Request for Pathology Approval for Research Involving Human Tissues

Request for Pathology Approval for Research involving Human Tissues

Please return this form when completed to: Dr. Rex Bentley, email [email protected], 919-684-6423, and copy Mr. Tom Dod, Pathology IRB & Grants Manager Rm 3109 Meyer Ward (Yellow Zone) or DUMC 3712 Tel 919-681-6062 // Email [email protected]

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. 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. Pager: 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 A: Determine if the study needs Pathology Approval

1) Is all of the tissue on the Surgical Pathology Tissue and Medical Devices Exceptions List? [See appendix or DUHS intranet, DUH Policies & Procedures, Tissue and Medical Devices Exceptions List, URL https://egrc.duhs.duke.edu/foundation/Workspace.aspx?workspaceId=-1&requestUrl= ] Choose yes or no.

2. Will all tissues be obtained via the Duke Biospecimen Repository and Processing Core (BRPC), Duke Brain Tumor Center Biorepository, or other existing Duke IRB-approved tissue biorepository or tissue bank? Choose yes or no.

3. Is (or was) all of the tissue obtained solely for research purposes? (All criteria a-e must be true to answer “yes”. If any criteria 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 pathologic evaluation of the tissue from the biopsy will be performed. 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.

DOES YOUR STUDY NEED FURTHER APPROVAL? If you answered YES to any of the above questions 1-3, 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 did not answer YES to any of the above questions 1-3, 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 B.

Choose an answer

pg. 1 version 4/23/2018 SECTION B: Information needed for full Pathology Review

1) Please provide a copy of the IRB research summary and the full research protocol, including sponsor’s protocol if applicable.

2) Will the study use 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 on a fee for service basis. Price estimates are available from the Histology Research Lab.

a. Describe the plan to identify the desired archival cases to be used for the study, or specify that the investigator will be responsible for identifying the desired archival cases. Please note that pathology assistance to identify desired cases is not available without prior arrangement. Click here to enter text.

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 Histology Research Laboratory, 684-6209. 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). Click here to enter text.

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 Histology Research Laboratory to arrange for a pathologist to perform this review on a fee for service basis: Click here to enter text.

e. Will routine (non-experimental) clinical care be based on central laboratory pathology review or special studies? Choose yes or no. If yes, then:

i) Describe the plan for notifying the Duke Pathology department of the central pathology review results or special studies, including 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. Click here to enter text.

3) Will the study use non-archival tissues (for example, fresh or flash frozen tissue or body fluids other than blood normally submitted for cytologic evaluation)? Choose yes or no. If yes, please complete the questions below. Please note that there is a minimum $75 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. For specimens being obtained through the surgical pathology laboratory, it is highly recommended that investigators use the Duke Biospecimen Repository and Processing Core BRPC for tissue collection. For specific cost estimates please contact the BRPC, Dr. Shannon McCall, director, 919-684- 2531, or the BRPC website: http://www.dukecancerinstitute.org/research/sharedresources/Biospecimen pg. 2 version 4/23/2018 %20Repository%20and%20Processing%20Core/). Tissue samples from autopsies are not generally available for research; documentation of prior review and approval by the director of the autopsy service (Dr. Alan Proia, 684- 2482) is necessary. 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 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 routine (non-experimental) clinical care be based on central laboratory pathology review or special studies? Choose yes or no. If yes, then:

i) Describe the plan for notifying the Duke Pathology department of the central pathology review results or special studies, including 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: 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 efforts) Choose yes or no. If yes, then please identify the pathologist: Click here to enter name.

TO BE COMPLETED BY REVIEWING PATHOLOGIST: Approved:

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. pg. 3 version 4/23/2018 pg. 4 version 4/23/2018 APPENDIX A:

Policy: Use of FFPE Tissues for Research QC and MethodValidation (LTR43263): Use of Clinical Archival Paraffin Tissue for Research, Clinical Assay Validation and the Preparation of Control Material within the Clinical laboratories. [Effective date 12/5/2012]

