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The Declaration of Helsinki requires every clinical trial be based on a written study protocol to describe how it be conducted and to ensure both the safety of study participants and the integrity of the data. Further, the clinical trial should be based on sound ethical principles and clinical equipoise, and the risks to subjects should be minimized and reasonable in relation to the anticipated benefits. However, despite the importance of sound and complete protocols to clinical research, investigators have historically received little guidance on how to address protocol elements nor the required ethical considerations involved in conducting clinical trials. Thus, protocol documents routinely do not reflect the questions and reasoning behind ethical choices that have been made. This shortcoming raises particular concerns in context of multi-regional studies and studies conducted in low-resource nations.
 
Recognizing the current lack of guidance concerning how to address ethical issues that arise in clinical trials, the Multi-Regional Clinical Trial Center at Harvard University (Harvard MRCT) convened a multi-stakeholder group to identify the main decision points and key issues in multi-regional clinical trials. Eleven “essential elements” were identified, and a Protocol Ethics Tool-kit, available on the web, was created. The Protocol Ethics Tool Kit helps ensure that key ethical quandaries are explicitly addressed when designing and drafting protocols for multi-regional clinical trials. Key decision points are discussed, from the use of placebo and post-trial access, to country selection and informed consent, including questions for consideration, case examples, and references. Harvard MRCT was careful to advance a global perspective. We hope that the Protocol Ethics Tool Kit, available at
 
http://mrct.globalhealth.harvard.edu/presentations/mrct-ethics-essential-elements
 
will help facilitate effective recognition, consideration, and discussion of ethical issues, and be freely available those who may not have had the tools to do so before. We are currently developing an on-line scalable teaching module, available soon, in partnership with the Global Health Network, sponsored by the University of Oxford.
 
Zachary E. Shapiro, MSc & Alla Digilova
Barbara E. Bierer, MD
On behalf of Harvard Multi-Regional Clinical Trial (MRCT) Center