Ethical requirements for musculoskeletal research involving human subjects

Musculoskeletal research is mostly clinical and participation of human subjects is extremely common. It shares most features with all the surgical research fields, with studies on operative procedures largely prevailing over those on pharmacological interventions. In the orthopedic research scenario, prostheses and other implantable hardware often correspond to the role that drugs play in medical research, with no less potential harm for the populations studied. Not rarely, vulnerable categories are involved, for instance children in pediatric orthopedics. In the emerging branch of musculoskeletal regenerative medicine, embryonic stem cells are not used, but only adult somatic stem cells, which considerably reduces but does not remove the ethical issues connected with these new applications. Given these premises, guaranteeing human subjects protection is mandatory for authors, editors and publishers, firstly because “the health of my patient will be my first consideration” (from the World Medical Association Declaration of Geneva [1]), but also because biomedical publishing is not exempt from possible litigation. Since editors are ultimately responsible for what is published, they have to enforce strict requirements to ensure that proper ethical standards are fulfilled. Sometimes such requirements seem to subject authors to a burden of paperwork that equals the scientific effort, but intolerance of this is generated by a misinterpretation: science and ethics cannot stand alone, nor can they be neatly separated in any research project. There are three milestones of ethical human research: the Declaration of Helsinki, informed consent and ethics committee approval. Most journals, as we do at Journal of Orthopaedic Traumatology, ask authors to make a precise statement under their own responsibility to guarantee that these requirements are met. But formally reporting adequate ethical standards cannot be considered sufficient for publication, if anywhere along the process of manuscript review relevant concerns are raised about the substantive ethical conduct of the investigators.