A population-based approach for implementing change from opt-out to opt-in research permissions

Area of Science:

• Health Informatics
• Clinical Research Management
• Patient Engagement

Background:

• Recent Common Rule changes necessitate efficient methods for documenting patient research preferences.
• Existing opt-out paper-based workflows are not scalable for population-level research.
• Electronic Health Record (EHR) systems offer potential for streamlined preference collection.

Purpose of the Study:

• To demonstrate the feasibility of an EHR-based active opt-in research preferences program.
• To establish a scalable system for documenting patient consent for research study contact and biobanking.
• To integrate research preference collection into routine clinical workflows.

Main Methods:

• Developed and disseminated an EHR portal questionnaire for patient research preferences (study contact and biobanking).
• Integrated the questionnaire into an obstetrical clinic's nurse intake workflow.
• Created registries to tabulate permissions and manage research patient contact within the EHR.

Main Results:

• Over 21,000 responses received from nearly 60,000 patients via EHR portal within four months.
• High consent rates: 75% for biobanking, 72% for future research contact.
• Lower consent rates observed when questionnaire administered in a clinical setting (obstetrics clinic).

Conclusions:

• An EHR-based opt-in system is feasible for establishing a research permissions registry.
• Patient-centric, population-based data collection in the EHR enhances research feasibility and recruitment.
• Integrating preference collection into EHR and clinic workflows streamlines consent management.