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					                                                                                  Confidentiality Guideline
                                                                                                IRB Office
                                                                                     Suite 200 Covell
                                                                                       (208) 495-5600
                                                                                   Fax (208) 459-5043

                                    Maintenance of Confidentiality

The College of Idaho IRB assumes that confidentiality will be maintained by affording research
documents at least the same protection as medical records.
Ordinary research: Participant files/data diskettes/audiotapes/photographs/videotapes are kept in a
   locked file cabinet, and access is available only to members of the research team.
Sensitive research: All participant files/audiotapes/photographs/videos are identified by code numbers
   only; the master list is kept separately. Access to the master list is available only to the Principal
   Investigator (PI) and his or her designee(s). Data should be protected in accordance with C of I IRB
   policies.
Research requiring a Certificate of Confidentiality: Because of the heightened risk to certain types
   of research participants if confidentiality is breached, a Certificate of Confidentiality must be
   obtained from the Department of Health and Human Services (i.e., this includes research producing
   data that may compromise participants’ employability or insurability or research that might implicate
   participants in illegal activities). A Certificate of Confidentiality protects the data from subpoena.
   Research does not have to be funded by NIH in order to obtain a Certificate of Confidentiality.
       The informed consent document states the limitations of the Certificate of Confidentiality. (See
   the model consent form for suggested language.) No research data that may be linked with the
   participants is entered on any networked computer. All entered data is coded. The master list is
   stored off-line and available only to the PI and his or her designee(s).

Research using coded samples/data: To protect participant identity, the samples/data are coded. If the
  investigator has access to the master list that links the code with individuals, the code is considered
  an identifier. If the investigator does not have access to the master list, and has a Code Access
  Agreement in place with the person supplying the samples/data, the IRB may consider the research as
  not involving human participants and therefore exempt from subsequent review.

Research using samples/data de-identified by the research team: The research team has access to
  existing identifiable data (e.g., medical records), but records the information in such a manner that
  individuals cannot be identified. Code numbers may not be used. This type of research may be
  exempt from subsequent review.
Research using previously de-identified samples/data: Research samples and data are stripped of
   identifiers prior to the research team receiving them. No master list exists. There is no link between
   samples or data and participants’ identities. The IRB may determine that research in this category is
   not human participant research and therefore exempt the study from subsequent review.
Research using anonymous sample/data: Anonymous samples and data are not only free of
   identifiers, including code numbers, but have never been identifiable by anyone (e.g., returned
   questionnaires). The IRB may determine that research in this category is not human participant
   research and therefore exempt the study from subsequent review.




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                                  The College of Idaho IRB
           Maintenance of Confidentiality When Participants are Paid for Participation

Although confidentiality safeguards may be adhered to when a study is conducted, there is a significant
risk of breach of confidentiality when payments to participants are involved. Therefore, the IRB
requires that:

   any link between a participant and a particular protocol be coded;

   only researchers and designated staff within the department sponsoring the study have access to the
    codes;

   the study name NOT be included on any check or payment voucher or any other paperwork that may
    be seen by individuals outside of the sponsoring department; and

   the department name NOT be included on any check or payment voucher or any other paperwork
    that may be seen by individuals outside of the sponsoring department.


             Maintaining Confidentiality with Research Tapes/Photographs/Videotapes

Research that requires taping/photographing/videotapes participants may contain information that is
sensitive in terms of risk of breach of confidentiality. Whenever possible, neither first nor second names
may be used during videotaping. Facial or other features also provide the potential for breach of
confidentiality, but may be an essential component of the taped/photographed event. Whenever this is
the case, the PI must provide compelling justification for inclusion of identifiable features. The IRB and
investigators must consider the following issues when a research proposal includes
taping/photographing/videotaping research participants.

Who May View Tapes/Photographs/Videotapes: Only research team members who have a bonafide
reason for viewing the tapes/photographs should be permitted to do so. These individuals should be
professionals who understand their responsibility to keep the information strictly confidential.
Short and Long-Term Storage of Tapes/Photographs/Videotapes: There may be occasional projects
in which it is desirable to keep tape/photographs indefinitely, but in most cases, tapes/photographs will
be kept for three years beyond completion of the study, as required by the Food and Drug
Administration (FDA). When tapes/photographs are kept beyond the completion of a study, precautions
must be taken to assure that they will be archived in accordance with the confidential nature of the data.
Archival documentation should state:
       a. where the tapes/photographs are stored (ie, medical library archives or in the department of the
       PI),

       b. through whom access may be obtained (ie, the name of the PI and any study collaborator[s]
       with the authority to impose or enforce the terms governing access),

       c. access provisions (ie, whether the tapes/photographs can be taken from the archive facility and
       for what period of time they may be released for viewing).




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Use of Tapes/Photographs/Videotapes for Teaching Purposes: If an investigator plans, or later
desires, to use the tapes/photographs for teaching purposes, concerns regarding confidentiality must be
addressed in one of two ways at the discretion of the PI:
1. Professional actors may be hired to act out the parts. Because it will be necessary for these
professionals to view selected tapes/photographs, a condition of their employment must be signing a
statement to the effect that they will maintain strict confidentiality. The principal investigator is also
obligated to instruct these individuals thoroughly regarding maintenance of confidentiality.
The taped/photographed performance can be used indefinitely for teaching. It is proper to introduce a
performance tape by explaining that the words and behaviors are true to those of an actual patient.
2. If the participants of a study are to be taped/photographed, fully informed consent must be obtained,
prior to taping/photographing, from the participant. The consent must specify that the tapes/photographs
will be used for educational purposes, both at The College of Idaho and, potentially, in other settings. If
tapes/photographs are to be used at other locations, special permission must be obtained from the IRB
and noted in the informed consent document.

If the other institutions at which tapes/photographs may be viewed have been identified at the time
informed consent is obtained, those institutions must be identified in the informed consent document. If
the other institutions have not yet been identified at the time initial informed consent is obtained, the PI
should attempt to re-consent participants once such settings have been identified.

* In special populations, caregiver consent is required even for cognitively healthy participants and very
mildly demented participants for whom competence is not an issue (e.g., individuals with Alzheimer’s
or schizophrenia).

** It must be stressed to the participants and, when applicable, their caregiver/surrogate that declining
permission to tape/ photograph will in no way affect their relationship with the researcher, nor will it
affect their participation in the study.

*** If at any time the participant either directly or indirectly dissents, the taping/photographing (or use
of the completed tape/photograph) must be terminated.




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