USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-91-107-H01

Project Title:

National Runner's Health Study (see LBL-93-2-74 and LBL-93-2-75 in 1994 database)

Principle Investigator: Dr. Paul T. Williams

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Explanation:

The researcher continues to pursue this study while seeking funding.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: February 17, 1995
IRB Approval Number: 95-2-111

Number of Human Subjects in the Last Reporting Period for this Project: 7,000
(Reporting periods vary.)

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

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

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or 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])

The objective of this study is to collect self-reported and medical history data as a basis for testing for correlations between various conditions (e.g., lung cancer and heart disease), running activity, and smoking history.

The study hopes to achieve this goal through the distribution of up to 500,000 questionnaires to active runners. Questionnaires are distributed to the readers of Runner's World magazine and to participants in long-distance running events. The investigator does not contact individuals who do not respond to the initial survey. The survey asks questions about exercise level, diet, weight, and personal habits. Subjects are also asked to sign a release for access to their medical records. If the release is signed, the investigator sends a separate request to the physician's office where the relevant information is abstracted by the physician or his staff and returned to the investigator. These items include results of any recent blood tests for cholesterol and lipoprotein levels.

The subjects participation is limited to completing the survey and allowing access to existing medical records. The only risk to the subject is potential loss of some personal privacy.