Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing

NCT ID: NCT03105492

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 553 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2019-04-10

Brief Summary

Background:

Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic data about their baby. This raises ethical concerns. Researchers want to find out if women want access to the kind of data PWGS provides. They want to know why and under what circumstances women would or would not want the data.

Objective:

To explore the views of pregnant women about possible use of PWGS. To find out whether they would want different categories of genetic data, and how they would use such findings.

Eligibility:

Women ages 18 and older who pregnant and speak English or Spanish

Design:

Participants will be recruited by their doctors.

Participants will take a survey about their views of PWGQ. They may take it online or on paper.

Detailed Description

The impending implementation of prenatal whole genome sequencing (PWGS) raises a host of ethical concerns given the massive amounts of genetic information that expecting parents will be able to learn about their baby. This project involves a cross-sectional quantitative survey of pregnant women to explore whether they want access to the kinds of information provided by PWGS, why and under what circumstances. The survey will address questions such as: What sorts of information do pregnant women want to know about their baby, and why? What, if anything, would they do with the information? What kind of guidance would pregnant women like from their medical team regarding fetal genetic testing? Given the range of practical and ethical challenges posed by PWGS, our data will inform practitioners approaches towards PWGS as the technology develops and becomes more widely available. It is imperative that government regulators and professional societies take into account the views of people directly affected by any policies that are created - including patients themselves - before crafting rules for whether, when and how to utilize PWGS.

Conditions

Pregnant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pregnant women

Women who are pregnant

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participants must be 18 years of age
• Participants must be pregnant
• Participants must speak English or Spanish

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Human Genome Research Institute (NHGRI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin E Berkman, J.D.

Role: PRINCIPAL_INVESTIGATOR

National Human Genome Research Institute (NHGRI)

Locations

INOVA Fairfax Hospital

Falls Church, Virginia, United States

Countries

United States

Other Identifiers

17-HG-N080

Identifier Type: -

Identifier Source: secondary_id

999917080

Identifier Type: -

Identifier Source: org_study_id