Institutional
Review Board
Human Research Seminar Series:
Use of Human Specimens in Research
Wednesday, October 24, 2012
Presented by:
David Wallach, CIP
IRB Director
James Pullman, M.D., Ph.D.
Clinical Professor of Pathology
Greg Cruikshank, M.A.
ICTR Translational Core Administrator
TABLE OF CONTENTS
Use of Human Specimens in Research .............................................................................. 1
Research Use of Human Tissue: Resources and Practical Guidelines …………………. 13
Einstein-Montefiore Biorepository: a Tool for Specimen Research ................................ 21
IRB Policy: Collection and/or Study of Human Specimens ..............................................29
Request for Approval of an Outgoing MTA ........................................................................39
Request for Approval of an Incoming Data Use Agreement (DUA) or Material
Transfer Agreement (MTA) .................................................................................................. 40
Use of Specimens in Research - Page 1 of 40
Science at the heart of medicine
Einstein Institutional Review Board (IRB)
Einstein-Montefiore Institute for
Clinical & Translational Research (ICTR)
Human Research Seminar Series
Use of Human Specimens in Research
Presented by:
David Wallach, CIP, IRB Director
James Pullman, M.D., Ph.D., Clinical Professor of Pathology
Greg Cruikshank, ICTR Translational Core Administrator
Overview
• Part 1: IRB/regulatory issues and review requirements for studies
involving:
> Existing data/specimens
> Prospective collection of data/specimens
> Data/specimen analysis as part of a collaboration
• Part 2: Tissue handling for research from the O.R. through
pathology up to distribution to tissue banks:
> Patient safety
> Research and regulatory issues
> NYS tissue bank requirements
• Part 3: Entry, maintenance, and exit of tissues in the tissue bank:
> Resources available and process for obtaining specimens
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Use of Specimens in Research - Page 2 of 40
What is Research?
• The following definition of research is found in the
Federal Regulations 45 CFR 46.102(e):
> Research means a systematic investigation
including research development, testing and
evaluation, designed to develop or contribute to
generalizable knowledge.
• FDA definition 812.3(h)
> Investigation means a clinical investigation or
research involving one or more subjects to determine
the safety or effectiveness of a device.
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What is a Human Subject?
• 45 CFR 46.102(f) defines human subject as a living individual*
about whom an investigator obtains:
> data through intervention or interaction with the individual, or
> identifiable private information.
• *Note: Institutional policy extends the definition to include
decedent research.
• FDA regulations define Subject as a human who participates in
an investigation, either as an individual on whom or on whose
specimen an investigational device is used or as a control. A
subject may be in normal health or may have a medical condition
or disease. (21 CFR 812.3(p))
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Use of Specimens in Research - Page 3 of 40
What is a Human Specimen?
• A human specimen consists of any sample of hair,
skin, cells, blood, tissue, organ, bodily fluid, excreted
or secreted material or derivative substance obtained
from a patient or volunteer, that may or may not
contain living or desquamated cells.
• Einstein IRB Guidelines for the Collection and/or Study
of Human Specimens are available at:
https://einstein.yu.edu/docs/administration/institutionalreview-board/policies/specimens.pdf
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What’s NOT a Human Subject?
(Research Not Involving Human Subjects)
• Research that involves the study of data or specimens
is not considered human subject research, as defined
under 45CFR46.102(f), if:
> the data or specimens were not collected specifically for
the currently proposed research project through an
interaction or intervention with living individuals, and
> the researchers cannot readily ascertain the identity of
the individuals (i.e. the specimens are de-identified or
coded).
• This determination must be made by the Einstein IRB
through the Exempt process.
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Use of Specimens in Research - Page 4 of 40
What’s the Difference Between De-Identified
and Coded?
• De-Identified Specimens contain none of the 18 HIPAA
identifiers, are not coded, and cannot be linked back in any way
to the original donor. The HIPAA identifiers consist of the
following data elements:
>
Name; Address; All Elements of dates (except year); Telephone Number; Fax
Numbers; E-mail Addresses; Social Security Number; Medical Record
Number; Health Plan Beneficiary Number; Account Number;
Certificate/License Number; Vehicle Identifiers and Serial Numbers including
License Plate Numbers; Device Identifiers and Serial Numbers; Web
Universal Resource Locators (URLs); Internet Protocol (IP) Address
Numbers; Biometric Identifiers including Voice/Fingerprints; Photos; or other
unique number, characteristics or code.
• Coded Specimens are recorded in such a manner that subjects
cannot be identified by the researcher directly or through
identifiers linked back to the original donor. The code must not
utilize any personal information of the subject, such as the HIPAA
identifiers listed above.
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Science at the heart of medicine
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Categories of Review and Submission Dates
Category
of Review
Einstein IRB Form
Submission
Deadline
Exempt
East: PATS Exempt Form
West: MS-Word Form
Any time
Expedited
Full
East: PATS Research Application
West: MS-Word Research Application
Any time
By required
deadline*
*Deadline and meeting dates are found online:
https://einstein.yu.edu/administration/institutional-review-board/meetingdates-deadlines.aspx
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Use of Specimens in Research - Page 5 of 40
Exempt Research
•
•
Certain federally defined categories of research are Exempt from federal
regulations. The Exempt Policy is found at:
https://einstein.yu.edu/docs/administration/institutional-reviewboard/policies/exempt.pdf
Review Procedure:
> Exempt research requires verification by the Einstein IRB.
> Researcher must submit to the Einstein IRB: Exempt Application
and detailed protocol. A complete grant application is required, when
applicable.
> Einstein IRB will send the PI a written exemption verification letter.
> Per institutional policy, research utilizing Fetal Tissue is not eligible
for Exemption. See the Fetal Tissue Research Policy
https://einstein.yu.edu/docs/administration/institutional-reviewboard/policies/fetal-tissue.pdf
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Exempt Research: Category 4
• Research involving the collection or study of existing
data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly
available or if the information is recorded by the
investigator in such a manner that subjects cannot be
identified, directly or through identifiers linked to the
subjects.
> In contrast to “Research NOT Involving Human
Subjects” and “Research in Which the Institution is
‘Not Engaged,’” this category allows the researcher to
view identifiable private information during the deidentification process.
Science at the heart of medicine
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Use of Specimens in Research - Page 6 of 40
Is Consent Required for the Study of Human
Specimens?
• Previously obtained specimens generally qualify for a
consent waiver (see next slide). Re-consent may be
required for genetic research studies, especially for
research posing possible risk to an individual through
breech of confidentiality, or harm to a particular
population, e.g., American Indian, Jewish, Hispanic, etc.
• Prospective collection of specimens generally requires
informed consent.
• The Einstein IRB makes the final determination when
reviewing the protocol.
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11
When Can Consent be Waived
For expedited studies, an IRB may … waive the
requirements to obtain informed consent provided the IRB
finds and documents that:
1) The research involves no more than minimal risk to
the subjects;
2) The waiver or alteration will not adversely affect the
rights and welfare of the subjects;
3) The research could not practicably be carried out
without the waiver or alteration; and
4) Whenever appropriate, the subjects will be provided
with additional pertinent information after participation.
Source: 45 CFR 46.116(c)(2)
Science at the heart of medicine
Use of Specimens in Research - Page 7 of 40
Expedited Review
•
Research must involve no more than minimal risk
and involve only procedures listed in one or more of
the federally defined categories.
>
>
Minimal risk means that the probability and magnitude of
harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily
encountered in daily life or during the performance of
routine physical or psychological examinations or tests.
The Expedited Policy, including the list of categories and
exceptions, is found at:
https://einstein.yu.edu/docs/administration/institutionalreview-board/policies/expedited.pdf
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Expedited Review
•
•
•
Protocol application and subsequent transactions are
reviewed by Einstein IRB Chairman (or designee) and
reported to the rest of the board at the next meeting.
The reviewer may ask for additional information,
request revisions to the protocol or the informed
consent document, or request that the study be
reviewed by the Full board.
The final determination regarding the appropriateness
of Expedited Review rests with the Einstein IRB.
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Use of Specimens in Research - Page 8 of 40
Expedited Review: Category 2
2. Collection of blood samples by finger stick, heel stick, ear stick,
or venipuncture as follows:
> from healthy, nonpregnant adults who weigh at least 110
pounds. For these subjects, the amounts drawn may not
exceed 550 ml in an 8 week period and collection may not
occur more frequently than 2 times per week; or
> from other adults and children, considering the age, weight,
and health of the subjects, the collection procedure, the
amount of blood to be collected, and the frequency with
which it will be collected. For these subjects, the amount
drawn may not exceed the lesser of 50 ml or 3 ml per kg in
an 8 week period and collection may not occur more
frequently than 2 times per week.
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Expedited Review: Category 3
3. Prospective collection of biological specimens for research
purposes by noninvasive means.
>
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b)
deciduous teeth at time of exfoliation or if routine patient care
indicates a need for extraction; (c) permanent teeth if routine patient
care indicates a need for extraction; (d) excreta and external
secretions (including sweat); (e) uncannulated saliva collected either
in an unstimulated fashion or stimulated by chewing gumbase or
wax or by applying a dilute citric solution to the tongue; (f) placenta
removed at delivery; (g) amniotic fluid obtained at the time of rupture
of the membrane prior to or during labor; (h) supra- and subgingival
dental plaque and calculus, provided the collection procedure is not
more invasive than routine prophylactic scaling of the teeth and the
process is accomplished in accordance with accepted prophylactic
techniques; (i) mucosal and skin cells collected by buccal scraping
or swab, skin swab, or mouth washings; (j) sputum collected after
saline mist nebulization.
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Use of Specimens in Research - Page 9 of 40
Expedited Review: Categories 5
5. Research involving materials (data, documents,
records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes
(such as medical treatment or diagnosis).
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Exceptions from Expedited Review
• Research involving the following populations require
Full board review:
> Patients in significant pain
> Patients who have an altered mental status (e.g.
Patients who are under the influence of sedatives or
narcotics, etc.)
> Patients who may not be capable of giving informed
consent (e.g. mental retardation, dementia, acute
psychiatric disorders)
> Women in labor
• Other exceptions requiring full board review include
studies that involve deception or
randomization.
Science at the heart of medicine
Use of Specimens in Research - Page 10 of 40
Full Board Review
• Applies to all research that doesn’t qualify for Exempt
or Expedited review.
• Protocols must be received by the Einstein IRB
Administrative Office by the deadline.
• 6 copies of the Application, detailed protocol and
required documents are required.
> Submission Checklists available on IRB website.
• The Principal Investigator and/or designated Key
Personnel are requested to attend the Einstein IRB
meeting.
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Research in Which the Institution is
“Not Engaged”
• Consultants or collaborators obtain de-identified or coded
private information or human biological specimens from an
institution engaged in human subjects research that retains
a link to individually identifying information.
• If the data/specimens are coded, an agreement prohibiting
the release of the key to the code to the consultants or
collaborators is required.
• An MTA may be required. Contact the Office of
Biotechnology for guidance.
• This determination must be made by the Einstein IRB
through the Exempt process.
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Use of Specimens in Research - Page 11 of 40
Protocol Approval/Expiration Dates
• Federal regulations limit IRB approval to a time period
of one year or less. If the approval lapses:
> All research activities involving human subjects must
stop, unless it is determined to be in the best interests of
already enrolled subjects to continue participating in the
research.
> Resubmission of the application materials to continue
the research may be required.
• The Einstein IRB determines the re-review period at
the time of the initial review, based on the degree of
risk to subjects.
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Informed Consent Documents Approval/
Expiration Dates
• Informed Consent Documents (ICDs), are “stamped”
on the first and last pages showing:
> Approval Date (From)
> Expiration Date (To)
• The most recently approved ICDs must be used when
enrolling research participants.
> For East Campus IRB protocols, current stamped
consents are available in PATS.
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Use of Specimens in Research - Page 12 of 40
Einstein IRB Contact Information
East Campus IRB
• Belfer Building, Room 1002
1300 Morris Park Avenue
Bronx, NY 10461
• Phone: 718-430-2237
• Fax: 718-430-8817
West Campus IRB
• 3308 Rochambeau Ave
Bronx, NY 10467
• Phone: 718-798-0406
• Fax: 718-798-5687
Website: http://www.einstein.yu.edu/irb
Includes: Policies and Procedures,
Submission Guidelines, Forms,
and Educational Materials
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Use of Specimens in Research - Page 13 of 40
Research Use of Human Tissue
Resources and Practical
Guidelines
James M Pullman, M.D., Ph.D.
