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Distribution of Benefits
Historically, women, Native people, minority groups, the elderly and
individuals such as children who were unable to give consent for themselves
have been excluded from research. Reasons for exclusion from research
have varied. In some instances, individuals or groups have been excluded
directly because differences in age, gender, biological factors, or ethnic
and cultural factors may impact upon the outcome of the research. For
example, frail, elderly individuals have been excluded from certain research
because they are unable to complete all of the tests involved in the study
or because of the risk of drug-related complications. In other instances,
certain groups have been excluded indirectly because individuals with
the condition of interest rarely meet the inclusion criteria. For example,
women usually develop heart disease later in life than men do, and consequently
a study with an age criterion suitable for men might exclude women. There
also have been times when barriers of communication, understanding, access,
time or financial expense have meant that an individual or group is excluded
from research. For example, researchers who develop recruitment posters
and information and consent materials in English only are likely to exclude
many members of Canadian society.
Under-inclusion of such groups has denied them access to the benefits
of research. In order to contribute to the fair distribution of benefits
to individuals and groups, the TCPS requires that researchers should not
exclude a particular group of individuals, unless there is a valid reason
for doing so.
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