The International Ethical Guidelines for Biomedical Research Involving
Human Subjects (CIOMS and WHO, 1993: 11) defines "research" as referring
to a class of activities designed to develop or contribute to
generalizable knowledge. Generalizable knowledge consists of theories,
principles or relationships, or the accumulation of information on which
they are based, that can be corroborated by accepted scientific
techniques of observation and inference. The International Guidelines
for the Ethical Review of Epidemiological Studies (CIOMS, 1991)
recognizes that it may be difficult to distinguish between research and
program evaluation. It offers the following guidance: "The defining
attribute of research is that it is designed to produce new,
generalizable knowledge, as distinct from knowledge pertaining only to a
particular individual or programme" (CIOMS, 1991, Guideline 52,23).
Health research includes both medical and behavioral studies that relate
to health. Research can be conducted in conjunction with patient care
(clinical research), or it can be conducted outside of the context of
clinical care. Research may involve only observation, or it may require,
instead or in combination, a physical, chemical, or psychological
intervention. Research may generate new records or may rely on
already-existing records.
