Handbook and Appendices: Human Research Ethics Committee (Tasmania) Network

HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK
Human Research Ethics

Committee (Tasmania)
Network
HANDBOOK
and Appendices
1
Research and Development Office
University of Tasmania
January 2005
2
Contents
Human Research Ethics Committee (Tasmania) Network Contact

Administrators’ Details........................................................................6
1. What is meant by ‘human research’?.............................................9
2. What is ‘human research ethics’ about?.........................................9
3. What does a ‘human research ethics committee’ do?....................9
4. What does the National Statement cover?....................................10
5. What kinds of health & medical and social science research

projects need the approval of the HREC (Tasmania) Network?..........12
6. How do I apply to the HREC (Tasmania) Network?.........................15
7. How long will it take for my application to be considered?...........16
8. When can the Minimal Risk application be used?...........................17
9. Are there parts of an application that I need to take particular care

with? .................................................................................................18
10. When do I need to submit my application?.................................18
11. What happens to my application after submission to the RDO?..20
12. What if my project has already been approved by another HREC?

21
13. What if my project involves more than one centre?....................23
14. What if my project involves a clinical trial?.................................23
15. When can I start my project?......................................................23
16. Where can I find general information about ethical issues in

research?...........................................................................................24
17. Does the HREC Network have specific policies about human
research?...........................................................................................24
18. Will I have any further contact with the HREC after my application
has been approved?..........................................................................24
19. Whom should I contact if I have any questions?..........................27
20. References...................................................................................27
Appendix A: Terms of reference for the Committees, requirements as

to composition and quorums for meetings.........................................31
Appendix B: Principles of Ethical Conduct..........................................41
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Appendix C: Clinical Trials..................................................................49
Appendix D: Research involving children and young people .............53
Appendix E: Human tissue and body fluid sampling .........................54
Appendix F: Research involving deception of participants,

concealment or covert observation...................................................64
Appendix G: Research involving Aboriginal and Torres Strait Islanders

65
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Abbreviations
The following abbreviations are used in this document:
AHEC Australian Health Ethics Committee

DHHS Dept of Health and Human Services
HREC Human Research Ethics Committee
LGH Launceston General Hospital
MSC Medical Scientific Committee (LGH)
SRC Scientific Review Committee (LGH)
NHMRC National Health and Medical Research Council
NWRH North West Regional Hospital
RAC Research Advisory Committee (RHH)
RDO Research and Development Office
RHH Royal Hobart Hospital
TGA Therapeutic Goods Administration
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Administrators’ Details
Web address: http://www.research.utas.edu.au/human_ethics/
Executive Officer
Marilyn Pugsley
Human Research Ethics Committee
Private Bag 1
HOBART TAS 7001
Telephone: (03) 6226 2763
Facsimile: (03) 6226 7148
Rachael.Cowen-Kitanovic
Ethics Officer – Health & Medical
Private Bag 1
HOBART TAS 7001
Telephone: (03) 6226 1751

Facsimile: (03) 6226 7148
Email: rachael.cowenkitanovic@utas.edu.au
Marilyn Knott
Ethics Officer – Social Sciences

Private Bag 1
HOBART TAS 7001
Telephone: (03) 6226 2764

Facsimile: (03) 6226 7148
Email: marilyn.knott@utas.edu.au
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Introduction
THE HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK
On 1 January 2002 a unified Human Research Ethics Committee (Tasmania)

Network began operating a statewide structure for the consideration of human
research ethics. It is a cooperative arrangement between the University of
Tasmania and the Department of Health & Human Services. The Network’s four
committees report to the Vice-Chancellor, Professor Andrew Glenn (Pro-Vice-
Chancellor Research, University of Tasmania), and Mr John Ramsay (Secretary –
Department of Health and Human Services).
These committees also report to the NHMRC through the Australian Health Ethics
Committee (AHEC). The HREC (Tasmania) Network operates in accordance with
the National Statement on Ethical Conduct in Research Involving Humans, and
the Statement of Policy & Procedures of the HREC (Tasmania) Network.
THE HREC (TASMANIA) NETWORK’S ETHICS COMMITTEES
The HREC (Tasmania) Network functions with three Ethics Committees:
Committee Chair
Tasmania Social Science HREC A/Professor Gino Dal Pont (626
2078)
Tasmania Health & Medical HREC Mr Murray Shanley

(mshanley@utas.edu.au)
The participating institutions that currently access these committees are:

Royal Hobart Hospital
Hobart Private Hospital
Launceston General Hospital
North West Regional Hospital
Calvary Health Care Tasmania
Australian Maritime College
Other departments of (or within) the Tasmanian Department of Health and
Human Services.
The terms of reference for the Committees, requirements as to composition and

quorums for meetings can be found in Appendix A.
PRINCIPLES OF THE UNIFIED HREC SYSTEM
 The HREC system is available on a fee-paying basis to any person or group

conducting human research in Tasmania.
 Tasmanian individuals, groups or institutions that are not part of the

University of Tasmania or the Department of Health and Human Services
may also participate on a fee-per-application basis.
 The HREC system accommodates workload by allocating applications

between the Committees.
 The HREC system seeks to:
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 provide a well-coordinated, systematic approach to the ethical
assessment of human research;
 provide consistency in approach and decision-making; and
 remove duplication in HREC procedures in Tasmania.
 The HRECs, which make up the unified system are decision-making bodies,
i.e. their decisions on the ethical aspects of projects are not subject to
institutional ratification.
 Any application is considered by only one of the three HRECs, which make up
the unified system.
 Each HREC that is part of the unified system recognizes the decisions made
by another HREC within the system.
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1. What is meant by ‘human research’?
‘Human research’ is defined as ‘research which involves or impacts upon
humans’ in the National Statement on Ethical Conduct in Research Involving
Humans.
The National Statement is a comprehensive guide to research ethics, which all

investigators are required to be familiar with. This introductory guide is not a
substitute for the National statement.
Human research includes:
 research which involves humans directly, as participants;
 research which impacts on humans, for example studies of human remains

that are linked to identifiable living humans or fieldwork in which a
researcher requires access to community-controlled resources.
2. What is ‘human research ethics’ about?

Human research ethics is concerned with the ethical principles and values, which
should govern research involving humans. There are four basic principles in
ethical research:
 Integrity of the researcher and the research to be undertaken;
 Respect for people, which means respect for their dignity and rights;
 Beneficence, which means the obligation to maximize possible benefits and

minimize possible harms;
 Justice, which means asking who ought to receive the benefits of research
and bear its burdens.
These principles are discussed in the ‘Preamble’ of the National Statement (at
Section 1 on page 11).
3. What does a ‘human research ethics committee’ do?

A Human Research Ethics Committee (HREC) reviews health and medical
research projects and social science research projects, which involve humans.
The HREC considers initial applications and reviews the progress of projects that
it has approved.
An HREC gives special attention to projects that involve potentially sensitive or

contentious areas of study, particular methodologies or particular kinds of
people.
An HREC is constituted and operates in accordance with the guidelines set down
in the National Statement. These guidelines are prescriptive in some areas but in
other areas allow flexibility in interpretation and decision-making.
Investigators therefore need to be familiar not only with the National Statement
but also with the policies and procedures of the institutions from which the
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projects are initiated. Other guidelines are also applicable and these are listed in
Section 20 below.
4. What does the National Statement cover?

The National Statement is a comprehensive guide to human research ethics.
Investigators should read the following sections carefully:
Preamble
This gives basic information on human research ethics: the historical context,
statutory considerations and the meaning of ethics and of research.
Principles of ethical conduct (Section 1)

The basic principles of ethical conduct, as described in this section, apply to all
human research.
Categories of personal information (Preamble and Section 14)

The National Statement describes data as identified, potentially identifiable or
de-identified. These are not new concepts but they are defined more clearly than
in previous guidelines.
Privacy of information (Section 18)

‘Privacy is a complex concept that stems from a core idea that individuals have a
sphere of life from which they should be able to exclude any intrusion’ (National
Statement page 52).
This section explains the main ethical issues relating to privacy. The information
privacy principles (Commonwealth Privacy Act 1988) are included in the National
Statement as an Appendix.
Since the National Statement was published there has been new legislation
relating to the privacy of private sector organizations. The ‘Guidelines Approved
under Section 95A of the Privacy Act 1988’ are available from the NHMRC.
Collectivities (Section 8)
Collectivities are defined as ‘distinct human groups with their own social
structures that link members with a common identity, with common customs and
with designated leaders or other persons who represent collective interests in
dealing with researchers’.
The ethical issues that arise in relation to research involving collectivities were
not addressed in previous guidelines, other than in relation to research involving
Aboriginal and Torres Strait Islander peoples.
Specific topics
The National Statement includes information on various topics, including –
 Multi-center research;
 Research involving children and young people, people with an intellectual or
mental impairment, people highly dependent on medical care, and people in
dependent or unequal relationships;
 Research involving Aboriginal and Torres Strait Islander peoples;
 Clinical trials;
 Epidemiological research;
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 Use of human tissue samples;
 Human genetic research;
 Research involving deception of participants, concealment or covert
observation.
Responsibilities of researchers
The responsibilities of researchers are spelt out in various parts of the National
Statement, particularly in ‘Integrity, respect for persons, beneficence and justice’
in Section 1, ‘Principles of ethical conduct’. This section must be read carefully by
all investigators.
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projects need the approval of the HREC (Tasmania) Network?
HREC approval is required for any of the following activities when these involve
staff, students or associates of the participating institutions:
 Health & medical and social science research projects involving

human subjects or impacting on humans.
This means any study, which involves the participation of human subjects or
impacts on humans, with the exceptions listed below under ‘Activities that
do not require ethical clearance’.
 Pilot studies.
This means pilot studies and preliminary trials associated with the main
research project and whose data will be included in the research.
 Higher-degree research involving human subjects.

