAU) under contract with the US Department of Energy (DOE) Contract No. DE-AC05-76OR00033. ORAU manages the FDA Investigational New Drug (IND) authorizations for Ca-DTPA and the analogous Zn-DTPA for DOE.
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, 1997, to May 31, 1998, 2 patients received IV DTPA for a total of 11 doses. The status of the Radiation Emergency Assistance Center/Training Site (REAC/TS) DTPA Registry through June 1997 shows 45 active co-investigators throughout the country. Since the beginning of the Registry, 617 patients have received 4560 doses of DTPA with a drug adverse reaction rate of approximately 2.7%, mostly very minor. Our extensive documentation of DTPA usage therefore shows the inherent safety of the drug.
We feel that the REAC/TS DTPA Registry is a valuable resource for the medical follow-up of workers involved in accidents involving the transuranic elements.
The DTPA package inserts and the consent form have been modified according to recent recommendations of the IRB, DOE/HQ, the FDA, and an independent review committee commissioned by the DOE.
Project Identifier: ORAU-89-60a
Project Title:
Amendment - Comprehensive Epidemiology Study of Department of Energy Atomic Workers
Principal Investigator:
Dr. Donna L. Cragle
Project started in: 1989
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $623
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 60a
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 18,574
Type 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 estimated volume of data collection under this protocol was 518,600 records for FY98. The data collection activities for FY98 included the Savannah River site in South Carolina and the Pittsburgh Energy Technology Center in Pennsylvania.
Project Identifier: ORAU-91-81
Project Title:
Use of Prussian Blue for Internal Decontamination of Radiocesium
Principal Investigator:
Dr. Ronald E. Goans
Project started in: 1991
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
From previous funding, the FDA has granted IND 51,700 to ORISE's Prussian Blue investigational drug application.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 81
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
Medical decorporation therapy of accidentally ingested radiocesium. Human subjects will not be administered radioactive substances.
Anyone in the DOE system or elsewhere with internal contamination with radiocesium are eligible for treatment with Prussian Blue.
ORAU-81, Use of Prussian Blue for Internal decontamination of Radiocesium and Thallium has been granted FDA IND 51,700. A supply of Prussian Blue has been obtained from the German company Heyl GMBH and we are in the process of setting up a Prussian Blue Registry at REAC/TS.
Prussian Blue, is to be used in the U.S.DOE complex as a decorporation agent for patients internally contaminated with medically significant amounts of cesium and thallium. In this document, the name Insoluble Prussian Blue (PB) without further specification indicates the following compound:
Ferric(III) hexacyanoferrate(II) "insoluble PB"
Fe4 [Fe (CN)6]3
Molecular weight: 859.3
Color Index No. 77.510
CAS Registry No. 14038-43-8
Prussian Blue is distributed by Oak Ridge Institute for Science and Education (ORISE). ORISE is managed by Oak Ridge Associated Universities (ORAU), under contract with the U.S. Department of Energy (DOE), Contract No. DE-AC05-76OR00033.
Insoluble Prussian Blue (PB), ferric hexacyanoferrate, Fe4[Fe(CN)6]3 is a drug that enhances excretion of isotopes of cesium and thallium from the body by means of ion exchange. It has had a long and successful history in the treatment of internal contamination with radiocesium. The Oak Ridge Institute for Science and Education (ORISE) undertaking for this IND will: (1) make Insoluble Prussian Blue more widely available at Department of Energy (DOE) facilities for physicians to treat individuals with significant radiocesium and radiothallium contamination and (2) quantitate efficacy and establish a drug profile based on wider experience. In the DOE system, internal contamination with radiocesium is expected to be much more important than with thallium.
Of the various radioisotopes of cesium, 137Cs is the most important. 137Cs is a common fission by-product material, a frequent active component of sealed sources, and an important radionuclide in radiation oncology. The use of 137Cs falls under the jurisdiction of the Nuclear Regulatory Commission (NRC). It is a ubiquitous radionuclide found throughout the DOE system and in hospitals performing either gynecological brachytherapy or interstitial therapy for solid tumors. Until the Goiânia incident in Brazil, there were very few cases of radiocesium contamination requiring decorporation therapy. However, there is an increasing potential for such contamination to occur and a need for specific therapy. The recent increase in workers performing remediation work at hazardous waste sites also requires that clinicians have Insoluble Prussian Blue available and understand the nature of its pharmacodynamics.
Insoluble Prussian Blue has been recommended for years as the drug of choice by national and international radiation protection societies for use in treating internal contamination with radiocesium. It was effectively used in the treatment of patients contaminated with 137Cs in the 1987 Goiânia, 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.
Project Identifier: ORAU-91-82a
Project Title:
Studies to Establish and Define ORAU Laboratory Standards for Lymphocyte Proliferation Tests (LPT)
Principal Investigator:
Dr. Donna L. Cragle
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 82a
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 8
Type 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 work place. 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.