Part 1: For uses other than for the clinical care of patients, release of FFPE block recuts (unstained slides or ‘paraffin curls’) is permitted as follows: 1) Recuts of clinical archival FFPE blocks can only be performed if: a) The case associated with the block is not a small biopsy case (eg. FNAs, cell blocks from fine needle aspirate collections, needle core biopsies, skin punch biopsies, endoscopic biopsies, etc.). Preparing recuts of these specimens poses too high a risk of sample depletions which would be in violation of block retention policies. b) For the case associated with the block, the diagnostic findings are not limited to a single block. c) The block does NOT contain a unique medically significant finding, even if this finding is not the primary diagnostic finding (eg. the only block with lymph node metastasis for a cancer case, a block with positive margins, blocks that document tumor stage, frozen section remnants) d) The block is NOT being held for legal review (‘non-circulating’ file) e) The recuts are performed in a DUHS CAP-accredited Clinical Laboratory. 2) All of the slides and paraffin blocks from the associated case must be reviewed by a DUMC pathologist with clinical privileges in anatomic pathology to verify that recuts will not deplete the paraffin block and that sufficient material remains for further diagnostic work if it should become required. a) The review must be documented and documentation should be retained by the pathologist of record and sent to the Anatomic Pathology Laboratory for archiving. 3) The release of archival FFPE recuts for research is permitted only in the context of DUHS IRB approved protocols with appropriate patient consent, if required by the protocol. The consent must be present in the patient’s electronic medical records or a copy can be sent to the laboratory.

Part 2: For research use, removal of a core of tissue (2-5mm) from a clinical archival FFPE block using a punch biopsy device is permitted as follows; 1) A core of tissue can be removed from a clinical archival FFPE block if: a) The case associated with the block is not a small biopsy case (eg. FNAs, cell blocks from fine needle aspirate collections, needle core biopsies, skin punch biopsies, endoscopic biopsies, etc.). Preparing cores of these specimens poses too high a risk of sample depletions which would be in violation of block retention policies. b) For the case associated with the block, the diagnostic findings are not limited to two or fewer blocks. c) The block does NOT contain a unique medically significant finding, even if this finding is not the primary diagnostic finding (eg. the only block with lymph node metastasis for a cancer case, a block with positive margins, blocks that document tumor stage, frozen section remnants) d) The block is NOT being held for legal review (‘non-circulating’ file) e) The cores of tissue is removed from the block by a DUHS CAP-accredited laboratory or facility (biorepository). f) >50% of the tissue which contains the diagnostic finding remains in the block after removal of the core 2) All of the slides and paraffin blocks from the case must be reviewed by a DUMC pathologist with clinical privileges in anatomic pathology to verify that a core biopsy will not deplete the paraffin block and that sufficient material remains in the blocks for further diagnostic work if it should become required. a) The review must be documented and documentation should be retained by the pathologist of record and sent to the Anatomic Pathology Laboratory for archiving. 3) The release of core biopsies from archival FFPE recuts for research is permitted only in the context of DUHS IRB approved protocols. The protocol must include consent for the use and potential depletion of a piece of tissue that was used in their diagnosis. The consent must be present in the patient’s electronic medical records or a copy can be sent to the laboratory. 4) Every effort should be made to use blocks that are greater than 2 years old.

pg. 5 version 4/23/2018 Part 3: FFPE blocks are retained by Clinical Laboratories indefinitely. This policy does not contain a provision for the release of entire paraffin blocks to entities outside of DUHS.

APPENDIX B: Duke University Hospital Department of Pathology

Surgical Pathology Tissue and Medical Devices Exceptions List and List of Specimens Exempt from Microscopic Examination

I. The following specimens may be excluded from routine submission to Surgical Pathology.

A. General Surgery/Plastic Surgery 1. Arthropods (lice, crabs, etc.) 2. Bezoars 3. Calculi (renal, ureteral, bladder) 4. Clinically normal tissue removed during cosmetic procedures (e.g., blepharoplasty and with the exception of mammoplasty) 5. Debridement for recent trauma 6. Debridement from decubitus ulcer 7. Fat contents from liposuction 8. Fecaliths 9. Foreign bodies that are medicolegal evidence (e.g., bullets) given directly to law enforcement personnel 10. Medical devices not contributing to patient illness, injury or death (e.g., gastrostomy tubes, stents, sutures) 11. Panniculectomy tissue 12. Portion of rib removed only to enhance operative exposure, provided patient does not have a history of malignancy 13. Scars from recent burns and trauma or old scars from non-neoplasm surgery 14. Subcutaneous tissue, excess removed incidental to surgical approach 15. Tissue expander implants 16. Tissue from cosmetic repair from the nose, ear and face 17. Tissue from extensive soft tissue and bony trauma 18. Toenails & fingernails that are grossly unremarkable 19. Thymus tissue, removed only to enhance operative exposure, provided the patient does not have a history or suspicion of malignancy 20. Atrial appendage tissue, excess removed incidental to surgical approach 21. MOHS surgery specimen for which the tissue diagnosis has been previously established by a pathologist 22. Debrided tissue for which the tissue diagnosis has been previously established by a pathologist and the base is to be subsequently treated with electrofulguration or liquid nitrogen treatment.

