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Investigators must report to the IRB any unanticipated harm or discomforts
to the subjects. Harms or discomforts could include those that occur as
a result of the research activities themselves (severe distress brought
on by study questions) or those related to the protection of study data
(inadvertent breach of confidentiality).
Investigators should also inform the IRB if other researchers have identified
unanticipated risks in similar contemporaneous studies.
Generally, a study with unanticipated risks resulting from study procedures
will be stopped while the investigator and the IRB review possible responses
and consider changes to the protocol. Changes to the protocol resulted
from the review would have to be approved by the IRB before the study
could be resumed.
Investigators should also let the IRB know if errors are made and protocols
are not carried out as approved. For example, a study coordinator who
has had to revise a consent forms many times may distribute the wrong
version of the form to the research staff. Errors need to be reported
as soon as they are identified so they can be fixed and their solutions
noted in the official record. (Protocols are subject to external audit
at any time.)
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