The ASSERT statement

The ASSERT statement is the articulation of A Standard for the Scientific and Ethical Review of Trials. It proposes a structured approach whereby research ethics committees review proposals for, and monitor the conduct of, randomized controlled clinical trials.

Note to Reader

The ASSERT statement is no longer under development, having been subsumed into the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) initiative. Please use a Search Engine to find the latest information about SPIRIT on the Internet.

In order to ensure the ethical conduct of research involving human subjects, the ASSERT checklist comprises items that need to be addressed by investigators applying for approval to conduct a clinical trial. These items are chosen to enable fulfillment of certain universally applicable requirements for the ethical conduct of research: social and scientific value; scientific validity; fair subject selection; favorable risk-benefit ratio; and respect for potential and enrolled subjects.

Through systematic evaluation of the checklist items, and the means whereby the informed consent of research participants will be acquired, research ethics committees will be able to discharge their social and regulatory obligations. Investigators and research sponsors, in turn, may use the checklist items to formulate a comprehensive research protocol that will enable the responsible conduct of a clinical trial from its inception through to the public dissemination of the research results.