Dept of Pathology
MMC
AECOM
How to get what you want
When you want it
How you want it
Use of Specimens in Research - Page 14 of 40
Removal of Human Tissue
• Reasons
– Clinical
• Therapy, diagnosis and prognosis
– Primary removal for research
• By prior agreement only
• Tissue Sources
– Operations (resections and collections)
– Biopsies
– Fluids
– Autopsy
Categories of Tissue Removal
• Resections
– Neoplasia (Tumor)
– Infection and Inflammation
– Malformation
• Collections (e.g. placentas)
• Biopsies
–
–
–
–
Excisional (larger)
Incisional (smaller)
Core Needle (Smaller)
Fine Needle (Smallest: single/groups of cells)
• All Categories may include:
– Lesional (abnormal) tissue
– Normal tissue
Use of Specimens in Research - Page 15 of 40
MMC Medical Staff Rules:
All Removed Tissue Sent Directly to Surgical Pathology
• Exceptions:
– Transplant harvests
– Microbiology culture
– Discarded by prior agreement
• liposuction, placentas
• 100% for Primary Clinical Pathology
– Diagnosis and Prognosis
– Research use by prior agreement only
• Pathology is the legal custodian of removed
human tissue
Routine Tissue Analysis in Pathology
1. All tissue sent directly to Pathology intact
– In fixative or not as per agreement
2. Pathology (grossly) examines all tissue
– Gross diagnosis
– Selection and submission for microscopic examination
– Storage of remainder, if any
3. Tissue processed into paraffin blocks and then
slides
4. Pathology examines slides microscopically
5. Re-examination or processing of remaining tissue if
necessary
6. Pathology report issued
7. Slides and blocks stored
Use of Specimens in Research - Page 16 of 40
Modification of workflow for research
(steps 2,5,7)
• IRB-approved protocol
• Procedure for collection
– Between researcher and pathology
– All details spelled out
• Prospective collection:
• Tissue not to be used for clinical purposes
– “left over”, to be discarded
– Used fresh or after embedding in paraffin blocks
• Tissue removed for research purposes only
– Explicit IRB agreement, usually with patient consent
• Retrospective collection:
• tissue submitted for clinical purposes
• in paraffin blocks
Categories of Tissue-based
Research
1.
2.
3.
4.
5.
Translational or Basic Science
Clinical Pathologic correlation studies
Clinical Research Trials
Non-approved clinical tests
“One shot” experiments or assays
IRB approval required for 1-3.
Patient consent and other approval required for 4 and 5..
Use of Specimens in Research - Page 17 of 40
Transport and Storage of Research Tissue
• NYS Public Health Law 1389:
– All removed tissue considered “regulated medical
waste”.
• Must be transported by authorized courier
– Hospital service
– Licensed Funeral Director
– Researcher only after IRB authorized release
• Must be accounted for at destination lab
– NYS Non-transplant tissue bank law
– Use and disposal for all samples reported to NYS
annually
• Transport outside of MMC or Einstein
– Material Transfer Agreement (MTA) required
Research Tissue Prospective Collection
• Appropriate operation scheduled
– Researcher notifies pathology
– Pathology research tech searches OR schedule
• Tissue arrives
– Promptly, no delay
– Fresh, in saline, sterile as necessary
– May be designated for research
• Pathologist examines tissue
– Chooses clinical tissue
– Chooses research tissue
– Submits a small sliver of research tissue for routine histology
• Verification of research tissue composition
• Assignment of a Research accession number
– tie with clinical accession number
– May be used for de-identification;
– For exempt studies tie to clinical information via honest broker
• Delivery to researcher (Temporary storage in pathology)
Use of Specimens in Research - Page 18 of 40
Research Tissue Retrospective Collection
• From Stored Tissue
– Paraffin blocks
• Unstained sections
• Cores from blocks
• Pieces of blocks
– Unstained sections on slides
– Frozen tissue
• Prospectively collected paraffin blocks
– Underutilized resource
– Easier, cheaper to store than frozen tissue
Scientific Considerations:
Sampling error
• Tissue Heterogeneity
–
–
–
–
–
Gross and microscopic levels
Tumor admixed with benign tissue
Variable tumor differentiation, necrosis
Different kinds of benign tissue
Verification by microscopy
• Adjacent tissue (<1 mm away)
• Non-reproducibility of needle biopsies
– Sample exact same area twice
– Get different tissue
• Results:
– Non-reproducibility
– Positive findings lost in background noise
Use of Specimens in Research - Page 19 of 40
Regulatory Considerations:
tracking extra-institutional tissue
• Paraffin blocks always retained by the
originating department
– NYS law: for 20 years
– Exception: prospectively chosen research tissue
• Reasons to retain blocks:
– Scant material (e.g. needle core biopsies)
– Requests from more than one clinical research
protocol
– Dissolution of the requesting entity (loss of funding)
– Virtual banking via computer makes it unnecessary to
physically distribute
Clinical Considerations: Tissue Depletion
• What constitutes “left over tissue”?
• Large samples not a problem
• Small samples:
– Incisional biopsies
– Needle core biopsies
– FNAs
• Cannot deplete diagnostic tissue
• Unknown future clinical needs
– Same patient
– Their descendants
Use of Specimens in Research - Page 20 of 40
Summary of Responsibilities
• Researcher or clinician:
– Generate IRB approved protocol
– Obtain consent, other documents as necessary
– Coordinate tissue collection with pathology
– Transport and store research samples
• Pathologist and pathology research tech:
– Coordinate timely submission from OR
– Select appropriate tissue (clinical and research)
– Store in appropriate medium (RPMI, saline, etc)
– Accession and track specimens
– Notify researcher for pickup
Use of Specimens in Research - Page 21 of 40
Institute for Clinical and Translational Research
Einstein-Montefiore Biorepository:
a Tool for Specimen Research
Einstein-Montefiore Institute for Clinical and
Translational Research
Biorepository
Research Informatics Core
Daniel Stein, Parsa Mirhaji, Xin Zheng, Greg Cruikshank
Biorepository Physical Footprint
•
•
•
•
Mazer 00-04, MRT 10th floor
2700 sf space available
Primarily -80C freezers planned but also LN2, 4C and RT storage
Partnership with tissue acquisition staff in place within Surgical
Pathology Cutting Room (Weiler and Moses).
Use of Specimens in Research - Page 22 of 40
Biorepository
• The BioR established in 2007
• Currently almost 120,000 samples are housed
• secure location reserved for -80°C 44 freezers, ambient
temperature sample storage,
• All freezers are dual compressor models configured for
emergency liquid nitrogen backup and are wired to
emergency backup electrical supply from a dedicated
generator.
• Monitored remotely 24/7, and SOP are in place to alert
BioR staff in the event of freezer malfunction/failure.
