Broad consent in the emergency department: a cross sectional study

Area of Science:

• Medical Informatics
• Clinical Research
• Patient Engagement

Background:

• The Medical Informatics Initiative (MII) developed a broad consent form (MII-BC) for clinical, insurance, and biomaterial data.
• The emergency department (ED) setting presents unique challenges for patient consent due to diverse patient populations and acuity.
• The BC-ED project evaluated the implementation of MII-BC in German EDs.

Purpose of the Study:

• To assess the feasibility of implementing a broad consent form in emergency departments.
• To investigate patient perceptions of voluntariness, information recall, motivation, and satisfaction with the broad consent process.
• To identify barriers and facilitators to broad consent in the ED setting.

Main Methods:

• A systematic sampling approach (every 5th/30th patient) was used across four German university hospital EDs.
• Patient recruitment and consent procedures were adapted to local site conditions.
• Data collection involved patient questionnaires, study nurse surveys, and routine clinical data, with descriptive analysis using SPSS.

Main Results:

• Of 1,138 patients approached, 553 (48.6%) were capable of consenting; 313 (58.5% of contacted eligible patients) consented to MII-BC.
• Primary reasons for non-consent included language barriers (35.4%) and difficulty grasping study details (21.5%).
• Patients reported high understanding (89.8%) and satisfaction, but discrepancies existed between consented options and patient recall.

Conclusions:

• Broad consent implementation in EDs is achievable, demonstrating patient willingness to participate in research.
• Language barriers and medical conditions significantly impact consent rates, necessitating targeted strategies for inclusivity.
• While patients generally understood the consent process, improved comprehension strategies are needed to address recall discrepancies.