VIFM INFORMATION
Ethics Committee Charter
DATE EFFECTIVE: 11/10/2011
NEXT REVIEW DATE: 11/10/2013
PURPOSE AND OBJECTIVES
1.
The Council of the Victorian Institute of Forensic Medicine (“the VIFM”) has appointed an Ethics
Committee to assist it in fulfilling its governance responsibilities relating to the ethical approval of
research projects and consideration of ethical issues, including the approval of research as required
by section 64(2)(e) of the VIFM Act 1985.
2.
The Council has delegated certain functions to the Ethics Committee, as set out below.
3.
The VIFM Ethics Committee will consider:
a.
applications for research projects involving the use of a deceased person or human tissue
retrieved from a deceased person whose death has been reported to the coroner
b.
applications for research projects involving the use of information collected, generated and
or/stored at the VIFM in the exercise of its statutory objects and functions
c.
any other questions of ethics affecting the operation of the VIFM as referred by the Director
of VIFM or the VIFM Council. These matters do not include issues concerning the conduct of
individual employees.
For example, in the past the VIFM Ethics Committee has considered the following issues:
d.
4.
o
the Institute’s policies in relation to the retention and storage of organs and
tissues, and
o
the Institute’s policies in relation to the approach to the relatives of deceased
persons for permission to retain and use organs and tissues.
and advise the VIFM Council on the development of guidelines and policies relating to the
ethical aspects of research at the VIFM.
The Committee shall:
a.
conform to the National Health and Medical Research Council (NHMRC) National Statement
on Ethical Conduct in Research Involving Humans and the legislative framework including the
Coroners Act 2008 (CA 2008), the Victorian Institute of Forensic Medicine Act 1985 (VIFM Act
1985) and the Human Tissue Act 1982 (HTA 1982);
b.
consider local, cultural and social attitudes in making decisions, and
c.
prescribe best practice guidelines and procedures relating to obtaining consent and
providing information to families, which must be open and accountable and recognise the
rights
of
families
and
the
need
to
maintain
confidentiality.
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VIFM Ethics Committee Charter
REPORTING RESPONSIBILITY & ACCOUNTABILITY
5.
The VIFM Council is VIFM’s governing body as provided by section 67(1) of the VIFM Act 1985. The
Ethics Committee is a standing Committee of Council.
6.
The VIFM Ethics Committee is accountable to the NHMRC through its registration with this body.
Registration with the NHMRC requires compliance with the NHMRC National Statement on Ethical
Conduct in Human Research and annual reporting to the NHMRC for monitoring purposes.
7.
The VIFM Ethics Committee is also accountable to the Health Services Commission for the use of
health information for a research purpose. The VIFM Ethics Committee is required to submit an
annual report to the Health Services Commission on research projects that have used health
information.
8.
The proceedings of all committee meetings will be minuted.
9.
The Committee reports to the Council by the tabling of approved minutes after each meeting and by
submitting an annual report of activities. It is the role of the VIFM Council representative on the VIFM
Ethics Committee to discuss any issues that arise from the minutes of each VIFM Ethics Committee
meeting with the Chair of the Ethics Committee before reporting to the VIFM Council if and when
required.
10.
The Chair of the VIFM Ethics Committee will meet with the Chair of the VIFM Council twice yearly to
report on general issues.
11.
The Chair of the VIFM Ethics Committee will provide a list of approved research projects to the
Coroners Court of Victoria Research Committee following each meeting.
12.
A report of the activities of the VIFM Ethics Committee will be included in the VIFM Annual Report.
AUTHORITY
RESEARCH
13.
The objects of the Institute are set out in section 64(2) and include:
(e) to conduct research in the fields of forensic pathology, forensic science, clinical forensic medicine
and associated fields as approved by the Council, and
(ha) to contribute to reducing the number of preventable deaths and to promote public health and
safety and the administration of justice.
TISSUE
14.
Section 64(2)(i) of the VIFM Act 1985 provides that the objects of the VIFM are to provide tissue
banking facilities and services referred to in section 66(4) of the Act.
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15.
Tissue for research is provided to researchers under the authority of section 26(2) of the HTA 1982.
Under this section the Institute obtains the consent of the senior next of kin to remove and donate
tissue for the purposes of research. If the case is one in which the coroner has or may have
jurisdiction to investigate the death, section 27(2) of the HTA 1982 provides that section 26(2) does
not operate unless a coroner has given consent to the removal of tissue from the body of the
deceased person. The Institute therefore must obtain the consent of the coroner unless a coroner
gives direction pursuant to section 27(3), that his or her consent is not required.
