Human Research Ethics Online Training

Necrotizing ulcerative gingivitis (NUG) is a painful acute infection of the gums accompanied by necrosis, ulceration, bleeding, malodour and possible systemic manifestations. It is now accepted that the micro-organisms present in NUG are also found in individuals without the disease and that an impaired host response is needed for the disease to occur. However, it was originally thought that NUG was an infectious disease.

Between 1937 and 1941 a survey [1] of all children admitted to the Metropolitan Hospital, New York City was performed. The aim of the survey was to determine the prevalence of NUG, possible aetiological factors and to compare the methods of treatment. One further aim was to determine “ease of communicability”.

To assess “ease of communicability” direct transmission of infectious micro-organisms from children with the disease to children without the disease was attempted; when attempts to infect children by placing the infectious material directly onto healthy gums and throats failed, additional cases were attempted. In these cases, the gums, pharynx and tonsils were first abraded before direct transmission.

In all cases none of the children developed the disease.

In the study report, no mention was made of consent being sought from either the children or their parents.

Question? 

Which basic tenets of ethical research practice do you think have been violated in this study?

Answer:

• Beneficence: benefits to research participants should be optimal, whilst risks should be reduced to a minimum. Participants were at risk of developing a painful, debilitating disease.
• Justice: no one group should disproportionately bear the risks of research (e.g. children).
• Respect: every participant has the right to informed consent.
• Vulnerable groups: the children and their families were in a dependant relationship and as such were a vulnerable group. In these situations, potential participants must be given assurances that their refusal/agreement to participate in research will in no way affect their on-going medical treatment.

[1] Schwartzman, J., and Grossman, L.: Vincent’s ulceromembranous gingivostomatitis. Arc Pediatr 58: 515, 1941

Photo by A/Prof Ivan Darby, The University of Melbourne.