Scientific Review of Human Subjects Research

By David B. Resnik

One of the key principles of ethical research involving human subjects is that it should be   scientifically rigorous (Levine 1988, Emanuel et al 2000). Scientific validity is important so   that research studies will not unnecessarily expose human subjects to risks (Emanuel et al   2000). Research should address important scientific questions.   Regulations and guidelines require that the research risks be reasonable in relation to the   benefits to the subjects or to society by means of the knowledge that is expected to be   gained (Emanuel et al 2000). If a study is unlikely to produce useful scientific results, there   is no acceptable level of risk to the subjects (Council for the International Organisations of   Medical Sciences 2002).   A poorly designed study might fail to yield useful knowledge, which undermines the ethical   justification for exposing human subjects to risks. For example, in 2001, Ellen Roche, a   healthy volunteer, died from inhaling hexamethonium as part of an asthma study conducted   at Johns Hopkins University. An investigation of this tragedy by the Office of Human   Research Protections found that the researchers had not adequately reviewed previous   research on the dangers of inhaling this drug, published in the 1950s and 1960s (Savulescu   and Spriggs 2002). In other words, the study was not ethically justifiable because the   scientific literature indicated that the research design did not include adequate safeguards   to protect subjects from the risks associated with inhaling hexamethonium