Ms. Sherry
E. Davis-Cross
902 Battelle Blvd.
K1-67
Richland, WA 99352-
Phone: 509-375-3610
Fax: 509-375-2592
E-mail: Sherry.Davis-Cross@pnl.gov
Number of Human Subjects projects reported: 14
Project Identifier:
PNNL-93-3-1
Project Title:
"Comprehensive Epidemiologic Data Resource (CEDR) Related Tasks"
Principal Investigator: Dr. John J. Fix, Pacific Northwest National Laboratory
Project started in: 1993
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Identifier or number: 93-3-1
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 05/05/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Hanford worker radiation exposure, work history and vital status records/data have been, and are being utilized in epidemiologic studies conducted by NIOSH and NIOSH-subcontractors under their memorandum of understanding with DOE. These studies often involve combining Hanford worker data with data from other DOE sites. The primary objective of such studies is to investigate the relationship of radiation exposures and worker health effects, including mortality.
Human subjects are not involved in the overall, long-term Comprehensive Epidemiologic Data Resource (CEDR) study (93-3). However, identifiable records are used in this particular task (93-3-1). Federal Regulations regarding the proper access, use and protection of the records which are promulgated in Federal Regulation 10 CFR Part 1008 (Volume 60, No. 124, pp. 33520-33522) and clarified in the DOE/EH-556 "Access Handbook for Conducting Health Studies at DOE Sites apply to the management of these records.
Project Identifier:
PNNL-96-1
Project Title:
"Imaging Neurological Processes of the Human Brain"
Principal Investigator: Dr. Dale H. Collins, Pacific Northwest National Laboratory
Project started in: 1996
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/04/99
Explanation of IRB approval:
Legacy Good Samaritan Hospital, Portland, Oregon.
Full Board Review
April 27, 1999
Legacy IRB: M1517-02
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The objective of this project is to conduct basic holographic imaging research of the EEG signals generated in the cortex of the human brain. EEG evoked potential data will be acquired through stimulation of the left index finger of one of the research staff at Legacy Good Samaritan Hospital, Portland Oregon. The right finger data were recorded in previous EEG holography and images were reconstructed at PNNL. The left finger will be stimulated to see if images appear on the right side of the brain as they should. Risk to the subject is minimal. PNNL will provide image reconstruction and data analysis for this work.
Project Identifier:
PNNL-96-20
Project Title:
"Study of Heat Stress and Performance in Carpenters at DOE Sites"
Principal Investigator: Mr. Wilfred Cameron, United Brotherhood of Carpenters Health and Safety Fund
Project started in: 1996
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 02/08/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The objective of this work is to identify factors that place people at risk of heat stress by studying volunteers working under hot and cool conditions. Factors under study include: workplace temperature, work effort level, work duration, physical condition, and medical history. Subjects doing routine work, using protective clothing and in containment will be tested during the summer months for the effects of heat stress. Their temperature and activity levels will be closely monitored during their work day to obtain objective evidence of the physiological condition and the development of heat stress. Urine samples and weight will be taken three times a day to determine fluid balance and fluid consumption. Cognitive, motor (strength) and balance tests will be given in the morning (baseline) and when they complete work to identify early indicators of heat stress onset, such as changes in behavioral performance and physiological measures of blood pressure, pulse, temperature and hydration.
Risk to the volunteers, who will perform no more than their routine work activities during this study, is minimal.
Note: This study will continue in FY2000, but only for the purposes of analyzing de-identified data.
Informed Consent will be obtained by researchers following an information/training session. Confidentiality and privacy issues are addressed as part of Informed Consent.
Project Identifier:
PNNL-96-4
Project Title:
"Field Evaluation of Polarized and Full Spectrum Polarized Lighting"
Principal Investigator: Mr. Eric E. Richman, Pacific Northwest National Laboratory
Project started in: 1996
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 02/04/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The purpose of this research is to determine any potential energy savings associated with the use of full spectrum and polarized lighting in federal office spaces in place of current standard lighting.
Over an 18-20 week period, the lighting in the subject's offices will be changed several times and they will be asked to give their candid evaluation, once a week in a one-page survey, of how effective, comfortable, and useful the lighting is in each case. An initial survey will be conducted to gather basic information about the subjects and their current lighting situation.
There is no risk to privacy as the identity of the human subjects will be coded and their responses to the survey will never be associated with their names. The subjects will be notified of the study and their rights in a project announcement letter.
Project Identifier:
PNNL-97-1
Project Title:
"Comprehensive Occupational Health Surveillance"
Principal Investigator: Dr. Scott Barnhart, University of Washington
Project started in: 1997
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/08/99
Explanation of IRB approval:
University of Washington - UW IRB 28-00097-C
Expedited Review 3/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 150
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The purpose of this study is to identify and describe the physical and chemical hazards that may exist in the subject's natural work environment. The findings of this study will be used to develop health and safety programs that are more focused and better able to decrease the potential health risks related to exposures.
Researchers will conduct interviews with employees at their normal worksite. The interviews will consist of a series of open-ended questions and will take 20-30 minutes to complete. Subjects will be asked to provide their job title and work location. Interviewers will ask about worker's activities at their site and if they are involved in any occupational health and safety mandated medical surveillance programs. Of particular interest is possible hazardous exposures that workers believe they may be exposed to and the protective equipment they use when working.
Risks are expected to be minimal. There may be some anxiety on the subjects part regarding their managements opinion where certain questions are concerned. They will be assured that site management has approved the study.
Subjects will be consented and informed of their rights to privacy, including the disposition of records. Code numbers will be assigned to each subject.
"Screening For Chronic Beryllium Disease at Hanford (DUPLICATE PROJECT SEE CRESP-97-27-0228-C)"
This project is a duplicate of project CRESP-97-27-0228-C.