16.
Tissue that has been removed for the purposes of an autopsy directed by the coroner (stored tissue)
may be provided for a research purpose under the authority of section 30(3) of the HTA 1982. This
provision does not require the specific consent of the senior next of kin. The NHMRC National
Statement provides that the Ethics Committee must determine a waiver of consent in accordance
with paragraph 2.3.6.
17.
Please refer to Appendix A for a more detailed discussion of the legislative authority for the donation
of autopsy tissue for research.
DATA
18.
The VIFM collects, produces and holds data in the course of performing its legislative objects and
functions as an independent statutory authority. Researchers are required to seek approval from the
VIFM Ethics Committee for the use of this information for research projects. In most cases
researchers are seeking de-identified information. There are, however, some applications that
require identifying information. The VIFM is able to disclose identifying information for an ethically
approved research project where the project is relevant to the statutory objects of the VIFM in
subsections 64(2)(e) and 64(2)(ha) of the VIFM Act 1985 (see paragraph 3.1).
19.
Approval of a research project by the VIFM Ethics Committee constitutes approval by the VIFM
Council for the purposes of section 64(2)(e) above.
20.
The sworn medical and scientific reports produced by the VIFM for the coroner under ss23, 24 and 25
of the CA 2008 are confidential and must only be provided to the Coroners Court. Researchers
wanting copies of these reports must apply to the Coroners Court in accordance with section
115(2)(d) of the CA 2008.
21.
Please refer to Appendix B for a more detailed discussion of the legislative authority for the use of
autopsy data in research.
ETHICAL FRAMEWORK
22.
VIFM operates under the National Code of Ethical Autopsy Practice which was endorsed by the
Australian Health Ministers’ Advisory Council and the Australian Health Ministers’ Conference in
2002.
23.
The VIFM Ethics Committee is established in accordance with the NHMRC National Statement on
Ethical Conduct in Human Research and operates under this framework.
Please refer to Appendix C for a more detailed discussion of the ethical framework
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SCOPE OF ACTIVITIES
24.
The VIFM Ethics Committee undertakes the following activities:
a.
consideration of and, where appropriate, approval of research projects submitted by
applicants external to the VIFM which have already been approved by the applicant's host
institute’s Human Research and Ethics Committee. Approval may be given for 3 years.
b.
consideration of and, where appropriate, approval of VIFM research projects which have
been approved by the VIFM Research Advisory Committee and referred to the VIFM Ethics
Committee. Approval may be given for 3 years
c.
consideration of ethical aspects of the Institute’s forensic pathology, scientific services and
clinical forensic medicine operations that arise from time to time, as referred by the Director
of VIFM or the VIFM Council
d.
consideration of issues raised by the Donor Tissue Bank Advisory Board
e.
maintenance of a register of approved projects
f.
monitoring of projects approved by the Ethics Committee through the tabling of annual
progress reports and final reports by researchers
g.
providing feedback on research projects to donor families where requested
h.
monitoring changes to research personnel undertaking approved projects, and
i.
consideration of variations or extensions to research projects.
MEMBERSHIP
NHMRC MEMBERSHIP REQUIREMENTS
25.
The composition of the VIFM Ethics Committee is in accordance with the NHMRC’s National
Statement on Ethical Conduct in Human Research. The minimum membership of the Committee is
eight. As far as possible there should be equal numbers of men and women and at least one third of
the members from outside the Institution. The minimum membership includes:
a.
A chairperson
b.
at least two lay people, one man and one woman, who have no affiliation with the institution
and do not currently engage in medical, scientific, legal or academic work
c.
at least one person with knowledge of, and current experience in, the professional care,
counseling or treatment of people
d.
at least one person who performs a pastoral care role in the community
e.
at least one lawyer, where possible not one who is engaged to advise the institution, and
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f.
26.
at least two people with current research experience that is relevant to research proposals to
be considered at the meetings they attend.
Wherever possible, one or more of the members listed above should be experienced in reflecting on
and analysing ethical decision-making.
VIFM MEMBERSHIP REQUIREMENTS
27.
In addition to the NHMRC membership requirements, the VIFM Ethics Committee will include two ex
officio appointments:
•
The Director of the VIFM
•
The Head of the Donor Tissue Bank of Victoria
28.
