Request for Use of Human Tissue Samples in Research

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1
Request for Use of
Human Tissue Samples in Research
For Office Use Only:
Date Received:
REB # ___________________
1.0 Purpose
This form is for research involving human biological materials; this applies to materials derived from living and
deceased individuals. Human biological materials include tissues, organs, blood, plasma, skin, serum, DNA,
RNA, proteins, cells, hair, nail clippings, urine, saliva and other body fluids (TCPS2 Article 2.1.b).
2.0 Instructions
Submit ONE Signed Softcopy of this form along with all attachments to compliance@uoit.ca. Hand written
forms OR hardcopies will NOT be accepted as an official submission. NO Research with human tissue samples
shall commence prior to receiving Approval from the Research Ethics Board.
Section 1: Principal Investigator Information (Students cannot be PI’s)
Name:
Title & Position:
Faculty:
UOIT Banner ID:
Telephone:
Email:
Section 2: General Information
Title of Research Project:
Anticipated Start Date:
Anticipated End Date:
Are any other organizations involved in this research?
Yes
No
If Yes, please list them
Office of Research Services ~ 2000 Simcoe St. N. Oshawa ON ~ Phone 905 721-8668, ext. 3693
Research Project Completion Form
2
Section 3: Research Project Information
a. In lay language, describe the purpose (objectives) and rationale of the proposed project. Please include
the hypothesis(es) & research questions to be examined.
300 words or less
b. State what type of human tissue sample you wish to use and how it was obtained.
c. If obtained from an organization other than UOIT, has that organization granted approval for it to be
used in this research?
Yes
No * If YES, please attach a copy with this submission
d. Does the material pose any potential Biosafety hazard?
Yes
No
If YES, please state the potential hazard
e. Has approval been sought from the Biosafety Committee?
Yes
No
* if YES, please state the date of this approval
f. Are there any commercial implications for this research?
Yes
No
If YES, please state what they are
Section 4: Storage & Disposal Information
a. Explain how you will store any unused material.
b. Explain how you dispose of any used or unused material.
Section 5: Consent, Confidentiality & Anonymity
a. Is the donor identifiable by the researcher?
Yes
No
If Yes, please provide a copy of the consent(s) given.
If No, please complete the following:
i.
Has the donor given consent for the tissue to be used in the original research?
Yes
No
Unsure
ii.
Has the donor given consent for the tissue to be used in subsequent research?
Yes
No
Unsure
Section 6: Benefits
a. Outline briefly the value and expected outcomes of the research.
Office of Research Services ~ 2000 Simcoe St. N. Oshawa ON ~ Phone 905 721-8668, ext. 3693
Research Project Completion Form
3
Section 7a: Principal Investigator Signature
I certify that the information provided in this Form is complete and accurate.
I will report any Serious Adverse Events (SAE) to the Ethics & Compliance Officer and the REB Chair as
soon as possible or no more than 3 days after the event.
I will seek approval to any changes or amendments to the protocol listed here before implementing them.
I will complete an Annual Renewal Request for this project if it is continuing beyond the one year
approval.
I will submit a Completion form to the Ethics & Compliance Officer once research has been completed.
I have complied with the Tri-Council Policy Statement and UOIT’s policies and procedures governing the
protection of human participants in research.
X
Signature of Principal Investigator
Name:
Date: DD/MM/YYYY
Section 7b: Co- Investigator Signature
I certify that the information provided in this Form is complete and accurate.
I will report any Serious Adverse Events (SAE) to the Ethics & Compliance Officer and the REB Chair as
soon as possible or no more than 3 days after the event.
I will seek approval to any changes or amendments to the protocol listed here before implementing them.
I will complete an Annual Renewal Request for this project if it is continuing beyond the one year
approval.
I will submit a Completion form to the Ethics & Compliance Officer once research has been completed.
I have complied with the Tri-Council Policy Statement and UOIT’s policies and procedures governing the
protection of human participants in research.
X
Signature of Co-Investigator
Name:
Date: DD/MM/YYYY
Office of Research Services ~ 2000 Simcoe St. N. Oshawa ON ~ Phone 905 721-8668, ext. 3693
Research Project Completion Form
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