By Robert Pistey, MD, MA
Investigators, are you conducting research that requires you to utilize normal or abnormal tissue specimens? Do you find the process of obtaining specimens from patients or their physicians challenging? Are you unsure about the IRB requirements for obtaining these specimens, including the process for obtaining consent from biospecimen contributors? Do you wish there was an easy way to obtain the specimens and associated data that you need?If so, read on. This article describes a resource right here at this institution which may be able to provide you with the samples and related data that you need to conduct your research. This resource is called BARC, which stands for the “Biospecimen Archive Research Core.”
The BUMC Department of Pathology and Laboratory Medicine operates this IRB-approved, fee-for-service archive of biospecimens obtained from Boston Medical Center patients who have given informed consent for experimentation on any extraneous normal or abnormal specimens removed during medical procedures at the hospital.
The purpose of the BARC is to collect high quality biospecimens of normal and diseased human material (blood, tissue) with appropriate clinical annotation (lab and clinical information); and to make these materials available to qualified researchers at BUMC and other institutions while ensuring the informed consent, safety, and anonymity of all biospecimen contributors. The BARC operates within the Department of Pathology which facilitates the collection and disbursement of biospecimens to qualified investigators.
The Medical Director of the BARC is Dr. Robert Pistey. He is the PI on the IRB protocol (H-27014) for this repository with overall responsibility for the components of the repository; specimen and data collection; specimen and data storage; specimen and data distribution in accordance with the IRB protocol; and the regulatory requirements. The BARC is funded by the Department of Pathology and is part of in the National Cancer Institute-sponsored Cancer Human Biobank project (CaHUB). Dr. Michael Roehrl is the Scientific Director responsible for new protocol development.Note: For the purpose of this article, the “repository investigators” will refer to Drs. Pistey and Roehrl and those who collect the samples from patients and store the samples and data. The “recipient investigators” will refer to those who obtain the samples and data from the BARC repository. “Biospecimen contributors” refers to the patients who have provided samples for the BARC.
The BARC contains samples of tissues frozen at -80ºC and -140ºC (maintained in vapor phase of liquid nitrogen) and/or blocked in paraffin.
Biospecimens that are removed for clinical diagnosis or treatment are usually discarded after all the necessary testing is complete. It is important to note that no tissue is submitted to the BARC unless there is excess tissue available. After obtaining informed consent for inclusion in the BARC, a portion of this tissue that was destined to be discarded is retained and either frozen or processed for future microscopic and molecular studies.
The BARC currently has thousands of individual frozen and microscope-ready specimens that have been collected over the past four years. Tumors and normal tissues from a variety of organ systems from adults and children (including gastrointestinal, genitourinary, endocrine, pulmonary, and the female reproductive tract) are available. The BARC inventory is updated biannually. A specific breakdown of available tissues by organ type and quantity may be viewed on the BARC website (http://www.bumc.bu.edu/busm-pathology/pathology-core-services/biospecimen-archive-research-core-barc). Clinical annotation is available on request and provides additional clinical and laboratory information beyond basic demographic information (e.g., age, gender, race).
When an investigator obtains samples from BARC, certain information is provided with the specimens about the biospecimen contributors including age, gender, diagnosis, and ethnicity. However, specific information which would cause the samples to be individually identifiable (including names, medical record numbers, social security numbers, etc.) are NOT released to recipient investigators. Additional clinical and laboratory information gleaned from the patient’s medical record can be provided if desired (e.g., blood test results and imaging studies) as long as the information does not exceed what is allowed under a limited data set.
Genetic analysis of samples may be performed by recipient investigators in accordance with IRB regulations.Since the samples are used for research and recipient investigators are not given identifiers, the biospecimen contributors are told that they will not receive any research results from the use of their samples.
In general terms, a repository has three major components:
As previously noted, samples for the BARC are obtained from Boston Medical Center patients by the repository investigators for inclusion in the BARC. Patients provide consent, using IRB-approved informed consent documents for inclusion of their samples in the BARC. Patients are told that their samples will be released to recipient investigators for research purposes without individual identifiers that would readily allow them to be identified. Patients are told that their samples may be used for genetic research. A copy of the consent forms given to patients to become biospecimen contributors can be seen by clicking here for the adult consent, and here for the parental consent for children’s specimens.
Once the samples and related data are obtained, it is the responsibility of the repository investigators to store the samples in accordance with the institutional, regulatory and IRB requirements. They must ensure that they have sufficient protections in place to protect the privacy of the biospecimen contributors and the confidentiality of their data. They must carefully track all samples that are taken into the repository, as well as all samples and data that are released to recipient investigators.
In general, in order for the repository investigators to release samples or data from the repository to recipient investigators, either from BMC or from outside institutions, they need to have certain requirements met. These include:
Items 2, 3, 4, and 5 above can be accomplished by the recipient investigator signing an “agreement” provided by the BARC repository. These measures are necessary because, even though the samples/data are coded by BARC, there is a remote possibility that the recipient investigators could use measures which would allow them to ascertain the identities of the biospecimen contributors.
Item number 1 above requires that the recipient investigator completes a simple, brief IRB application explaining the research. At BUMC, the IRB application is submitted via INSPIR II; at other institutions, the IRB application is submitted in accordance with that institution’s requirements. In most instances, only IRB approval from the recipient’s own institution is required to obtain specimens from BARC.
Because the samples and data provided to investigators will be “coded”, the IRB protocol will qualify for EXEMPT review as long as all of the following are true, as the research will not meet the Federal definition of “human subjects research”:
The BUMC recipient investigator submits the Exempt IRB application (Not Human Subjects Research); then the IRB reviews it and provides the recipient investigator with an IRB approval letter. The recipient investigator can then send this Exempt letter to the repository investigators/administrators and they can then release the samples.
The recipient investigator’s IRB application is quite simple because most of the issues related to obtaining informed consent, HIPAA, data security, specimen collection, etc. have already been addressed by the BARC repository investigators.Click here to see a “sample” IRB Exempt/Not Human Subjects Research application for recipient investigators wishing to obtains samples from the BARC. A “cheat sheet” to assist investigators with completing the application is also available.
As the BARC website notes, the fee for samples is as follows:
BARC is a repository of normal tissue and tumor samples which is available to researchers. The requirements for recipient investigators to obtain samples from BARC are minimal and easy to complete. BUMC and non-BUMC investigators are encouraged to take advantage of this valuable resource.
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