Science at the heart of medicine
Biorepository Storage Models
Einstein Biorepository operates as honest broker in custodial
care of specimens.
• Individual investigators storing specimens from ongoing
prospective studies
‰ samples are property of investigator-use determined by
investigator
• Group of investigators contributing to a “subrepository”
storing specimens for collaborative/prospective studies
‰ samples property of collective-use determined by a
designated Scientific Review Board (SAB)
Science at the heart of medicine
Use of Specimens in Research - Page 23 of 40
Biorepository Data
• Tracking of de-identified/coded specimens with barcode to exact
location: FreezerworksÆ caTissue
• Electronic record generation upstream from repository (Surg. Path
or earlier)
• Establishing connection with MMC EMR for clinical data annotation
with the infrastructure of the Research Informatics Core (RIC)
and/or clinical research data warehouses from research teams
• Provide “Subrepository” SAB secure handling of data regarding
subjects
> To open specimen use to medical community
> To track and evaluate investigator requests
• Connection to global financial accounting (SFMS)
For Prospectively Collected
Subrepositories-Specimen Annotation Key
Without robust annotation of
specimens:
• Researchers ability to ask
questions limited
• SAB’s ability to evaluate
utilization and use of
specimens limited
Result
• Specimens stored end
up underutilized
Science at the heart of medicine
Use of Specimens in Research - Page 24 of 40
Biospecimen Repository Dataflow
Build an institutional resource to locate tissue specimens for analysis
based on specimen, clinical, and genomic characteristics
Adopting caTissue
to support work flow
Institute for Clinical and Translational Research
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caTissue Integrated Tool for Data Capture
ICTR Research Informatics Core
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Use of Specimens in Research - Page 25 of 40
Specimen Repository Data Mapping for Users
2. Implemented tools for every user group
Adopted CaTissue Tool
Einstein-Montefiore
Research Community
Built Data Entry Interfaces
Migrated Legacy Data
Bio-Repository Excel Collection
Tool
Add New
SPECIMEN_GROUP_ID
Specimen Search
Interface
Integrated
Specimen Database
PROCEDURE_DATE
EBR-0000000001
EBR-0000000002
EBR-0000000003
EBR-0000000004
EBR-0000000005
EBR-0000000006
EBR-0000000007
EBR-0000000008
EBR-0000000009
EBR-0000000010
EBR-0000000011
EBR-0000000012
EBR-0000000013
EBR-0000000014
EBR-0000000015
EBR-0000000016
EBR-0000000017
12/5/2008
12/11/2008
12/12/2008
1/13/2009
5/29/2009
7/7/2009
8/27/2009
8/14/2009
8/20/2009
7/17/2009
7/6/2009
7/9/2009
10/24/2009
11/13/2009
11/20/2009
10/24/2009
4/19/2009
PRI MARY_DIAGNOSIS
ETOH
SubAcute Fulminant Hepatic Failure-Drug Toxicity
SubAcute Fulminant Hepatic Failure-Drug Toxicity
ETOH
Adenoma
Colorectal Metastasis
Hepatitis C
Hepatitis C
Hepatic Artery Injury
Primary Sclerosing Cholangitis
Cholangiocarcinoma
Hepatitis C
Wilson Disease
Possible Autoimmune Hepatitis, Possible drug toxicity
Hepatitis C
SubAcute Fulminant Hepatic Failure-Drug Toxicity
Hepatitis C
SECONDARY_DIAGNOSI S
PROCEDURE
Transplant
Transplant
Transplant
Transplant
Resection
Resection
Transplant
Transplant
Transplant
Resection
Resection
Transplant
Transplant
Transplant
Transplant
Transplant
Transplant
HEP C
Hepatocellular Carcinoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma
Extracted Clinical Data from
Medical Record & Other Clinical
Data Sources via Query Engine
ICTR Research Informatics Core
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Searching and Distributing Stored Samples
Once stored samples are held in freezers, inventory can be searched
and distributed through separate “EM-BRED” web portal being
developed by RIC
• Example: a scientist is checking the availability of liver tumor
specimens for grant proposal. For that particular study, patients with
Albumin values less than 3 g/dL are of interest.
ICTR Research Informatics Core
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Use of Specimens in Research - Page 26 of 40
Searching Samples stored in Subrepository
Enter Specimen Searching Criteria
Research community can
conduct Blood or Tissue
Search by clinical attributes
ICTR Research Informatics Core
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Tissue Hit List
Get Results
ICTR Research Informatics Core
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Use of Specimens in Research - Page 27 of 40
Email Request for Specimens of Interest
Send Request
ICTR Research Informatics Core
Other Services
• Housing specimens from completed projects to be used in
future specimen studies (IRB and MTA needed prior to
receipt of specimens for external projects)
• Specimen Shipment to collaborators (IATA certified for
shipment of dangerous goods)
ICTR Research Informatics Core
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Use of Specimens in Research - Page 28 of 40
Thank you
If you have questions or need assistance
Daniel Stein, MD
Scientific Director
Phone:718-430-2446
daniel.Stein@einstein.yu.edu
ICTR Research Informatics Core
Greg Cruikshank
Translational Core Administrator
Phone: 718-430-3314
greg.cruikshank@einstein.yu.edu
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Use of Specimens in Research - Page 29 of 40
Institutional
Review Board
Collection and/or Study of Human Specimens Policy
APPLICABILITY
These guidelines apply to:
1. De-Identified, coded, and identified specimens.
2. Existing and prospectively collected specimens.
3. Specimens stored for future research or with potential for commercial uses.
4. Specimens obtained from, or provided to, collaborating institutions.
5. Genetic research
IMPORTANT NOTE: The use of commercially available cell lines (those purchased through
catalogues) is not considered human subject research and, therefore, is not governed by 45 CFR
46 or 21 CFR 50&56 and does not come under the jurisdiction of the CCI/IRB.
I. DEFINITIONS
A. HUMAN SPECIMEN
A human specimen consists of any sample of hair, skin, cells, blood, tissue, organ,
bodily fluid, excreted or secreted material or derivative substance obtained from a
patient or volunteer that may or may not contain living or desquamated cells.
B. DE-IDENTIFIED SPECIMEN
A human specimen that contains none of the 18 identifiers defined by the HIPPA
regulations, is not coded, and cannot be linked back in any way to the original donor.
