Argonne National Laboratory

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Argonne National Laboratory
Most recent approval: 09/15/05
IRB approval number: 13968A

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 2005

Type(s) of Human Subjects Involvement:

Internal administration of radioactive substances to human subjects:

• For clinical research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objectives

Study 1) Characterize cadmium (Cd) exposures due to cigarette smoking in a group of postmenopausal women and age-matched men, and

Study 2) Determine the relationship between cadmium in cigarette smoke and calcium release from bones among a subset of postmenopausal women from Study 1.

The proposed project will test the hypothesis that cadmium in cigarette smoke contributes to the etiology of osteoporosis in humans, particularly among postmenopausal women.

Osteoporosis is a disease that critically affects the quality of life of elderly persons. By 90 years of age, one-third of women have broken a hip which can result in a dependent lifestyle. Understanding the extent to which environmental factors, such as Cd in cigarette smoke, contribute to osteoporosis in our aging population is an important undertaking.

Methodology

Study 1) Analyze cadmium concentrations in blood and mainstream smoke (once per month for 3 months) among postmenopausal females and age-matched males, for smokers vs. non-smoking controls. For a subset, determine time-course of change in blood cadmium concentration after a single smoking session.

Study 2) Using Ca-41 as a marker, analyze Ca-41 and cadmium concentrations in blood during two or three periods for each subject (postmenopausal females only): smoking (three weeks), not smoking (at least three days, preferably three weeks or longer), smoking resumption (for those who decide to resume smoking). Conduct parallel analyses of blood Ca-41 and cadmium concentrations for non-smoking controls.

Radioactive Substances
Ca-41 (intravenous, 100 nCi) Note: This amount of Ca-41 is small enough to be declared non-radioactive by European standards. This project was categorized as low risk during the process of IRB review.

Procedures involving humans
1) Answer screening and study questionnaire
2) Receive intravenous Ca-41
3) Provide samples of blood, cigarettes, saliva, and food
4) Keep diary of cigarette smoking and food intake
5) Bone density ultrasound measurement of heel bone

Identification of Risks (respectively, per 1 to 5 above))
1) Loss of confidentiality
2) Bruising at site of injection, fainting, infection at site of injection, effects of small amount of radiation
3) Bruising at site of injection, fainting, infection at site of blood draw
4) Loss of confidentiality
5) None

Evaluation of Risks for Each Procedure
1) Loss of confidentiality is unlikely (see below).
2) Occurrence of minor bruising is likely, especially in older people.
Fainting or becoming lightheaded during blood drawing is unlikely.
Infection is unlikely. Every care will be taken to avoid these complications. Effects of small amount of radiation from Ca-41 are extremely unlikely. For example, risk is similar to radiation risk from flying a short time in an airplane and one-thousand times less than a set of dental x-rays. The amount of Ca-41 to be administered is declared to be non-radioactive by European standards.
3) Occurrence of minor bruising is likely, especially in older people.
Fainting or becoming lightheaded during injection is unlikely.
Infection is unlikely. Care will be taken to avoid these complications.
4) Loss of confidentiality is unlikely (see below).
5) For this standard diagnostic ultrasound, there are no known harmful effects.

Privacy/confidentiality
All study records that identify individual subjects will be kept completely confidential. Each subject will be identified by a unique study subject number (e.g., A1-0). Only members of the primary research team will have access to the original data. Data for each participant will be stored in a locked file cabinet. All locked file cabinets will be located in Room B321, Building 202 at Argonne National Laboratory. This room will be kept locked at all times when not occupied by one or more team members.

Consent
All subjects will provide written consent to their participation. The consent forms have received final approval by the required IRB review process.

Project Identifier: ANL-05-UCIRB14132B

"Focus Groups to Measure the Value of Public Confidence in the Government and Law Enforcement Agencies to Prevent Terrorist Attacks"

Principal Investigator: Dr. Thomas E. Baldwin, Argonne National Laboratory

Project started in: 2005

Project Funding Information: