Dr. Joe L. Mauderly
Inhalation Toxicology Research Institute
P.O. Box 5890
Albuquerque, NM 87185
Phone: 505-845-1123
Fax: 505-845-1193
Email: moderly@lucy.tli.org
Projects are approved by an IRB located at: Inhalation Toxicology Research Institute.
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- 1479
Number of Human Subjects Projects reported: 4
Project Identifier: ITRI-94-IRB#94-004
Project Title:
In Vivo Measurements of Aerosol Deposition in the Nasal and Oral Airways of Human Subjects
Principal Investigator:
Dr. Kuo-Shi Cheng
Principal Investigator's Institution: Inhalation Toxicology Research Institute
Project started in: 1994
This project ended in Fiscal Year 1996.
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: January 14, 1994
IRB Approval Number: IRB # 94-004
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
To experimentally measure the deposition efficiency of ultrafine particles in the nasal and oral airways of humans
Objective: To experimentally measure the deposition efficiency of ultrafine particles in the nasal and oral airways of 10 human adults. The effects of particle size and respiratory flow rate on the nasal and oral efficiency were examined using different sizes of particles under conditions that simulate breathing patterns.
Methodology: A passive procedure in which the aerosol was drawn up through the nose and mouth of breath-holding subjects at two flow rates: 10 liters per minute (l/min) and 20 l/min. The particles were of polystyrene latex or silver 3, 8, 20, and 150 nanometers (nm) in size. The subject sat in a chair in front of the exposure apparatus. After being fitted with a nose and mouth tube, the subject breathed filtered air and practiced holding his/her breath for 30 seconds. During the time of breath-holding air was drawn through the nose and out of the mouth. Subjects who could not perform breath-holding were eliminated from the study. There were no risks associated with the study. There were no health benefits to the participating subjects.
Reviewed and Terminated 9/12/96.
Project Identifier: ITRI-95-IRB#94-034
Project Title:
Deposition of Inhaled Toxicants in the Olfactory System
Principal Investigator:
Dr. Johnnye Lewis
Principal Investigator's Institution: Inhalation Toxicology Research Institute
Project started in: 1995
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: April 07, 1995
IRB Approval Number: IRB#94-034
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
Three year IRB approval.
Objective: Investigate gender differences in carboxylesterase levels in human nasal tissue smears in response to atmospheric pollution.
Methodology: Human nasal cytology smears are provided by Clinician, Dr. Lillian Calderon, National University of Mexico, Mexico City. Dr. Calderon collected these samples as part of an ongoing histopathological examination of adults living in polluted atmospheres (Mexico City). Control samples were collected in a port city with good air quality. The smears were fixed immediately after collection, the slides were coded, and they were sent to the Inhalation Toxicology Research Institute (ITRI). The smears were then processed using standard techniques for immunoreactivity to carboxylesterase. The presence of the enzyme suggests that the individual was exposed to environmental toxicants. There was no risk to the patients.
Project Identifier: ITRI-95-IRB#95-030
Project Title:
Pilot Study Measurement of Lead (210Pb) in Former Uranium Miners
Principal Investigator:
Dr. Raymond A. Guilmette
Project started in: 1995
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 07, 1995
IRB Approval Number: IRB#95-030
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 10
Type of Human Subjects Involvement:
Objective: Pilot study; evaluate methodology to measure the amount of an isotope of lead (210Pb) in the skulls of former uranium miners as a metric of cumulative exposure to radon and its progeny during their mining years.
Methodology: The measurements will be done in the whole-body-counting facility at the Inhalation Toxicology Research Institute (ITRI). The subjects are recruited from the University of New Mexico Epi Cog uranium miners cohort. The subject sits in a chair and the 210Pb emissions are collected with a detector over 1 hour. There is no risk to the subject.
Project Identifier: ITRI-96-IRB # 96-019
Project Title:
In Vivo Measurement of 210Pb in Former Uranium Miners
Principal Investigator:
Dr. Raymond A. Guilmette
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: July 11, 1996
IRB Approval Number: #96-019
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 20
Type of Human Subjects Involvement:
Objective/Methodology: To evaluate the amount of radiation exposure for miners by assessing the amount of 210Pb using a whole body counter. The subjects are recruited from the University of New Mexico Epi. Cog Uranium Miners Cohort. The subject sits in a chair for 1 hr, and the 210Pb emissions are collected. There is no risk to the subject.