The 18 HIPAA identifiers consist of the following data elements: Name; Address; All
Elements of dates (except year); Telephone Number; Fax Numbers; E-mail Addresses;
Social Security Number; Medical Record Number; Health Plan Beneficiary Number;
Account Number; Certificate/License Number; Vehicle Identifiers and Serial Numbers
including License Plate Numbers; Device Identifiers and Serial Numbers; Web Universal
Resource Locators (URLs); Internet Protocol (IP) Address Numbers; Biometric Identifiers
including Voice/Fingerprints; Photos; or other unique number, characteristics or code
(except as specified in I.C.)
C. CODED SPECIMEN
A human specimen that is recorded in such a manner that subjects cannot be identified
by the researcher directly or through identifiers linked back to the original donor. The
code must not utilize any personal information of the subject, such as the 18 HIPAA
identifiers listed in ‘B’, initials or the last 4 digits of the Social Security number, etc.
D. IDENTIFIED SPECIMEN
A human specimen that contains identifiers, such as the 18 identifiers listed above in ‘B’
that make it possible for the investigator to link it back to the original donor.
E. GENETIC TEST
New York Civil Rights Law Section 79-1 defines a genetic test as:
1. "Any laboratory test of human DNA, chromosomes, genes, or gene products to
diagnose the presence of a genetic variation linked to a predisposition to a
genetic disease or disability in the individual or individual's offspring; such term
shall also include DNA profile analysis. ‘Genetic test’ shall not be deemed to
include any test of blood or other medically prescribed test in routine use that has
been or may be hereafter found to be associated with a genetic variation, unless
conducted purposely to identify such genetic variation. The CCI/IRB also
includes any measurement of certain metabolites associated with heritable
diseases as a genetic test.
2. "Genetic Predisposition shall mean the presence of a variation in the composition
of the genes of an individual or an individual’s family member which is
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F.
G.
H.
I.
J.
scientifically or medically identifiable and which is determined to be associated
with an increased statistical risk of being expressed as either a physical or
mental disease or disability in the individual or having offspring with a genetically
influenced disease, but which has not resulted in any symptoms of such disease
or disorder."
HUMAN SUBJECT RESEARCH
1. A living individual about whom an investigator conducting research obtains (1)
data through intervention or interaction with the individual, or (2) identifiable
private information.
2. Intervention includes both physical procedures by which data are gathered and
manipulation of the subject or subject's environment that are performed for
research purposes.
3. Interaction includes communication or interpersonal contact between investigator
and subject.
4. Private information must be individually identifiable (i.e. the identity of the subject
is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving
human subjects.
NOT HUMAN SUBJECT RESEARCH
The analysis of prospectively collected, de-identified specimens or those identified with a
code not derived from individual personal information, does not constitute human subject
research under the HHS human subjects regulations (45CFR Part 46) if:
1. The specimens are not obtained from an intervention with the subject specifically
for the investigator’s research, and
2. The investigator(s) cannot readily ascertain the identity of the individual(s) to
whom the specimens pertain.
EXEMPT RESEARCH
As provided in the Department of Health and Human Services Code of Federal
Regulations, 45 CFR 46.101 (b), the use of existing specimens, de-identified or
containing a code that is not derived from individual personal information (See Sections
I.B and C), qualifies as Exempt research, category 4. (The specimens must exist at the
time the protocol is reviewed.)
NON EXEMPT RESEARCH
Research projects that have been determined to involve human subjects and are not
exempt under HHS regulations at 45 CFR 46.101 (b) as defined in I.H.
ENGAGED IN HUMAN SUBJECT RESEARCH
1. Once an activity is determined to involve non-exempt human subjects research, it
must be determined whether the institution (AECOM/MMC/NBHN) is engaged in
that research, because certain regulatory requirements apply.
2. AECOM/MMC/NBHN researchers are engaged in a particular non-exempt
human subjects research project when its employees or agents for the purposes
of the research project obtain: (1) data about the subjects of the research through
intervention or interaction with them; or (2) identifiable private information about
the subjects of the research [45 CFR 46.102(d),(f)].
3. Institutions whose employees or agents obtain identifiable private information or
identifiable specimens from other institutions for the purposes of a non-exempt
human subjects research project, without directly interactive with human
subjects, still are considered engaged in human subjects research.
4. Obtaining identifiable private information means receiving or accessing
identifiable specimens for research purposes. Obtain is interpreted to include an
investigator’s use, study, or analysis for research purposes of identifiable
specimens already in the possession of the investigator.
5. Example of ‘Engaged’:
Institutions whose employees or agents intervene or interact for research
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purposes with any human subjects of the research by performing invasive or
noninvasive procedures, such as: blood draw; collecting buccal mucosa cells
using a cotton swab; asking someone to provide a specimen by voiding or
spitting into a specimen container, obtaining informed consent.
K. NOT ENGAGED IN HUMAN SUBJECT RESEARCH
1. Institutions whose employees or agents release to investigators at another
institution identifiable private information or identifiable biological specimens
pertaining to the subjects of the research.
2. Institutions whose employees or agents consult or collaborate on the human
subjects research by obtaining coded private information or human biological
specimens from an institution engaged in the research that retains a link to
individually identifying information (such as name or social security number), if
the consultants or collaborators and the holder of the key enter into an
agreement prohibiting the release of the key to the consultants or collaborators
under any circumstances.
II. REVIEW REQUIREMENTS
A. CCI/IRB Review - Not Required
De-identified or coded specimens sent to another institution when AECOM/MMC/NBHN
is not involved in the research do not require CCI/IRB review. The PI is required to
submit:
1. A Material Transfer Agreement
2. Written confirmation that the specimens are de-identified or coded, and that
AECOM/MMC/NBHN is not involved in the research.
3. For coded specimens include a written statement that the key to the code will not
be released.
For information regarding Material Transfer Agreements, see Section VII.
B. CCI/IRB Review - Required
1. Research using de-identified or coded specimens when AECOM/MMC/NBHN is
involved in the research requires review by CCI/IRB. Submit the following to the
appropriate CCI/IRB:
a. Exempt Application Form indicating the research classification (Exempt 4,
Not Engaged or Not Human Research).
b. Detailed protocol
c. A written agreement from the holder of the code that the key to the code
will not be released to the investigator under any circumstances, when
properly coded specimens are received from or sent to another institution
for human research,
d. A copy of the sending or receiving institution’s written authorization, IRB
approval letter, or exempt verification.
e. Note: All materials listed above must accompany the CCI/IRB Exempt
Application Form. See Section VII for MTA requirements.
2. Identified Specimens
a. All AECOM/MMC/NBHN research utilizing identified specimens requires
Expedited or, in some cases, Full Review as determined by the CCI/IRB.
