USDOE Human Subjects Research Database, Fiscal Year 1997

University of California, Berkeley

Public Information Contact:

Dr. Troy Duster
Institute for the Study of Social Change
2420 Bowditch
University of California
Berkeley, CA 94720-5670

Phone: 510-642-0813
Fax: 510-642-8674
Email: nitrogn@socrates.berkeley.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: University of California, Berkeley.
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-1349

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

UCB-92-ER61393
Pathways to Genetic Screening

Go to Human Subjects Research 1997 main page

Project Identification:

Project Identifier: UCB-92-ER61393

Project Title:

Pathways to Genetic Screening

Principal Investigator: Dr. Troy Duster

Project started in: 1992


Fiscal Year 1997 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.

Explanation:

We are operating under a no-cost extension to October 31, 1997.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)
Amount: $0
Comments:
We are operating under a no-cost extension to October 31, 1997.


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

Protocol/Subproject Identifier: ER61393

IRB Review:
Type of Review: Full Board
Most Recent Approval: August 20, 1997
IRB Approval Number: 97-8-60

Number of Human Subjects who participated in this project/protocol during FY 1997 (10/1/96 - 9/30/97): 1

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

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

Abstract:
(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 proliferation of genetic screening and testing is requiring increasing numbers of Americans to integrate genetic knowledge and interventions into their family life and personal experience. This study examines the social processes that occur as families at risk for two of the most common autosomal recessive diseases, sickle cell disease (SC) and cystic fibrosis (CF), encounter genetic testing. Since each of these diseases is found primarily in a different ethnic/racial group (CF in European Americans and SC in African Americans), this research will clarify the role of culture in integrating genetic testing into family life and reproductive planning, and will facilitate the development of culturally sensitive genetic services. A third type of genetic disorder, the thalassemias primarily affect Southeast Asian immigrants, although another risk group is from the Mediterranean Region. Thalassemias, like CF and SC, have a similar pattern of inheritance and raise similarly serious biomedical challenges and issues of information management. This study has expanded its original focus on CF and SC to include families at risk for the thalassemias.

The study gathers data by interviewing members of families in which a gene for CF, SC or thalassemia has been identified. Data collection consists primarily of focused interviews with individuals from families in which at least one member has been identified as having a genetic disorder (or trait). Index cases are identified in medical settings or in advocacy groups. Snowball sampling is used to recruit other family members. Interviews are tape recorded, transcribed, coded, and entered into a computerized data base. Analysis is conducted using a variety of qualitative methods including "grounded theory" and narrative analysis. This study does not involve exposing respondents to any substances. It elicits only verbal responses to questions. Records are kept in locked cabinets. In order to protect confidentiality they are identified and filed by number. The identity of respondents is never revealed in reports of research findings. The most significant risks to which individuals are exposed is the risk of inconvenience and the risk that discussion of sensitive topics may be uncomfortable to them. Respondents are informed that they have the right to have the tape recorder turned off or to withdraw from the interview at any time. They are compensated for their participation and for any incidental expenses they may incur with $20 in cash for individual interviews.


Go to list of projects at University of California, Berkeley