Ms. Sherry E. Davis-Cross
902 Battelle Blvd.
K9-81
Richland, WA 99352
Phone: 509-375-3610
Fax: 509-372-6328
Email: Sherry E Davis-Cross@pnl.gov
Projects are approved by an IRB located at: Pacific Northwest National Laboratory.
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: DOE.MPA.PNNL96-2000
Number of Human Subjects Projects reported: 12
Project Identifier: PNNL-94-4
Project Title:
PBPK Breath Analysis Instrumentation Demonstration (See PNNL-96-94-4 in FY96 database)
Principal Investigator:
Dr. Karla D. Thrall
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Activities involving Human Subjects will commence in Fiscal Year 1998
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Protocol/Subproject # 1
Protocol/Subproject Identifier: 94-4
IRB Review:
Type of Review: Expedited
Most Recent Approval: October 13, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The goal of this research is to develop procedures and demonstrate the use of a portable or semi-portable real-time monitoring instrument for characterizing human tissue levels of volatile chemicals in waste-site cleanup workers - such as carbon tetrachloride, toluene, or benzene.
Human subjects will be sought from staff at various DOE sites. The subjects will be asked to breathe into a breath-inlet system connected to a mass spectrometer for a period of 2-3 minutes upon entering and exiting chemical hazards control zones in which they work. Various organic chemicals found in the exhaled breath will be identified and quantified. Workers will not be exposed to any chemical other than that which occurs in their routine cleanup activities.
Risk: Readings are expected to be well within allowable occupational exposures. Standard medical practices will be used to minimize any risk of respiratory infection that could result from use of the breath-inlet device and appropriate confidentiality practices and Informed Consent will be employed according to federal regulation.
Volunteers will be consented before they enter into the project.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 23, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
Same as 94-4 with the exception that human subjects located at the Pantex Plant were to have their breath analyzed for the presence of Toluene only. This work was not initiated.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 29, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
Same as 94-4, except that the work was to be conducted at Oak Ridge National Laboratory. This work was not initiated.
Project Identifier: PNNL-95-3
Project Title:
Noninvasive Approach to Testing for H. Pylori Infections Using Breath Analysis (See PNNL-96-95-3 in FY96 database)
Principal Investigator:
Dr. James J. Toth
Project started in: 1995
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 29, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 20
Type of Human Subjects Involvement:
Volunteers will drink Ensure to determine the impact of the meal upon ammonia concentrations normally found in the breath. Another set of volunteers, diagnosed with H Pylori will drink 100 mg of FDA-approved N-14/C-13 urea
The objective of this research is to develop a low-cost noninvasive diagnostic test to identify the Helicobacter Pylori bacteria through breath analysis. Tests will be conducted to determine the specificity, sensitivity, efficacy and safety of the ammonia-based urea breath test using the near-infrared, laser-based, spectrometer. The study will be conducted in the following stages:
Instrument Development
Animal Studies
PBPK Modeling (in animals)
Preliminary Meal Study (first set of volunteers)
Pilot Study using Urea (second set of volunteers)
Because it is a simple test to determine the effects of a common breakfast drink on naturally occurring ammonia in the human mouth, the first set of volunteers will be solicited from the general public by the physician involved in this work. The second set of volunteers will be solicited from patients of the doctor who have been diagnosed with helicobacter pylori by gastro intestinal (GI) endoscopy and are currently under treatment for the infection. Informed Consent has been developed for each of the tests in two languages.
Volunteers will be asked to fast for 6 hours prior to the tests and in both cases, preliminary base line breath tests will be administered. In the first test, volunteers will be given a standard breakfast drink and breath tests will be administered to determine the impact of the drink on naturally occurring ammonia in the mouth. In the patient test, volunteers will be given a water solution, containing 100 mg of FDA-approved N-14/C13 urea and five breath samples will be taken over the next 40 minutes.
Risk: All tests will be administered and monitored in the doctor's office. Because urea is a naturally occurring bodily substance and the urea being administered is of a very low level, in addition to being FDA approved for these kinds of tests, there is minimal risk associated with the study.
Confidentiality was explained as part of the Informed Consent which was given to all subjects.