Researchers are required to submit to the CCI/IRB the appropriate
Research Application and required documents for review. The CCI/IRB
will provide researchers with written approval when review is complete.
b. Research involving identified specimens sent to another institution when
AECOM/MMC/NBHN is not involved in the research requires CCI/IRB
review. Submit the following to the appropriate CCI/IRB.
i. CCI/IRB Exempt Application Form
ii. A copy of the receiving institution’s written authorization, IRB
approval letter or exempt verification.
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iii. A copy of the informed consent under which the specimens were
collected.
iv. A HIPAA Authorization form or a HIPAA Waiver request.
NOTE: See Section VII for MTA requirements.
III. INFORMED CONSENT: WHAT IS REQUIRED?
A. Informed consent is required for the prospective collection of identifiable specimens for
research purposes. When appropriate, the CCI/IRB may approve a consent waiver.
B. Informed consent may be waived for:
1. The use of de-identified specimens or those identified with a code that is not
derived from individual personal information and are either left over from
standard clinical care or have been collected from subjects enrolled in another
protocol.
2. The use of identifiable specimens collected from subjects enrolled in another
protocol, provided that the research participant gave consent for future research.
3. For leftover identified surgical specimens, the surgical consent that authorizes
the use of the material for research may be sufficient. The decision whether or
not to require a protocol-specific informed consent document is made by the
CCI/IRB.
C. The informed consent document must contain all the elements required in 45 CFR 46. In
addition for specimen research include language as relevant to each protocol, regarding
the items listed below.
For genetic research refer to numbers 7 through 9 below and to Appendix ‘A’ for sample
consent language. Refer to Appendix ‘B’ for template language for the use of identified
specimens for future research and Appendix ‘C’ for template language for the use of deidentified specimens for future research.
1. Specimens collected specifically for research purposes.
2. The potential for future research use (which may or may not be known).
3. Whether or not the specimens will be destroyed at some point in the future.
(Researchers are required to know whether or not specimens collected under
sponsored protocols will be stored for future research. If the specimens will be
sent to the sponsors/agencies and will not be kept for future research,
sponsors/agencies are required to provide written documentation to the
investigator that the specimens will be destroyed, and when (e.g., after the assay
is complete, or once the study is complete.)
4. Subject’s right to withdraw consent at any time for future use of their specimens,
when required by the sponsor.
5. Results that have the potential for some commercial value in the future and that
subjects will not receive payment for such commercial value.
6. Results that have the potential to affect a research participant's insurability.
7. GENETIC RESEARCH - For Genetic research as defined under section I. E. of
this policy, the consent language must be customized for each genetic test. NY
CLS 79-2(b) defines what the informed consent document must stipulate, as
outlined below.
Written informed consent to a genetic test shall consist of written authorization
that is dated and signed and includes at least the following:
a. a general description of the test;
b. a statement of the purpose of the test;
c. a statement indicating that the individual may wish to obtain professional
genetic counseling prior to signing the informed consent.
d. a statement that a positive test result is an indication that the individual
may be predisposed to or have the specific disease or condition tested for
and may wish to consider further independent testing, consult their
physician or pursue genetic counseling;
e. a general description of each specific disease or condition tested for;
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f.
the level of certainty that a positive test result for that disease or condition
serves as a predictor of such disease. If no level of certainty has been
established, this subparagraph may be disregarded;
g. the name of the person or categories of persons or organizations to
whom the test results may be disclosed;
h. a statement that no tests other than those authorized shall be performed
on the biological sample and that the sample shall be destroyed at the
end of the testing process or not more than sixty days after the sample
was taken, unless a longer period of retention is expressly authorized in
the consent; and
i. the signature of the individual subject of the test or, if that individual lacks
the capacity to consent, the signature of the person authorized to consent
for such individual.
8. For Genetic research as defined under section I.E. of this policy, also state
a. Whether or not participants will be informed of the results of genetic tests,
and if so, whether and how counseling will be performed.
b. If genetic tests may reveal other information unrelated to the study. For
example, in cases where parents and children are both tested, the test
may disclose the possibility that the father is not the biological parent.
Although these types of information will not be disclosed, the participant
must be informed about the potential findings.
9. Genetic research utilizing identified, stored human tissue for general research
purposes as defined under section I. E. of this policy, the consent language must
comply with NY CLS 79-9(e) as listed below. See Appendix ‘B’ attached to this
policy for template language.
a. A statement that the sample will be used for future genetic tests;
b. The time period during which the tissue will be stored, or if no time limit is
specified, a statement that the tissue will be stored for as long as deemed
useful for research purposes;
c. A description of the policies and procedures to protect patient
confidentiality;
d. A statement of the right to withdraw consent to use of the tissue for future
use at any time and the name of the organization that should be
contacted to withdraw consent;
e. A statement allowing individuals to consent to future contact for any or all
purposes, including the following: (i) research purposes; (ii) provision of
general information about research findings; and (iii) information about
the test on their sample that may benefit them or their family members in
relation to their choices regarding preventive or clinical care; and
f. A statement explaining the benefits and risks of consenting to future
contact for the purposes set forth in subparagraph 'e.' of this paragraph.
In no event shall information about specific test results on stored human
tissue donated for general research purposes be disclosed to an
individual without obtaining informed consent.
IV. POLICY FOR USE OF HUMAN EMBRYOS AND HUMAN EMBRYONIC STEM CELLS FOR
RESEARCH (Policy pending.)
V. PAYMENT FOR SPECIMENS
Specimens may not be sold. However, it is permissible to charge a reasonable processing fee,
subject to institutional approval by the Executive Dean of Albert Einstein College of Medicine or
designee, and/or the Director of the Research and Sponsored Programs of Montefiore Medical
Center, and other institutions that may be involved.
VI. SAMPLE INFORMED CONSENT LANGUAGE AND TEMPLATE
A. Sample Genetic Research (See Appendix A).
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B. Future Use of Specimens For Potential Human Research Template (See Appendix B
(identified specimens) and Appendix C (de-identified specimens)).
VII. MATERIAL TRANSFER AGREEMENT (MTA)
A. YU Employees
1. Specimens Sent to Another Entity
YU employees should refer to the AECOM Office of Biotechnology website at
http://www.aecom.yu.edu/biotechnology/ for an appropriate MTA when sending
materials to another entity (academic institution, non-profit, federal agency, or
commercial company). Refer to Section II. to determine if the research protocol
requires CCI/IRB review.
