Research on human subjects in the JEM

A little more than a year ago, we published an editorial calling for papers describing research on human subjects (1). Research on human subjects is becoming more feasible because of advances in methodology, and investigations on human subjects are needed to advance the areas of human physiology and disease covered by the Journal. Patient-oriented research in particular is often perceived as being applied rather than basic research, but we reasoned that these demanding investigations can provide essential new biological insights and have an important place in our Journal, even though the depth of mechanistic analysis is of necessity more limited than in research on simpler systems. To encourage submissions of papers that involved human studies, we made a commitment to judge them on their capacity to advance the field within the context of human research. During the ensuing year, there has been a striking increase in the number of submissions involving human subjects. In parallel, the number of accepted papers that required human subjects increased more than threefold in 2004 compared with 2003, with 10% of papers published in 2004 involving human subjects. We also are pleased to have witnessed an increased number of papers in which human pathogens were studied but without a need for human subjects. In 2004 the number of accepted papers in this sphere was 5%, a twofold increase over 2003. These changes bring some balance to experimental medicine in the Journal, which clearly retains its focus on “basic” research and disease models in which deeper mechanistic studies are possible. We hope that future studies in these more tractable experimental systems will be inspired by findings in patients. Editorial challenges The increase in human subject papers has placed new demands on our peer review process, especially as the increase was superimposed on a high submission rate in other areas. We are still in the process of adjusting to these new needs. Glenn Heller (Memorial Sloan-Kettering Cancer Center, New York, NY) and Madhu Mazumdar (Weill Cornell Medical College, New York, NY) have essential roles as Consulting Biostatistics Editors. We also are benefiting from the expert advice of a number of referees who are familiar with human research, several of whom have joined our Advisory Editorial Board. Most recently, we welcomed David Hafler (Harvard Medical School, Boston, MA), Kevin Tracey (North Shore University Hospital, Manhasset, NY), and Jean-Laurent Casanova (Necker Medical School, Paris, France), who bring broad expertise in autoimmunity, inflammation, and infectious disease biology, respectively.