Project Identifier: ORAU-92-87
Project Title:
Oak Ridge Y-12 Beryllium Workers Follow-Up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease
Principal Investigator:
Dr. Donna L. Cragle
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 01, 1998
IRB Approval Number: 87
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 370
Type of Human Subjects Involvement:
The overall purposes of the Y-12 Beryllium Workers Study, sponsored by the U.S. DOE and conducted by the Center for Epidemiologic Research (CER) at the Oak Ridge Institute for Science and Education (ORISE) are to: (1) investigate variables that may contribute to interlaboratory differences in results from the peripheral blood lymphocyte proliferation test (LPT) for chronic beryllium disease (CBD); (2) assess the sensitivity, specificity, and predictive value of the peripheral blood LPT and other noninvasive procedures and their potential use as routine screening tests for CBD; and (3) determine the prevalence of CBD among current and former beryllium exposed employees at the Oak Ridge Y-12 Plant. The first two objectives are addressed under a research protocol. The third objective is addressed through an initial screening program and a subsequent follow-up surveillance program, both designed to incorporate findings from the research phase. Several cases of CBD have already been diagnosed at the Y-12 Plant. The screening program will be developed to identify other cases if they exist, and those who are sensitized to beryllium, so that they may be placed under medical surveillance and/or early treatment. The rationale for the surveillance program is based on the implied assumption that early detection of beryllium sensitization or CBD among present and former beryllium workers will result in a more favorable prognosis.
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.
Project Identifier: ORAU-97-BU-1
Project Title:
Prevention of Stress and Health Consequences of Workplace Downsizing and Reorganization: Oak Ridge Review
Principal Investigator:
Dr. Lewis D. Pepper
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 17, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 776
Type of Human Subjects Involvement:
This project has three objectives: to identify the consequences of downsizing at US Department of Energy sites; identify factors which intensify or mitigate any adverse effects on health and/or performance of workers who remain after downsizing; and to design a pilot intervention project to address any adverse impacts and to highlight positive impacts. Data collection in this phase of the project will include an employee survey and review of summary archival data. We estimate that approximately 10,000 individuals, or 42% of employees, will receive the "Boston University Workplace Survey" (BUWS). The sampling intent is for a representative random selection in which all employees are eligible without exception. After the sample for each site is drawn, the selected names, addresses, and department affiliation will be entered into a tracking database. Each selected individual will be assigned a random identifier which will be used to monitor participation and initiate follow-up if necessary. To ensure confidentiality, the individual's name will not be recorded on the survey but on a separate tracking postcard. The names will not be used in analyzing either survey or site data. Participation is completely voluntary, and all records associated with this project will be kept confidential to the extent allowable by law. All participants will be notified of the study results.
Project Identifier: ORAU-97-UC1
Project Title:
Medical Surveillance Program for Construction Workers at Oak Ridge, TN : Phase I
Principal Investigator:
Dr. Eula Bingham
Project started in: 1997
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Phase I was scheduled to end at the end of September 1997, and Phase II was supposed to start in October, 1997. Funding for Phase II (exempt) was delayed until February 1, 1998. Phase I received no new funding in FY98.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 14, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
A. Objectives (General) To assist in the development of a health surveillance program for building trades workers who may have been exposed to health hazards as a result of prior work at Oak Ridge. (Specific) (1) Identify and propose a resolution to policy issues involving medical intervention programs for former construction workers at Oak Ridge according to possible past exposures to hazardous substances. (2) Assist in developing the site risk characterization protocol. (3) Develop notification protocols and related worker education materials. (4) Develop a medical protocol. (5) Develop programs and procedures for determining program eligibility and claims management, including coordination and benefits. (6) Develop a data management plan for epidemiological analysis based on the program. (7) Develop an implementation plan for Phase II of the project.
B. Methodology. (1) Identify and locate workers and make lists of workers and crafts. (2) Document the history of construction and operations and draw up time lines and dates. (3) Identify sources of exposure data and create a database of available sources. (4) Determine significant hazards and make a list of significant hazards. (5) Identify markers of early adverse health effects and make a list of markers. (6) Hold medical surveillance ethics workshop and develop a guidelines document. (7) Locate hazards and make a list of specific locations. (8) Develop and design a process to triage medical surveillance efforts.
Project Identifier: ORAU-98-100
Project Title:
Frequency of Hand/Wrist Problems Among Sign Language Communicators
Principal Investigator:
Mr. William M. Hart
Project started in: 1998
This project ended in Fiscal Year 1998.
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Explanation:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: July 01, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 4
Type of Human Subjects Involvement:
Sign language is the fourth "most used" language in the United States, yet sign language communicators have been largely ignored as at at-risk population for the development of hand/wrist disorders. This study examined the frequency of hand/wrist disorders among sign language communicators. A three-page self-reporting questionnaire was mailed out, completed, and returned without any identifying marks. SPSS software was used to analysis the data. Four volunteers from ORAU participated in the study's instrument validation. No ORAU subjects were actually involved in the study population. 397 participants were solicited outside of ORAU and 215 respondents were involved in the actual study.
Results are still being processed.