In cases where a student undertakes a project outside the University, but the
project is directly connected with the student’s University studies, it must be
submitted to the HREC for approval.
In general, it is the role of the HREC – and not the role of an investigator, School
or Department – to determine whether a project must be cleared through the
formal approval process.
Investigators should contact the Executive Officer or Chair if they are unsure
whether they –
 require a full application;
 require an application to be considered as Minimal Risk;
 do not require an application to the HREC.
Activities that DO NOT require formal ethical clearance
Each Institution needs to determine those activities involving human subjects

that do not need to have ethical review). The decision about the regulation of
activities must be done with reference to the NHMRC National Statement on
Ethical Conduct in Research involving Humans (see page 8 of the National
Statement).
The HREC (Tasmania) Network has indicated that the following activities do not
need ethical review:
Activity Documents to be Special considerations

provided to
participants
Teaching of research practices Information Sheet If the instrument is just a

that involve the students using questionnaire that is
Consent Form
as research participants * totally anonymous, then a
Consent Form is not
 their family
needed
 friends
 fellow students
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Activity Documents to be Special considerations
provided to
participants
Student research projects as Information Sheet If the instrument is just a

part of undergraduate questionnaire that is
Consent Form
programs * totally anonymous, then a
Consent Form is not
Coursework components of
needed
Honours *
Coursework components of
Masters programs*
Quality Assurance Information Sheet

surveys/questionnaires where
the aim of the
survey/questionnaire is to
develop a better internal
practice and in which the
participants are in no way
identifiable.
Audits within hospitals that are Information Sheet if the

trying to determine which audit involves
practices are most effective randomising patient
and which are not going to be treatment
published.
Interviews with professionals Information Sheet Participants should be

recorded on audiotape or given the right to review
Consent Form
videotape for the purpose of the final tape before it is
teaching and learning, which published on a website or
involve using the videotapes used in lectures.
and/or audiotapes in lectures
or seminars, or on the website
of the particular disciplines
involved.
Evaluations that are Information Sheet

specifically evaluating policies,
decisions and work practices
to industries / government
departments / businesses and
are totally unidentifiable
Note: This is based on the premise that all the above activities observe the basic
underlying principles of the National Statement:
 Respect for all peoples.
 Justice for all peoples.
 Beneficence to all peoples.
This means that all participants MUST receive an Information Sheet that tells
them:
 Who is conducting the activity?
 What is required of them as participants?
 The voluntariness of involvement.
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 The right to withdraw at any time and if applicable, to withdraw their
information gathered to date.
 Whether anonymity is assured or not.
 The details of the Ethics Committee as a third party for concerns or
complaints.
It also means that some participants may need a consent form depending on the
activities being undertaken, for example videotaping and audiotaping, or
whether they are identifiable in the final reports/theses.
*In respect of teaching activities and Coursework Honours and Coursework

Masters, the following should be noted:
1. Any ethical issues should be dealt with in course approval procedures at the
Faculty Teaching and Learning Committee.
2. It is the course co-ordinator and ultimately the Head of School who have
responsibility for the ethical conduct of teaching in each course and unit.
3. Course coordinators, Heads of School and Teaching and Learning Committees

may seek the advice and assistance of a HREC in developing ethical
frameworks for teaching. The Research and Development Office will provide
advice and arrange workshops for interested groups to discuss these issues.
4. An individual student, course co-coordinator, supervisor or Head of School

may, even if a study comes within the excluded activities, nonetheless seek
formal review from the Ethics Committee.
The Ethics Committee will review any application that comes forward.
5. The exclusion from the need for formal ethical review does not extend to
components of a coursework program that involve the production of a thesis
or other work that may be “published” (in the broad sense of the word). These
projects come under the banner of “research” and so, where they involve
human subjects, are subject to the formal ethical review process.
NB: If any course co-coordinator or Head of School would like ethical advice in
respect of any of the above activities, or is unsure about the ethical issues
involved, please contact any of the following persons to discuss the matter:
A/Professor Gino Dal Pont, Chair 6226 2078
Marilyn Pugsley, Executive Officer 6226 2763
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6. How do I apply to the HREC (Tasmania) Network?
All applications must be made on an official application form (obtained from
http://www.research.utas.edu.au/human_ethics/ as the forms are constantly
being updated). The application must be submitted by the project’s chief
investigator. Student researchers may not be named as chief investigators.
Supervisors are normally the chief investigators for projects undertaken by
students.
The requisite forms need to be sent to:

Postal Address: Deliver Address:
Ethics Officer Ethics Officer
Research House Research House
University of Tasmania University of Tasmania
Private Bag 1 Cnr French & College Roads
HOBART TAS 7001 SANDY BAY TAS 7005
Forms
There are several forms that investigators need to be familiar with:
Standard Application Forms

Separate application forms are available for Social Science Research and for
Health & Medical Research.
Amendment Forms
One Human Research Amendment Form is now current for all HRECs.
Minimal Risk Form

These forms are only available for Tasmanian Social Science research projects or
qualitative research involving health and medical questions that do not impact
on the hospitals’ staff and/or patients and resources.
Clinical Trials
See Appendix C.
Genetics Research Requirements Form

This needs to accompany any Health & Medical Application involving genetics.
1. These forms are available from the Research and Development

Office in Hobart. They are also available on the web: Statement of
Policy & Procedures of the HREC (Tasmania) Network.
http://www.research.utas.edu.au/human_ethics/
What your application needs to show
In Appendix B: Principles of Ethical Conduct you will find practical advice about
the way in which research projects should be conducted in order to comply with
the principles of ethical conduct. Specifically, Sections 3–9 of that Appendix
explain the information required on the application form and how HREC will
consider it.
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7. How long will it take for my application to be considered?
INITIAL APPLICATIONS
Investigators should submit their applications at the earliest possible time and
should allow a minimum of one month for social science projects and two months
for health & medical projects, before hearing a result. While the committees
make every effort to consider projects promptly, delay is sometimes
unavoidable.
When exceptional circumstances present an unforeseen opportunity to carry out

important research, the applications can be considered out of session.
Researchers need to contact the Executive Officer or the Chair of the Committee
to arrange this.
Applications may be considered either by circular or at the regular committee

meetings. The schedule of meetings is normally placed on the University’s Ethics
website: http://www.research.utas.edu.au/human_ethics/
RESEARCH DESIGN AMENDMENTS
Protocol amendments will initially be sent to the Chair, who will either approve
the amendment or refer it to the full committee meeting. The decision to send it
for full review by an HREC would depend on the severity of the changes that are
involved.
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8. When can the Minimal Risk application be used?
Some social science projects can be considered as providing minimal risk to
participants. In accordance with Section 2.27 in the National Statement, an HREC
may establish procedures for expedited review of research involving minimal risk
to participants.
In order to determine whether your research fits into this category, you must
complete a Minimal Risk form. This procedure is not applicable for health &
medical applications unless they involve qualitative methodologies and do not
impact on the hospital or patients, staff and resources.
 The Minimal Risk form must be completed instead of the full ethics
application form.
 An Information Sheet and Consent Form must accompany the Minimal Risk
form. A Consent Form is not necessary for projects that involve totally
anonymous questionnaires where identification of the participant is
impossible.
 Any questionnaires/surveys, interview questions must be provided.
These will be considered by the Chair or Deputy Chair. The Chair, the Executive
Officer or the Ethics Officer will inform the researchers of their approval or if
there are any concerns that need to be addressed.
Note: The Chair reserves the right to change the classification of the Minimal
Risk applications if the risk is perceived to be greater than normal. In these
cases, the researcher will be advised to submit a full application, along with
relevant documentation, to the next committee meeting.
Methodological/Scientific Consideration
The methodological robustness of any Minimal Risk application is entirely the

responsibility of the School/Department from which the researcher comes.
Supervisors and researchers need to be aware of the following excerpt from the
National Statement on Ethical Conduct in Research Involving Humans (page 5):
But scientific inadequacies also have ethical implications. Projects

without scientific merit are wasteful of resources and needlessly
subject participants to risks. Accordingly, an essential condition of
the ethical acceptability of research is the determination that the
scientific quality of a proposal and the skill and experience of the
researchers are such that the objectives of the proposal can
reasonably be expected to be achieved.
Some schools have internal committees that review research for scientific merit
prior to submitting applications to the Ethics Committees.
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9. Are there parts of an application that I need to take
particular care with?
The approval of projects is often held up, not because the project raises serious
ethical concerns, but because the investigator has not paid sufficient attention to
parts of the application. In particular,
 Scientific methodology and statistical power must be strong enough to

support the aims in health & medical applications;
 The methodology and analysis of data must be clear and be relevant to the
aims of the project;
 The procedure for recruiting subjects must be clearly and thoroughly

described and must adhere to the guidelines of the Privacy Principles;
 The Information Sheet and Consent Form must be prepared carefully and
thoroughly, following the standard guidelines that are provided with the
application form;
 The application must be carefully edited for grammatical and spelling errors.
The application form includes notes to assist investigators. The notes are
provided in comment boxes that are not visible until the cursor is moved over
them. This enables the final application to be provided to the committee without
the unnecessary addition of the comments.
10. When do I need to submit my application?

The Health & Medical HRECs meet monthly and the Social Science HREC meets
every 3 weeks for the first part of the year and then reverts to monthly, with the
possible exception of January. The schedule of meetings is to be found on the
web at: www.research.utas.edu.au/rdo/ethics/human.htm
SOCIAL SCIENCE SUBMISSION DATES
The submission date for social science research is approximately 10 days before
the meeting date. This allows adequate time for the Ethics Officer to:
 enter the applications on the database;
 photocopy the applications for the committee;
 ensure that all necessary documentation is attached.
 Create an agenda for the social science ethics committee
These tasks are facilitated by the Ethics Officer - Social Sciences, at the
Research and Development Office.
HEALTH & MEDICAL SUBMISSION DATES
The submission date for health & medical research is usually seven weeks before
the actual meeting date of the Ethics Committee. This is to ensure that the Ethics
Officer has adequate time to:
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 enter the applications on the database;
 give sufficient copies of the applications to the scientific committee secretary
 obtain any missing documentation;
 arrange for external review of applications that are not to be reviewed by the
scientific committees of the hospitals.
 Receive copies of changed documentation from the scientific committee

secretary after the scientific committee meeting
 Collate revised and approved applications to formulate an agenda for the

ethics committee.
These tasks are facilitated by the Ethics Officer - Health & Medical, at the
Research and Development Office.
MEETING DATES
The Ethics Committees meet as follows:

Tasmania Health & Medical HREC Every four weeks. Meetings are held
on Wednesdays.
Tasmania Social Science HREC Every 3 weeks for the first half of
the year and then changing to every
fourth week. Meetings are held on
Mondays.
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11. What happens to my application after submission to the
RDO?
INITIAL APPLICATIONS FOR SOCIAL SCIENCE RESEARCH
 All applications must be submitted to the Ethics Officer – Social Sciences.
 An email is sent confirming the receipt of your project and including the
reference number which you must provide when making any contact (either
by email, memo or telephone). The RDO sees an average of 400 applications
a year, so it is not always easy to remember the individual projects.
 It is the researchers’ responsibility to inform the RDO of the link between an

ethics application and a grant or consultancy. Please inform the Grants or
Consultancy office at the RDO of the relevant connection.
 The Ethics Officer will then place the application on the next Ethics
Committee Agenda.
 If the research has received approval, an email will be sent confirming this. A
signed approval letter will be completed and sent within a week of the email.
 If the research requires revision, an email will be sent to researchers, and

when revisions have been approved an email will be sent confirming
approval. A signed approval letter will be completed and sent within a week
of the email.
INITIAL APPLICATIONS FOR HEALTH & MEDICAL RESEARCH
 All applications must be submitted to the Ethics Officer – Health & Medical.
 An email is sent confirming the receipt of your project and includes the
reference number which you must provide when making any contact (either
by email, memo or telephone). The RDO sees an average of 400 applications
a year so it is not always easy to remember the individual projects.
 The Ethics Officer will then send:
 any application that does not access hospital patients, staff or

resources for external review in consultation with the Chair of the
committees and/or the Executive Officer.
 any applications that do involve hospital patients, staff or resources to a

scientific committee. (RHH, Hobart Private Hospital & Calvary Health
Care research applications are sent to the Research Advisory Committee
(RAC). LGH, North West Regional Hospital, Clifford Craig research
applications are sent to the Scientific Review Committee (SCR.)
 Once the Ethics Officer has received the approval from the reviewer and/or
the scientific committees, it will then be placed on the next Ethics
Committee agenda relevant to the study.
 If the research has received approval from the Ethics Committee, an email
will be sent to the chief investigator confirming this. A signed approval letter
will be completed and sent within a week of the email.
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 The approval letter for Clinical Drug Trials will take longer due to extra
CTN forms, Indemnity forms to be signed by various committees and CEOs.
 If the research requires revision, an email will be sent to researchers, and

when revisions have been approved an email will be sent confirming
approval. A signed approval letter will be completed and sent within a week
of the email.
COMMITTEE DECISION MAKING
All Committee members are encouraged to express their views on a proposal.

