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.