Where one of the above appointees is on leave, the person acting in their position can attend the
VIFM Ethics Committee meeting on their behalf. These ex officio appointments do not preclude other
VIFM staff from being appointed to the VIFM Ethics Committee as long as at least one third of the
membership are external to the VIFM, as required by the NHMRC National Statement.
29.
There will always be a position available for a coroner on the VIFM Ethics Committee and the State
Coroner will be invited to nominate a coroner for appointment to the committee when a member’s
term expires, prior to the approval of appointments by the VIFM Council.
APPOINTMENTS
30.
The members and the Chair of the Committee are appointed by the VIFM Council following the
completion of a nomination process, consistent with Government Board appointments. Nominees for
appointment will sought by expression of interest.
31.
Appointments will be reviewed every three years and members can be reappointed by the VIFM
Council. Ex officio appointments are not subject to this provision.
INDUCTION & TRAINING
INDUCTION OF NEW MEMBERS
32.
The Executive Officer will provide new members to the committee with relevant induction materials
as soon as practicable after their appointment.
33.
New members will also be invited to attend a talk and tour of the relevant parts of the building by the
Head of the Donor Tissue Bank of Victoria.
TRAINING OF MEMBERS
34.
The Executive Officer will organise training sessions for the committee members, as approved by the
Chair of the committee.
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35.
Members will also be encouraged to attend relevant external ethics training, and requests for
payment of training costs for members will be considered by the Executive and Finance Committee of
the VIFM Council.
ROLES & RESPONSIBILITIES
THE CHAIR
36.
The Chair of the Ethics Committee must:
•
confirm the agenda for each meeting
•
chair the meeting
•
ensure that members declare potential or actual conflicts of interest
•
ensure each item on the agenda is considered and decisions are made
•
be available to the Executive Officer for out-of-session consultation and advice; and
•
confirm the minutes, and
•
liaise with the Chair of the VIFM Council.
THE MEMBERS
37.
The members of the Ethics Committee must:
•
become familiar with the National Statement on Ethical Conduct in Human Research, the
information principles in the Information Privacy Act 2000 and the Health Records Act 2001,
and the National Code of Ethical Autopsy Practice
•
consider whether each application to the Ethics Committee meets the requirements of the
National Statement and is ethically acceptable
•
prepare for and attend at least 2 scheduled Ethics Committee meetings per year, subject to
the requirements of paragraph 34
•
advise the Chair when he or she cannot attend a meeting and provide his or her views on the
applications to the Chair
•
attend ethics and other relevant training when required
•
disclose any potential or actual conflicts of interest in accordance with paragraph 37, and
•
maintain strict confidentiality regarding all VIFM Ethics Committee papers, circular
resolutions and discussions.
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THE EXECUTIVE OFFICE R
38.
The Executive Officer must:
•
receive applications from researchers
•
advise researchers about applicable fees and the availability of data and/or tissue
•
arrange for payment of application fees
•
submit applications to the VIFM Scientific Review Panel for advice
•
liaise with researchers on any further information required for the submission
•
prepare the agenda in consultation with the Chair
•
circulate the agenda and papers to members a week prior to the scheduled meeting
•
organise researchers to attend meetings when appropriate
•
take minutes in the meetings
•
confirm the minutes with the Chair
•
provide the minutes to be tabled in the VIFM Council meeting
•
receive, table and respond to any correspondence
•
seek annual reports from researchers
•
keep a register of current projects
•
maintain files of past applications and approvals, and
•
notify researchers of the decisions of the Ethics Committee and arrange for researchers to
sign the ‘Agreement for Provision of Tissue’
•
provide feedback to donor families when requested
•
ensure membership of the Ethics Committee complies with the NHMRC National Statement
on Ethical Conduct in Human Research
•
organise the appointment of new members when required
•
organise training sessions for members
•
complete the annual reporting requirements of the NHMRC, and
•
organise the triennial performance review of the Committee.
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MEETINGS
FREQUENCY
39.
The VIFM Ethics Committee will meet at least 4 times a year. Extraordinary meetings may be called
by the Chair, as required.
QUORUM
40.
A quorum shall be a majority of the members of the Committee including at least one of the nonVIFM members. The NHMRC National Statement requires that if a member cannot attend a meeting,
he or she is given the opportunity to provide comments on the applications to be considered and
these comments are conveyed to the members at the meeting.
DECISION MAKING
41.
Wherever possible the VIFM Ethics Committee endeavors to reach decisions by general consensus.
This need not involve unanimity. Dissenting views will be noted in the minutes.