When these views differ, the issues are discussed with consensus as the
objective.
The HREC may, in complex or difficult cases, invite the investigator to speak to
the committee. The HREC may also seek advice and assistance from experts in
appropriate cases, particularly when collectives are involved, such as indigenous
groups, religious groups, cultural groups, or disabled groups.
In cases where a proposal raises ethical concerns the HREC endeavours to

resolve them by discussion with the investigator and, if necessary, suggesting
modifications to the proposed protocol.
When research being considered involves a committee member, this project will
be sent to the corresponding alternative committee to avoid conflict of interest.
In the case of the Social Science committee where there is no alternative
committee to send it to, the supplementary member will sit on the committee
when that project is considered.
In the unlikely event of a committee member being an investigator on a project

that is being considered by that committee, that member declares a conflict of
interest (which is recorded in the minutes), and does not participate in the
discussion unless answering questions posed by other members.
REVISIONS REQUESTED BY THE HREC
The HREC may require changes to the application materials before final approval
of the application can be given. These suggested changes will be emailed to the
chief investigator and student (if involved).
All revisions should be emailed to the designated reviewer as designated by the

Ethics Officer, as soon as possible. In the majority of cases the HREC has agreed
that the revisions can be approved by the committee Chair or the Executive
Officer and do not need to be reviewed by the full HREC.
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Where Ethics Approval has been sought from other Australian Human Research Ethics Committees (not including Clinical Drug Trials that involve
CTN/CTX forms)
Research Research Research being Research being Research being done at Needs to Documentation needed
involves involves done in OTHER done at UNI Uni Tas or DHHS & be
Researchers Researchers INSTITUTIONS TAS or DHHS & Reviewed
where
EMPLOYED by NOT by
where NO PATIENTS/STAFF/RESO
Uni Tas or EMPLOYED by
resources are URCES are being used
DHHS Uni Tas or DHHS
being used
 Application
that had been submitted to
Chair
approving Ethics Committee
 Copy of
 
 approval from that Ethics
committee
 Information
Sheet and Consent Form
Chair  Application that had been submitted

to approving Ethics Committee
 Copy of approval from that Ethics

  committee

 Information Sheet and Consent Form
with Tasmanian investigators and
Tasmanian ethics committee details
(these can be in addition to the
centre that approved the ethics)
   Tasmanian  Application that had been submitted

scientific to approving Ethics Committee
and Ethics
 Copy of approval from that Ethics
Committee
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s committee

with Tasmanian investigators and
Tasmanian ethics committee details
(these can be in addition to the
centre that approved the ethics)
Chair  Application that had been submitted

to approving Ethics Committee
   Copy of approval from other

institutional Ethics committee
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13. What if my project involves more than one centre?
A multicentre study is one which is being conducted by a number of centres or
institutions. Clinical Drug Trials or Commonwealth research are the most
common of these.
OUTSIDE TASMANIA
Ethical approval is normally obtained from the HREC of the principal centre or
institution. In these cases the Tasmania investigator who is collaborating with
investigators from other institutions is required to submit information on the
project and evidence of its approval. This approval will normally be recognised by
the HREC (Tasmania) Network Committees and will be sent to Chairs for
information. However, the HREC reserves the right to ask for further information
and, if necessary, can refuse ethical approval.
There is a detailed treatment of multicentre research in the National Statement

(Section 3). This includes reference to the duties of researchers who are involved
in multicentre research.
WITHIN TASMANIA
If research is being done at more than one institution within Tasmania, the
research needs to be reviewed ONCE only for scientific merit, safety, validity and
ethics by the HREC (Tasmania) Network. As hospital resources are involved it
will still be reviewed by the scientific committee of each hospital to make a
determination that all costs have been covered.
Clinical Drug Trials are the most common research that this will affect.
If more than one Tasmanian institution wants to be involved in a particular drug

trial, one centre should be nominated as the centre that forwards the protocol,
application form, patient Information Sheets, Consent Forms and investigator
brochures to the RDO for administration through the scientific and ethics
process.
The Health & Medical Application Form Guidelines detail the actual process that
institutions need to follow when trials are to be conducted in this manner.
A clinical drug trial may have been in operation for some time at one institution
when another institution within Tasmania decides to run it. Again, this process is
detailed in the Health & Medical Application Form Guidelines.
14. What if my project involves a clinical trial?

Refer to the detailed application procedure at Appendix C: Clinical Trials.
15. When can I start my project?

Projects that require ethical approval MUST NOT commence until approval has
been given by the HREC.
23
research?
There is extensive literature on research ethics. The National Statement on
Ethical Conduct in Research Involving Humans, which all investigators must be
familiar with, provides a good introduction. There is also a Handbook on Ethical
Conduct Concerning Research, which is a commentary on the National
Statement. To review current topics and access other relevant links, please look
at the following website: http://www.nhmrc.gov.au. Parts of the statement are
attached in Appendix B: Principles of Ethical Conduct.
See also Section 20: References in this Handbook.
research?
The University of Tasmania HREC has specific policies on the following topics:
 Clinical trials (see Appendix C);
 Research involving children and young people (see Appendix D);
 Human tissue and body fluid sampling (see Appendix E);
 Research involving deception of participants, concealment or covert
observation (see Appendix F).
 Aboriginal and Torres Strait Islander Research (see Appendix G).
18. Will I have any further contact with the HREC after my
application has been approved?
18.1 ANNUAL PROGRESS REPORTS
A progress report on ethical aspects of projects is required for each project

annually until its completion. The purposes of these reports are:
 for the HREC to check that projects continue to conform with approved
ethical standards;
 to check the current status of each project – whether it is complete, in

progress, abandoned, or not yet commenced.
Progress Reports are due on the anniversary date of approval unless

specified otherwise by the approval conditions. The Research and
Development Office will send a reminder when reports are due. This reminder
will continue to be sent until it is acknowledged by the researcher sending a
return email to the sender. The form is available on the website.
With regard to Honours projects, there have been cases where the project has
not been completed and the chief investigator has asked that it be placed on
hold in the hope that another student will take up the research. Projects should
be placed on hold only if there is a definite plan to do the research within the
same year. In other cases, a ‘Final Report’ form should be completed and the
project recorded as ‘not commenced’ or ‘abandoned’ (as appropriate).
24
18.2 NOTIFICATION OF CHANGES IN THE PROJECT AND OTHER
MATTERS
Investigators are required to inform the HREC immediately of anything which

might affect ethical acceptance of the project, including:
 adverse effects on subjects;
 withdrawal of a subject because of his/her concerns about the project;
 proposed changes in the protocol or research design;
 unforeseen events that may affect continued ethical acceptability of the
project;
 cases where investigators are added to, or cease involvement with, the
project.
Research design amendments for all applications will be sent to the Chair who
will approve the change or refer it to the Ethics Committee at his/her discretion.
Decisions made through the process of expedited review are reported to the
following meeting of the HREC.
18.3 MONITORING OF ETHICALLY SENSITIVE PROJECTS
The HREC may monitor more closely projects which are ethically sensitive, and
may also conduct random audits.
‘Tailored monitoring’ is practised by many HRECs. It means that the level of

monitoring relates to the level of concern, in terms of ethical implications raised
by the project. The most common form of tailored monitoring for ethically
sensitive projects is for the HREC to ask for progress reports in which the ethical
concerns that have been identified by the HREC are addressed.
However, the ethical conduct of research ultimately relies on the ethical

sensitivity of the researchers themselves. It is essential for researchers to be
aware of, and to follow, accepted ethical practices.
18.4 MONITORING MULTICENTRE PROJECTS
The HREC may take advice from the principal centre participating in the project
but itself monitors that part of the research which takes place at the University of
Tasmania.
18.5 TENURE OF PROJECTS
An application has approval for four years as long as the annual reports have
been received.
If the project is to continue beyond the four years, a ‘Request for Extension’ form
indicating why the application should be extended must be provided to the HREC
along with a Progress Report indicating how long the project is likely to continue.
A copy of the most recently approved application form, Information Sheet and
Consent Form, which incorporates any amendments that have been approved,
need to be provided with the letter requesting an extension. These documents
must be what is currently guiding research and be the actual Information Sheets
and Consent Forms that are being used by the researchers. The reasons for this
are that:
25
 changes in the project and/or in the HREC membership may have occurred
during the tenure of the project and research processes need to be reviewed
in light of these;
 there may have been changes in professional and social attitudes towards
different kinds of research and particular ethical issues, which may
necessitate changes in research practices.
18.6 COMPLAINTS
If the HREC receives a complaint about the conduct of a project it will normally
be followed up with the chief investigator.
Researchers who have complaints or ethical concerns about a project should

contact the HREC Chair or Executive Officer to discuss the issues. The complaint
will be included on an HREC agenda and advice given on actions to be taken will
be discussed. The researcher may be invited to appear before the Committee to
discuss the concerns.
Participants who have complaints or ethical concerns may contact the HREC
Chair or Executive Officer and researchers. University students who are subjects
in health & medical and social science research projects and who have personal
concerns may wish to consult a University Student Counsellor. This information is
included routinely in subject Information Sheets.
Complaints against the HREC should be referred in the first instance to the
Executive Officer or Chair of the relevant HREC. If the complainant is still
dissatisfied, he/she may contact the Pro-Vice-Chancellor (Research) at the
University, Mr John Ramsay of the Department of Health and Human Services or
the CEOs of the participating institutions.
Other interested people (for example, members of the public) who have
concerns or complaints may contact the HREC Chair or Executive Officer.
When a concern or complaint is received by the Executive Officer he/she will

inform the Chair of the nature of the concern/complaint and any action that
he/she has taken. The complaint and the action taken will be discussed with the
researcher and reported to the HREC. The HREC will make a decision on any
further action to be undertaken.
All concerns and complaints are formally recorded, treated very seriously and
handled promptly. If a concern or complaint is unresolved at the Committee
level, it is referred to the Pro-Vice-Chancellor (Research).
18.7 CONTRAVENTION OF ETHICAL OR ADMINISTRATIVE

REQUIREMENTS
If the investigators contravene ethical or administrative requirements this will be

followed up by the Committee.
(a) Suspension or discontinuation of research
The HREC may withdraw approval of a project:
26
 if it is satisfied that the project is not being or cannot be conducted in
accordance with the approved protocol and that, as a result, the welfare and
rights of participants are not or will not be protected (National Statement
Section 2.44); or
 in the event of non-compliance with administrative requirements; for

example, failure to submit annual reports within two months of the required
date. The Pro-Vice-Chancellor (Research) has asked to be informed if efforts
to obtain administrative compliance have been unsuccessful.
If there are valid reasons for a delay in sending a report, the researcher
needs to supply a written explanation of the reasons and an expected
submission date.
(b) Contravention of NHMRC or University guidelines
In the case of a serious breach of ethical guidelines, the relevant investigator will
be subject to procedures detailed in the University’s Code of Conduct in
Research (http://www.research.utas.edu.au/policies)
19. Whom should I contact if I have any questions?

