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One
of the regulatory criteria for approval is: When
appropriate, there are adequate provisions to protect
the privacy of subjects and to maintain the confidentiality
of data.
Therefore,
the IRB must consider these issues as they arise during
the review of a study.
Privacy
is the ability of an individual or group to seclude
themselves or information about themselves and thereby
reveal themselves selectively. The boundaries and content
of what is considered private differ among cultures
and individuals, but share basic common themes. Privacy
is sometimes related to anonymity, the wish to remain
unnoticed or unidentified in the public realm. When
something is private to a person, it usually means there
is something within them that is considered inherently
special or personally sensitive. The degree to which
private information is exposed therefore depends on
how the public will receive this information, which
differs between places and over time. Privacy can be
seen as an aspect of security — one in which trade-offs
between the interests of one group and another can become
particularly clear. Privacy may be sacrificed or knowingly
“waived” to some degree when an individual decides to
participate in research.
Privacy
refers to persons and their interest in controlling
the access of others to themselves. (Confidentiality
refers to the agreement between the investigator and
participant in how data will be managed and used.) For
example, based on their privacy interests people want
to control:
• The time and place where they give information.
• The nature of the information they give.
• The nature of the experiences that are given to them.
• Who receives and can use the information.
For example, persons might not want to be seen entering
a place that might stigmatize them, such as a pregnancy-counseling
center that is clearly identified as such by signs on
the front of the building.
What is private depends on the individual and can vary
according to gender, ethnicity, age, socio-economic
class, education, ability level, social or verbal skill,
health status, legal status, nationality, intelligence,
personality, and the individual’s relationship to the
investigator. For example, protecting the privacy interests
of a young child might mean having a parent present
at a session with an investigator. Protecting the privacy
interests of a teenager might mean having a parent absent.
Confidentiality has been defined as
"ensuring that information is accessible only to
those authorized to have access”.
Confidentiality in human subjects research refers to
the researcher’s agreement with the participant about
how the participant’s identifiable private information
will be handled, managed and disseminated. IRB members
should consider various strategies to maintain confidentiality
of identifiable data, including controls on storage,
handling and sharing of data. When appropriate, IRBs
should also know how certificates of confidentiality
could be used to maintain the confidentiality of identifiable
data.
Reference:
AAHRPP tip sheet/evaluation tool and Wikipedia; federal
regulations governing human subjects in research
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