B. Neurosurgery - Ruptured disks/ osteoarthritic bone removed during spinal surgery.

C. Obstetrics & Gynecology 1. Intrauterine contraceptive devices, without attached soft tissue 2. Placentas delivered by cesarean section that appear normal at time of delivery 3. Placentas from routine and uncomplicated pregnancies and deliveries that appear normal at the time of delivery (e.g., do not meet criteria for examination) 4. Vaginal foreign bodies 5. Vaginal mucosa and vulvar skin (perineal body) removed during repair of rectocele and cystocele

D. Ophthalmology 1. Chalazion, unless recurrent 2. Extraocular muscle and tendon tissue removed during strabismus surgery 3. Iris removed at time of peripheral iridectomy 4. Lens cataracts, not otherwise specified pg. 6 version 4/23/2018 5. Lens cataracts removed by phacoemulsification 6. Ophthalmic plastic surgical tissues, without underlying malignant or systemic disease 7. Scleral tissue removed at time of trabeculectomy 8. Subretinal/choroidal membranes 9 Explanted devices and materials, eg, explanted intraocular lenses, buckles, valves, 10. Vitreous fluid/tissue without suspicion of neoplasia

E. Oral Surgery 1. Bone associated with extracted tooth 2. Dental appliances 3. Dental restorations 4. Hardware (arch bars, wire, bone plates, screws, etc.) 5. Impacted teeth 6. Mobile primary teeth 7. Teeth, not otherwise specified 8. Teeth removed for dental caries, periodontal disease 9. Teeth when there is no attached soft tissue 10. Temporomandibular joint

F. Orthopedics 1. Bone donated to the bone bank 2. Bone from osteotomies 3. Bone segments removed as part of corrective or reconstructive orthopedic procedures (e.g., rotator cuff repair, synostosis repair, spinal fusion) 4. Bone spurs, in addition to bunions 5. Bunions 6. Orthopedic appliances (hardware) and other radiopaque mechanical devices removed at surgery 7. Patellar shavings 8. Synovium from reconstruction (e.g., anterior cruciate ligament) 9. Tendon 10. Toes removed for functional deformity (e.g., hammer toe, mallet and claw toes) 11. Tissues excised as part of routine procedures for restoration or repair of joint diseases, or reconstruction of joint alignment or functional anatomy following surgery, e.g. partial or complete meniscus and/or attachments, tendon and/or attachments, ligaments and/or attachments, articular cartilage, bone, synovial tissues, intervertebral disc tissues. Grossly normal tissues must not have any concerns or evidence related to neoplasia, inflammatory/autoimmune disease, or infection.

G. Otolaryngology 1. Cartilage or bone removed during septoplasty, rhinoplasty or septorhinoplasty 2. Middle ear (myringotomy) tubes 3. Otologic reconstructive or other appliances removed at surgery 4. Middle ear ossicles

H. Pediatrics 1. Foreskin from circumcision of newborn or any child 2. Supernumerary (accessory) digits

I. Urology 1. Foreskin from elective circumcision (adult) 2. Penile implant

J. Vascular Surgery 1. Intravascular catheters 2. Mammary artery/vein, excess from cardiac or peripheral vascular bypass 3. Pacemaker devices 4. Saphenous vein segments harvested for coronary artery bypass 5. Venous segment excess harvested for grafting, not otherwise specified

pg. 7 version 4/23/2018 K. Thoracic surgery - Ribs incidentally removed to facilitate exposure and the operation

L. Miscellaneous - Therapeutic radioactive sources

II. The following specimens may be submitted to Surgical Pathology for gross examination without microscopic examination (gross only).

A. Foreign bodies removed at surgery (prostheses/implants) B. Endoscopically removed foreign bodies C. Artificial heart valves (mechanical) D. Varicose veins E. Traumatic amputation

III. Regardless of exceptions and/or exemptions, gross and microscopic examinations will be performed whenever the attending physician requests it, or at the discretion of the pathologist when such examinations are indicated by the clinical history.

IV. This exemption list specifically does not prohibit tissues being removed solely for research purposes where prior patient consent and IRB review, including pathology consent, are required.

V. Documentation of the removal and disposition of specimens and devices not sent to Pathology is the responsibility of the attending physician and Department/Service removing such specimens.

pg. 8 version 4/23/2018