The first points of contact are the Ethics Officers or the Executive Officer. They
will be able to answer your queries or refer to the committee Chairs if necessary.
Marilyn Pugsley
Executive Officer
Research Services
University of Tasmania,
Private Bag 1,
HOBART TAS 7001
Telephone: (03) 6226 7479

Facsimile: (03) 6226 7148
Rachael Cowen-Kitanovic Marilyn Knott

Ethics Officer - Health & Medical Ethics Officer - Social
Sciences
Research Services Research Services,
University of Tasmania, University of Tasmania,
Private Bag 1, Private Bag 1,
HOBART TAS 7001 HOBART TAS 7001
Telephone: (03) 6226 1751 Telephone: (03) 6226 2764

Facsimile: (03) 6226 7148 Facsimile: (03) 6226 7148
Email: rachael.cowenkitanovic@utas.edu.au Email:
marilyn.knott@utas.edu.au
20. References
1. Statement of Policy & Procedures of the HREC (Tasmania) Network.
http://www.research.utas.edu.au/human_ethics/
27
2. National Statement on Ethical Conduct in Research Involving Humans,
Australian Government Publishing Service, 1999.
This document is available in the University Morris Miller and Clinical School
Libraries.
http://www.nhmrc.gov.au/publications/pdf/e35.pdf
3. NHMRC Human Research Ethics Handbook: Commentary on the National

Statement, NHMRC, 2001.
http://www.nhmrc.gov.au/hrecbook/01_commentary/contents.htm
4. Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres
Strait Islander Health Research
This document is to be used in conjunction with the National Statement on
Ethical Conduct in Research Involving Humans.
5. Code of Conduct in Research for the University of Tasmania.

Refer to http://www.research.utas.edu.au/policies for the most up-to-date
version. This describes the standards of conduct and performance required
of all those engaged in research at the University of Tasmania.
6. Declaration of Helsinki, World Medical Association, Helsinki, 1964.

Recommendations guiding physicians in biomedical research that involves
human subjects. This document has undergone several revisions, the most
recent being in 1996.
http://www.nhmrc.gov.au/issues/helsinki.htm
7. Joint NHMRC/AV-CC Statement and Guidelines on Research Practice,

NHMRC, 1997.
http://www.nhmrc.gov.au/research/general/nhmrcavc.htm
8. Guidelines Approved under Section 95A of the Privacy Act 1988, NHMRC,
2001.
http://www.nhmrc.gov.au/publications/pdf/e43.pdf
9. Essentially Yours: The Protection of Human Genetic Information in Australia,

Australian Law Reform Commission, 2003.
http://www.austlii.edu.au/au/other/alrc/publications/reports/96
10. Access to Unapproved Therapeutic Goods – Clinical Trials in Australia,

Therapeutic Goods Administration, Department of Health and Aged Care,
2001.
http://www.tga.health.gov.au/docs/pdf/unapproved/clintrials.pdf
11. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95),

Therapeutic Goods Administration, Department of Health and Aged Care,
2000.
http://www.tga.health.gov.au/docs/pdf/euguide/ich/ich13595.pdf
12. Human Research Ethics Committees and the Therapeutic Goods

Legislation, Therapeutic Goods Administration, Department of Health and
Aged Care, 2001.
http://www.tga.health.gov.au/docs/pdf/unapproved/hrec.pdf
28
Human Research Ethics
Committee (Tasmania)
Network
HANDBOOK APPENDICES

November 2003
29
Contents

Administrators’ Details........................................................................6
1. What is meant by ‘human research’?.............................................9
2. What is ‘human research ethics’ about?.........................................9
3. What does a ‘human research ethics committee’ do?....................9
4. What does the National Statement cover?....................................10

projects need the approval of the HREC (Tasmania) Network?..........12
6. How do I apply to the HREC (Tasmania) Network?.........................15
7. How long will it take for my application to be considered?...........16
8. When can the Minimal Risk application be used?...........................17
9. Are there parts of an application that I need to take particular care

with? .................................................................................................18
10. When do I need to submit my application?.................................18
11. What happens to my application after submission to the RDO?..20

21
13. What if my project involves more than one centre?....................23
14. What if my project involves a clinical trial?.................................23
15. When can I start my project?......................................................23

research?...........................................................................................24
research?...........................................................................................24
18. Will I have any further contact with the HREC after my application
has been approved?..........................................................................24
19. Whom should I contact if I have any questions?..........................27
20. References...................................................................................27
Appendix A: Terms of reference for the Committees, requirements as

to composition and quorums for meetings.........................................31
Appendix B: Principles of Ethical Conduct..........................................41
30
Appendix C: Clinical Trials..................................................................49
Appendix D: Research involving children and young people .............53
Appendix E: Human tissue and body fluid sampling .........................54

concealment or covert observation...................................................64
Appendix G: Research involving Aboriginal and Torres Strait Islanders

65
Appendix A: Terms of reference for the Committees,

requirements as to composition and quorums for
meetings
COMMITTEE CONSTITUTION AND TERMS OF REFERENCE
ESTABLISHMENT
The HREC (Tasmania) Network began operations on the 1st January 2002.
The following terms of reference accord with the requirements set out in the
National Statement:
 To provide a system for ethical review of human research

projects in Tasmania;To provide a system for ethical review of research
projects which has the potential to cater for all human research in Tasmania;
 To consider the ethical implications of all proposed research

projects which involve or impact upon humans and approve only those projects
which conform to the National statement on ethical conduct in research
involving humans;
 To consider the ethical implications of all proposed teaching

exercises which use students as subjects and approve only those exercises
which conform to the National statement on ethical conduct in research
involving humans;
 To consider whether the conduct foreshadowed in the of

the research that is approved may contravene the law;proposals that are
approved is lawful.
 To maintain a record of all research and teaching projects

received and reviewed, with decisions and conditions;
 To monitor the progress of research projects and teaching

exercises so as to be satisfied that they continue to conform with approved
ethical standards;
31
 To establish and administer mechanisms for receiving and
handling complaints or concerns about the conduct of an approved research or
teaching project;
 To establish a mechanism for handling any serious breach

of ethical guidelines;
 To advise the participating institutions regarding ethical

approval for research and teaching projects;
 To report annually to the Australian Health Ethics

Committee (AHEC) information relevant to its procedures;
 To provide AHEC with access, upon request, to information in

the Committees’ register.
 The HREC (Tasmania) Network will not generally consider

ethical questions questions unrelated to research proposals and conduct.
relating to issues such as clinical ethics, professional ethics and general issues
in research ethics (eg publication, authorship, intellectual property and
supervision).
32
1 COMMITTEE STRUCTURE
There are 2 Committees constituted under the NH&MRC National Statement on

Ethical Conduct in Research Involving Humans:
Tasmania Health & Medical Human Research Ethics Committee
Tasmania Social Sciences Human Research Ethics Committee
Membership
The membership of the Committees shall comprise:
A core membership of seven (7) as required by the National Statement,

being men and women and consisting of a:
(a) Chair
(b) Lay member (male)
(b) Lay member (female)
Member with knowledge of, and current experience in, areas of research
(c)
regularly considered by Committee
Member with knowledge of, and current experience in, professional care,
(d)
counseling or treatment of people
Minister of religion or person who performs a similar role in the
(e)
community
(f) Lawyer
Further persons co-opted to the Committees for their particular expertise

and experience and representing course structures within the respective
faculties.
Social Science Committee Membership

There will be supplementary representation by external members on the
Tasmanian Social Science HREC. There can be Designated members and
Supplementary members for categories (b), (d), (e) and (f). Members in
the category will ensure that coverage of all meetings is maintained.
If for any unseen circumstance, neither can attend, comments will be

provided.
33
Decisions reached by the Committee
As set out in the National Statement the primary role of human research
ethics committees is to protect the welfare and the rights of participants in
research and the primary responsibility of each member is to decide,
independently, whether the conduct of each research proposal submitted to
the Committees will so protect participants.
Payment
External members of the Committees who are not affiliated with The
University of Tasmania and Department of Health & Human Servioces, will
be given a meeting fee as determined by the Secretary of DHHS and the
Pro Vice Chancellor – Research. This fee is of $45.00/meeting to cover
reimbursement of travel, parking and extraneous costs associated with
attending meetings and other business associated with their membership
of the Committees. There is otherwise no remuneration to members.
2.2 Responsibilities
The Committee considers the ethical implications of the proposed research

that involve human participants and determines whether or not it is
ethically and methodologically acceptable. These projects can come from
the University of Tasmania, Department of Health & Human Services,
Calvary Health Care Tasmania and the Australian Maritime College. And
Hobart Private.
In performing their responsibilities the Committees are governed by the

National Statement, relevant state and commonwealth legislation, policies
and codes, Statement of Policy and Procedures of the HREC (Tasmania)
Network and in their decision making take into account community
attitudes and expectations.
Provide for the monitoring of approved research projects until completion

so that the Committees may be satisfied that the projects are conducted in
accordance with the approved protocol as required under Sections 2.33-
2.38 of the National Statement..
Establish working procedures in accordance with Section 2.13 of the

National Statement.
Perform all other duties as determined by the National Statement.
2.3 Terms of Office
34
The terms of office of members shall be for two years up to but not
including the first day of April in the relevant anniversary year.
Members may, if eligible, be re-appointed for additional consecutive terms

to serve a maximum of 6 years.
2.4 Attendance
The Committees may invite such categories or numbers of persons to

attend parts of specified meetings, or complete meetings, as the
Committee believes might be appropriate to facilitate its work.
The membership of the committee involves designated and

supplementary members. It is expected that the designated and
supplementary members determine between themselves which meetings
they attend and it is the responsibility of those members to notify the
Ethics Officer for Social Science (6226 2764) who to send the agenda too
for each meeting.
2.5 Frequency of Meetings
The Committees shall meet as frequently as necessary to meet the demand

for ethical clearance for research applications.
Tasmania Health & 10 meetings

Held on Wednesdays
Medical per year
Tasmanian Social 11 meetings

Held on Mondays
Sciences per year
2.6 Quorum
The quorum for meetings of the Committees shall be a majority of the

number of members in category 3.1.1.
2.7 Conduct of business
The Committees shall receive and examine written applications for ethics
clearance for human research projects
35
Tasmania Health
& Medical Agenda papers are dispatched two weeks prior
to the meeting.
Tasmania Social Agendas are dispatched on the Monday prior to

