IWK Research Ethics
USE OF TISSUE OR BODY FLUID
FOR RESEARCH PURPOSES
The Tri-Council Policy Statement requires that all research involving human substances follow TriCouncil Policy and have approval from an approved Research Ethics Board. This policy applies to
left over biopsy samples, primary cell lines, saliva, organs, excreta, rectal swabs and other tissue or
body fluids. The researcher will give evidence that the ethics review has been undertaken in an
Aarms-length@ manner, and that there is valid rational for the study.
A. Non-anonymous tissue or body fluid
The collection and use of human tissue for research purposes shall be undertaken with the free and
informed consent of competent donors.
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an Aarms length@ ethics review of the proposal
the free and informed consent of competent donors or
free and informed consent shall be by an authorized third party for incompetent donors
in the case of deceased donors, free and informed consent which has been expressed in a
prior directive or through the exercise of free and informed consent, by an authorized third
party, shall be respected
These principles generally apply prospectively, that is prior to the recovery of tissue intended for
research purposes. The general elements of free and informed consent: [TCPS 1998, Article 2.1].
Article 10.1 also apply when the tissue to be used in research is acquired incidentally from a
therapeutic interventions. Individuals who do not wish to contribute tissue to particular research
projects must be free to withhold consent without fear of penalty.
In prospective studies, for the purpose of obtaining free and informed consent, researchers who seek
to collect non anonymous human tissue for research shall, as a minimum, provide potential donors or
authorized third parties information about: [TCPS 1998 Article 10.2]
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the purpose of the research
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the type and amount of tissue to be taken, as well as the location where the tissue is to be
taken
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the manner in which the tissue will be taken, the safety and invasiveness of acquisition, and
the duration and conditions of preservation
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the potential uses for the tissue including any commercial uses
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the safeguards to protect the individuals privacy and confidentiality
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identifying information attached to the specific tissues, and its potential traceability;
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how the use of tissue could affect privacy and
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any research on biological tissues which may result in significant benefit to the individual or
third parties, need for information, or significant harm, such as molecular genetic studies,
requires consent be obtained.
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This information may be appended to the surgical consent form and the consent for autopsy form at
the time such consent is obtained.
B. Anonymous Tissue or Body Fluid
Research on anonymous or anonymized tissues also requires review by the REB. A request form is
available at Laboratory Services Office or at the Research Services Office.
Unless applicable law so requires permission of the donor is not required :
$
if collected tissue has been provided by persons who are not individually identifiable, (i.e.
anonymous and anonymized tissue) AND
$
if there are no potential harms to them
Research using stored body fluids tissues or organs also requires review and approval by the IWK
REB.
Extraordinary cases should be dealt with individually by the researchers to the satisfaction of the
REB. Requests for the REB should be submitted to the Research Services Office at any time by
providing information as outlined on the AUse of Tissue or Body Fluid for Research@ form.
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THE IWK HEALTH CENTRE
Application for Ethical Approval of Studies Involving
Use of Tissue or Body Fluid for Research
1.
Principal
Investigator
Dept. /Program
Signature
Co-Investigator(s)
Dept. /Program
Signature
Dept. /Program
Signature
These signatures confirm that the co-investigators have read the proposal and agree to
participate in the research described in this application.
2.
Project Title
3.
Funding
In addition to completing this form, a study budget must be submitted

Available:
Amount $
IWK Account #
Funding Source:


4.
Requested For: Amount $
Funding Source:
Deadline
Funds not required for the conduct of the research.
Sponsoring Company (if applicable)
(a) Please disclose actual, perceived or potential conflicts of interest of the researchers,
department, institution etc. e.g. commercial interests, consultative relationships.
(b) Has a contract between the researcher(s) and company been reviewed
 Yes
 No
*The Tri-Council Policy Statement requires that all research involving human substances be conducted with
ethical approval. This includes leftover biopsy samples, primary cell lines, saliva, organs, excreta, and rectal
swabs
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5.
Will the subject who provides the material be known to you? No 
Yes

No 
Yes

No 
Yes

Names of subject (if known):
6.
Is the person who will collect the material known to you?
Name:
7.
Is the Physician caring for this subject known to you?
Name:
8.
Potential harms or benefits to subjects
Is the donor identifiable or is the tissue truly anonymized (i.e. no possibility of traceback to
the donor)?
 identifiable
 anonymized
9.
Objectives of Study
(Must be written in simple language - grade 6 reading level)
10.
Background and Rationale
(May refer to appended materials in lieu of completing this section)
11.
What methods were used to calculate sample size?
12.
How will the data be analysed statistically?
13.
Ascertainment of subjects
Cases - Number
Patient Diagnosis/Diagnoses
Controls - Number
14.
Check the tissue/human substances that will be obtained for the study
leftover biopsy leftover excised tissue excised organ primary cell lines saliva
excreta rectal swabs urine other explain:
15.
What is the primary purpose for obtaining the tissue?
clinical autopsy research research and clinical
therapeutic procedure (eg. surgery)
other explain:
diagnosis
16.
Will identifying information (paper or electronic) be retained on the samples?
 Yes
 No If yes, what
17.
Will linkage to patient records be sought? be possible with
 Yes
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 No If yes, how will it be sought?
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18.
Will consent be obtained from these subjects for this Research?
 Yes
 No
If yes, provide copy of consent form
19.
If the answer is ANo@ please justify below.
20.
Will the result of the study be provided to the subject?
 Yes
21.
 No
Could the study results lead to a discovery of:
 genetic condition
If so, is there
 potential benefit
 non paternity  an unsuspected condition
If so, is there
 potential benefit
22.
 potential risk  no apparent benefit?
 potential risk
 no apparent benefit?
Is Monitoring proposed?
 for data integrity
 for lab integrity
 for compliance with consent (if required)
 for compliance with anonymization
procedure
23.
Does the research have potential for commercial use or profit:
 Yes
(If so the subject=s ownership needs to be disclaimed in the consent form)
 No
24.
May there be leftover tissue on completion of the research?
 Yes
 No
(If yes, provide your plan for the leftover tissue. Because the left over samples may represent
a valuable non-renewable resource, and at the same time a potential threat to the privacy of
subjects, justification is required for either discarding or banking the tissue).
Research Services Office Use:
Reviewed by:
Comments:
Approved by:
Date:
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