Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS

Area of Science:

• Public Health
• Epidemiology
• Medical Research Governance

Background:

• The Australasian Maternity Outcomes Surveillance System (AMOSS) monitors rare and serious pregnancy conditions.
• AMOSS is a multi-centre population health study with minimal ethical impact.

Purpose of the Study:

• To delineate the ethics and governance review pathway for the AMOSS study.
• To identify inefficiencies in the multi-centre research approval process.

Main Methods:

• A prospective, descriptive study of ethics/governance review processes for Australian and New Zealand maternity units (n=303) from 2009-2011.
• Analysis of review applications, site governance approvals, and letters of support over 33 months.

Main Results:

• Ethical review processes varied significantly, from single applications to full Health Research Ethics Committee (HREC) submissions.
• Obtaining approval involved 46 ethics applications, 131 governance applications, and 136 support letters, requiring an estimated 3261 staff hours.
• Approval was secured for 291 hospitals, representing a substantial resource burden.

Conclusions:

• AMOSS is a valuable resource for maternal morbidity research.
• The highly variable and repetitive ethics approval processes are burdensome and hinder efficient research implementation.
• There is an urgent need for harmonized multi-centre ethical review (HoMER) to streamline processes.