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Protocol Ethics

Focus Area: Ethical Frameworks

Protocol Ethics

Protocol ethics refers to addressing ethical issues in the design of studies and documenting their rationale in a section of the study protocol easily understood by review boards.


There are limitations on current systems for reviewing clinical trials regarding:

  • Effectiveness – quality of the review and ability to detect ethical problems
  • Efficiency – time for protocol review
  • Expertise – in some regions, local ethics committees lack the level of expertise or sufficient resources required to review complex protocols

Study teams developing protocols may also not have a rigorous methodology to ensure that all ethical issues have been considered and addressed.

This project was driven by the need to ensure that key ethical questions are addressed when navigating the complicated process of designing protocols for multi-regional clinical trials.

Eleven Essential Elements:

1. Addressing Relevant Question
2. Choice of Control and Standard of Care
3. Choice of Study Design
4. Choice of Subject Population
5. Potential Benefits and Harms
6. Informed Consent
7. Community Engagement
8. Return of Research Results and Management of Incidental Findings
9. Post Trial Access
10. Payment for Participation
11. Study Related Injury


Current status: Dissemination; update planned


Increased transparency regarding ethics in the protocol and study design


  • Develop a Protocol Ethics toolkit that provides systematic guidance for protocol writers who seek assistance in addressing the ethical considerations of their planned clinical trial and ethics committee members who seek guidance for ensuring study protocols have adequately addressed ethical issues.
  • Disseminate the toolkit through our partner organizations.

Key Milestones:

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

  • August 2012 – A Workgroup of experts representing 18 stakeholder organizations started meeting twice a month to work on the protocol ethics initiatives. Work group co-chairs: David Forster – Vice President, Office of Compliance, Western IRB; Susan D’Amico – Divisional VP, Quality Assurance AbbVie (Abbott).
  • November 2013 – Launched the Protocol Ethics toolkit in conjunction with PRIMR – the toolkit includes a detailed points-to-consider document that guides the user towards drafting a standardized protocol ethics section
  • November 2014 – Collaborated with the Global Health Network to make this guidance available as e-learning resource.
  • January 2016 – Published article “Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees” in Journal of Medical Ethics
  • December 2017User 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 Lead: Carmen Aldinger / Emily Statham