MODULE THREE:
PROJECTS INVOLVING USE OF HUMAN TISSUE
SAMPLES
BEFORE YOU BEGIN
Researchers should read Module Three: Projects Involving Use of Human Tissue
Samples – Guidelines before completing this form. Please note that this form also
covers Human Genetic Research.
PROJECT TITLE:
HREC # (if known):
3.1
Purposes for Which the Samples Will Be Used
Indicate the purposes for which the samples in this research will be used (tick all
that apply)
Research-related biochemistry or pathology tests
Diagnostic tests
Pharmacogenetic/pharmacogenomic tests
Genetic analysis
Genetic testing
Storage for future use in this research
Storage for future use in other research
Storage in a Tissue Bank (name the Tissue Bank:
)
Other (please specify)________________________________
3.2
Source of Human Tissue Samples
What is the source of the sample/s you wish to use? (tick all that apply)
Obtained from participants involved in this research project
Obtained from patients undergoing treatment who are not part of this
research project
Obtained from a Tissue Bank
Obtained from tissue archives
Other (specify):
Module Three, Version 2 - January 2008
Page 1 of 9
Name the institution/s or organisation/s from which the sample/s is/are being
obtained.
3.3
Type and Volume/Size of Samples
(a)
What are the type, volume/size and number of sample/s you wish to use and the
purpose for which you wish to use them? Give details, for example: 20 x 10mls
whole blood, 20 x 1ml blood plasma, arterial blood vessels 10mm length, uterine
muscle 10mm x 2mm x 2mm. Also include the number of paraffin blocks, e.g. 20
paraffin blocks. An example of a response is as follows:
TYPE OF SAMPLE
Urine
Bowel tissue
VOLUME/SIZE OF SAMPLE
10ml
5x2x2mm
TYPE OF SAMPLE
(b)
VOLUME/SIZE OF SAMPLE
NUMBER
40
10
NUMBER
Are these samples being collected for
routine diagnostic purposes and later use for research?
research purposes only?
3.4
(a)
Collection and Processing of Fresh Tissue
By whom will the sample/s be collected and processed? An example of a
response is as follows:
TISSUE TYPE
Bowel tissue
COLLECTED BY
Surgeon
TISSUE TYPE
(b)
COLLECTED BY
PROCESSED BY
Site pathology lab
PROCESSED BY
Will collection of the sample/s involve any increase in risk to the participant
greater than the risk associated with the planned therapeutic/diagnostic
procedure?
Yes
No
Not applicable
If Yes, give details.
Module Three, Version 2 - January 2008
Page 2 of 9
3.5
Consent to Use Fresh Tissue
Will consent be obtained to use fresh tissue for this research? Yes
No
If Yes, will consent be sought to use fresh tissue:
For this research only (specific consent)
For future research that is an extension of, or closely related to, this
research project; or use in the same general area of research (extended
consent)
For any future research (unspecified consent) [NS 2.2.14]
If No, justify why consent will not be sought.
3.6
Consent to Use Stored Tissue (Banks/Archives)
(a)
At the time of collection of the stored sample/s for which purpose/s was consent
obtained? (Tick all that apply)
Diagnostic/therapeutic use
Previously approved research project
Specify HREC project # and institution:
Donor specified research
Unspecified research (further consent required)
Unspecified research (no further consent required)
Unknown or for another specified purpose (elaborate below)
(b)
Do you propose to obtain further consent from individual donors for your use of
their stored samples in this research?
Yes
No
If No, provide justification for not seeking further consent.
(c)
Will the tissue be imported from another country for use in Australia? [NS 3.4.4]
Yes
No
If Yes, state the country and provide details of its ethical and professional policies
governing the collection of tissue for use in research. [NS 3.4.4]
Module Three, Version 2 - January 2008
Page 3 of 9
3.7
If Yes, did the tissue collection exist overseas, or was it imported to Australia,
before 2007? [NS 3.4.4(c)]
Yes
No
Consent to Use Cadaveric Tissue [NS 3.4.8 & 3.4.9]
(a)
Do you propose to use tissue obtained post-mortem?
