Northeast Regional Cancer Institute

Funding for Human Subjects Research:

DOE: Medical Sciences, SC-73

$166,678.00 (Est.) for: Fiscal Year 2005
Percent of funding associated with the use of human subjects: 61-80 Non-Federal

Information on Use of Human Subjects:

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

Identifier or number: NRCI-01001

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Northeast Regional Cancer Institute
Most recent approval: 09/22/05

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 863
Reporting period for number of human subjects: Year prior to last IRB approval date

Type(s) of Human Subjects Involvement:

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: This is a population-based study of cancer risk factors and screening behaviors in Northeast Pennsylvania. The objectives of this study are 1) to document the prevalence of cancer risk factors in this community, 2) to identify those risk factors that are unusually common, and 3) to document cancer screening practices in this community.

Methods: The study uses an anonymous telephone survey employing random digit dialing to contact a representative sample of adult residents living in a six county area in Northeast Pennsylvania. The data collected includes information on cancer risk factors (family history of cancer, occupation, tobacco and alcohol use, diet, exercise, and the use of selected medications), screening behaviors, and basic demographics.

Exposures: This protocol is observational research; it does not involve the administration of ionizing radiation or radioactive or other chemical substances.

Human Subjects: The methods used for identifying and enrolling study subjects are similar to those used by the CDC's Behavioral Risk Factor Surveillance System (BRFSS). Subjects are recruited by telephone using random digit dialing. The last four digits of the telephone numbers are randomly generated by computer and combined with known residential exchanges (first three digits of telephone number) in the target counties. All English-speaking persons, age 18 and older, regardless of gender, race, ethnicity or income, have an equal chance of being included in the study. After a household is contacted, the resident whose next birthday is nearest the date of contact is selected as the study participant. When an eligible subject is reached, the study is explained, verbal consent is obtained, and a trained member of the research staff interviews the subject using a structured interview schedule. Data are collected by specially-trained interviewers who have received extensive training in administration of the instrument, medical terminology, and screening practices. The interview is conducted using a computer-assisted interview system, and responses are recorded directly into computer files.

Participation in this protocol is anonymous and voluntary. The only risk to participants is the possible disruption of their routines resulting from the time taken to complete the interview, approximately 10 to 15 minutes.

Protection from risk is provided to subjects on two levels. First, interviewees are protected by the anonymity of the survey. Participation is voluntary, and all participants are informed that they may end the interview at any time. Second, a study-specific, limited-use data file is created for research purposes. This limited dataset does not include any personal identifiers and contains only those data items that are required for the proposed analysis. The participant's telephone number is not recorded with the interview data, and no identifying information is requested or recorded if volunteered. After the completion of an interview, it is not possible to link the interview data to any personal identifier. All members of the Northeast Regional Cancer Institute's research staff have completed Human Subjects Protection training.