Biosample Application Form - Alberta Cancer Research Biobank

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Application and Instructions to request Human
Biological Materials and/or Data
Information is available at www.abtumourbank.ca and by contacting us through
biobank@albertahealthservices.ca
INSTRUCTIONS AND GUIDELINES
1. Confirm Sample Availability. The availability of suitable samples can be confirmed by
contacting the ACRB at biobank@albertahealthsercives.ca.
2. Ethics Approval: Before submitting an application package for Human Biological
Materials (HBMs) and/or data from the ACRB, the applicant must obtain approval for the
research study from the applicant’s local/institutional Research Ethics Board (REB).
3. Submit Application Package: After obtaining REB approval, please refer to the flow
diagram in Appendix 1 for an outline of next required steps. A completed application
package can be submitted to the ARCB staff or through
biobank@albertahealthsercives.ca. Expected time lines are listed in Appendix 1.
A complete application package includes:
a. Application form, typically signed by the individual who holds the Ethics Protocol
b. A scientific abstract
c. C.V. of Applicant
d. Ethics Protocol plus relevant amendments
e. Letter of Approval from the REB for the Ethics Protocol
4. Execute Material Transfer Agreement (MTA): Upon approval of the application the
ARCB staff will prepare the MTA and provide these to the applicant for signatures.
5. Invoicing and shipment of materials will be arranged.
6. By requesting and accessing HBMs from the ACRB, the applicant(s) must acknowledge
the ACRB (Alberta Cancer Research Biobank supported by the Alberta Cancer
Foundation) in all relevant publications (Materials and Methods section), presentations
and speaking engagements. The ACRB will provide contact information for researchers
who receive HBMs to the Alberta Cancer Foundation (ACF), who may contact
researchers for assistance with providing information to ACF donors.
7. The ACRB may contact the applicant researcher to request information with regard to
publications that relate to the use of HBMs.
8. The researcher(s) are encouraged to provide feedback to the ACRB on the quality of
HBMs received following their research investigations, provide recommendations to
further improve the service, and give permission to list names of researcher(s) on the
ACRB web page.
A Fee Schedule is available upon request via email (biobank@albertahealthservices.ca).
Contact: biobank@albertahealthservices.ca
IDENTIFICATION
Name and Educational Qualifications (MD, PhD, etc.) of Applicant Investigator:
Employer(s) of Applicant Investigator:
Mailing Address:
Phone Number:
Fax Number:
Email Address:
Courier Name:
Courier Account No.:
Please list ALL co-investigators who will be using the requested materials and/or
data:
Name and Educational
Qualifications
Primary Employer
Additional co-investigators (please attach list)
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E-mail Address
Contact: biobank@albertahealthservices.ca
RESEARCH PROPOSAL
Title of Proposed Research:
Pilot Study
Fully funded proposal
Funding Source(s) / Granting Agencies:
Amount of Funds Available for this Research Project:
$
RESEARCH ETHICS BOARD (REB) OR COMMITTEE APPROVAL
Name of REB:
Location of REB:
Summary of materials previously received from the ACRB:
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Contact: biobank@albertahealthservices.ca
MATERIALS REQUESTED
Are you requesting human biological materials for research? Yes
No
Blood
Serum*
Plasma*
RBCs
DNA, prepared from Buffy Coat
*Serum and Plasma may be thawed once for aliquoting
FFPE Sections (Tumor Tissue only)#
#Tumor
Bank offers FFPE materials from a subset of participants through our Open Source
sample collection. In addition, clinical FFPE materials are held by regional Pathology and
Laboratory Services. Costs vary depending on number of sections of FFPE material/case. Please
specify if Tissue Micro Arrays (TMAs) are required in addition to slides.
Snap Frozen Tissue (check all that apply)
Tumor Tissue
Regional Metastasis Tissue (lymph node)
Distant Metastasis Tissue
Normal Tissue Adjacent to Tumor
Normal Tissue (no adjacent tumor tissue)
If you are requesting snap frozen tissue, please specify the quality of tissue that you are
requesting (please see Appendix 2 for Definitions)
Snap frozen tissue quality requested (check all that apply):
Describe Inclusion/Exclusion Criteria:
Criteria that HBMs
and participant clinical
information must meet
(e.g., age, gender,
histological type, etc.)
Specify the cancer
type (breast, ovarian,
etc.) and the material
type requested
(primary tumor tissue,
DNA, etc.)
Specify number(s) of
materials/participants
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Gold
Silver
Contact: biobank@albertahealthservices.ca
Will you request access to de-identified clinical data?
