Researchers follow strict ethical and scientific
principles to make sure that patients are protected
and valid results are produced. A plan of how the
study will be run, which is called a protocol, is
written to ensure that every research involved in
the study follows the same ethical and scientific
principles.
The protocol is written by the study's sponsor.
All researchers taking part in the study will use
the same protocol. It describes how the study will
be conducted in great detail: the number of participants
to be enrolled, the amount of drug to be used,
the types of medical test to be provided, etc.
To ensure patient safety, the protocol must be
reviewed and approved by the organization that
sponsors the study as well as by an Institutional
Review Board. This Board consists of people with
a variety of backgrounds and may include clergy,
health professionals and members of the general
public. In the review of the protocol, the board
seeks to ensure that participants in the study
will not be exposed to unreasonable or unethical
risks. |