Why Patients Decline Genomic Sequencing Studies: Experiences from the CSER Consortium

Area of Science:

• Genomics and Bioinformatics
• Clinical Research
• Bioethics

Background:

• Genomic sequencing (GS) is increasingly used in clinical and research settings.
• Limited research exists on reasons why individuals decline participation in GS research.
• Understanding these reasons is crucial for informed consent and overcoming participation barriers.

Purpose of the Study:

• To identify and analyze the reasons why potential participants decline enrollment in genomic sequencing research.
• To compare reasons for declining GS research with those for genetic testing and other genetic studies.
• To inform strategies for improving recruitment and implementation of GS in research and clinical practice.

Main Methods:

• Data were aggregated from seven sites within the National Institutes of Health's Clinical Sequencing Exploratory Research (CSER) consortium.
• Analysis included recruitment procedures, enrollment decline rates, and reported reasons for decline from 1088 potential participants.
• Descriptive statistics were used to analyze the collected data.

Main Results:

• Enrollment decline rates varied significantly across sites (12-64%, median 28%), influenced by age and disease status.
• The primary reason for decline was study logistics (35%), similar to other genetic research.
• Privacy/discrimination concerns (13%) and psychological impact (8%) were less frequent reasons for decline.

Conclusions:

• Study logistics represent a significant barrier to genomic sequencing research participation.
• While privacy and psychological concerns were cited, they were not the primary drivers of decline in this study.
• Addressing logistical challenges is key to enhancing recruitment for GS studies and facilitating broader clinical implementation.