Yes
answer b and c below
No
proceed to question 3.8
(b)
If Yes, will this be
in accordance with donors’ expressed wishes
with the consent of the senior available next of kin
(c)
If next of kin consent is being sought, describe how you will ensure that the
tissue will be disposed of in accordance with their wishes.
3.8
Storage of Sample/s and Data
(a) Give details of how you will ensure that all samples and/or data used in this
research will be stored securely following collection [NS 3.4.1-3.4.3].
(b)
Describe how you will monitor storage and use of the sample/s and/or data [NS
3.4.1-3.4.3].
3.9
Tissue Banking
Does this research involve the collection of sample/s with the intent to establish
or contribute to a Tissue Bank?
Yes
No
If Yes, give details regarding how the samples and data will be gathered, secured
and released [NS 3.2.1, 3.2.3, 3.2.6]. Include the name of the custodian of the
bank and indicate whether this custodian is independent of tissue/data collectors
and researchers [NS 3.2.5, 3.2.7].
3.10 Genetic Register
Does this research involve the collection of data with the intent to establish or
contribute to a Genetic Register?
Yes
No
If Yes, give details regarding how the data will be gathered, secured and
released. Include the name of the custodian of the register and whether this
custodian is independent of data collectors and researchers. [NS 3.2.7].
Module Three, Version 2 - January 2008
Page 4 of 9
3.11 Cell Lines
Does this research involve the development of one or more cell lines?
Yes
No
If Yes, give further details, including any anticipated commercial development
and sharing of the cell line/s with other researchers.
3.12 Protection of Privacy
(a)
In what form will the sample/s and/or data be supplied to the research team?
Individually identifiable
Re-identifiable (Coded)
Non-identifiable data*
*Note: The National Statement specifies that “human tissue samples should always be
regarded as, in principle, re-identifiable”. [NS p.29]. Also note that identifiers should
not be removed without participant consent if removal would make it difficult to
communicate personal results. [NS 3.5.5(a) and 3.4.6]
(b)
If the sample/s and/or data will be individually identifiable or coded, how do you
propose to protect the privacy of the donor with respect to recording, storage and
release of the sample/s and/or data?
(c)
Will the sample/s and/or data collected and used be destroyed once the research
is completed?
Yes
No
If No, explain why the sample/s and/or data will not be destroyed, and who will
have access to them in the future.
(d) Will medical records or other data sources be accessed to obtain information to be
stored and/or used in association with the samples?
Yes
No
If Yes, provide details regarding how privacy issues will be addressed (or refer to
relevant sections of your application).
(e) Have all of the relevant points above been addressed in the Participant
Information and Consent Form? (Note: the HREC will normally require this). [NS
3.4.5]
Yes
No
Module Three, Version 2 - January 2008
Page 5 of 9
If No, provide details and explain why specific information has not been included.
3.13 Genetics
(a)
Does the proposed research involve any form of
(i) Analysis of genetic material
Yes
No
(ii) Genetic testing
Yes
No
If Yes to (ii), complete questions 3.13(b) – 3.13(e).
If No to (ii), proceed to question 3.14.
(b)
Does the testing involve participation of the following:
(i) Specific research participants Yes
No
(ii) Families
No
Yes
If Yes to families, outline the arrangements for obtaining consent from the family
member/s (refer to National Statement 3.5.8 – 3.5.10).
(c)
Does the proposed research require confirmation of information provided by
research participants about their families?
Yes
No
If Yes, outline the arrangements for obtaining verification and/or consent from
the family member/s.
(d)
Does the proposed research have the potential to generate information that may:
(i) Be relevant to the health of family members who are not part of this study?
Yes
No
(ii) Result in potential harm to individuals or their families?
