Essential Elements of Ethics

This free and open access e-Learning resource has been adapted from the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard (MRCT Center) Ethics Tool Kit. The Ethics Tool Kit was created to encourage protocol authors to address ethical issues in the design of studies and document their rationale in a section of the protocol that will be easily understood by review boards and investigators. This e-Learning resource will guide the development of a dedicated “Ethics section” of the protocol in which these Essential Elements are addressed or cross-referenced to other sections of the protocol. This tool will enable a quality and efficient review of a protocol’s ethical considerations by ethics committees.

The following Essential Elements of Ethics modules and associated detailed Points to Consider provide guidance and suggestions – not requirements or mandates – on key ethical questions likely to arise in the course of writing a protocol and informed consent (or templates for such documents) for clinical trials and clinical research. This online resource will assist (1) clinical researchers as they write their study protocol to recognize and address common ethical challenges in clinical trials, and (2) ethics committee members as they review and analyse clinical trial protocols in an efficient and comprehensive manner. The guidance provided may also prove useful beyond the protocol, to the extent that it can prompt the protocol author to consider policies, procedures and local regulatory requirements.

In many cases, there will be several reasonable approaches and this resource strives to simply clarify the possibilities and various rationales. Some of these topics may already be addressed within a protocol. Where they are relevant and left unaddressed, completion should offer the ethics committee a better sense of the protocol’s ethical issues within the proposed clinical trial.