Request for Pathology Approval for Research Involving Human Tissues
When completed, please return this form with research protocol to:
Carol Elliott, MS, RAC, CCRP
Email:
919-684-4530
PURPOSE OF APPROVAL: To document that the proposed study will not interfere with pathologic evaluations of tissues needed for routine current or future clinical care, and will not interfere with the routine patient care activities of the pathology department. Please note: Use of blood does not need approval.
Study Title: Click here to enter text.
eIRB#: Click here to enter text.
Principal Investigator (PI): Click here to enter text.
Email: Click here to enter text.
Tel #: Click here to enter text.
Person completing this form, if not PI, and contact information:
Click here to enter text.
Please describe briefly what tissues will be needed for this study:
Click here to enter text.
SECTION I: Determine if the study qualifies for automatic pathology approval
Part A:
1. If this study requires access to clinical archival paraffin human tissue, will all requested material be obtained through the Pathology BRPC Shared Resource, under their fee-for-service model? (Email: ), online form at http://pathology.duke.edu/biospecimen-repository-processing-core. If your study does not require access to clinical archival paraffin human tissue, select “Not Applicable”.
Choose yes no or not applicable.
2. Does your study also require collection of new or non-clinical archival tissue specimens?
Choose yes or no.
DOES YOUR STUDY NEED FURTHER APPROVAL?
If you answered “yes” to #1 and “no” to #2, then your study has automatic pathology approval. Skip part B and in the “AUTOMATIC APPROVAL?” area below, select “This study has automatic pathology approval” and stop.
Part B:
1. Is all of the tissue for this study on the Surgical Pathology Tissue and Medical Devices Exceptions List? [See appendix or DUHS intranet, DUH Policies & Procedures, Tissue and Medical Devices Exceptions List, Search “pathology: at URL https://egrc.duhs.duke.edu]
Choose yes or no.
2. Is (or was) all of the tissue obtained solely for research purposes?
(All criteria a-e must be true to answer “yes”. If any criterion is not met, or if you are unsure if it meets criteria, answer “no”)
a) The biopsy or surgery is an additional procedure performed for the sole purpose of collecting tissue for the study.
b) The patient will have an established diagnosis at the time of the additional biopsy.
c) No routine pathologic evaluation of the tissue from the biopsy will be performed at Duke.
d) No routine (non-experimental) clinical care will be determined by evaluation of the research tissue.
e) Patients will be consented to the additional biopsy including the lack of any pathologic evaluation of the tissue
Choose yes or no.
3. Will all tissues be obtained via the Duke Brain Tumor Center Biorepository?
Choose yes or no.
4. Will all tissues be obtained via the Duke Biospecimen Repository and Processing Core (BRPC)?
Choose yes or no.
If Yes, will patients be dually-consented by your team to BRPC protocol?
a. Yes, our clinical research team will consent patients to BRPC protocol.
b. No, BRPC staff will be asked to consent patients to BRPC protocol.
Choose yes or no.
DOES YOUR STUDY NEED FURTHER APPROVAL? If you answered YES to any of the above questions 1-4, your study has automatic pathology approval. Select “This study has automatic pathology approval” and stop here. Please note that the PI (or the existing tissue bank or biorepository) will be solely responsible for collecting, processing, storing, shipping, and disposing of any tissues obtained for research.
If you answered NO to all of the above questions 1-4, your study does not qualify for automatic approval, and we need additional information about your study for a full review. Select “This study needs a full pathology review” and then complete Section II.
AUTOMATIC APPROVAL?
Choose an item.
THIS SPACE INTENTIONALLY LEFT BLANK
SECTION II: Information needed for full Pathology Review. New Protocol Review Fee applies.
1) Please provide a copy of the full research protocol, including lab manual, as available.
2) Will the study use clinical archival paraffin embedded tissues, smears, or cytologic specimens?
Choose yes or no.