Yes
No
(iii) Reveal information about an identifiable participant’s future health or risk of
having children with a genetic disorder?
Yes
No
(iv) Identify non-paternity, non-maternity or non-relationship to siblings?
Yes
No
Module Three, Version 2 - January 2008
Page 6 of 9
If the answer to any of 3.13(d) is Yes, describe your plan for either disclosing or
withholding that information, and justify why you propose to manage it in this way.
[NS 3.5.1] (Refer to National Statement 3.5.2 and 3.5.3 for details of what this plan
should take into account.)
If the answer to any of 3.13(d) is Yes, describe how qualified genetic counselling will
be made available to participants and/or family members. (Refer to National
Statement Chapter 3.5.2(b))
(e) Is there a risk that the research may be misrepresented or misused in ways that
lead to prejudice, disrespect or other harm to participants or communities?
Yes
No
If Yes, how will you counter the possibility of such harm? [NS 3.5.4]
(f)
Will participants be advised of the following:
(i) Whether the research has the potential to generate information that they may
be legally required to disclose to a third party (e.g. insurer, employer)? [NS
3.5.12 (a)]
Yes
No
(ii) That their genetic material or information may have uses unrelated to
research, and will not be released for such uses without their consent unless
required by law? [NS 3.5.12 (b)]
Yes
No
(iii) About any proposal, subject to their consent, to store their genetic material
and data for future as-yet-unspecified research? [NS 3.5.12 (c)]
Yes
No
N/A
(iv) That if they do not consent to ‘future use’, their samples and data will be
disposed of once sample storage and record-keeping requirements have been
met? [NS 3.5.12 (d)]
Yes
No
(v) That their wishes about the method for disposing of their tissue will be taken
into account at the time of disposal? [NS 3.5.12 (e)]
Yes
No
N/A
(vi) That they are free to withdraw from the research, and request that their
genetic material and data be disposed of (or any practical limitations on the
granting of this request)? [NS 3.5.12 (f)]
Yes
No
(vii) That, if the research involves studying large numbers of genes, they will not
be given the names of all individual genes being studied? [NS 3 5.12 (g)]
Yes
No
N/A
Module Three, Version 2 - January 2008
Page 7 of 9
If you answered No to any of the above, explain why they will not be advised.
3.14 Cultural or Religious Sensitivities
Are there cultural or religious sensitivities to be considered in relation to the
collection use and/or storage of the tissue sample/s?
Yes
No
If Yes, what are they and how will they be managed?
3.15 Institutional Policy
Does the research conform to policy at the relevant institution/s regarding the
collection, storage, use and disposal of tissue samples for research? [NS 3.4.3]
Yes
No
If Yes, briefly outline how this will be done. [NS 3.4.3]
3.16 Post-Study
(a)
Is the tissue research likely to produce information relevant to the health and
well-being of the donor?
Yes
No
If Yes, give details.
If No, do not complete questions 3.16(b) – 3.16(d); go to question 3.16(e).
(b)
Will this information be made available to the donor?
Yes
No
If yes, provide details of
(i) the procedures for identifying participants for appropriate follow-up [NS 3.4.6]
(ii) who will be responsible for communicating this information to participants
and how will this information be communicated (eg telephone call, individual
letter, copy of publication, consultation with a medical practitioner or other)?
(i)
(ii)
If you will not be contacting research participants please explain why.
Module Three, Version 2 - January 2008
Page 8 of 9
(c)
Where will this information be stored (eg in the research files, with the
participant’s medical record)?
(d) Have all of the relevant points above been addressed in the Participant
Information and Consent Form? (Note: the HREC will normally require this).
Yes
No
If No, provide details and explain why specific information has not been included.
(e) Specify the procedure/s to be followed if a participant, or a relative of a living or
deceased participant, requests access to stored samples or data generated by this
research.
Module Three, Version 2 - January 2008
Page 9 of 9