Project Identifier: PNNL-96-1
Project Title:
Imaging Neurological Processes of the Human Brain
Principal Investigator:
Dr. Dale H. Collins
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
All work involving human subjects was completed the previous year
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: January 24, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The objective of this project is to conduct basic research of the electroencephalogram (EEG) signals generated in the cortex of the human brain using holographic imaging technology. Doctors at two medical institutions will gather data from volunteers using a 64 channel system and by shifting an electrode cap, which will be placed on the volunteer's scalp. The cap, with 64 electrodes spaced approximately 1.4 cm apart, will be implemented over a 10 cm x 10 cm aperture and will be shifted approximately three times to collect the data. Volunteers will be fitted with an elastic cap containing embedded electrodes or a net of elastically connected plastic tubes that hold wet sponges against their scalp. Several locations on the face or behind the ears will be cleaned with an alcohol pad and an electrode will be attached to those sites. A small amount of electrode jelly will be applied to make good contact, and the skin under each electrode will be gently rubbed to permit brain waves to be recorded clearly. Volunteers will be seated in a comfortable chair in a quiet room and asked to listen to a series of sounds or spoken words presented over headphones or to view images or words on a computer monitor. They will be asked to make decisions about what they see or hear and provide a response. Total time will be typically 2-6 hours, with frequent breaks as needed. Some volunteers may be asked to return for MRI scans to help determine which areas of the brain are generating electrical signals.
Risks associated with this study, such as sensitivity to the electrode gel, are considered minimal.
Data for this work is stored at the participating hospitals under anonymous computer codes. Confidentiality and privacy are addressed in the Informed Consents, which will be obtained by the research physician and has been approved by both the hospital and PNNL IRBs.
Project Identifier: PNNL-96-17
Project Title:
Breast Cancer Prevention, Education, and Detection
Principal Investigator:
Dr. Heinz J. Roye
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 06, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 53
Type of Human Subjects Involvement:
The overall purpose of this program 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.
Subjects will be asked to fill out a questionnaire, and they will be interviewed by a doctor or nurse and a genetic counselor to determine their family history and potential genetic risk for breast cancer. A chart will be developed indicating family members and any cancer that they can remember them having had. They will be asked to give the genetic counselor documents to verify the information (medical report documenting diagnosis). The information will help the subject's health care provider and genetic counselor determine if they are eligible for the project and for testing for BRCA1 and BRCA2 genetic mutations.
Risks: Possible emotional distress at the outcome of the tests and the decision to inform family members. Special attention must be paid to the possible mixing of medical and genetic records.
Privacy/confidentiality/consent: Subjects will be consented twice during this project, first before they complete a questionnaire, perform pre-test counseling and education, and second before providing a blood sample for genetic testing. Records for this project are accessible only to specific researchers, IRB, physicians and genetic counselors conducting the study. Information gained from this study may be used as part of a scientific publication, but subjects will in no way be personally identified.
Project Identifier: PNNL-96-20
Project Title:
Study of Heat Stress and Performance in Carpenters at DOE Sites (Courtesy Review)
Principal Investigator:
Mr. Wilfred Cameron
Principal Investigator's Institution: United Brotherhood of Carpenters Health and Safety Fund
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 25, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 18
Type 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.
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
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: April 09, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 20
Type 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.
Risk is nonexistent.
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
Principal Investigator's Institution: University of Washington
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: January 20, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 569
Type 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.
Project Identifier: PNNL-97-10
Project Title:
Screening For Chronic Beryllium Disease at Hanford
Principal Investigator:
Dr. Scott Barnhart
Principal Investigator's Institution: University of Washington
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 05, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 25
Type of Human Subjects Involvement:
The purpose of this initial study of beryllium exposure at Hanford is to determine the prevalence of beryllium sensitization in an exposed population of Hanford workers, and to begin to determine the high risk jobs of former workers and high risk areas for exposure in future remediation workers. Initial determinations of sensitization will be cross-sectional and will be linked to retrospective chest radiograph and spirometry data where available. This sensitization/disease prevalence and exposure information will be used to determine the feasibility of medical monitoring for beryllium disease in exposed workers in a second study.
Subjects will be asked to: (1) fill out and return a Consent Form and a Hanford Worker Beryllium Survey (phone contacts will be available for questions); (2) grant permission to review employment and medical records to see if they may have been exposed to beryllium while on the job; and (3) let a licensed person collect a blood sample to determine if there is an immune reaction to beryllium.
Risk to privacy is minimized by the careful control, storage, and destruction of personal identifiers and blood samples.
Subjects will be consented at required stages of this program.