CIRCULAR RESOLUTION
42.
Where the Chair considers it appropriate, an item requiring urgent decision by the VIFM Ethics
Committee can be directed to members via circular resolution. Members will be given a minimum of
5 working days to provide their views to the Chair.
DECLARATION OF A CONFLICT OF INTEREST
43.
VIFM Ethics Committee, as a committee of VIFM Council, adopts the State Services Authority conflict
of interest general policy, definitions, principles and responsibilities.
44.
A conflict of interest is a real, perceived or potential conflict between the personal, professional or
business interests of a Committee member and the member’s duty to act in the interests of the VIFM
Ethics Committee. Wherever a conflict of interest or duty may be perceived, the matter must always
be resolved in favour of the public interest rather than the individual Committee Member.
45.
VIFM Ethics Committee members will:
46.
•
not allow personal interests, or the interest of any associated person, to conflict with the
interests of the VIFM Ethics Committee; and
•
avoid and disclose, actual, perceived or potential conflicts of interest.
The Executive Officer must ensure that the meeting agenda will have a standing item requiring
members to advise of any interests they may have with regard to any agenda item for the meeting.
Committee members must declare their interests at the beginning of each meeting, or at any other
time it becomes apparent.
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47.
The Executive Officer must record all instances of actual, apparent and potential conflicts of interest
advised by each member, including the nature and extent of the conflict, in the minutes of the
meeting.
48.
Following the disclosure by a Committee member of any actual, apparent or potential conflict of
interest, the Committee must determine the appropriate course of action to be taken.
AGENDA & PAPERS
49.
The Executive Officer compiles the agenda for the Ethics Committee meeting in consultation with the
Chair of the Committee. The Executive Officer will distribute the agenda and papers a week prior to
the scheduled meeting.
MINUTES
50.
The Executive Officer takes the minutes in the meeting. The minutes are confirmed by the Chair and
then tabled at the following meeting for approval by the Committee. Minutes confirmed by the Chair
are tabled at the next meeting of the VIFM Council.
PERFORMANCE REVIEW
51.
The performance of the VIFM Ethics Committee is monitored annually by the NHMRC and will be
reviewed triennially by the Committee/VIFM Council through surveying members and researchers.
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APPENDIX A
LEGISLATIVE FRAMEWORK FOR THE USE OF TISSUE FOR RESESARCH
1. THE VIFM ACT 1985 AND THE CORONERS ACT 2 008
Section 64(2)(i) of the Victorian Institute of Forensic Medicine Act 1985 (the VIFM Act 1985) provides that the
objects of the VIFM are to provide tissue banking facilities and services referred to in section 66(4) of the Act.
Section 66(4) provides that the Institute has the functions to:
•
receive tissue taken in accordance with the Human Tissue Act 1982 (the HTA 1982) from living
persons in Victoria and to process, store and supply the tissue for transplantation, other therapeutic purposes
or for medical or scientific purposes
•
to remove tissue or receive tissue taken from deceased persons in accordance with the HTA 1982
(whether or not the coroner has jurisdiction to investigate the deaths) and to process, store and supply the
tissue for transplantation, other therapeutic purposes or for medical or scientific purposes
•
to remove tissue or receive tissue taken under the laws of another State or Territory or another
country and to process, store and supply the tissue for transplantation, other therapeutic purposes or for
medical and scientific purposes.
Section 22 of the Coroners Act 2008 (the CA 2008) provides that where a reportable or reviewable death
occurs and the body is in Victoria, the body is under the control of the coroner until the coroner releases the
body under section 47 of the CA 2008.
2. THE HUMAN TISSUE ACT 1982
There are two sources of authority in the HTA 1982 for the removal and use of tissue from deceased persons
for therapeutic, medical or scientific purposes: sections 26 and 27, and 30(3).
2.1
Sections 26 and 27 of the HTA 1982
The removal of tissue from the body of a deceased person for the purpose of an ethically approved research
project is regulated by sections 26 and 27 of the HTA 1982.
Section 26(2) of the HTA 1982 provides that where a body of a deceased person is in a place other than a
hospital (e.g. VIFM), a registered medical practitioner or prescribed person is authorised to remove tissue from
the body of the deceased for therapeutic, medical or scientific purposes. The tissue can only be used for these
purposes where:
•
the deceased person had previously consented to this use
•
the senior available next of kin consents to the use, or
•
next of kin cannot be found and there is no known objection by the deceased person to the removal
and use of his or her tissue.
