Guidelines for the Victorian-Specific...
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Guidelines for the Victorian-Specific Module 1 of 21 January 2015
Guidelines for the Victorian-Specific Module
Overview
As part of the ethics application process, a completed Victorian-Specific Module to address
Victorian-specific legislation must be attached to the NEAF application.
Completion of the Victorian-Specific Module is mandatory for all research conducted in the State
of Victoria.
In Victoria there is a requirement to comply with legislation relevant to human research involving
information privacy (Information Privacy Act 2000), health information (Health Records Act
2001), the use of ionising radiation (Radiation Act 2005 and Radiation Regulations 2007),
removal of human tissues (Human Tissue Act 1982) and the use of poisons or controlled
substances (Drugs, Poisons and Controlled Substances Act 1981). In addition, consent under
circumstances where the Guardianship and Administration Act 1986 or the Mental Health Act
2014 applies must meet the requirements set out in the applicable Act.
The Victorian Specific Module and these Guidelines may be modified and updated from time to
time. Please access the form from the website (www.health.vic.gov.au/clinicaltrials or
www.health.vic.gov.au/healthandmedicalresearch) each time you make a new application, to
ensure that you have the latest version.
For each project, Section 1 of the Victorian Specific Module must be completed, and Sections 2,
3, 4 and 5 should be completed as applicable to the individual research project. The Checklist
should be completed for all projects, and can be used to identify the necessary sections.
These guidelines provide useful information and specific instructions for completing Sections 2, 3
and 5 of the Victorian Specific Module.
National Mutual Acceptance (NMA)
If a research project is being submitted for HREC review under the NMA initiative and there is a
Victorian site participating in the trial, the Victorian-Specific Module must be submitted to the
reviewing HREC.
If the Coordinating Principal Investigator (CPI) is based outside Victoria, it is recommended that
the Victorian-Specific Module is completed by a Victorian Principal Investigator (PI) or delegate
based at a participating Victorian site, as they will have familiarity with the relevant legislation.
The CPI should sign the completed Victorian-Specific Module in the ‘Research Project Details’
section on the cover page. However, if a Victorian PI has completed the VSM on behalf of an
interstate CPI, the Victorian PI should sign.
Guidelines for the Victorian-Specific Module 2 of 21 January 2015
Information for Victorian Specific Module Section 2:
Research Involving the Recruitment of Participants who may be Incompetent to Consent
The Guardianship & Administration Act 1986 information paper “Medical research procedures
involving patients under a legal incapacity” should be used as a reference.
For further information, refer to the document “General medical health needs, annual
examination, non-psychiatric treatment, special procedures and medical research procedures -
Chief Psychiatrist’s Guideline” (www.health.vic.gov.au/mentalhealth/cpg/non-psych-
treatment2008.pdf)
Consent and competence
Consent must be:
• Given by a competent person;
• Given by a person who has been adequately informed of the risks and benefits for the
participant of participation; and
• Given freely.
Competence involves:
• Comprehending and retaining information relevant to making the decision;
• Believing this information;
• Understanding any further implications of the decision; and
• Weighing the information in the balance and arriving at a decision.
A thorough assessment of a participant’s competence and capacity to make a valid informed
decision is necessary prior to their recruitment into the research project. The details of this
assessment should be clearly documented in a patient’s health record, where appropriate.
In those circumstances where participants have NO capacity to make a valid informed decision
and the research project involves a medical research procedure, the provisions of the
Guardianship and Administration Act 1986 (Vic) will apply.
In those circumstances where participants have some capacity to understand and provide a valid
informed consent, consideration should be given to the extent of that capacity in the context of
the study contemplated; for example, the stress and anxiety of an accident and emergency room,
the nature and seriousness of the participant's clinical condition. These factors may impact on the
reality and capacity of a participant to peruse and digest a detailed participant information
statement. In such cases, a more limited verbal process of informing participants of the proposed
research may be more appropriate. In this event, accurate documentation must be included in
the participant's health records. The more detailed Participant Information and Consent Form can
be provided for further consideration at a later stage. This is in accordance with Section 4.4.5 of
the National Statement.
Dependency and consent
If the research involves participants in a dependent relationship with the researcher, for example,
employees, students etc., it should be considered whether an independent person should make
the initial approach and/or seek consent [National Statement 4.4.12].
Normally any interpreter needs to be independent. However, with low-risk research, an English-
speaking relative or friend may be acceptable.
