This free and open access e-Learning resource has been adapted from the Multi-Regional Clinical Trials Center at Harvard University (Harvard MRCT) 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.
Do you have a specific protocol in mind?
If you already have a specific protocol in mind the Essential Elements of Ethics course should be used in conjunction with the accompanying Points to Consider workbook and Points to Consider Checklist. The workbook provides space for researchers to consider and answer each question as they work through the course to create their protocol-specific Ethics Section. The Checklist summarizes the Points to Consider so that each point can be checked as researchers write their study protocol and ethics committee members review clinical trial protocols.
The quiz for each module has been created to test your knowledge of the course material and to gain certification to demonstrate that you have successfully completed the entire course. Each quiz must be taken in order and we recommend that each quiz is taken directly after completing its associated module. A certificate will be issued on successful completion of all eleven quizzes (minimum of 80% required).
Note: It is not compulsory to take the quizzes; this is only if certification is desired, and course modules can be accessed independently.
To provide feedback or comment on any aspect of this course please visit the course discussion forum: Click here