Carle Connect - Carle Tissue Repository Human Subjects and Informed Consent

Human Subjects and Informed Consent

Carle Tissue Repository

Updated June 29, 2011

The Carle 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 Carle 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.

Recognizing that the intent of the IRB review process is to protect subjects from harm due to human subjects’ research, the Carle Tissue Repository shall obtain appropriate IRB approval for all human subject research activities.

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 not be a part of the research project.

Written informed consent is required for the donation of specimens and medical data. The most feasible approach is for staff 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 provides adequate time and information to allow donors to fully consider all of the issues involved with their donation. Alternatively, the consenting process may be done after surgery, when the donor is not so distracted with uncertainties of surgery and in clear mind to give consent. A copy of the consent form will be offered to the donor for their records and the original consent document will be retained by the Carle Tissue Repository. All personnel who will consent donors for the Carle Tissue Repository must pay specific attention to the following items:

Consenters will adhere to standard practice when performing the consent process.

Only current consent forms may be used.

Donors who are too distressed should not be consented.

Avoid consenting donors 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.

Responses to frequently asked questions that donors may have should be known by the consenter or referred on to the Carle Tissue Repository.

An adequate consent process includes a dialogue between the donor and the person obtaining consent.

Donors must understand the difference between surgical consent form and specimen banking consent forms.

Donors need to know that the alternative to donating leftover specimens is to NOT donate, and that there will be no negative consequences to their medical care or rights.

Consenters need to understand the value of stored specimens 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 de-identified and given a Carle Tissue Repository number. Any information that could identify the donor is retained by the Honest Broker. No surgical pathology numbers, medical record number, etc, will accompany a case.