Yes
No
**Please list data elements you may require**
Documents to Attach:
A scientific abstract
A brief CV of the applicant researcher with publications relevant to the proposed research
Proposal and or/ Application and Amendments submitted to a local Research Ethics Board
Approval Letter from the local REB
_________________________________________
Signature of Researcher and/or
Grant Holder
_________________________________________
Signature of the Co-Researcher and/or
Grant Holder
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_________________________
Date
_________________________
Date
Contact: biobank@albertahealthservices.ca
Appendix 1. ACRB APPLICATION PROCESS SUMMARY
Researcher
Feedback
Submit
Clarification of
Inclusion Criteria
(1 Week)
Review
Tumor Bank
Staff Delegate
Review
Tissue
Distribution
Committee (TDC)
Submit
Application
for Review
(2 Weeks)
Adapted from Application
Research Agreement
and
Material Transfer
Agreement
Negotiate/
Approve
Repository
Owner or
Delegate
Data/Sample
Release &
Invoicing
Stages in the application and application review process. Timelines in parenthesis above
are approximations based on a standardized request of ~100 individually de-identified
solid tissue/serum/plasma samples from one cancer site. An application may require
additional time for processing if they include: multiple HBM types, multiple cancer sites, a
larger sample size, paraffin embedded tissue, and DNA isolation. Applicants can expect
longer timelines if additional information is required to determine specimen availability.
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Contact: biobank@albertahealthservices.ca
Appendix 2. DEFINITIONS
Levels of frozen tissue quality. Please see the table below for details. If no level of specimen
quality is indicated in the request, the Tumor Bank will supply Silver quality tissue. Devitalization
times are provided for each sample released.
Gold
Harvested directly from the
Time from
participant, from either an intraoperative biopsy or ASAP ≤ 30 min
harvest
following surgical resection.
Post-translational
modifications of
Suitable for the
proteins; Proteins and mRNAs with
following types of
short life spans; Whole genome
research studies
transcriptome analysis, etc.
Anticipate being 50 – 80 % of
Availability
cases
Silver
Harvested ASAP following
specimen removal within a
range of > 30 min following
surgical resection.
Proteomic or gene expression
studies.
Anticipate being 20 – 50 % of
cases
Alberta Health Information Act (HIA): Government legislation that sets out rules respecting the
use and disclosure of health information for research purposes in Alberta.
Alberta Health Services Non-identifying Health Information Standard: A standard set by
Alberta Health Services which, when applied to a dataset, determines if the information is
individually identifying or non-identifying.
Applicant researcher: The researcher submitting the Tumor Bank application form to request
the release of HBMs and a principle investigator of the research project using the released HBMs.
Data Matching: “data matching” means the creation of individually identifying health information
by combining individually identifying or non-identifying health information or other information
from 2 or more electronic databases, without the consent of the individuals who are the subjects
of the information (Health Information Act, R.S.A. 2000, c H-5, s. 1 (1)(g))
Devitalization Time: The period of time between removal from the body and the flash
freezing/FFPE storage of a tissue specimen.
Formalin Fixed, Paraffin Embedded (FFPE): Fixed tissue samples embedded in paraffin wax,
ready to be sectioned for histological review.
Human Biological Materials (HBMs): Available human biospecimens in the Tumor Bank’s
collection (Flash Frozen Tissue, Paraffin Embedded Tissue, Urine, DNA from Buffy Coat, Red
Blood Cells, Serum and Plasma).
Individually Identifying: “individually identifying”, when used to describe health information,
means that the identity of the individual who is the subject of the information can be readily
ascertained from the information. (Health information Act, R.S.A. 2000, c H-5, s.1 (1)(p))
Material Transfer Agreement: An agreement to transfer tangible materials (such as human
biological materials) between Alberta Health Services and a recipient institution.
Notification of Intent: A document completed prior to the Tumor Bank Application Form outlining
a researcher’s intention to request human biological materials and/or data.
Research Ethics Board (REB): An independent body (a review board or a committee,
institutional, regional, national or supranational) constituted of medical and scientific professionals
and non-medical members, whose responsibility it is to ensure the protection of the rights, safety
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Contact: biobank@albertahealthservices.ca
and well-being of human subjects involved in research and to provide public assurance of that
protection, by, among other things, reviewing and approving/providing favorable opinion on, the
research project, the suitability of the investigator(s), facilities, and the methods and material to
be used in obtaining and documenting informed consent of the research program participants.
Tissue Distribution Committee (TDC): The Tumor Bank’s Tissue Distribution Committee (TDC)
is responsible for the authorizing the release of samples and or data through the Tumor Bank’s
application and review process.
ACRB application form: This document is the foundation of review by the TDC and serves the
purpose of formally identifying the contact information and educational qualifications of the
applicant PI and co-investigators, the project’s research proposal and available funding, local
REB approval(s) and HBMs and/or data requested.
Tumor Bank Staff Delegate: The Tumor Bank staff member assigned to service the applicant
researcher’s request for human biological materials throughout the entire application process.
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