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Protocol Ethics

Focus Area: Ethics, Conduct, and Oversight

Protocol Ethics

The moniker “Protocol Ethics” refers to addressing ethical issues in the design of clinical trials and documenting their rationale in a section of the study protocol easily understood by institutional review boards/research ethics committees. Study teams designing and developing clinical trial protocols may benefit from a systematic methodology to ensure that ethical issues have been considered and addressed.

Launched in August 2012, this project was driven to ensure that key ethical questions are addressed when navigating the process of designing protocols for multi-regional clinical trials. Released in November 2013, this project defined eleven essential elements that are recommended to be addressed in the design of multi-regional clinical trials.

In 2018, the MRCT Center initiated an update to the Protocol Ethics Toolkit to include, at a minimum, post-trial responsibilities and access to investigational products, transparency issues, and data integrity expectations. The revision is ongoing and is seeking stakeholder commentary.

Current status: Dissemination; Revision

Impact:

Increased clarity and transparency of ethics in study design and protocol

Objectives:

  • Update the Protocol Ethics Toolkit to provide systematic guidance for (1) protocol writers to address the ethical considerations of planned clinical trials and (2) ethics committee members to ensure study protocols have considered and addressed ethical issues.
  • Disseminate the toolkit.

Project co-chairs: David Forster (Western IRB), Susan D’Amico (Abbott)

Key Milestones:

  • August 2012: A Workgroup of experts representing 18 stakeholder organizations started meeting twice a month to work on the protocol ethics initiatives.
  • November 2013: Launched the Protocol Ethics toolkit in conjunction with PRIMR – the toolkit includes a detailed points-to-consider document to guide the user towards drafting a standardized protocol ethics section
  • November 2014: Collaborated with the Global Health Network to disseminate this guidance as an e-learning resource.
  • January 2016: Published “Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees” in Journal of Medical Ethics
  • December 2017: User statistics for e-learning course “Essential Elements of Ethics:” Since its launch, 1,375 e-learners from around the world have taken 22,048 modules and 625 certificates for completion of the entire course were issued

Related external links:

2018 Edition of the International Compilation of Human Research Standards (including Declaration of Helsinki and Belmont Report)

Project Managers: Carmen Aldinger / Emily Statham