Deficiencies in paediatric research applications delaying ethics committee approval

Area of Science:

• Medical Ethics
• Clinical Research Administration

Background:

• Ethics committee (EC) approval is mandatory for clinical research execution.
• Limited guidance exists for optimizing submissions, particularly for pediatric and adolescent research requiring age-adapted information.

Purpose of the Study:

• To analyze the types and frequency of objections raised by the EC of the Canton of Zurich for clinical research applications.
• To identify common deficiencies in submissions to improve the ethics review process.

Main Methods:

• Retrospective analysis of 86 research applications submitted to the EC of the Canton of Zurich from 2014-2015.
• Validation using a random sample of 20 applications from 2018-2019.
• Categorization of objections into formal, legal, ethical, and scientific.

Main Results:

• Of 80 analyzed applications (2014-2015), 62% received objections from the EC.
• The majority of objections were formal (n=503) and legal (n=287).
• Most frequent deficiencies included missing age-adapted patient information (49%) and incorrect informed consent templates (46%), persisting in 2018-2019.

Conclusions:

• Thorough preparation of submission documents by investigators is crucial.
• Adherence to formal and legal requirements can significantly optimize and accelerate the EC review process.
• Expedited review facilitates earlier commencement of clinical research.