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Application and Instructions to request Human Biological Materials and/or Data

Information is available at and by contacting us through

Instructions and Guidelines

  1. Confirm Sample Availability. The availability of suitable samples can be confirmed by contacting the ACRB at .
  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 . Expected time lines are listed in Appendix 1. A complete application package includes:
  4. Application form, typically signed by the individual who holds the Ethics Protocol
  5. A scientific abstract
  6. C.V. of Applicant
  7. Ethics Protocol plus relevant amendments
  8. Letter of Approval from the REB for the Ethics Protocol
  9. 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.
  10. Invoicing and shipment of materials will be arranged.
  11. 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.
  12. The ACRB may contact the applicant researcher to request information with regard to publications that relate to the use of HBMs.
  13. 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 ().

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 / E-mail Address

Additional co-investigators (please attach list)

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:

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): Gold Silver

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 / Describe Inclusion/Exclusion Criteria:

Will you request access to de-identified clinical data? Yes No

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/orDate

Grant Holder

______

Signature of the Co-Researcher and/or Date

Grant Holder

Appendix 1.ACRB Application Process Summary

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.

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 / Silver
Time from harvest / Harvested directly from the participant, from either an intra-operative biopsy or ASAP≤30 min following surgical resection. / Harvested ASAP following specimen removal within a range of > 30 min following surgical resection.
Suitable for the following types of research studies / Post-translational modifications of proteins; Proteins and mRNAs with short life spans; Whole genome transcriptome analysis, etc. / Proteomic or gene expression studies.
Availability / Anticipate being 50 – 80 % of cases / 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 storageof 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 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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