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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, addressed, and documented appropriately.

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, the resulting toolkit defined eleven essential elements that are recommended to be addressed in the design of multi-regional clinical trials. In November 2014, in collaboration with Global Health Network, an e-learning course was launched with the content of the toolkit which has been utilized by learners around the world.

Current status: Dissemination

Impact:

Increased clarity and transparency of ethics in study design and protocol

Deliverables:

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
  • December 2019: User statistics for e-learning course “Essential Elements of Ethics:” Since its launch, 2,449 e-learners from around the world have taken 41,125 modules and 15,990 certificates for completion of modules were issued

Related external links:

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

Project Leadership:

  • Barbara Bierer, MD. Faculty Director, MRCT Center

Program Managers:

  • Carmen Aldinger, PhD, MPH, PMP
  • Sylvia Baedorf Kassis, MPH