Ottawa Statement does not impede randomised evaluation of government health programmes

Area of Science:

• Public Health
• Bioethics
• Health Services Research

Background:

• Watson et al. argue ethical guidance hinders research evaluation of government health programs.
• They suggest health programs themselves are outside ethics review scope if not directly controlled by researchers.
• This perspective is challenged regarding cluster randomized trials.

Purpose of the Study:

• To argue that research ethics review scope is determined by participant protection, not researcher control.
• To assert that randomized evaluations of health programs necessitate ethical oversight.
• To refute the claim that study programs occur independently of research activities in cluster randomized designs.

Main Methods:

• Ethical analysis of research scope in the context of health program evaluation.
• Critique of the "researcher control" argument for excluding programs from ethics review.
• Examination of the impact of randomized health program evaluations on participant liberty and welfare.

Main Results:

• The scope of research ethics review is defined by the need to protect participants.
• Randomized evaluations of health programs directly affect participant welfare and liberty.
• In cluster randomized trials, the research design is integral to program implementation, not independent of it.

Conclusions:

• Research ethics committees (RECs) must evaluate cluster randomized trials of government health programs.
• These trials trigger ethical considerations, including equipoise, that require REC review.
• Participant protection must be the primary determinant of ethics review scope.