Sciences the meeting
and shall give a final decision of:
[a] Approved
[b] Approved with comments
[c] Not approved
As required by the National Statement, where there is less than full

attendance at a meeting, the Chair must be satisfied, before a decision
is reached, that the minimum membership listed in 3.1.1 have received all
papers and have had an opportunity to contribute their views and that
these have been recorded and considered.
As the minutes of each meeting are forwarded to all members soon after
the meeting, absent members have the ability to comment at that time or
at the next meeting if they have any significant issues or approve the
minutes and therefore the matters reported on in those minutes.
The Committees shall endeavour to reach decisions by general agreement.
The Committees have the authority to issue notification of approval to

investigators prior to the Human Research Ethics Committee’s
consideration of the minutes of their meetings as the minutes are sent to
members, via email, within a few days of the meetings and members will
confirm that they are a true and accurate record of the decisions reached
prior to any approvals being notified.
The Committees shall, as a condition of approval of each protocol, require

that project supervisors immediately report to the respective Committee
anything which might warrant review of ethical approval of the protocol,
including serious or unexpected adverse effects on participants, proposed
variations to the approved protocol, and any unforeseen events that might
affect the continued ethical acceptability of the project.
36
The Committees have the discretion to suspend or withdraw approval for
any project which no longer complies with the approved research protocol
or where the research ceases to be ethically acceptable.
2.8 Agenda formulation
The Agendas will follow a format as below with items appearing if

applicable:
 Details of date, time and place
 Record attendance and apologies
 Approve and sign minutes of previous meetings
 Record Conflict of Interest
 Record out of session approvals
 Detail projects outstanding
 Record new research proposals
 Report serious adverse events – local and international
 Amendments that chairs have approved
 Amendments that the committee are required to review
 Detail annual progress reports, final reports and requests for extension
of projects beyond the normal 4 year term.
 Other business
 Chairs report
 Publications and Items of Interest
 Next meeting date
2.9 Tabled Papers
It is not customary to allow for tabled papers as the agenda papers are
enough work within themselves. If there is information that needs to
append paperwork already sent, it will be sent to members giving at least
24 hours notice.
2.10 Matters by circular
If there is not enough business to call a formal meeting, matters will be

sent to members via mail with any comments regarding the agenda to be
37
collated by the Executive Officer and sent to all members for final
ratification.
38
2.11 Amendments
Amendments are included in the agenda papers

for review by the full HREC as well as the
Tasmania Health Tasmanian Scientific Research Advisory
& Medical Committee
Tasmania Social
All amendments are sent to the Chair for review.
Sciences
2.12 Attendance by Researchers at meetings
If the committees have difficulty with proposals where there are significant
ethical issues, the researchers will be invited to attend a meeting, at their
convenience, to address the issues. This is often a proactive way in dealing
with issues.
3. Minimal Risk consideration for Social Science projects
The National Statement (Section 2.27) provides for human research ethics
committees to establish procedures for expedited review of research involving
minimal risks to participants.
Procedures as per the National

HREC (Tasmania) Network Policy &
Statement on Ethical Conduct
Procedures for Minimal Risk Review
in Research Involving Humans
A Minimal Risk Form has been developed in

order to help users determine the status of
their application.
(a) The class or classes of
research to which an expedited
review procedure is to apply If they answer most questions as ‘No’ it is
deemed as Minimal Risk however the Chair
determines at the time of his review
whether it is truly minimal risk or not.
The Chair is the designated authority by the

(b) The scope of the
full committee to deal with Minimal Risks.
Chairperson’s authority
39
The Chair will delegate minimal risk
projects in his absence or when there is too
(c) delegation of tasks to sub-
high a workload, to a deputy Chair as
committees
approved by the full Committee
(d) the relationship between

the Chairperson of the full
Not relevant
Committee, and the
Chairpersons of such sub-
committees;
The tracking of Minimal Risk applications is

undertaken by the Ethics Officer – Social
(e) the method of reporting Sciences and reported to the full
and ratification of decisions by Committee for ratification. The same
the full committee conditions for annual reporting by the
Minimal Risk researchers still apply.
There is no minimal risk for projects that have potential for physical or
psychological harm e.g. research involving invasive physical procedures and
research exploring sensitive personal or cultural issues.
Where the Chair of a Committee considers that research may involve a departure
from any of the ethical principles in the National Statement, the application must
be considered by the full Committee and cannot be dealt with by expedited
review.
Servicing of the Committees

Administration of the committees is undertaken by the Executive Officer under
direction of the:
 Chairs of the Committees,

 Members of the Committees
 direct supervisor (Manager,Research Services)
 the Pro-Vice Chancellor(Research) & the Secretary of the Department of
Health & Human Services.
Executive Officer
The Executive Officer of the Human Research Ethics Committee shall be
responsible:
 for co-ordinating the functions of the Committees
40
 maintaining an overview to ensure that the Committees
meet membership and other requirements of the National Statement on
Ethical Conduct in Research Involving Humans, 1999 (hereafter referred to
as the National Statement)
 be available for advice and guidance to the Committee as
required.
 Organise an annual gathering for the members of all
committees
 Organise meetings as necessary for the Chairs of the
Committees to discuss policy and emergent issues.
 Facilitate the budget and costs of the HREC (Tasmania)
Network.
Reporting
The Committees shall report annually, in the form of the required report to the
Australian Health Ethics Committee under the National Health & Medical
Research Council on their composition, membership, and activities.
The Committee shall report annually to the Academic Senate of the University
of Tasmania, Department of Health & Human Services and any
participating institutions.
Each month, a report on the specific activity of each hospital will be provided to the administration of
that hospital.
Appendix B: Principles of Ethical Conduct
1. HISTORICAL CONTEXT OF HUMAN RESEARCH ETHICS
Protection of the rights and interests of subjects of research has been recognised
internationally in statements such as the Nuremberg Code (1949) and the World
Medical Assembly’s Declaration of Helsinki (first printed 1965; last revised 1996).
Many countries have also developed their own ethical codes relating to research
involving humans. In Australia a Statement on Human Experimentation was
produced initially by the National Health and Medical Research Council (NHMRC)
in 1966, based on the Declaration of Helsinki. The Statement on Human
Experimentation has undergone several revisions and the current edition, the
National Statement on Ethical Conduct in Research Involving Humans, is a
national standard for the conduct of ethical research in Australia. There are links
to some of these documents in Section 20 of the Handbook.
The Ethics Committee system had its roots in the 1976 edition of the NHMRC
Statement on Human Experimentation. At that time it became a condition for
41
NHMRC funding that a project be approved by an institutional medical ethics
review committee. In the 1982 edition it was stated that all health & medical and
social science research projects involving human subjects and relating to health
must be considered and approved by an Institutional Ethics Committee (IEC)
which is constituted and functioning in accordance with NHMRC guidelines.
The subsequent expansion in the nature of the Committees’ work is described in

the following passage: ‘The growing ethical culture has resulted in a progressive
broadening of the scope and types of research that is submitted for ethics
approval. Initially the focus was on human experimentation in a medical context
but this has expanded to include population health research and research
undertaken in the social sciences.’YES
In developing the National Statement, the ‘NHMRC has drawn on internationally

accepted principles … by reference to which the ethical acceptability of any
research involving humans, whether related to health or not, can be determined’
(Preamble, page 3).
The Australian Health Ethics Committee (AHEC) requires institutions to certify

annually that they comply with the NHMRC requirements. This information is
reported to the NHMRC which reports, in turn, to Federal Parliament and to the
Privacy Commissioner. The HREC (Tasmania) Network also maintains a close
informal link with AHEC, which provides the Committees with information,
guidance and support.
The historical context of the HREC system is described in the Preamble to the
National Statement.
42
2. PRINCIPLES OF ETHICAL CONDUCT
(Reference in National Statement: Section 1)
The basic ethical principles which govern research involving humans are stated
in Section 1 of the National Statement on Ethical Conduct in Research Involving
Humans. The principles cover:
 Integrity, respect for persons, beneficence and justice;
 Consent;
 Research merit and safety; and
 Ethical review and conduct of research.
3. RESEARCH MERIT AND SAFETY
Research merit
The Head of School/CEO/Institutional representative is required to sign on the

application form to indicate that he/she has read the application and considers
that it is sound with regard to:
(i) educational and/or scientific merit and
(ii) research design and methodology.
If the Head of School/CEO/Institutional Representative is one of the investigators,

this statement must be signed by a nominated appropriate person.
This does not preclude the Committee from questioning the research merit or
methodology of any proposed project where if feels it has the expertise to do so.
The Committee accepts that some projects, in particular some undergraduate

projects, are limited in scope. Supervisors should, wherever possible, ensure that
student projects relate to important research questions. Student projects which
are of limited research value must be low risk and will not be approved if they
cause harm.
Where possible, the Institution should have a mechanism such as a scientific

research committee that reviews applications for their scientific and
methodological merit and editorial supervision prior to being submitted to the
HREC.
Literature review
Research proposals must demonstrate that the research is based on a thorough

study of current literature. See Section 1.13 in the National Statement. A
literature review is normally required as part of the application.
Safety
The safety aspect of research is important. High-risk projects require a higher

level of justification than low-risk projects. If an application involves high risk,
43
appropriate referral with legal, insurance and supervisory staff of the institution
should be undertaken before an application is submitted to an HREC.
4. DISCLOSURE OF FUNDING SOURCES
(Reference in National Statement: 2.21)
A researcher must disclose the amount and sources or potential sources of

funding for a project and must declare any affiliation or financial interest.
Care must be taken that potential subjects are not coerced or induced to
participate because of financial arrangements that are in place.
5. CONFLICT OF INTEREST / POWER ISSUES
If any of the researchers that are listed on the application have an involvement
with associations, businesses, institutions, or the intended participants, this
should be declared in the application form with justifications for their
involvement, protocols they have in place to guard against biased data, and
information about protection of the relationship/s they are exploiting and ways in
which the voluntariness of participants is not compromised.
Particular attention will be paid by the HREC to applications that involve children,
fellow employees, and subordinates.
6. ETHICAL REVIEW OF RESEARCH
The HREC’s primary role is to protect the welfare and the rights of participants in
research and the primary responsibility of each member is to decide
independently whether, in his or her opinion, the conduct of each research
proposal submitted to the HREC will so protect participants (National Statement
2.5).
The HREC considers each application individually. Special attention is given to

projects which involve potentially sensitive or contentious areas of study,
particular methodologies or particular kinds of people.
Potentially sensitive or contentious areas of study
These include studies which involve possible breaches of legislation.
They also include studies where there is a risk of physical, psychological or social
harm. The Committee gives particular consideration to projects which involve:
 the collection of body tissues or fluid samples;
 the administration of any substance or agent;
 treatments or therapeutic techniques;
 the possibility of physical harm, pain, or discomfort above the everyday

norm, in the subjects or others;
 the possibility of emotional distress, anxiety or embarrassment above the

everyday norm in the subjects or others;
 obtaining information which may be prejudicial to participants;
44
 obtaining data containing personal information.
Projects which involve particular methodologies
Covert research techniques are of particular concern. For example:
 the use of procedures (eg tape recordings, photographs) without subjects’

knowledge;
 the use of deception about the purpose of the study.
Projects which involve particular kinds of people
The HREC takes particular care when participants include any of the following:
 children and young people;
 people with an intellectual or mental impairment;
 people highly dependent on medical care;
 people in dependent or unequal relationships;
 collectivities;
 Aboriginal and Torres Strait Island people.
7. THE PRINCIPLE OF INFORMED CONSENT
(Reference in National Statement: 1.7–1.12)
Voluntary informed consent is an important ethical and legal principle. The

ethical and legal requirements of consent have two aspects: the provision of
information and the capacity to make a voluntary choice (National Statement
Section 1.7).
In other words, it is not sufficient that a person consents to take part in a

research study. This consent must be truly informed; it must be based on full
and accurate information which has been understood. Further, consent must be
voluntary. The person’s consent to participate must not be subject to any
coercion or influence which would impair its voluntary character (National
Statement Section 1.10).
Investigators are normally required to provide a draft Information Sheet and