If no, skip to question #3. If yes, please complete the questions below. Per DUHS hospital policy, the Pathology Department is prohibited from releasing paraffin blocks outside the department for research purposes. All archival paraffin tissue for research must be cut in DUHS CAP-accredited clinical laboratory, and cases must meet the criteria outlined in the policy “Use of Clinical Archival Paraffin Tissue for Research, Clinical Assay Validation and the Preparation of Control Material within the Clinical laboratories.” (See Appendix A below). The Histology Research Laboratory, 684-6209, can recut blocks directly on a fee for service basis. Facilitation of histology services can also be requested online from the BRPC Shared Resource Mechanism as described in Section I, Part A or by emailing .
a. Describe the plan to identify the desired archival cases to be used for the study, or specify that the investigator or a member of the study team will be responsible for identifying the desired archival cases. Please note that pathology assistance to identify desired cases is not available without prior arrangement.
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b. Describe the plan to choose the desired blocks to be cut from archival cases identified above. Pathologist assistance is available if needed to identify appropriate blocks to recut on a fee for service basis from the Biospecimen Repository and Processing Core, .
Click here to enter text.
c. Describe in detail the type and quantity of material to be prepared from the archival paraffin blocks (i.e. unstained slides, stained slides, section thickness, type of glass slide, special handling of sections, etc).
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d. Please provide the name of the DUMC staff pathologist who will be reviewing the slides and blocks to verify compliance with the Policy on “Use of Clinical Archival Paraffin Tissue for Research, Clinical Assay Validation and the Preparation of Control Material within the Clinical laboratories” (see Appendix A below), or state that you will be asking the Biospecimen Repository and Processing Core to arrange for a pathologist to perform this review on a fee for service basis:
Click here to enter text.
e. Will there be a central pathology review of the tissue being submitted for research?
Choose yes or no.
If yes, then please confirm that the results of all central pathology reviews that suggest a clinically significant discrepancy in diagnosis will be communicated to the DUMC pathologist of record or the pathology department QA officer, or provide justification for non-notification.
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f. Will routine (non-experimental) clinical care be based on central laboratory pathology review or special studies?
Choose yes or no.
If yes, then a copy of the central pathology review must be provided. Please indicate the time anticipated to receive a written copy of the report and/or slides for Pathology files. Include the name and contact information for the outside laboratory and indicate whether the laboratory is CLIA-certified to provide actionable results.
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3) Will the study use non-archival tissues (for example, fresh or flash frozen tissue or body fluids that would normally be submitted for pathologic evaluation)? This specifically excludes blood, urine and saliva.
Choose yes or no.
If yes, please complete the questions below. Please note that there is a minimum fee for pathology assessment and handling for any fresh tissue donated through surgical pathology for research, and tissues will only be available during normal weekday working hours. Tissue procurement from specimens in the surgical pathology laboratory is facilitated by the Duke Biospecimen Repository and Processing Core (BRPC) Shared Resource whether or not patients are consented to BRPC protocol. For specific cost estimates please contact the BRPC Operations Manager, Melissa Flowers at 684-6928 or email . More information can be found at: http://pathology.duke.edu/biospecimen-repository-processing-core.
Use of diagnostic cytopathology specimens for research requires documentation of prior approval from the director of cytopathology (Dr. Claudia Jones, 684-3950).
a) Describe the tissue type and quantity (size or weight) needed for the study:
Click here to enter text.
b) Describe the plan for identifying when and where the desired tissue will be available (Pathology assistance to identify desired cases is not generally provided without prior arrangement), or specify that the investigator or a member of the study team will be responsible for identifying when and where the tissue will be available:
Click here to enter text.
c) Describe the plan for pathology assessment of the specimen/tissue prior to its use for research or banking, or justify why pathology assessment is not necessary.
Click here to enter text.
d) Describe how the specimen/tissue should be processed/stored in the Pathology department prior to receipt by the PI, and a plan for prompt pickup of tissue from pathology (Pathology will not ship or store tissue overnight for PIs; failure of PI to pick up tissue donated by patients may result in cessation of tissue collection). If Pathology will not collect, process, store, or ship tissue, enter “Not Applicable”
Click here to enter text.
e. Will there be a central pathology review of the tissue being submitted for research?
Choose yes or no.
If yes, then please confirm that the results of all central pathology reviews that suggest a clinically significant discrepancy in diagnosis will be communicated to the DUMC pathologist of record or the pathology department QA officer, or provide justification for non-notification.
