Request for Pathology Approval for Research involving Human Tissues
Please return this form when completed to:
Dr. Rex Bentley, email Rex.Bentley@duke.edu, 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 dod00001@mc.duke.edu
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
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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, 919-6842531, or the BRPC website:
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http://www.dukecancerinstitute.org/research/sharedresources/Biospecimen%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:
X
Rex C. Bentley
Professor, Department of Pathology
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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.
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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.
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.
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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.
1.
2.
3.
4.
General Surgery/Plastic Surgery
Arthropods (lice, crabs, etc.)
Bezoars
Calculi (renal, ureteral, bladder)
Clinically normal tissue removed during cosmetic procedures (e.g., blepharoplasty and with the exception
of mammoplasty)
Debridement for recent trauma
Debridement from decubitus ulcer
Fat contents from liposuction
Fecaliths
Foreign bodies that are medicolegal evidence (e.g., bullets) given directly to law enforcement personnel
Medical devices not contributing to patient illness, injury or death (e.g., gastrostomy tubes, stents, sutures)
Panniculectomy tissue
Portion of rib removed only to enhance operative exposure, provided patient does not have a history of
malignancy
Scars from recent burns and trauma or old scars from non-neoplasm surgery
Subcutaneous tissue, excess removed incidental to surgical approach
Tissue expander implants
Tissue from cosmetic repair from the nose, ear and face
Tissue from extensive soft tissue and bony trauma
Toenails & fingernails that are grossly unremarkable
Thymus tissue, removed only to enhance operative exposure, provided the patient does not have a history
or suspicion of malignancy
Atrial appendage tissue, excess removed incidental to surgical approach
MOHS surgery specimen for which the tissue diagnosis has been previously established by a pathologist
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.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
B.
Neurosurgery
- Ruptured disks/ osteoarthritic bone removed during spinal surgery.
C.
1.
2.
3.
4.
5.
Obstetrics & Gynecology
Intrauterine contraceptive devices, without attached soft tissue
Placentas delivered by cesarean section that appear normal at time of delivery
Placentas from routine and uncomplicated pregnancies and deliveries that appear normal at the time of
delivery (e.g., do not meet criteria for examination)
Vaginal foreign bodies
Vaginal mucosa and vulvar skin (perineal body) removed during repair of rectocele and cystocele
D.
1.
2.
3.
4.
5.
6.
7.
8.
9
Ophthalmology
Chalazion, unless recurrent
Extraocular muscle and tendon tissue removed during strabismus surgery
Iris removed at time of peripheral iridectomy
Lens cataracts, not otherwise specified
Lens cataracts removed by phacoemulsification
Ophthalmic plastic surgical tissues, without underlying malignant or systemic disease
Scleral tissue removed at time of trabeculectomy
Subretinal/choroidal membranes
Explanted devices and materials, eg, explanted intraocular lenses, buckles, valves,
pg. 6
version 2/9/2016
10.
Vitreous fluid/tissue without suspicion of neoplasia
E.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Oral Surgery
Bone associated with extracted tooth
Dental appliances
Dental restorations
Hardware (arch bars, wire, bone plates, screws, etc.)
Impacted teeth
Mobile primary teeth
Teeth, not otherwise specified
Teeth removed for dental caries, periodontal disease
Teeth when there is no attached soft tissue
Temporomandibular joint
F.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Orthopedics
Bone donated to the bone bank
Bone from osteotomies
Bone segments removed as part of corrective or reconstructive orthopedic procedures (e.g., rotator cuff
repair, synostosis repair, spinal fusion)
Bone spurs, in addition to bunions
Bunions
Orthopedic appliances (hardware) and other radiopaque mechanical devices removed at surgery
Patellar shavings
Synovium from reconstruction (e.g., anterior cruciate ligament)
Tendon
Toes removed for functional deformity (e.g., hammer toe, mallet and claw toes)
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.
1.
2.
3.
4.
Otolaryngology
Cartilage or bone removed during septoplasty, rhinoplasty or septorhinoplasty
Middle ear (myringotomy) tubes
Otologic reconstructive or other appliances removed at surgery
Middle ear ossicles
H.
1.
2.
Pediatrics
Foreskin from circumcision of newborn or any child
Supernumerary (accessory) digits
I.
1.
2.
Urology
Foreskin from elective circumcision (adult)
Penile implant
J.
1.
2.
3.
4.
5.
Vascular Surgery
Intravascular catheters
Mammary artery/vein, excess from cardiac or peripheral vascular bypass
Pacemaker devices
Saphenous vein segments harvested for coronary artery bypass
Venous segment excess harvested for grafting, not otherwise specified
K.
Thoracic surgery
- Ribs incidentally removed to facilitate exposure and the operation
L.
Miscellaneous
- Therapeutic radioactive sources
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II.
The following specimens may be submitted to Surgical Pathology for gross examination
without microscopic examination (gross only).
A.
B.
C.
D.
E.
Foreign bodies removed at surgery (prostheses/implants)
Endoscopically removed foreign bodies
Artificial heart valves (mechanical)
Varicose veins
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.
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