Consent Form with their application. These documents have different purposes.
Information Sheet
The purpose of the Information Sheet is to give potential subjects sufficient

information to be able to make an informed decision about whether or not they
wish to participate. See the Guidelines for Information Sheets attached to the
application form.
45
Consent Form
Written consent
Investigators are normally required to obtain written evidence of consent, with

subjects signing a Consent Form before participating in the project. See the
Guidelines for Consent Forms attached to the application form Information in the
Information Sheet and Consent Form must be consistent.
The investigator is expected to go through the Consent Form with subjects to

ensure their comprehension of the project, to reiterate any risks or side effects
and important ethical principles such as the voluntary nature of participation,
and to answer any questions that subjects may have. The investigator may wish
to bring in a third party to confirm a subject’s understanding and consent in
circumstances where the capacity of the subject to give voluntary and informed
consent is in doubt.
Other procedures for obtaining consent
While written consent is the norm, there are various kinds of study where other
procedures for obtaining consent are more appropriate, for example:
 Some questionnaire-based projects: See Section 5, ‘Activities that do not

require ethical clearance’, in the Handbook.
 Some studies using minors as subjects: The verbal consent of children may
be appropriate. See Appendix D.
 Some qualitative research: Written consent is not an inflexible requirement

for qualitative research. For example, in some cases obtaining written
consent may jeopardise the validity of the research. Examples are studies
based on interviews where obtaining written consent could interfere with
building rapport, and studies with subjects for whom protection of identity is
essential.
It is important that the fact of consent is recorded in some way. For example,
consent might be recorded on a taped interview, observed by a third party, or
recorded by other means, depending on the study.
If the investigator considers that written consent is inappropriate, the onus lies
on him/her to put evidence before the Committee to justify an alternative form of
recording consent.
When is consent not required?
In special circumstances the HREC may give approval for consent to be waived,
in accordance with the guidelines set down in the National Statement. For
example:
 Epidemiological research: There are some conditions under which an HREC

may approve access to identified or potentially identifiable data without the
consent of those the data identifies (See National Statement Section 14.4.).
46
 Use of human tissue samples: There are some conditions under which an
HREC may waive the requirement for consent (See National Statement
Section 15.8).
8. DATA MANAGEMENT
The management of data is one aspect of the more general issue of privacy of
information. (See National Statement Section 18 and the Joint NHMRC/AV-CC
Statement and Guidelines on Research Practice Section 2).
General principles
Investigators have responsibility for the collection, management, storage,

disposal and use of personal information obtained in research and teaching.
Confidential information collected by students working under the supervision of a

staff member is the responsibility of the supervising staff member.
Investigators from the University must inform the Head of School and the HREC
of any breach of confidentiality of data which includes personal information.
Mechanisms for ensuring confidentiality
Collection of data
Investigators should collect information which identifies individuals only if this is

essential for their study.
The public interest in privacy must be taken into account. This includes both
freedom from unauthorised interference with, or use of, personal information and
also freedom from authorised practices which are unduly embarrassing, intrusive
or prejudicial.
Management of data
An investigator must maximise the security of identifying data. Some procedures

for this are:
 removing identifying data from records at the earliest possible time;
 using coding procedures where re-identification is necessary;
 separate storage of data containing personal information.
Storage of data
Records should be stored securely at the Institution which is generating the

research. Access should be restricted at all times to nominated persons. All raw
data needs to be stored for at least five years from the date of publication. For a
more complete picture for University of Tasmania projects refer to the
University’s Code of Conduct in Research
(http://www.research.utas.edu.au/policies). Raw data includes audiotapes,
videotapes, questionnaires, interview transcripts, experiments and samples
taken.
47
Computer-held data
Investigators who are unsure about appropriate security procedures for

computer-held data should contact the User Support staff in the Information
Technology Services of the originating Institution.
Disposal of data
Investigators must consider whether or not there is a possibility that the findings
of the research project will be published. The University’s Code of Conduct in
Research (Note 2.2) requires that, if research results are published, the data
must be held for a period of at least five years from the date of any publication
which is based on them. If the project is funded under a contract, the data will
need to be kept for seven instead of five years, or for 13 years if the contract is
signed under seal. If the research will not be published, this data does not need
to be retained. Data collected in relation to medical projects normally needs to
be kept for longer periods.
Please note that data containing personal information (eg information which
identifies research subjects) should be destroyed or returned to the original
confidential source as soon as it is no longer necessary for it to be retained.
Paper records are to be destroyed by shredding or burning under appropriate

supervision. Shredding machines are provided in various places at the University.
Use of data
Results must not be published in a form that permits individual subjects to be

identified unless the individual has consented.
Confidentiality and the law
In rare circumstances research data may be perceived as relevant in the context

of legal proceedings. Thus, a court may seek access to confidential material.
Although the University will attempt to maintain the confidence, it may be
overruled.
9. INSURANCE AND COMPENSATION FOR INJURY TO RESEARCH SUBJECTS
There is a possibility that research subjects will be injured as a result of their

participation in a research project.
The originating institution of the research normally has liability policies which
provide indemnity to the institution in the event of negligence being proved
against it. This is the only cover that the institution normally has for research
subjects. It is possible, therefore, that a research subject may be injured but not
have any legal entitlement to compensation.
It is important for investigators to inform potential subjects fully of the nature of

the proposed research and any possible risks associated with participation, so
that the person’s decision to participate is made in full knowledge of the risks
involved.
48
Appendix C: Clinical Trials
Participation in clinical trials must be approved by the Ethics Committees.
CLINICAL DRUG TRIALS
Registered drugs: Some trials are based on registered drugs, often comparing
the efficacy of different combinations of drugs. Many of the trials coordinated by
the Australia Leukaemia Foundation, for example, are of this type.
Unregistered drugs: The Therapeutic Goods Administration (TGA) has several

schemes related to drugs which are not registered for marketing in Australia.
CLINICAL TRIAL NOTIFICATION (CTN) AND CLINICAL TRIAL EXEMPTION

(CTX) SCHEMES
Clinical trials of unregistered drugs are conducted under the CTN or CTX
Schemes, administered by the Therapeutic Goods Administration’s Drug
Evaluation Branch.
Under these schemes, Ethics Committees are responsible for ensuring that the
rationale, experimental plan and safety of proposed trials have been adequately
evaluated, and that previously conducted drug evaluations are acceptable.
Under the CTN Scheme, information on safety and toxicity is provided by the
investigator and evaluated by the Ethics Committee. The CTN Scheme is used
mainly for:
 new indications, dosages or patient groups for well-known drugs;
 extensions to trials of extensively evaluated new drugs.
Under the CTX Scheme, summary data is initially reviewed by the TGA. The CTX
route is used mainly for a new product at an early stage of development. Ethics
Committee approval is required.
AUTHORISED PRESCRIBED SCHEME
This is normally used for drugs that may be registered in other countries but not
in Australia, whether because of low occurrence of medical conditions that it
treats or where drugs marketed elsewhere contain a similar makeup of the drug,
or where supplies of a normally marketed drug are not available in Australia.
In order to be eligible for an authorisation, a medical practitioner must:
(a) if engaged in clinical practice at a hospital, be endorsed by the Health &

Medical Ethics Committee that reviews that hospital’s research, or
(b) be a specialist who is endorsed by a relevant specialist medical college or

society as an appropriate person to hold such an authorisation, or
(c) be a general practitioner who is endorsed by a relevant specialist medical

college or society as:
• being an appropriate person to hold such an authorisation; and
• having particular expertise in treatment of the relevant medical

condition.
49
Authorisation allows a medical practitioner to prescribe an unregistered product
containing the named drug without the need to obtain approval from the TGA for
each individual patient.
SPECIAL ACCESS (SAS) SCHEME
The SAS Scheme allows individual patients to obtain access to drugs not yet
registered for marketing in Australia. Arrangements vary according to the health
status of the individual. Ethics Committee approval is not required.
The policy for each hospital on unregistered drugs can vary. Researchers need to
contact each hospital to confirm what the policy is and follow the processes
advised.
At the Royal Hobart Hospital, ‘unregistered medications should not be

administered to patients within the Royal Hobart Hospital unless approval has
been given by the Drugs and Therapeutics Committee, or are part of an
approved clinical trial’.
ACCESS TO UNAPPROVED THERAPEUTIC DEVICES
Under the Therapeutic Goods Act 1989 (proclaimed February 1992), a

therapeutic device is any item used in health care which is not a drug.
Therapeutic devices include materials, equipment, instruments, apparatus,
implants and appliances used in health care. The use of an unapproved device or
an existing device for different purposes is defined as a clinical trial.
The Therapeutic Devices Branch of the TGA, under Section 19 of the Therapeutic
Goods Act 1989, administers four schemes which provide access to medical
devices not registered or listed in the Australian Register of Therapeutic Goods
(ARTG).
Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTE)

Schemes
Medical devices used in clinical trials are subject to either the CTN or the CTE
Scheme. Both schemes require Ethics Committee approval.
The Authorised User Approval (AUA) Scheme
In certain situations there is a need to use an unregistered product over a period

of time on a group of patients suffering from a serious illness. Endorsement by
either the IEC or an appropriate specialist society is required with an application.
The Individual Patient Use (IPU) Scheme
Devices obtained under the IPU Scheme are outside the terms of reference of the
IEC.
50
APPLICATIONS TO UNDERTAKE CLINICAL TRIALS
One Centre (one of the hospitals)
Investigators who wish to undertake clinical trials are required to submit the
following documents for consideration by the Ethics Committee.
Form RHH/Hobart Private / LGH/NWRH/Clifford Craig

NWRH / Calvary Health
Care
Application Form
Information Sheet and

Consent Form
Clinical Trial Protocol
Amendments 1 electronic and two hard, 1 electronic and two hard,

Investigator’s brochure signed copies signed copies
CTN form
Patient/Drug Information
Brochures
Indemnity form
Recruitment posters
Two or more sites (Royal Hobart Hospital and Launceston General

Hospital)
If the clinical trial is to be carried out at more than one site, one site needs to be
designated as the administrative site. For example, if the trial is going to be run
at Royal Hobart Hospital and Calvary Hospital, EITHER RHH OR Calvary would
nominate to be the administrative site.
Note:
 Trials will only be considered by one Ethics Committee and one Scientific
Committee for scientific validity and safety.
 All centres need to have their hospitals review the resourcing for the trials.
This means that each site needs to submit budgets and ‘Approval of
Assistance from Other Department’ forms. Depending on the hospitals, these
forms are reviewed by the Scientific Committees.
 The adminstrative site will submit the application to the Ethics Support
Officer. The Ethics Support Officer will then send it to the respective
committees.
51
Investigators who wish to undertake clinical trials are required to submit the
following documents for consideration by the Ethics and Scientific Committees.
Form RHH/Hobart Private / LGH/NWRH/Clifford Craig

NWRH / Calvary Health
Care
Application Form

Consent Form for each site*
Clinical Trial Protocol
Amendments
Investigator’s brochure 1 electronic and two hard, 1 electronic and two hard,
CTN form signed copies signed copies
Patient/Drug Information
brochures
Indemnity form
Recruitment posters
Budget and ‘Approval of

Assistance from Other
Departments’ forms
A site starting a trial that has already been granted approval must submit:
Form RHH/Hobart LGH/NWRH/Clifford Craig

Private/NWRH/Calvary
Health Care

Consent Form. (These
should be based on the
current ones being used at
the original site but with
the local investigator. The
ethics details will be that of
the original approving
committee and will be sent
to that committee.)
52
Clinical Trial Protocol (for 1 electronic and two hard, 1 electronic and two hard,
Scientific Committee) signed copies signed copies
Amendments (if any have

been received since the
beginning of the trial)
CTN form
Indemnity form
Recruitment posters
Budget and ‘Approval of

