Maternal Immunization Safety Monitoring in Low- and Middle-Income Countries: A Roadmap for Program Development.

Guide to Active Vaccine Safety Surveillance: Report of CIOMS Working Group on Vaccine Safety - Executive summary.

CIOMS guidelines remain conservative about vulnerability and social justice.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Critical analysis of the Council for International Organizations of Medical Sciences 2016 International Guidelines for health-related research involving humans.

Schuklenk’s critique of the CIOMS guidelines: All procedure, no substance.

Revised CIOMS research ethics guidance: on the importance of process for credibility- Udo Schuklenk.