2. Specimen Received from Another Entity
YU employees must contact the AECOM Office of Biotechnology at 430-3357 to
sign an incoming MTA if they will be receiving materials from another entity
(academic institution, non-profit, federal agency, or commercial company).
Before requesting the signature from the Office of Biotechnology, CCI must
review the protocol. Refer to Section II.
3. An MTA is not required when specimens are sent to or received from another
entity (academic institution, non-profit, federal agency, or commercial company)
having a contract with the institution that addresses the exchange of material.
B. MMC employees are required to contact the Director of the Office of Research and
sponsored Programs for an appropriate MTA at 718 920-4151 Ex. 230 if they will be
receiving or sending materials to or from another entity (academic institution, non-profit,
federal agency, or commercial company).
C. NBHN employees are required to contact the Research Director for an appropriate MTA
at 718-918-7070 if they will be sending materials to another institution.
Dated: 6.01
Revised: 1.02
Approved by JCC 11.06
Revised 4.07
Revised 5.21.07
Revised 5.29.07
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APPENDIX ‘A’
Sample Template Including Instructions for Genetic Research
NY State Law and CCI/IRB definition of Genetic Test: New York Civil Rights Law Section 79-1 defines
a genetic test as:
a. "Any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the
presence of a genetic variation linked to a predisposition to a genetic disease or disability in the
individual or individual's offspring; such term shall also include DNA profile analysis. ‘Genetic
test’ shall not be deemed to include any test of blood or other medically prescribed test in
routine use that has been or may be hereafter found to be associated with a genetic variation,
unless conducted purposely to identify such genetic variation. The CCI/IRB also includes any
measurement of certain metabolites associated with heritable diseases as a genetic test.
b. "Genetic Predisposition shall mean the presence of a variation in the composition of the genes
of an individual or an individual’s family member which is scientifically or medically identifiable
and which is determined to be associated with an increased statistical risk of being expressed
as either a physical or mental disease or disability in the individual or having offspring with a
genetically influenced disease, but which has not resulted in any symptoms of such disease or
disorder."
CONSENT REQUIREMENTS:
I.
NYS Law requires the following information be included in the consent:
A.
PURPOSE (Why are we doing this research)
i.
Include –
a.
A simple explanation of the general description of each specific disease
or condition tested for.
b.
A statement that tests conducted under this research study may reveal
genetic information.
B.
GENETIC COUNSELING INFORMATION:
i.
A statement that the individual may wish to obtain professional genetic
counseling prior to signing the informed consent.
SAMPLE: You may wish to obtain professional genetic counseling prior to
signing the informed consent. A genetic counselor is a person qualified to provide
information about what the results of this type of test may mean to you and your
family. You or your insurance company will be responsible for the cost of these
services.
ii.
The level of certainty that a positive test result for that disease or condition
serves as a predictor of such disease. If no level of certainty has been
established, this subparagraph may be disregarded.
SAMPLE WHEN TEST SERVES AS A PREDICTOR: If the test is positive, it
means that there is a ____% chance you might have ….. you may wish to talk
with your doctor, go for another blood test or speak to a genetic counselor. If no
level of certainty has been established, this subparagraph may be disregarded.
C.
PROCEDURES (How will the test be done?)
Provide detailed information specific to your study.
SAMPLE: We will obtain 10 ml of blood from your arm by a needle stick when you come
to ……. This will only be done one time.
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D.
II.
ADDITIONAL TESTS ON YOUR SAMPLE
Include a statement that no tests other than those authorized shall be performed on the
biological sample and that the sample shall be destroyed at the end of the testing
process or not more than sixty days after the sample was taken, unless a longer period
of retention is expressly authorized in the consent.
SAMPLE: No other tests other than those explained under this study will be done on
your sample. The sample will be destroyed at the end of the research study.
Alternatively, include the CCI Future Use consent language. See Appendix B (identified)
or Appendix C (de-identified).
E.
WHO CAN CONSENT
The individual subject of the test or, if that individual lacks the capacity to consent, the
signature of the person authorized to consent for such individual must sign. An
authorized person is a health care proxy legal guardian.
CCI/IRB Policy requires the following information be included in the consent: (CCI/IRB policy
requirements and are in addition to the NYS Law requirement.)
A.
Whether or not participants will be informed of the results of genetic tests, and if so,
whether and how counseling will be performed.
SAMPLE: Since the significance of these tests are not known for you, we will not
disclose the results of the genetic testing. No formal counseling will be provided under
the research study. If you request, you will be referred to a genetic counselor. You or
your insurance carrier will be responsible for the genetic counselor’s fee.
OR
You will be told the results of the genetic tests and formal counseling will be provided
under the research study at no cost to you.
B.
If genetic tests may reveal other information unrelated to the study. For example, in
cases where parents and children are both tested, the test may disclose the possibility
that the father is not the biological parent. Although these types of information will not be
disclosed, the participant must be informed about the potential findings.
SAMPLE: Genetic tests may reveal medical information that is not related to this
research study. For example, in cases where parents and children are both tested, the
test may disclose the possibility that the father is not the biological parent. This
information will not be revealed to you and will remain confidential.
Dated: 6.01
Revised 1.02, 1.07, 1.09
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APPENDIX ‘B’
NOTE: This template is required when
obtaining specimens for future research that
will be identified (linked back to the original
donor).
See Appendix ‘C’ if the specimens will be deidentified.
APPENDIX ‘C’
NOTE: This template is required when
obtaining specimens for future research that
will be de-identified (not linked back to the
original donor).
When uncertain, use the Appendix ‘B’ template.
USE OF DE-IDENTIFIED SPECIMENS FOR
USE OF IDENTIFIED SPECIMENS FOR FUTURE FUTURE RESEARCH:
RESEARCH:
In addition to the research you are consenting to
under this research study, Dr. ________________
In addition to the research you are consenting to
under this research study, Dr. ________________ or other researchers at this or other institutions
may wish to study the samples in future research,
or other researchers at this or other institutions
may wish to study the samples in future research, including genetic analysis. These samples, taken
including genetic analysis. These samples, taken from your body, would NOT be linked back to you.
from your body, would be able to be linked back to No one will know your name or protected health
you. Information about you may be shared with
information.
other researchers who will keep the information
confidential. However, it is possible that
At this time, the researcher does not know what
information about you may become known to
the future studies will be. Your specimens may
people other than the researchers.
also be submitted to a tissue/cell/DNA bank. The
specimens may be kept for a long time and may
At this time, the researcher does not know what
exceed 50 years.
the future studies will be. Your specimens may
also be submitted to a tissue/cell/DNA bank. The
In some research using human blood or tissue, the
specimens may be kept for a long time and may
specimens and their parts may enable researchers
exceed 50 years. You have the right to withdraw
to develop medical tests or treatments that have
consent to use of the tissue for future use at any
commercial value. You will not receive any money
time by contacting the supervisor of the study
that may result from any such commercial tests or
named on the first page of the consent or the CCI treatments.
office at 718-430-2253. Unused specimens will be
destroyed.
