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American Law and the Governance of Research Ethics – Time for International Change

Alexander M Capron

(2010) 22 SAcLJ 769

Professor Capron indicates that the US has taken the lead among nations in adopting a system of ethical review conducted by committees known as institutional review boards (“IRBs”). The “Common Rule” implemented by the Office for Human Research Protections (“OHRP”) specifies the requirements for the establishment of IRBs, their operation and the standards for their decisions about research protocols and in overseeing ongoing research. A research institution must comply with these requirements in order to receive a “Federal Wide Assurance” (“FWA”) from OHRP. All research institutions that receive support from the US government for human subject research or whose staff collaborates on such research must have obtained an FWA. Professor Capron explains that the present US rules are a response to particular problems and scandals in research and were developed in the context of the bureaucracy underlying US medical science. It is inappropriate for research ethics committees around the world to have to apply for an FWA from a US agency, as many do. Despite its influence on a number of jurisdictions, there is nothing magical about the US regulatory approach and no reason for it to constitute the global norms and procedures for research ethics. Professor Capron argues that however salutary a role the US rules may have played, the time has come for a less US-centric form of global governance of the ethics of research with human subjects. The dominance of the US regulations discourages governments from taking sufficient responsibility to ensure that research conducted within their jurisdictions is ethical. Yet, some means of common governance is needed to avoid a “race to the bottom”. All countries should have and enforce basic standards of research ethics and accountability for sponsors and investigators. Governance includes less formal means of directing action or regulating behaviour, not only through law. International arrangements can take four forms: formal or informal at either a governmental or non-governmental level. Professor Capron considers a possible arrangement would be for governments to agree on a common framework that would set enforceable standards and then proceed to develop a system akin to the WHO’s International Health Regulations with enforceable obligations and defined decision-makers.