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Regulation 4A of the Human Tissue Regulations 2006 prescribes forensic technicians, mortuary technicians and
scientists employed at VIFM as being empowered to remove ocular or skin tissue. Under section 47 of the HTA
1982 these prescribed persons are deemed to have been prescribed to remove tissue of any kind.
Under section 27 of the HTA 1982 the coroner must give consent to the removal of the tissue from the
deceased person where the coroner has jurisdiction over the death.
2.2
Section 30 of the HTA 1982
Tissue which has been removed from a deceased person for the purpose of the autopsy directed by the
coroner and which is stored at the VIFM can be used for ethically approved research projects under the
authority of section 30 of the HTA 1982. This tissue primarily comprises histology slides and blood samples.
Section 30(3) of the HTA 1982 provides that:
"Authority under the Coroners Act 2008 to remove tissue is, subject to any order to the contrary by a
coroner, authority for the use, for therapeutic, medical or scientific purposes, of tissue removed from the body
of the deceased person for the purpose of the post-mortem examination."
The consent of the next of kin is not required under s30(3) of the HTA 1982 for the use of the tissue for a
research purpose. However, under the NHMRC National Statement only an Ethics Committee can grant waiver
of the consent for research for the use of human tissue for a research project. The VIFM Ethics Committee will
consider this issue on a case by case basis in accordance with paragraph 2.3.6 of the National Statement.
2.3
Cost recovery
The unauthorized selling and buying of human tissue is prohibited under sections 38 and 39 of the HTA 1982
respectively.
Section 39A of the HTA 1982 allows for recovery of certain costs of tissue banks. A person who owns or
controls a tissue bank prescribed by the regulations may charge an amount to recover the reasonable costs
associated with the removal, evaluation, storage, processing at the tissue bank and distribution from the tissue
bank of tissue removed in accordance with the HTA 1982.
Regulation 6 of the Human Tissue Regulations 2006 prescribes the Donor Tissue Bank of Victoria for the
purposes of s.39A.
3. CHARTER OF HUMAN RIGHTS AND RESPONSIBILITIES ACT 2006
The Charter of Human Rights and Responsibilities protects and promotes human rights by imposing an
obligation on all public authorities to act in a way that is compatible with human rights. Whilst the impact of
the Charter on the use of human tissue for research has not been tested, obtaining the consent from the
senior next of kin for the donation of tissue for research is consistent with the Victorian Charter of Human
Rights and Responsibilities which requires that a person must not be subjected to medical or scientific
experimentation or treatment without his or her full, free and informed consent (section 10(c)).
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APPENDIX B
LEGISLATIVE AUTHORITY FOR THE USE OF DAT A FOR RESEARCH
The VIFM collects, produces and holds data in the course of performing its legislative objects and functions as
an independent statutory authority. Researchers are required to seek approval from the VIFM Ethics
Committee for the use of this information for approved research projects. In most cases researchers are
seeking de-identified information, on which there are no legislative restrictions for release. There are,
however, some research applications that require identifying information (see below).
Reports for the coroner
Reports produced by the VIFM in consequence of request by a coroner under ss23, 24 and 25 of the Coroners
Act 2008 (CA 2008) are confidential and must only be provided to the Coroners Court. Access to these reports
for other purposes, such as research, is subject to the provisions of the Coroners Act 2008 and the Coroners
Court Rules.
Section 115(2)(d) of the CA 2008 provides that a coroner may release a document to “a person who is
conducting research if the coroner is satisfied that the research has been approved by an appropriate human
research ethics committee”.
Researchers seeking court documents such as an autopsy report must apply to the Coroners Court in
accordance with section 115(2)(d) of the CA 2008 using Form 45 of the Coroner Court Rules 2009.
Identifying information - personal and health information
Personal information and health information collected by the VIFM in the course of carrying out its objects and
functions under ss64(2) and 66(1) of the VIFM Act 1985 respectively, may be disclosed by the VIFM where
necessary or convenient to be done for, in connection with or incidental to the performance of the VIFM’s
objects and functions pursuant to s66A(1) and (3) of the VIFM Act 1985.
Personal information and Health information is identifying information as defined by the Information Privacy
Act 2000 (IPA 2000) and the Health Records Act 2001 (HRA 2001) respectively. Only the HRA 2001 applies to
information about a deceased person (for 30 years after the death).
VIFM's objects under section 64(2) of the Act include:
(e) to conduct research in the fields of forensic pathology, forensic science, clinical forensic
medicine and associated fields as approved by the Council, and
(ha) to contribute to reducing the number of preventable deaths and to promote public
health and safety and the administration of justice.