Your specimens may be used for future research,
even though the purpose of the future research is
In some research using human blood or tissue, the not known at this time.
specimens and their parts may enable researchers
to develop medical tests or treatments that have
PARTICIPANT:
commercial value. You will not receive any money
PLEASE INDICATE YOUR CHOICE BY
that may result from any such commercial tests or
INITIALING ONE (1) OF THE FOLLOWING
treatments.
OPTIONS
Your specimens may be used for future research,
even though the purpose of the future research is
not known at this time.
PARTICIPANT:
PLEASE INDICATE YOUR CHOICE BY
INITIALING ONE (1) OF THE FOLLOWING
OPTIONS
___ I consent to have my specimens used for
T:\Procedural Manual\Policies\specimens.doc
___ I consent to have my specimens used for
future research studies.
___ I consent to have my specimens used for
future research studies only for the study of
_____________________________________.
___ I do NOT consent to have my specimens used
for future research studies. (The specimens will be
destroyed at the end of the study.)
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future research studies.
___ I consent to have my specimens used for
future research studies only for the study of
_____________________________________.
___ I do NOT consent to have my specimens used
for future research studies. The specimens will be
destroyed at the end of the study.
PARTICIPANT:
FOR FUTURE CONTACT, PLEASE INITIAL
YOUR CHOICES BELOW
I consent to be contacted in the future to learn
about:
_____ New research protocols that I may wish to
join.
_____ General information about research
findings.
_____ Information about the test on my sample
that may benefit me or my family members in
relation to choices regarding preventive or clinical
care.
_____ I DO NOT AGREE TO BE CONTACTED IN
THE FUTURE, EVEN IF THE RESULTS MAY BE
IMPORTANT TO MY HEALTH OR MY FAMILY'S
HEALTH.
Dated: 6.01
Revised 1.02, 1.07
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Albert Einstein College of Medicine of Yeshiva University
Office of Biotechnology
Request for Approval of an Outgoing MTA
Instructions: Complete and submit this form with the
Material Transfer Agreement (MTA)
to the Office of Biotechnology.
1. Investigator’s Name:
2. Name of Collaborating Institution:
3. What is the state of the specimens that you will be sending?
De-identified - (A human specimen that contains none of the 18 identifiers defined by the HIPAA
regulations, is not coded, and cannot be linked back in any way to the original donor. The 18 HIPAA
identifiers consist of the following data elements: Name; Address; All Elements of dates (except year);
Telephone Number; Fax Numbers; E-mail Addresses; Social Security Number; Medical Record Number;
Health Plan Beneficiary Number; Account Number; Certificate/License Number; Vehicle Identifiers and
Serial Numbers including License Plate Numbers; Device Identifiers and Serial Numbers; Web Universal
Resource Locators (URLs); Internet Protocol (IP) Address Numbers; Biometric Identifiers including
Voice/Fingerprints; Photos; or other unique number, characteristics or code (except as specified in ‘Coded’
below))
Coded - (A human specimen that is recorded in such a manner that subjects cannot be identified by the
researcher directly or through identifiers linked back to the original donor. The code must not utilize any
personal information of the subject, such as the 18 HIPAA identifiers listed in ‘De-Identified’, initials or the
last 4 digits of the Social Security number, etc.)
NOTE: If the specimens will be coded, confirm that “the key will not be released.”
I confirm that the key to decipher the code will not be released to the
consultants or collaborators under any circumstances.
Identified - (A human specimen that contains identifiers, such as the 18 identifiers listed above in ‘DeIdentified’ that make it possible for the investigator to link it back to the original donor.)
NOTE: Identified specimens may not be sent out of the institution without CCI approval (see below).
4. Other than by releasing specimens, does AECOM/MMC/NBHN have any involvement in the research?
No
Yes - If AECOM/MMC/NBHN is involved in the research, CCI approval is required (see below).
5. Name of person completing this form:
Date:
6. Investigator’s Signature:
Date:
Albert Einstein College of Medicine of Yeshiva University
Committee on Clinical Investigations (CCI)
Obtain CCI approval before submitting to the Office of Biotechnology only if:
Identified specimens will be released
or
AECOM/MMC/NBHN will be involved in the research.
7. CCI Number:
CCI Approval:
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Date:
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Albert Einstein College of Medicine of Yeshiva University
Office of Biotechnology
Request for Approval of an Incoming
Data Use Agreement (DUA) or Material Transfer Agreement (MTA)
Instructions: Complete and submit this form with the
DUA or MTA to the Office of Biotechnology.
1. Investigator’s Name:
2. Name of Provider Institution:
3. What will you be receiving?
Stem cells/cell lines or other pluripotent material (NOTE:
Einstein-Montefiore ESCRO approval is required.)
Cell lines (non-pluripotent)
Other human material (non-pluripotent)
Data
4. Are the data/materials identifiable to you?
Yes (go to Section C)
Section A: For de-identified data/material only:
What is the source of these data/materials?
Commercial/Governmental (Einstein IRB review is
not required, go to Question 5)
Other (for cell lines go to Section B,
for all other data/materials go to Section C)
Section B: For cell lines from non-Commercial/Governmental
sources:
No (go to Section A)
Section C: For all other data/materials:
Einstein IRB #:
Please Note:
a. The Provider Institution must be named as a
Protocol Site in your protocol. If it isn’t,
submit an amendment to the Einstein IRB.
b. Written approval from the Provider Institution
must be obtained and forwarded to the Einstein
IRB prior to initiating the collaboration.
Attach a copy of the IRB approval from the
deriver/provider and continue below.
5. Name of person completing this form:
Date:
6. Investigator’s Signature:
Date:
7. If applicable, obtain Einstein IRB approval and/or Einstein-Montefiore ESCRO approval
before submitting to the Office of Biotechnology.
Einstein IRB Approval:
Date:
Einstein-Montefiore
ESCRO Approval:
Date:
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Revised: 7/27/07, 9/19/11