Deciding whether a study needs ethics review, and which standards apply
Whether a study needs ethics review, and which standards it must meet, depend on what kind of study it is and where it is done. Research is set apart from practice by testing a hypothesis, usually under a formal protocol. Whether an observational study needs ethics committee approval is debated, and countries and journals answer differently. A paediatric trial must be approved by an ethics committee, and in the United States only a study that is not exempt needs review by an institutional review board, though some exempt categories need a limited review. What applies in one place does not necessarily apply in another, so in many respects ethics are contextual, and no universal standard exists.
Practice and research
Practice is the diagnosis and treatment of individuals. Research is essentially the testing of a hypothesis: whether there is reasonable assurance that an intervention will produce a safe and effective treatment or prevention across a broader population. Research usually follows a formal protocol that sets out the specific objectives and the procedures for conducting the study. Practice concerns the individual, while research concerns generalisable information and treatment according to a study protocol.
Observational studies
The Declaration of Helsinki makes clear that all experimental procedures involving human beings should be well defined in a protocol, and that the protocol must be approved by an ethics committee before any experimental procedure starts. The situation is less clear for observational studies. Some countries may waive the requirement for ethics committee approval of observational studies because there is no experimental intervention. In 2017 ethics committee approval was needed for all research in Canada, including the review of patient records, while in Turkey retrospective studies were excluded from the code of ethics approval.
Ethics committee approval of observational studies is much debated. Some argue that most observational studies are not ethically sensitive and that ethics requirements are an unnecessary barrier, and others hold that ethical requirements are important to prevent bad practices in research. Regulatory authorities and legal bodies are not enemies of research; they work towards improving research practices to the ultimate benefit of patients and society.
Differences in guidelines on observational studies may lead to serious confusion when the studies are published. For example, US peer-reviewed journals rejected or retracted manuscripts based on several French observational studies because their protocols had not been approved by an ethics committee. Under French law, which comes under the European regulations, only biomedical research that involves an intervention and is not performed in the normal medical follow-up of patients needs ethics approval. The authors stated that they had not sought approval because the studies used routine techniques, but this went against US requirements, so the manuscripts were rejected. Even where French law requires no ethics approval for such studies, an ethics opinion is compulsory.
The Committee on Publication Ethics recommends ethics approval for all observational studies, or suggests requesting a supporting letter from the ethics committee where a study is exempt from approval.
Paediatric trials
Paediatric trials must be approved by an ethics committee. That approval has become a major hurdle, because many committee members are not experienced in paediatrics and often lack any knowledge of paediatric legislation.
Exempt and non-exempt studies in the United States
Under the US Common Rule (45 CFR 46, subpart A, in effect from 2018), only non-exempt studies involving human participants require review by an institutional review board, and some exempt categories require a limited review.
Which standards apply
What applies in one state or one situation does not necessarily apply in another, so in many respects all ethics are contextual: they depend on who is looking at the question and who is making the decision. Generally accepted standards and principles do exist, such as ICH E6 good clinical practice (GCP), but not all countries allow GCP to apply within their borders; most Western countries do.
No universal ethics standard exists because people are tribal. A universal standard is very difficult to reach, as the difficulty of creating the European Union shows. The European Union, though it says it is harmonised, still allows local jurisdiction and local standards to apply, so each member state can have its own standards, which may exceed those of the Union.