"Medical Surveillance Program/Former DOE Hanford Production Workers (DUPLICATE, SEE UOW-96-DE-FC03-96SF21258)"
This project is a duplicate of project UOW-96-DE-FC03-96SF21258.
"Hanford Building Trades Medical Screening Project (DUPLICATE PROJECT, SEE CPWR-96-DE-FC03-96SF21262)"
This project is a duplicate of project CPWR-96-DE-FC03-96SF21262.
Project Identifier:
PNNL-97-6
Project Title:
"Inherited Breast Cancer, Identification, Education, Counseling and Testing of High Risk Patients in a Military Setting"
Principal Investigator: Dr. Heinz J. Roye, Pacific Northwest National Laboratory
Project started in: 1997
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 06/16/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 45
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The objective of this project is to develop a breast cancer genetic screening and counseling module for high-risk women to determine genetic susceptibility for breast cancer in military women beneficiaries, and to develop education programs for youth and mature multi-ethnic beneficiaries.
Researchers will ask patients and clinicians their opinions about the dissemination and satisfaction with breast cancer education and information on early detection of breast cancer. Human subjects will be part of the Familial Breast Cancer Project that will include genetic counseling, testing, and receipt of test results.
Risk of loss of privacy is minimized by separation of research and medical or genetic records.
Subjects will be consented as required during the research.
Project Identifier:
PNNL-97-8
Project Title:
"Fundamental Research on Solvent-laden Soils"
Principal Investigator: Dr. Karla D. Thrall, Pacific Northwest National Laboratory
Project started in: 1997
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
Most recent IRB approval: 09/29/98
Explanation of IRB approval:
The IRB has agreed with the PI to delay Continuing Review until major changes to the protocol are finalized. Human subjects are not, and will not be used before the review is approved by the IRB.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The objective of this research is to determine real-time response for human percutaneous bioavailability of organic solvents in soil and water. This data will be used in biologically based dose-response models to estimate human health risk assessments.
Subjects will be exposed to various organic solvents (trichloroethylene) over varied amounts of time, either by a patch that holds the solvent against the skin, or by moving their hand through soil or water. At predetermined intervals, their breath will be analyzed to detect any biological uptake of the solvents.
Exposure to the solvents could make subjects dizzy. However, at the doses planned for the study, side effects and long term effects are not expected. Risk is considered minimal.
Pregnant volunteers, those with skin disease, or known allergic reaction to the solvents will be excluded from this project. All other subjects will be consented.
Project Identifier:
PNNL-98-5
Project Title:
"Advanced Techniques in Latent Fingerprint and Visualization"
Principal Investigator: Dr. Gary M. Mong, Pacific Northwest National Laboratory
Project started in: 1998
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 02/17/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Objectives: To obtain samples of human sebaceous secretions as they appear on human fingerprints, phalanges, or palms. Subjects will be grouped according to approximate age and sex. There is no desire or possibility of using the data collected to identify individuals; project is interested in chemical constituency of the materials collected only.
Methodology: Subjects are asked to voluntarily touch small filter paper media. A number is assigned to the sample to cross-correlate age and gender. No personal identifiers are used. Samples are then subjected to chemical identification testing.
Substances: Subjects contact soft filter medium only, no hazardous materials will contact the subjects.
Human Subjects: Are not exposed to any hazardous materials or undue risks. No physical identifiers, names, or other personal information are taken. Subjects are asked to have not used certain cosmetics within 6 hours and are given a consent form to sign.
"Surveillance Methods for Solvent-related Hepatotoxicity (DUPLICATE PROJECT OF NIOSH-98-032)"
This project is a duplicate of project NIOSH-98-032.
Project Identifier:
PNNL-99-2
Project Title:
"Field Study at Hanford's 222S Facility"
Principal Investigator: Dr. Karla D. Thrall, Pacific Northwest National Laboratory
Project started in: 1999
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 01/20/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The ultimate goal of this research is to demonstrate a portable real-time monitoring instrument capable of characterizing human tissue levels of volatile chemicals in workers within the DOE complex. The development of this instrument greatly enhances ongoing efforts to improve the health of workers in the field. This research will provide the means of relating a quantitative measurement of organic chemicals in the exhaled breath of a worker.
Workers will pass through the breath analysis system upon entry and exit of the chemical hazards control zone in which they normally work. Standard chemical sensors are placed on their work clothes to record chemical exposures. They will breath into the analysis system twice a day for 1-2 minutes and the amount of various volatile chemicals in their breath will be identified and analyzed. Workers will be consented and private information will be coded for privacy. The codes will be destroyed when the research is completed. Risk to workers is minimal.
Project Identifier:
PNNL-99-5
Project Title:
"Hanford Cultural Resources Project"
Principal Investigator: Mr. Darby C. Stapp, Pacific Northwest National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 09/15/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The Cultural Resources Project assures DOE-RL that potential impacts of site operations on cultural resources at Hanford are identified and evaluated, and that historic properties are protected in a systematic, documented manner as required by National preservation, protection, religious freedom, and repatriation acts. In addition, PNNL provides DOE/RL with information it needs to interact with federal, state, tribal agencies, and other partices on technical cultural resource issues, thereby assisting DOE-RL in maintaining positive working relationships with organizations concerned with the cultural heritage of the Hanford Site.
PNNL conducts cultural resource reviews whenever a Hanford Site project or activity has the potential to disturb the ground surface, or affect historic structures.
Human Subjects may be involved during various steps in the process in the identification and evaluation of properties; they may be included in interviews, consultations, and ethnographic field work, including the gathering of oral histories.
Although risk to the human subjects is minimal, informed consents, photograph release forms and methods for conducting, recording and storing records have been developed to ensure that their privacy, rights and welfare are fully protected.