Assistance from Other
Departments’ forms (to be
submitted to the Scientific
Committees for resourcing
sign-off)
CLINICAL TRIALS RUN BY RESEARCHERS IN PRIVATE PRACTICE
Most clinical drug trials are conducted by staff of the private and public hospitals
in Tasmania and are submitted to the Tasmania HREC for approval. (See Section
12, ‘What if my project has already been approved by another HREC?’in the
Handbook.)
However, it is sometimes the case that the trial does not involve hospital
patients, for example when the participants are patients in the investigator’s
private practice. In such cases the investigator must apply to the University
HREC for approval.
The following documents are required:
 ‘Application: Investigation Involving Human Subjects’;
 an Information Sheet and Consent Form localised for use with the specific
patients who will participate;
 full details of the proposed trial – for example, protocol, amendments and
investigator’s brochure;
 forms which need HREC approval and signature, for example, a clinical trial
agreement, trial terms agreement, clinical study indemnity form and CTN
form.
The HREC’s procedure is to obtain external technical and clinical advice on the
proposed trial before it considers the application in regard to ethical issues.
Investigators must therefore allow sufficient time for this process to take place.
Appendix D: Research involving children and young people

53
IMPORTANCE OF THE RESEARCH
In Section 4.1(a) of the National Statement it is stated that research involving

children and young people should only be conducted where ‘the research
question posed is important to the health and well-being of children or young
people’.
It can be argued that some student projects involving children or young people
may not pose an important research question but can be justified on the grounds
that they provide a valuable educational opportunity for student researchers.
In all cases,
(i) Supervisors should ensure that student projects have research value
wherever possible; and
(ii) The research must not be harmful to the children taking part.
ISSUE OF CONSENT
Parents’ consent
Section 4.2 of the National Statement refers to the necessity of obtaining

parent/guardian consent in ‘all but exceptional circumstances’.
Parents’ consent is normally required for studies which involve children and
young people under 18 years of age. However, the investigator can apply to the
HREC for dispensing with written parental consent.
The HREC will make a decision regarding the necessity of parents’ consent after
taking into account the following:
 The nature of the project:
 The level of risk to subjects – is it a ‘minimal risk’ project?
 The age and maturity of the subjects – are the subjects mature teenagers?
If parents’ consent is not required, investigators should, if practicable, inform

parents about the project (for example, in a school newsletter) and parents
should have the opportunity not to permit their son’s/daughter’s participation.
Investigators must also bear in mind that some schools require parents’ consent
for all health & medical and social science research projects.
Children’s and young people’s consent
The consent of subjects is required provided that the subjects are of an age
where their willingness to participate can be ascertained. Verbal consent is
sometimes appropriate.
Appendix E: Human tissue and body fluid sampling

The following guidelines are an elaboration of 15.1(c) in the National Statement

regarding ‘the professional removal of samples to be used’.
54
1. USE OF ROUTINE BLOOD AND TISSUE SAMPLES FOR RESEARCH
A discussion paper prepared by Dr Rob Loblay for the Royal Prince Alfred Hospital
(Sydney) Human Ethics Committee provides useful guidelines. The discussion
paper is reproduced below.
Introduction
Samples of tissue, blood and other body fluids collected from patients are
used for research in a variety of circumstances:
(a) samples collected for research purposes only;
(b) samples collected for routine diagnosis and/or treatment, and also used
for a concurrent research project;
(c) samples collected for routine diagnosis, stored, and retrieved at a later
date for research not envisaged at the time of collection.
For research in categories (a) and (b) there is generally no difficulty in

seeking informed consent. However, in category (c), where long periods of
time may have elapsed between collection of the specimens and initiation
of a research project, there are considerable practical problems in obtaining
informed consent. If this were mandatory many such research projects
would be difficult or impossible to conduct.
Ethical questions
1. What consent is required for research on routinely collected

specimens? Is fully informed consent necessary in all cases? Could
‘blanket’ consent be obtained routinely from all patients at the time of
admission?
2. How should confidentiality be ensured? Should the patient, the family

and/or the relevant doctor(s) be notified of important findings if the
research was done without specific informed consent?
3. Whose legal property are stored specimens and who should have
access to results? In some circumstances tissues or genetic material
could have potential for commercial exploitation, and this may become
an important issue in certain cases.
55
Issues to be considered
Research on routinely collected clinical specimens can potentially involve a

wide spectrum of sample types and procedures. This needs to be taken into
account before considering the ethical questions.
(i)Type of sample:
 Serum
 Other body fluids: urine, CSF, bile, exudates, secretions, pleural,

peritoneal or joint fluid.
 Solid tissue: biopsies, surgical specimens, post-mortem tissue.
 Living cells: peripheral blood leucocytes, bone marrow cells, lymphoid

tissues (may be frozen and stored in liquid nitrogen or propagated as
immortal cell lines in tissue culture).
 Foetal tissues and placenta (such tissues have unique considerations

and are not covered by this paper).
(ii) Research procedures
A range of procedures may be employed on stored material, depending on

the particular research questions being examined. For example:
 microscopic examination
 biochemical analysis
 immunoassay
 genetic typing
 in situ hybridization (DNA, RNA)
 DNA amplification and gene sequencing
 propagation of cells (eg hybridomas, cell lines)
 propagation of genetic material (DNA amplification and cloning)
 genetic manipulation (mutagenesis, transfection, creation of transgenic

animals, gene therapy).
56
Discussion
(i)Problems with ‘blanket’ consent:
‘Blanket’ consent given for unspecified research cannot be regarded as

informed consent, even if approved by an ethics committee. Nor can it take
account of the various different kinds of research which might conceivably
take place in the future.
Patients may misunderstand the request and become confused or

frightened at the prospect of being used as ‘guinea pigs’, and may as a
result refuse consent for necessary diagnostic and/or therapeutic
procedures.
An unjustified burden would be placed on nursing and resident medical

staff requesting consent, both in terms of time and responsibility.
Its legal validity could be challenged.
(ii) Use of stored material for research purposes
It has not always been normal practice to seek Ethics Committee approval
for such research, and informed consent is rarely (if ever) obtained at
present. In discussing the possible need for approval and/or consent, the
following factors need consideration:
 Nature of the research:

At one end of the spectrum, proposals which are principally quality
assurance exercises for diagnostic tests would not normally require
informed consent. At the other end, those involving propagation of cell
lines and/or genetic material would clearly always require informed
consent. Between these extremes consent may be required, depending
on the circumstances.
 Nature of the tissue:

Research on certain tissues would be more likely to require informed
consent of the donor, e.g. foetal tissue, placenta, brain, ova, sperm.
 Whether the tissue is from a living patient or a post mortem specimen:

For research on post-mortem specimens, informed consent would
probably only be required from the family if they might have an
interest in the result.
 If there might be an impact on the patient and/or family:

For example, in some circumstances research results could lead to an
alteration of diagnosis or treatment, or might carry potential for
discrimination, stigma, guilt or anxiety. Alternatively, the process of
seeking consent might itself create needless anxiety or concern,
depending on the type of study and how it is to be explained.
57
(iii) Use of routine specimens for a concurrent research project
Clearly, informed consent is necessary if additional amounts are to be

collected over and above that required for diagnostic or therapeutic
purposes. When diagnostic specimens are also intended to be used in a
concurrent research project, but no additional blood or tissue is collected,
consent would normally be required, but might be waived in certain
circumstances. In addition to the factors listed above, one might consider:
 Whether seeking consent might cause unnecessary concern or anxiety

to patients, and might therefore prejudice their investigation and
management.
 Whether there are major logistic difficulties which might render the
project impracticable.
(iv) Confidentiality and notification
The principles relating to confidentiality would generally be the same as

those which apply to all other types of research. One possible difference
might be that the results could be incorporated into the routine medical
and/or laboratory records, or a computerised hospital database. The results
would then be accessible to a wide range of hospital staff.
It would seem reasonable to think that there should be a mechanism

whereby the patient or family could be notified of unexpected findings in
which they might have an interest. This would depend on the nature of the
information and its implications. In some instances, eg. where the
information might cause needless anxiety, it might be more appropriate for
the information to be transmitted to the family doctor and/or Attending
Medical Officer in the first instance.
(v) Legal ‘ownership’ of clinical research specimens
It is generally assumed that ‘ownership’ of a clinical specimen rests with

the ‘controlling’ diagnostic department (ie. where the specimen is stored),
and ultimately with the hospital and State Health Department. Whether this
is strictly true from a legal point of view it may be worth seeking a formal
opinion.
The Human Tissue Act (NSW 1983, Section 31) permits the use of post-
mortem tissue specimens for ‘scientific purposes’ without the need for
further consent from the next of kin. Such tissues are presumably
considered state property.
Notwithstanding, there might be circumstances in which the patient or

family would have a legal claim on ‘ownership’ of tissues. This would be
particularly so with germ cells (sperm/ova), and when cells or genetic
material were being propagated for purposes which might have some
clinical or commercial application. However, the courts will ultimately
decide the issue.
58
Recommendations
‘Blanket’ consent for research on routinely collected clinical specimens is

inappropriate, for the reasons outlined above. It would almost certainly
create as many legal and ethical problems as it would solve. A flexible
approach is favoured by which the ethics committee could make decisions
on a case-by-case basis, and suggest the following guidelines:
1. All research proposals involving routinely collected and/or stored

specimens should come before the ethics committee.
2. Applicants may request that informed consent be waived, and should

provide justification.
3. In considering a request for waiving informed consent, the ethics

committee should take into account the following:
• type of tissue/specimen;
• nature of the research;
• whether the patient/family might have an interest in the finding;
• whether seeking consent might cause them needless anxiety and
• the possibility of commercial application.
Using these guidelines
Informed consent would not normally be required for projects which are
primarily quality assurance (eg. laboratory quality control, setting of
reference ranges etc.).
Consent should always be obtained (a) for research involving foetal

tissue/placenta, germ cells, and propagation of immortal cell lines or
genetic material, and (b) if there is potential for commercial exploitation.
Consent would sometimes be required for other projects, depending on

the nature of the research and whether the patient/family might have an
interest in the result (eg. application of new techniques to study the cause
of a disease, development of new diagnostic or screening tests,
retrospective surveys of diagnosis, etc.).
59
Examples
A patient with rheumatoid arthritis has had a routine biopsy taken of a skin
lesion for diagnostic purposes, and the histopathology specimen is stored. It
is retrieved five years later for a research project. Consider the following
circumstances:
1. The slides are reviewed as part of a retrospective survey of the

pathology of all rheumatoid lesions biopsies at the hospital over a ten
year period.
 This should not require special consent. Normal precautions

would need to be taken to ensure confidentiality.
2. Stored blocks are retrieved, recut and stained with a new method being
tried because of its increased diagnostic sensitivity and specificity in
detecting vasculitis.
 This would probably not require consent unless it was

thought that the result might alter the prognosis and therapy for
the patient concerned, which would depend on the time which had
elapsed since the biopsy.
3. Stored tissue is re-cut and probed for a new infectious retrovirus

suspected of causing rheumatoid arthritis.
 This could possibly have significant implications for the

patient and/or family members, and informed consent might be
desirable. However, the issue is not clear-cut since the chances of
finding such a virus are remote, and it could be argued that
seeking consent might cause needless anxiety, stigma or family
concern.
4. DNA is extracted from stored tissue, and particular genes are amplified
and sequenced in order to determine the genetic basis of susceptibility
to rheumatoid arthritis.
 Informed consent would normally be required for a project

