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Human Subjects and Informed Consent
Research Tissue Repository
Updated April 2008








The Tissue Repository
will ensure that the integrity of all diagnostic specimens is maintained and
that no tissue banking procedure will compromise the tissue diagnosis of any
subject.
The specimens and information collected by the Tissue Repository will be
used for human subjects’ research and applicable laws, including HIPAA
regulations and ethical requirements must be observed. While all specimens
and clinical data are coded, a link to the participant/subject is maintained
and Tissue Repository procedures must be approved by
Institutional Review Board (IRB) review.
Recognizing that the intent of the IRB review process is to protect
subjects from harm due to human subjects’ research, the Tissue Repository
shall obtain appropriate IRB approval for all activities. The participant
recognizes that informed consent should be required whenever subject samples
are collected prospectively, since patient care may theoretically be
affected.
Tissue banking with coding of tissues poses extremely low risk of loss of
confidentiality of the subjects involved because:
·
Researchers
will never have access to the subject identification; and
·
The Honest
Broker will never have access to research results.
Written informed consent is
required for all prospective collection of specimens and subject data. The
methods by which informed consent of prospective cases is obtained will
depend on the requirements of the CFH IRB, and other local conditions.
In
most cases, the most feasible approach is for the same people (e.g., surgeon
or nurse) to obtain informed consent at the time of the surgical consent.
This approach also provides an opportunity to explain the differences
between the two consents. The person obtaining the informed consent should
assure that the consent process provided adequate time and information to
allow subjects to fully consider all of the issues involved with their
participation. The consenting process may be done after surgery, when the
subject is not so distracted with uncertainties of surgery.
In
order to avoid problems with the consent process, all personnel involved
have to be properly trained. This training includes attention to the
following items:
·
Consenters
must have the requisite clinical background to administer consent. Nurses,
surgeons and pathologists do not necessarily understand the process of
tissue banking, its application and its risks for the subjects. Therefore,
each consenter will be introduced to these items by the Tissue Repository
Director.
·
Required
careful reading of the consent form and the subject information sheet
regarding tissue banking.
·
Documentation in a progress note, noting the date of the consenting.
·
Signature
dates for the consenter and subjects must coincide.
·
Introduction to the concept of Honest Broker and tiered consent form.
·
Need to
avoid outdated consent forms.
·
Need to
avoid consenting subjects who are too distressed to be consented.
·
To avoid
consenting subjects who are compromised by language barrier, comprehension
or sedation. If such problems are present but can be reasonably and
comfortably circumvented, one needs to document procedures used to
accommodate language or comprehension problems.
·
Response to
frequently asked questions that subjects may have.
·
Giving the
forms for the subject to read without any explanation is not an adequate
consent process.
·
Subjects
must understand the difference between surgical consent form and tissue
banking consent forms.
·
Subjects
need to know the alternative to donate leftover tissues is not to donate,
and there will be no consequence to their subsequent medical care or rights.
·
By
consenting, one is not giving up any rights.
·
Consenters
need to understand the great value of stored tissues for clinical research.
Protection of subject identity is part of the consent process. The informed
consent has language describing the procedures for protection of subject
identity. Subject specimens and data transferred from the Tissue Repository
will be identified only by accession number. Any information or identifier
that could identify the donor is retained by the Honest Broker. No surgical
pathology numbers, medical record number, etc, will accompany a case.
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