SOP for Cancer Biospecimen Utilization
PURPOSE & SCOPE
To outline the application process required to collect and request the use of cancer biospecimens, as defined by the Oversight Committee.
- Institutional Review Board (IRB): Applicable guidelines, certifications, and Verification of Training (VoTF) requirements are administered by the University of Arizona (UA) Human Subjects Protection Program, Office for the Responsible Research Conduct of Research, http://rgw.arizona.edu/compliance/human-subjects-protection-program
- TACMASR: Tissue Acquisition and Cellular/Molecular Analysis Shared Resource is the “core” lab that is responsible for management of the UACC Biospecimen Repository (Tumor Bank). TACMASR also provides histological and pathological services to UACC investigators. http://uacc.arizona.edu/research/shared-resources/tacmasr
- 400-1 Policies Governing the UACC Biospecimen Repository
- SOP 400-3: Biospecimen Oversight Committee: Roles and Responsibilities
- Application Form Request for Use of Biospecimens
APPLICATION PROCESS FOR USE OF BIOSPECIMENS
The University of Arizona Cancer Center Biospecimen Repositories (including the Cancer Prevention & Control, GI SPORE, Skin, Lymphoma, Neurosurgery, and Prostate repositories) are the property of the University of Arizona Cancer Center and will be available to UACC members and collaborating investigators for specifically identified and approved proposals ONLY.
4.1 Proposals to utilize banked materials should represent either peer-reviewed research studies or clinical trials, or research stemming from previously peer-reviewed proposals.
4.2 It is the responsibility of the investigator to determine if the proposed project is considered human research, and thus requires IRB approval, prior to applying to the Repository (Form Determination of Human Research).
4.3 A copy of any IRB correspondence approving the research project must be submitted to the Biorepository, along with the completed Application form Request for Use of Biospecimens.
4.4 Refer to the IRB website for instructions, forms and a link to the investigators manual: http://rgw.arizona.edu/compliance/human-subjects-protection-program
4.5 Note that that the IRB does not require submission of Determination of Human Research form, for the use of de-identified biospecimens.
4.6 However, a completed, Determination of Human Research form must be included in the application packet in order to obtain de-identified materials from the Biorepository.
4.7 To request an Application Form, contact TACMASR by email at UACC-TACMASS@uacc.arizona.edu. The form is also available on the TACMASR website http://uacc.arizona.edu/research/shared-resources/tacmasr
4.8 UACC Consent or waiver of consent is required for the storage and future use of data/human cancer biospecimens entered into research repositories.
4.9 If consent is required, patients will be provided with only one consent form for the purpose of biospecimen banking. Specifically, the UACC research repository consent.
4.8 The investigator applicant includes a detailed description of the criteria and the amount of material that is requested; this procedure applies to requests for block samples.
4.9 The Tumor Bank Coordinator will assist the investigator with the application process and with preparation of biospecimens that meet their research objectives. The Tumor Bank Coordinator will confirm that banked material which meets the investigator’s criteria is available and sufficient to meet the request.
4.10 If needed, Biorepository personnel will request that the investigator contact the contributing surgeon to discuss the proposed studies utilizing material they have contributed from their surgical patients.
4.11 A designated technician will work with the investigator to ensure that the investigator’s criteria for tissue (e.g.; type, grade, quality) are met.
4.12 The Tumor Bank Coordinator submits the completed application form to the Oversight Committee via email.
4.13 The Biospecimen Oversight Committee evaluates the objectives of the proposed study, preliminary data supporting the hypothesis, the research plan and the expected outcomes, and approves/disapproves the application by a majority vote.
4.14 The Tumor Bank Coordinator will follow up with the investigator regarding the Committee’s response.
4.15 Human subject biospecimens and data may not be sold for profit; however, collaboration with third parties may be allowable with strong scientific justification for the collaboration (i.e., one that will lead to a grant application and/or publication in a peer-reviewed journal). In the event a collaboration is approved, repositories are permitted to recover the costs of providing human biospecimens (including collection, processing, storage, and distribution) provided that such costs are established in accordance with the UA’s Financial Services Office policy.
4.16 Biospecimen Oversight Committee appeals are to be made to the Associate Director of Shared Resources, University of Arizona Cancer Center.
4.17 In the event TACMASR is not able to provide the requested service, inquiries are to be made to the Associate Director of Shared Resources, University of Arizona Cancer Center.
4.18 In the event the Associate Director of Shared Resources, University of Arizona Cancer Center is unavailable or in conflict, appeals and inquiries are to be made to the Associate Director of Translational Research, University of Arizona Cancer Center.
4.15 Preparation of material is handled as a routine request for service through the University of Arizona Cancer Center Shared Resource, TACMASR, and is charged accordingly for work performed.
4.16 Recipient agrees to acknowledge the contributions of the University of Arizona Cancer Center in all publications resulting from the use of specimens obtained from the UACC Biorepositories. Recommended wording to use in the methods or acknowledgment sections is as follows: “specimen samples were provided by the University of Arizona Cancer Center, which is funded by the National Cancer Institute (NCI P30CA023074).
UACC BIOSPECIMEN OVERSIGHT COMMITTEE: CURRENT SITTING MEMBERS IN 2016
Principal Investigator: Setsuko Chambers, MD, PI and Chair, UACC Physician-scientist, Director of Women’s Cancers,
Co-Leader, Cancer Biology, Professor and Vice-Chair of Obstetrics and Gynecology
Department of Pathology Chair: Achyut Bhattacharyya, MD, Pathologist, Professor of Pathology and Director of TACMASR
University of Arizona Cancer Center: Amanda Baker, PharmD, PhD, UACC Research Associate Professor of Medicine, Co-Director, Research, Education and Training
Faculty representative, Surgery: Ron Heimark, PhD, UACC Cancer Biology Researcher, Professor and Vice Chair for Research, Department of Surgery
Faculty representative, Surgical Oncology: James Warneke, MD, Associate Professor, Department of Surgery
Ad hoc, UACC Leadership, Meredith Mullins, JD, MBA, Associate Director of Administration UACC
Ad hoc, Senior TACMASR Representative: Doug Cromey, MS, Associate Scientific Investigator
Ad hoc, Biospecimen Operations Manager, Carole Kepler, BS, MT(ASCP), Senior Research Specialist
Ad hoc, Tumor Bank Coordinator, Betsy Dennison, BS, Senior Program Coordinator
Ad hoc, Regulatory Coordinator, Mitzi Miranda, BS, Senior Program Coordinator