Ms. Kelly E. Ormond
676 N. St. Clair #1280
Chicago, IL 60611
Phone: 312-926-7466
Fax: 312-926-3553
E-mail: kormond@nmh.org
Number of Human Subjects projects reported: 1
| NWU-02-0380-007 | "Assessing the attitudes and understanding of participants in NUgene: Impacts on informed consent for a large scale DNA research and banking project" |
"Assessing the attitudes and understanding of participants in NUgene: Impacts on informed consent for a large scale DNA research and banking project"
Principal Investigator: Ms. Kelly E. Ormond, Northwestern University
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Northwestern University
Most recent approval: 06/27/02
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 2002
Type(s) of Human Subjects Involvement:
Current and future genetics research will tackle the genetic components contributing to complex diseases involving multiple genes and variable environmental components; this research will require access to genotypes for large and heterogeneous populations. With this in mind, Northwestern University, in partnership with the Center for Genetic Medicine’s healthcare partners, is launching a large-scale, longitudinal genetic epidemiology project called NUgene (separately funded from this proposal and approved by the NU IRB - project 700-002). With an estimated enrollment of at least 100-200 participants per month over the first year of the NUgene study, we propose to attach a pilot study to measure some of the ethical, legal, and social issues related to informed consent in large population-based genetic research studies. Our proposed methodology would involve a cross-sectional survey of all participants who are enrolled in the NUgene study over approximately a one-year period of time (estimated at 1200-2000 for the first year). Based on this potential subject base, we expect a total enrollment of approximately 200 individuals in our specific study.
Objectives:
The pilot study’s general objectives are to elicit quantitative and qualitative information regarding why individuals opt to participate in a large scale genetic research projects, and to assess participant knowledge and attitudes towards the consent process for large scale genetic research projects. The goals of this pilot project are to determine whether the Quality of Informed Consent (QuIC) can be used to assess informed consent in a genetic research study, and to use our pilot data to develop a larger scale assessment that can be used in conjunction with NUgene and other studies in the future. Our ultimate goal is to learn more about how genetic research participants view the informed consent process and to develop models of how to better ensure informed consent and awareness around these research projects.
Methodology:
Study Population: Our pilot study population will be drawn from individuals who opt to participate in the NUgene research study. As a result, inclusion criteria for our study will be identical to those for NUgene, and will include English-speaking adults over 18 years old who are seen at various clinics within the Northwestern Memorial Hospital system. Individuals with cognitive impairments or those who do not speak English will be excluded from this pilot study.
Methods: At the conclusion of NUgene enrollment (after the participants undergo the informed consent process, including signing the NUgene study consent form), participants would be informed of this study, and provided with a separate recruitment letter and consent form detailing the study. If subjects are interested in participation, they provide their contact information at the time of NUgene enrollment, and would be contacted within 2-4 weeks by telephone for an interview lasting approximately 30 minutes. Quantitative and Qualitative data would be collected through semi-structured interview questions as follows:
Quantitative data will include the following:
(1) demographics- age, gender, education level, socioeconomic status, occupation, reported ethnicity, religion, marital status, number of children.
(2) personal health status (e.g. acute/chronic illness),
(3) perceived health status (e.g. likert scale),
(4) positive family history for known or suspected genetic illness, and whether family members/self have ever met with a genetic counselor and/or undergone genetic testing,
(5) science and genetics comfort levels (likert scales), and
(6) administration of a modified version of the QuIC.
Participants would then be asked a series of semi-structured open-ended questions regarding the purpose, benefits and risks of participation in the study, including perception of privacy protections and related concerns.
Ionizing radiation, radioactive substances, chemical substances: Not applicable.
Involvement of Human Subjects:
The procedures to which human subjects are exposed are described above, and consist solely of a telephone interview. As such, there are no physical, financial or social risks to participating in this study. Psychological risks are minimal, and if subjects feel uncomfortable answering any question they can decline to answer the question.
While initially information that identifies participants will be collected for the purposes of scheduling interviews, this material will not be correlated to subject responses in any manner. All subject data will be coded, with no linkage to the participant consent forms or to contact information, and therefore will be anonymous. Audio recordings will be destroyed upon completion of the study. All study related materials will be held in a secure location and will not be made available to individuals outside of the study, or if requested by the Northwestern IRB, funding agency or other legal requests.