The VIFM may disclose personal and health information to a researcher with an ethically approved research
project where that research is within the meaning of the above objects of the institute.
Health Information Principle 2.2(c) under the HRA 2001 permits this disclosure by providing that an
organisation may use health information about an individual for a purpose other than the primary purpose for
which the information was collected where the use or disclosure is required, authorised or permitted, whether
expressly or impliedly, by or under law.
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VIFM Ethics Committee Charter
APPENDIX C
ETHICAL FRAMEWORK
1. THE NATIONAL CODE OF ETHICAL AUTOPSY PRACTICE
VIFM operates under the National Code of Ethical Autopsy Practice which was endorsed by the Australian
Health Ministers’ Advisory Council and the Australian Health Ministers’ Conference in 2002. This code requires
that:
•
there is a clear delineation between the uses to which retained tissues/organs can be put such as
diagnosis, research or education
•
all research using organs or tissues derived from autopsies must have the approval of a properly
constituted Ethics Committee
•
the use of organs for research should be the subject of a separate and specific consent. The approach
to the family to seek this consent should be through a suitably trained person wherever possible
•
If families agree to the retention of organs or tissues for research or teaching, their options and the
benefits and implications of each option must be explained to them, and
•
ethics committees approving research involving use of retained tissue must be provided with details
of its eventual disposal and this should conform with the requirements agreed to by the donor family.
2. THE NHMRC NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN
RESEARCH
The VIFM Ethics Committee is constituted and conducts its decision making in accordance with the National
Statement on Ethical Conduct in Human Research. The Chief Executive Officer of the National Health and
Medical Research Council (the NHMRC) is required to issue human research guidelines under section 10(1) of
the National Health and Medical Research Council Act 1992. These guidelines have been developed jointly
with the NHMRC and the Australian Research Council (ARC) and the Australian Vice Chancellors’ Committee
(AVCC).
The NHMRC National Statement provides:
•
“Any wish expressed by a person about the use of his or her post-mortem tissue for research should
be respected. If no such wish is discovered, consent for the use of tissue should be sought from the
senior available next-of-kin.
•
At any time of seeking this consent it should be agreed with the next of kin how the tissue is to be
disposed of when the research has been completed. Researchers should try to accommodate any
reasonable wishes of the next of kin about this.
•
There should be no trade in human tissue for research purposes”.
This is consistent with the HTA 1982 which prohibits the unauthorized selling and buying of human tissue
(sections 38 and 39 of the HTA 1982). Section 39A of the HTA 1982 allows for recovery of certain costs of
tissue banks.
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3. ETHICAL GUIDELINES FOR THE USE OF DATA FOR RESEARCH
The NHMRC National Statement on Ethical Conduct in Human Research requires that consent to participate in
research must be voluntary and based on sufficient information and adequate understanding of both the
proposed research and the implications of participation in it. Although not explicit in the Statement, the VIFM
Ethics Committee considers that in relation to research involving information about deceased persons, the
guidelines should be applied, with consent of the senior next of kin substituted for that of the participant.
The requirement for consent may sometimes be justifiably waived and in this case the participant or senior
next of kin will not know that the tissue or data are involved in the research. The National Statement provides
that only a Human Research Ethics Committee may grant waiver for research using (identifying) personal
information or personal health information. In deciding to waive the requirement for consent, the Ethics
Committee must be satisfied that:
•
involvement in the research carries no more than low risk to participants
•
the benefits from the research justify any risks of harm associated with not seeking consent
•
it is impracticable to obtain consent
•
there is no known or likely reason for thinking that participants would not have consented if they had
been asked
•
there is sufficient protection of their privacy
•
there is an adequate plan to protect the confidentiality of the data
•
in case the results have significance for the participant’s welfare there is, where practicable, a plan for
making information arising from the research available to them
•
the possibility of a commercial exploitation of derivatives of the data or tissue will not deprive the
participants of any financial benefits to which they would be entitled, and
•
the waiver is not prohibited by State, federal or international law.
The National Statement also requires each institution to make publicly accessible (for example in annual
reports) summary descriptions of all its research projects for which consent has been waived, once that
research has been completed.
Document ID: IN-36-VECC -1.0
Page 14 of 14
Date Effective : 11/10/2011
Next Review Date : 11/10/2013
This document is uncontrolled when printed. See IQMS for latest version.