Click here to enter text.
f. Will routine (non-experimental) clinical care be based on central laboratory pathology review or special studies?
Choose yes or no.
If yes, then a copy of the central pathology review must be provided. Please indicate the time anticipated to receive a written copy of the report and/or slides for Pathology files. Include the name and contact information for the outside laboratory and indicate whether the laboratory is CLIA-certified to provide actionable results.
Click here to enter text.
4) Is a Duke Pathologist a listed investigator in this project? (This is advised where pathology tissue procurement/activities will require substantial effort).
Choose yes or no.
If yes, then please identify the pathologist: Click here to enter name.
APPROVED:
TO BE COMPLETED BY REVIEWING PATHOLOGIST:
Note: Approval does not guarantee availability of desired tissue, nor does it guarantee pathologist availability to participate in the study. All charges resulting from collection and/or processing of tissue for research from the pathology department should be charged to the study.
APPENDIXA:
Clinical Laboratories
Surgical Pathology\Policies and QI Plan / Last Reviewed By:
Dotson, Albert (Electronic Signature Timestamp: 6/9/2016 4:57:44 PM)
Use of FFPE Tissues for Research QC and Method Validation (LTR77616)
POLICY NAME: Use of Clinical Archival Paraffin Tissue for Research, Clinical Assay
Validation and the Preparation of Control Material within the Clinical laboratories.
EFFECTIVE DATE: December 5, 2012 Updated May 15, 2016
DEFINITIONS: FFPE: Formalin fixed, paraffin embedded material. Formalin is a chemical that infiltrates into tissue in order to prepare and preserve tissue architecture. FFPE ‘blocks’ are created for the routine histologic evaluation of tissue specimens collected in the clinical care of our DUHS patients.
Block: a cube of paraffin in which is embedded a portion of tissue that has been dehydrated and infiltrated with paraffin to facilitate the precise preparation of thin sections of tissue for further analysis.
Clinical Tissue Archives: refers to the residual patient specimens (including FFPE blocks) that are present after all immediate-need diagnostic testing is performed and the primary and any ancillary orders are resulted.
Non-Clinical Archival Clinical Tissue Use: refers to the use of FFPE from the clinical tissue archives for use other than the routine clinical care of our patients. Routine clinical care includes the use of archival tissue when testing is a condition of enrolment into interventional clinical trials. Non-clinical uses include basic research, clinical research, the preparation of control material for the DUHS Clinical Laboratories and the validation of clinical assays within the DUHS Clinical Laboratories.
Recuts: In the initial evaluation of tissue, histologic sections are cut from the block in order to prepare microscopic slides for evaluation. When additional sections are requested for further analytical purposes, the block must be “recut” to prepare t these sections
SCOPE: This policy applies to all DUHS Clinical Laboratories and Pathology Departmental Laboratories. It also governs the availability of tissue for research by our DUMC investigators, and hospital and health system staff and faculty.
PURPOSE:
To provide standards and a formal process around the non-clinical use of clinical archival FFPE tissue that ensure the safety of our patients and compliance with regulatory mandates from the CMS and the CAP.
The formalin fixed paraffin embedded (FFPE) tissue archives are an extremely valuable research resource for our clinical investigators at Duke, our Duke patients, and our collaborators around the world. Clinical research is an important aspect of patient care at an academic medical center, and our clinical laboratories support our research mission. The ability of clinical laboratories to release FFPE is governed by our retention policies. The policy on the retention of clinical archival FFPE tissue exists to ensure that material is available for a patient’s continued clinical care, after completion and verification of the initial anatomic pathology case. Continued care may be in the form of physician-ordered ancillary molecular testing, immunohistochemistry, histochemistry, or outside consultation. In rare cases, block retention is required for legal review. Finally, retention of clinical archival FFPE is important after the death of patient both for potential clinical or legal review, and for potential genetic testing by surviving family members. This policy governs only FFPE that is reviewed for diagnostic purposes and does not cover tissue that was specifically collected for research under an approved DUHS IRB protocol.
FFPE (‘block’) retention is mandated by the US code of federal regulation Title 42, Chapter IV Subchapter G CFR493.1105: Standard: Retention requirements which states: