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@violet.berkeley.edu
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
Number of Human Subjects Projects reported: 1
Project Identifier: UCB-92-ER61393
Project Title:
Pathways to Genetic Screening
Principal Investigator:
Dr. Troy Duster
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
We are using funds left over from 11/1/94 through 10/31/95. We have not requested or received additional funding.
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Protocol/Subproject # 1
Protocol/Subproject Identifier: ER61393
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 14, 1996
IRB Approval Number: 94-8-96
Number of Human Subjects who participated in this project/protocol during
10/14/95 - 10/14/96: 2
Type of Human Subjects Involvement:
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 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 cystic fibrosis and sickle cell disease, have a similar pattern of inheritance and raise similarly serious bio-medical challenges and issues of information management. This study has expanded its original focus on cystic fibrosis and sickle cell disease to include families at risk for the thalassemias.
The study gathers data by interviewing members of families in which a gene for cystic fibrosis, sickle cell 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.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 18, 1995
IRB Approval Number: 95-8-95
Number of Human Subjects who participated in this project/protocol during
08/18/95 - 08/18/96: 0
Type of Human Subjects Involvement:
The objective of this subproject is to produce a video that presents the perspectives of patients, their families and various types of health care providers on living with and caring for persons with sickle cell disease. This video documents contrasting perspectives and facilitates effective communication between professionals, patients and their families. Participants are recruited from among those who have agreed to be interviewed for the main project. Health care workers are recruited in person or by telephone from the clinics which have cooperated with us during the larger study. A second consent form has been approved by the University IRB. Participation in this subproject is entirely voluntary and those who wish to participant in the video are informed they have the right to withdraw from the video at any point up until its completion. Risks to patients will be minimal because their health status is already known to some people. However, distribution of the video will result in a wider population having knowledge of all participants' relationship to sickle cell disease. This is fully explained in the consent form.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 08, 1995
IRB Approval Number: 94-8-96
Number of Human Subjects who participated in this project/protocol during
06/08/95 - 06/08/96: 3
Type of Human Subjects Involvement:
The objective of this subproject is to clarify cultural issues and processes identified during the earlier phase of the study in which participants were interviewed individually. This is done by convening and tape recording focus groups. Each group is made up of from 3 to 8 individuals with certain key characteristics in common. These characteristics usually include cultural background and relationship to a specific genetic disease. For example, one group is made up of mothers of affected children, another of fathers, a third of siblings, a fourth of grandparents, etc. By convening groups that share salient social characteristics, we are able to generate interaction that represents each cultural perspective more clearly than it can be conveyed by one individual in a private dialogue with an interviewer. This process brings to light issues that are the focus of common interests and facilitates their expression in culturally specific terms. These focus groups are conducted in community settings and thus tend to reflect community, as opposed to purely biomedical, perspectives. They are tape recorded, transcribed and analyzed using the same inductive methods used in the larger study. These methods include "grounded theory" and narrative analysis.
Participation in focus groups poses a somewhat different risk than participation in individual interviews, such as potential for embarrassment, loss of confidentiality and inconvenience. Although participants have the assurance that researchers will not violate confidentiality, there is a possibility that other focus group participants may do so. Participants are warned of this danger, and to mitigate it, they are introduced to each other only by first names and encouraged only to provide information that they feel comfortable sharing with others. They are compensated for any inconvenience and expenses created by their participation with $50 in cash.