Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

Area of Science:

• Health Services Research
• Informed Consent
• Comparative Effectiveness Research

Background:

• Traditional informed consent may not suit comparative effectiveness research (CER) integrated into routine care.
• Limited research exists on stakeholder views for streamlined consent in CER.

Purpose of the Study:

• To explore multi-stakeholder perspectives on alternative disclosure and consent models for CER.
• To assess the acceptability of Opt-In, Opt-Out, and General Approval models in different CER designs.

Main Methods:

• A deliberative engagement method was used with 58 multi-stakeholder participants.
• Participants evaluated three consent models for observational and randomized CER studies (hypertension, spinal stenosis).

Main Results:

• A majority favored the General Approval model for observational hypertension CER.
• For randomized hypertension and spinal stenosis CER, most preferred traditional Opt-In consent.
• Stakeholders preferred streamlined consent for observational designs over randomized ones.

Conclusions:

• Multi-stakeholder groups favor streamlined consent for observational CER but not randomized CER.
• Informed consent requirements should be adapted to specific research designs, not standardized.