of this kind. depending on the nature of the gene in question.
5. The suspect gene is cloned and microinjected into fertilized mouse ova
in order to create transgenic animals susceptible to rheumatoid
arthritis.
 Informed consent would be mandatory.
60
6. The same gene is engineered into an expression vector, and the gene
product is commercially developed as part of a diagnostic kit for
screening individuals at risk.
 This raises the question of whether the patient has any

legal claim on a patent or on any profits which might arise from the
use of his or her tissues. This will probably be decided by the
courts, and may depend on the extent to which the DNA or cells
have been modified from their original state.
(End of discussion paper)
2. HUMAN TISSUE HANDLING
REGISTRATION OF PREMISES
Under Section 20 of the Human Tissue Act 1985, blood can be removed at a
hospital and at premises or in a vehicle used by the Australian Red Cross, or by
another body approved by the Minister.
BEST CODE OF PRACTICE
Introduction
When tissue sampling is carried out it should only be done by a qualified

practitioner, which means a nurse, trained personnel or pathology staff.
When blood or other body fluid sampling (with the exception of urine, faeces,
semen and saliva) is carried out it must be by people who have been trained and
who hold a certificate of competence. The project’s chief investigator must
accept responsibility for ensuring that staff carrying out the tissue
sampling are certified.
The chief investigator, although not necessarily directly involved in taking the
blood, is nevertheless responsible for the consequences of the blood being taken
and is responsible for the supervision of the best code of practice.
The effectiveness of precautions depends upon vigilant compliance on the part of

each individual and taking responsibility for his/her own potential exposure.
People in charge of sampling procedures must ensure that appropriate protective
barriers (aprons, gloves, masks, etc) are to hand and easily accessible to
personnel.
Wearing gloves for all invasive and sampling procedures should be routine. It is
recognised that loss of tactile sensation with gloves could make blood-taking
difficult. In the case of blood-taking, students and technicians must be trained in
identifying the correct circumstances in which to wear gloves.
61
Routine procedures
Blood and body fluids (other than urine)
At all times personnel must have access to gloves and plastic aprons when there
is the possibility of direct contact with blood/body fluids or body substances.
Holed or torn gloves must be changed before handling is continued.
Facial protection must be used in cases where splashing of human body fluids is
possible.
Note: Mouth pipetting of any human fluid is banned absolutely.
Human tissue
When using human tissue (biopsies, surgical specimens, post-mortem tissue,

placenta) masks with full facial protection must be worn.
Procedures must be conducted in a designated area that can be cleaned

extensively (see ‘Procedure for cleaning equipment’ below).
The investigator must place all material in a bio-hazard container before he/she
leaves the laboratory. Hands must be thoroughly washed.
Safe handling of ‘sharps’
Needles must not be recapped unless an authorised containment device (eg

Necon) is being used.
Sharps must be disposed of into a sharps container as soon as possible after use.
All personnel are responsible for the disposal of their own sharps/needles.
Syringes and needles are to be disposed of as one unit unless an authorised

needle containment device is being used.
Sharps containers must not be overfilled.
Procedure to be followed in the event of ‘sharps’ injury
Anyone who, through a sharps injury, has been exposed to blood or body fluids
must contact the Department of Emergency Medicine (Casualty) in the Royal
Hobart Hospital or the Launceston General Hospital. The staff of the Department
of Emergency Medicine will take the appropriate course of action.
Procedure for cleaning equipment
Needles must not be cleaned. They must be disposed of in sharps containers.
Surgical instruments must be washed in detergent (eg Decon) and subsequently

autoclaved.
Following any experiment all other equipment, including any perfusion

apparatus, must first be washed with Sodium Hypochlorite 0.5%w/v, then washed
in detergent (eg Decon) before being rinsed in distilled water, and finally washed
in Absolute Ethanol if the apparatus is to be left dry.
62
Procedure for the disposal of all blood or body fluids and substances
All blood or body fluids and tissue with the exception of urine must be disposed
of in a secure manner which means in a container with the appropriate bio-
hazard warnings on the outside of the container.
Sealed bio-hazard containers must be handed to the person who is responsible

for the disposal of the material by incineration. The responsible person must also
consider the possibility of the contents not being suitable for incineration.
Note: There are special requirements for foetal tissues. These are not covered in
this handbook.
Registered areas (areas registered under section 20 of The Human Tissue

Act 1985)
Any area in which blood or body fluids, with the exception of urine, is to be taken
should conform with the following requirements:
 It must be well lit, and clean and uncluttered with other material.
 There must be a bed or couch upon which the donor can lie. This avoids the
possibility of injury arising in the event of fainting.
 There must be appropriate skin sterilising facilities including a wash basin,

antiseptic solution and appropriate alcohol swabs.
 With venepuncture, appropriate tourniquets which will impede the flow of

venous blood must be available and there must be an appropriate selection
of sterile needles and syringes or vacuum collection systems.
 An appropriate wall chart must be supplied with details of strict procedures

to be used, together with the chart indicating how sharps are to be disposed
of, the telephone numbers of the local safety officer, the nearest medical
practitioner/s and the ambulance station.
Summary
Tissue sampling is to be carried out only by a registered medical practitioner.
People taking blood by venepuncture must be trained.
Blood and other body fluids (except urine, faeces, semen and saliva) should be
taken by trained people and responsibility accepted by a registered medical
practitioner.
The best practice for all sampling procedure must be used at all times.
3. ACCESS TO INDIVIDUAL PATIENTS’ RECORDS
Many projects utilise patients’ records. All such projects must be submitted to the
Ethics Committee for approval.
For some projects researchers require access only to records from which data
that identifies individual patients has been stripped. For other projects identifying
information is required. The Committee considers each application individually
63
while recognising the importance of maintaining the confidentiality of patients’
records.
Subjects’ consent should generally be obtained for the use of their records for
research purposes, but the Committee may waive this requirement in
accordance with NHMRC Statement on Human Experimentation and
Supplementary Notes, Note 6(7)):
Consent of subjects should generally be obtained for the use of their

records for medical research, but in certain circumstances an ethics
committee may approve the granting of access to records without
consent. This course should only be adopted if the procedures
required to obtain consent are likely either to cause unnecessary
anxiety or to prejudice the scientific value of the research and if, in
the opinion of the ethics committee, it will not be to the disadvantage
of the subjects.
In cases where the chief investigator is not associated with the Royal Hobart
Hospital he/she will be required to sign a statement regarding the confidentiality
of patients’ records.

concealment or covert observation
Section 17.1 in the National Statement states that, ‘as a general principle,
deception of, concealment of the purposes of a study from, or covert observation
of, identifiable participants are not considered ethical because they are contrary
to the principle of respect for persons in that free and fully informed consent
cannot be given’.
Section 17.2 states that in some fields of research there may be exceptional
circumstances where such studies are acceptable.
However, research in some areas of psychology involves deception or failure to

‘tell the whole story’. The HREC will recognise this when interpreting the term
‘exceptional circumstances’.
64
Appendix G: Research involving Aboriginal and Torres Strait
Islanders
Any researcher involving Aboriginal and Torres Strait Islanders as the target of
their research are required to abide by the following guidelines and demonstrate
that they have addressed the issues therein:
 Values and Ethics - Guidelines for Ethical Conduct in

Aboriginal and Torres Strait Islander Health Research
 Guidelines for Ethical Research in Indigenous Studies

(Australian Institute of Aboriginal and Torres Strait Islander Studies 2002
Ethics Committees under the HREC (Tasmania) Network and review of studies that
specifically target Aboriginal and Torres Strait Islander people
Currently none of the Ethics Committee have specific representation by an Aboriginal

and Torres Strait person. The amount of projects that involve Aboriginal and Torres
Strait Islanders is small.
The Committees do, however, have a policy relating to projects that specifically
involve Aboriginal and Torres Strait Islander peoples. The Committee may adopt any
or a combination of the following in reviewing said applications:
 Referring relevant research proposals to a properly

constituted and appropriate Aboriginal HREC for consideration (if possible
in the same region as the invited participants)
 Invite Riawunna to advise who would be the most

appropriate people who could attend a committee meeting after having
reviewed the application and sought their own independent advice.
 seek external review by relevant Aboriginal and Torres

Strait Islander advisors and/or elders from the regions that the research is
expected to take place.
65

Handbook and Appendices: Human Research Ethics Committee (Tasmania) Network

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HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK

Human Research Ethics

Human Research Ethics Committee (Tasmania) Network Contact

1. What is meant by ‘human research’?.............................................9

2. What is ‘human research ethics’ about?.........................................9

3. What does a ‘human research ethics committee’ do?....................9

4. What does the National Statement cover?....................................10

5. What kinds of health & medical and social science research

6. How do I apply to the HREC (Tasmania) Network?.........................15

7. How long will it take for my application to be considered?...........16

8. When can the Minimal Risk application be used?...........................17

9. Are there parts of an application that I need to take particular care

10. When do I need to submit my application?.................................18

11. What happens to my application after submission to the RDO?..20

12. What if my project has already been approved by another HREC?

13. What if my project involves more than one centre?....................23

14. What if my project involves a clinical trial?.................................23

15. When can I start my project?......................................................23

16. Where can I find general information about ethical issues in

19. Whom should I contact if I have any questions?..........................27

Appendix A: Terms of reference for the Committees, requirements as

Appendix B: Principles of Ethical Conduct..........................................41

Appendix D: Research involving children and young people .............53

Appendix E: Human tissue and body fluid sampling .........................54

Appendix F: Research involving deception of participants,

Appendix G: Research involving Aboriginal and Torres Strait Islanders

AHEC Australian Health Ethics Committee

Telephone: (03) 6226 1751

Human Research Ethics Committee

Telephone: (03) 6226 2764

THE HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK

On 1 January 2002 a unified Human Research Ethics Committee (Tasmania)

THE HREC (TASMANIA) NETWORK’S ETHICS COMMITTEES

The HREC (Tasmania) Network functions with three Ethics Committees:

Tasmania Health & Medical HREC Mr Murray Shanley

The participating institutions that currently access these committees are:

The terms of reference for the Committees, requirements as to composition and

PRINCIPLES OF THE UNIFIED HREC SYSTEM

 The HREC system is available on a fee-paying basis to any person or group

 Tasmanian individuals, groups or institutions that are not part of the

 The HREC system accommodates workload by allocating applications

 The HREC system seeks to:

 provide consistency in approach and decision-making; and

 remove duplication in HREC procedures in Tasmania.

The National Statement is a comprehensive guide to research ethics, which all

Human research includes:

 research which involves humans directly, as participants;

 research which impacts on humans, for example studies of human remains

2. What is ‘human research ethics’ about?

 Integrity of the researcher and the research to be undertaken;

 Beneficence, which means the obligation to maximize possible benefits and

3. What does a ‘human research ethics committee’ do?

An HREC gives special attention to projects that involve potentially sensitive or

4. What does the National Statement cover?

Principles of ethical conduct (Section 1)

Categories of personal information (Preamble and Section 14)

Privacy of information (Section 18)

 Health & medical and social science research projects involving

 Higher-degree research involving human subjects.

 require a full application;

 require an application to be considered as Minimal Risk;

 do not require an application to the HREC.

Activities that DO NOT require formal ethical clearance