The Ethics of Medical Research

1) Research on Vulnerable Populations:

Because much medical research aims at identifying effective, or more effective, treatments for disease, the patient/client population is an important study group. Enrolling patients/clients in controlled clinical trials is a widely used way of determining the best treatment for their condition. However, in virtue of their status as patients/clients, these participant-subjects are vulnerable, and therefore special attention needs to be paid to justifying their participation.

Typically this justification includes: i) demonstrating that a state of clinical equipoise exists with respect to treatment for the condition in question. Clinical equipoise is a state of genuine uncertainty within the medical community as to the efficacy of current or proposed treatments for a diseased condition. Using vulnerable participant-subjects or enrolling them in a placebo-controlled trial where a clearly effective or superior treatment is available would be unjustified; however, where there is clinical equipoise, reliable knowledge about an effective treatment is lacking, and so research on informed, consenting participant-subjects may be performed (TCPS 11); ii) demonstrating that using healthy human  or non-human participant-subjects would not yield the necessary data;  and iii) ensuring that benefits from the new knowledge are desired by and will accrue to the population in question (ie. persons with that particular diagnosis) although not necessarily to the individuals in the trial. Even where these conditions are met, extreme care must be taken to ensure that vulnerable participant-subjects are not exploited for research purposes (see below, and TCPS 11.1).