Project Identifier: PNNL-97-2
Project Title:
Medical Surveillance Program/Former DOE Workers
Principal Investigator:
Dr. Scott M. Barnhart
Principal Investigator's Institution: University of Washington
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Human Subjects work will begin in FY98
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 01, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 618
Type of Human Subjects Involvement:
The focus of the needs assessment phase of this project is to identify former Hanford workers who may be at significant risk for disease based on workplace exposure to radioactive or other hazardous substances and to establish contact with the workers. Based on the information collected, the project teams will make recommendations to DOE concerning the need for future follow-up programs, including plans for the development of medical monitoring for former workers that would be funded by Congress. Phase II, if authorized, would be the implementation of medical monitoring programs for targeted groups of former workers. These programs would seek to benefit workers by helping to prevent or minimize illnesses related to exposures in years past, and to improve the health of the former worker.
Risk to subjects is minimal. Codes will be used to protect personal data and all records will be destroyed at the close of the project.
Subjects will be consented as necessary at each stage of the project.
Project Identifier: PNNL-97-5
Project Title:
Former Workers' Notification and Medical Screening - Hanford
Principal Investigator:
Dr. Knut Ringen
Principal Investigator's Institution: Center to Protect Workers Rights
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Subjects were not contacted in FY97 during the Needs Assessment
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: 97-5-1
IRB Review:
Type of Review: Expedited
Most Recent Approval: October 27, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The objective of this program is to assist in the development of notification, medical screening, and intervention programs for building trades workers who may have been exposed to health hazards as a result of prior work at Hanford. The following will be conducted in the Phase I, Needs Assessment:
1. Review policy issues and provide project coordination.
2. Conduct site needs assessment and develop worker history risk characterization protocols as the basis to triage workers at risk.
3. Develop notification protocol and related worker education materials.
4. Develop medical protocol.
5. Develop programs and procedures for the determination of program eligibility and claims management, including coordination of benefits.
6. Develop a data management plan for epidemiological analyses based on the program.
7. Develop an implementation plan for Phase II.
Transfer of data from three DOE sites to the data manager for this program was recently approved by the IRB.
Risk to subjects is minimal as personal data is protected by code and physically protected until the time it is destroyed or returned to the site.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 27, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The objective of this project is to implement the notification, health evaluation (including medical screening) and intervention program for former building and construction trades workers at the DOE Hanford site who may have been exposed to health hazards as result of prior work at Hanford.
Specific aims for Phase II, which will be conducted in FY98 are:
1. Identify and locate former workers who are considered "at risk".
2. Ascertain the health concerns of workers identified in Phase I.
3. Communicate risk information to the workers and discuss actions to be taken.
4. Provide medical screening.
5. Assist in coordination of referrals, diagnostic work up, and follow-up treatment.
6. Ensure dialogue with local parties concerned with the project.
7. Evaluation project impact, including former workers satisfaction with the project.
Risks to the subjects, such as possible loss of privacy is minimized by coding and multiple layers of protection to the data. All personal data is coded and encrypted and maintained in separate data bases.
Subjects will be well informed of the purpose of the program and will be consented as required during various phases of the research.
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:
Ms. Susan M. Adams
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: 97-6
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 11, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 60
Type 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.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 13, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 60
Type of Human Subjects Involvement:
The objective of this Needs Assessment Task is to determine the information needs of patients and providers regarding screening and early detection of breast cancer. About 40 providers and 60 patients will be interviewed. The aim of the study is to look at factors that affect the flow of information about breast cancer between women and their providers. In addition, researchers will look at factors that affect women and their providers decisions to talk to each other about the risk factors for breast cancer.
Researchers will ask providers questions about their typical practices of informing women about risks, as well as discussing breast self-examination, mammography, genetic counseling, and testing for breast cancer with both the provider and the patients. They will discuss the roles of each, the quality and quantity of the interactions between providers and patients, and the satisfaction levels of both.
Other than the possible discomfort of discussing these issues, there is no risk to the subjects. Interviews will be numerically coded and all subjects will be consented.
Project Identifier: PNNL-97-8
Project Title:
Fundamental Research on Solvent-Laden Soils
Principal Investigator:
Dr. Karla D. Thrall
Project started in: 1997
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Work was funded late in FY97. Human Subjects work will begin in FY98.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
Subjects skin will be exposed to small amounts of hazardous chemicals in soil or water to determine possible absorption, detectable through breath analysis.
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 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.