The SIDCER-FERCAP Foundation

Promoting the development of human research ethics

Guidelines



International Guidelines
Download Title

Guidelines for ECs that Review Biomedical Research

Operational Guidelines for Ethics Committees That Review Biomedical Research (2000) by World Health Organization (WHO)

Surveying & Evaluating Ethical Review Practices

Surveying and Evaluating Ethical Review Practices (2002) a complementary guideline to the Operational Guidelines for Ethical Committees that Review Biomedical Research by World Health Organization (WHO)

Ethical and GCP Aspects of Clinical Trials

Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorisation Applications to the EU Regulatory Authorities (2012) by the European Medicines

Biomedical Research Involving Human Subjects

International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) by the Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO)

Guideline for Good Clinical Practice

ICH Harmonised Tripartite Guideline-Guideline for GCP E6(R1) (1996) by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Declaration of Helsinki (2013)

Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (1964, latest version, 2013) by the World Medical Association (WMA)

Ethics Review of Health-Related Research

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) by World Health Organization (WHO)

Research Ethics Committees

Research Ethics Committees: Basic Concepts for Capacity-Building (2009) by World Health Organization (WHO)