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Submitting
Protocols with Special Populations/Concerns
Special population: Participants engaging in illegal behavior
Click
on links below for more information:
General concerns when collecting data about illegal behavior
- Any research that is
gathering data
on participants who are engaging in illegal behavior puts those
participants at risk of being discovered and perpetrator and facing
legal repercussions. This is most certainly true if the data
collected details illegal behavior. However, it is
also true if the data collected is not about the illegal
behavior per se, but that the population of interest is those who
engage in illegal behavior.
- A number of illegal
behaviors are often not recognized as such by researchers, but these
behaviors raise the same concerns as any other illegal behavior.
These include: underage drinking, underage smoking, and sexual
behavior that,
because of the age of the participants, is illegal.
- Even though the
researchers and the University of Florida do not condone any illegal
behavior,
it is the researchers' and IRB's responsibility to determine how to
study this population to offer them and/or society some benefit, while
protecting these participants from the risk of negative repercussions
of
participation in research.
- Generally, participants
can be protected from later having the data collected used against them
when subpoenaed in court by one of two strategies discussed further on
this page.
- Having no identifiers linked with the data
- Obtaining a federal exception from having data obtainable by courts of law, a Certificate of Confidentiality
Truly anonymous data collection
- One method for managing data that is collected from
participants who are engaging in illegal behavior is to collect the
data completely anonymously. This is a case where the requirement for a signature on the informed
consent
document can be waived by the board. No
information that could identify the participants, directly or
indirectly, should be
recorded. This data includes but is not limited to: photographs, video,
voice, or unique personal information (such as name, birthdays,
address, etc). Depending on the population being studied, certain
demographic information, alone or in combination with other facts about
a person, could easily lead to their identification (for example, a sex
offender's race, age, and specific crime, in a particular county). The
guidelines for HIPAA compliance include a list of such potential
identifiers.
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Use
of non-identifying codes to track anonymous participants across time/sessions
- In some cases a group of participants are examined at
multiple points, and the research design necessitates tracking of
participants from one time point to the next.
- In these cases, the IRB suggests having participants generate an identifying number that they can
remember, but that you could not trace them back to. Subject-generated codes can be unique, and easily and
reliably
generated by participants, and usually involve some combination of
parts of
family first names, letters of hometowns, etc.
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Certificate
of Confidentiality
- Some research designs necessitate collection of identifying
information. In order to decrease the risk to participants, there is a
federal mechanism for preventing the data from being subpoenaed by a
court of law. This mechanism is a Certificate of Confidentiality, which may be provided by NIH.
- It is the researchers' responsibility to apply for this
certificate and to then furnish it to the IRB board along with their
protocol. If the researchers wish, they may first submit their protocol
and their intent to apply for a Certificate of Confidentiality to the
board.
- Fore more
information on a certificate of confidentiality, click here.
Please read the information carefully and note that there may be a
substantial wait to obtaining this certificate. The delay should be
inquired about to the granting agency. The IRB has no knowledge or
control over the granting of these certificates.
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