A Reuters news service article this week reported that many babies are subjected to excessive or unnecessary pain in the course of medical research. The article provided a link to an online report from the journal Acta Paediatrica.
The authors of the article in question (freely available through the link above) summarized their review of 46 recent (previous 2 ½ years) clinical trials testing analgesic treatments for pain caused by medical procedures performed on neonates—babies in the first month of life. As anyone who has visited the doctor knows, medical procedures can cause pain, sometimes more, sometimes less.
The article’s authors found that a majority of the studies used a concurrent control group that did not receive any analgesia, or placebo, to compare with an experimental analgesic drug or method. The problem with that is that there are numerous standard pharmacologic and non-pharmacologic analgesic methods that may be used for neonates and older infants. By denying those to some subjects, the investigators did a disservice to these neonates, the authors argue. Their argument is entirely reasonable. They further find fault with ethics committees that approve such research, journals that publish the results, and parents of the infants, who provided consent either out of ignorance or for some other unknown reason. All of this should stop, they argue, in favor or research designs in which all subjects receive at least standard-of-care analgesia.
This looks like an easy one: a fundamental criterion for ethical research on human subjects is that risks be minimized to the extent possible and reasonable, and consistent with good scientific and medical practice. Further, risks of research must be reasonable and proportionate to the likely benefits, direct (to the subjects) or indirect (to society at large, in the form of useful knowledge gained).
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.