Children and consent
In most States the legal age of majority is 18 years. For a person aged under 18 years, consent
can be obtained if the person is competent (see above for components of competency). Youth
does not necessarily indicate incompetence - this needs to be formally evaluated on a case by
case basis and will vary according to the age of the child, their maturity and the nature of the
research project and procedures involved.
The National Statement recommends that specific consent should be obtained from the child or
young person wherever they are capable of deciding AND from a parent or guardian in most
circumstances [NS 4.2.7]. Exceptions may be where there is “standing parental consent” for
school-based research [NS 4.2.10-11] or where an HREC determines that it is appropriate for
Guidelines for the Victorian-Specific Module 3 of 21 January 2015
only the young person to consent [NS 4.2.8-9]. Where a child is assessed as NOT having the
requisite capacity to provide a valid informed consent, parental/guardian consent MUST be
obtained in all circumstances. In all cases, children need to be informed about the project so that
they can understand what is going on and so that they are aware they are not required to
participate if they do not want to.
In studies involving participants under the age of 18, two Participant Information and Consent
Forms will usually be required: one for the participant and one for the parent/guardian.
Researchers should ensure that the Participant Information and Consent Form intended for the
participant under 18 is written in language that will be understood by the age group.
For clinical trials and other relevant situations, clear documentation should be made in each
participant's health record of an assessment as to their capacity to provide informed consent to
participate in the study.
Note: The reference to “parent” includes a person with “parental responsibility”.
Cognitive impairment, Intellectual disability or mental illness and issues of consent
For research involving people with cognitive impairment, intellectual disability or mental illness,
researchers need to evaluate each participant’s competence. If the participant is competent,
researchers must obtain their valid consent. It would be wise to consult relatives or carers as part
of the consent process. The HREC should be informed about how the evaluation of competence
will be made, as outlined in the National Statement 4.5.9.
It is important to remember that the PICF for such individuals must be designed to facilitate
adequate understanding of the research to which they are being invited to take part.
Definition of Medical Research Procedure
With reference to The Guardianship and Administration (Further Amendment) Act 2006, “medical
research procedure” means:
• a procedure carried out for the purposes of medical research, including, as part of a clinical
trial, the administration of medication or the use of equipment or a device; or
• a procedure that is prescribed by the regulations to be a medical research procedure for the
purposes of The Guardianship and Administration (Further Amendment) Act 2006
However, “medical research procedure” does not include:
• any non-intrusive examination (including a visual examination of the mouth, throat, nasal
cavity, eyes or ears or the measuring of a person's height, weight or vision); or
• observing a person's activities; or
• undertaking a survey; or
• collecting or using information, including personal information (within the meaning of the
Information Privacy Act 2000) or health information (within the meaning of the Health
Records Act 2001); or
• any other procedure that is prescribed by the regulations not to be a medical research
procedure for the purposes of this Act.
For research that involves a “medical research procedure”:
Note that if the participant(s) are not competent to give consent as the result of a disability and
the research involves a “medical research procedure” as defined in the Guardianship and
Administration Act 1986 (Vic) (see above) then researchers must apply steps 1–4 as described in
Sections 42Q, 42R, 42S and 42T of the Guardianship and Administration (Further Amendment)
Act 1986 (Vic). In summary, these steps are:
• Step 1 – Section 42Q – Approval of the research project by the relevant HREC
• Step 2 – Section 42R – Is the patient likely to recover within a reasonable time?
• Step 3 – Section 42S – Consent of person responsible
• Step 4 – Section 42T – Procedural authorisation
Section 42A: There may be rare cases where the medical research procedure comes under the
provisions for “Medical Emergency”, when the proposed procedure is necessary as a matter of
urgency to save life, prevent serious damage to health or prevent significant pain or distress. In
such cases, consent does not need to be obtained from the patient or the person responsible.
It is the principal researcher’s responsibility to ensure that he/she and all members of the
research team are fully conversant with the requirements of the Guardianship and Administration
Guidelines for the Victorian-Specific Module 4 of 21 January 2015
Act 1986 (Vic) and, in particular, Division 6 of Part 4A of the Act which describes these steps in
detail.
Essential Links:
• Guardianship and Administration Act 1986 (Vic) –
www.austlii.edu.au/au/legis/vic/consol_act/gaaa1986304/
• Guardianship and Administration (Further Amendment) Act 2006 (Vic) -
www.legislation.vic.gov.au/Domino/Web_Notes/LDMS/PubStatbook.nsf/51dea49770555ea6ca2
56da4001b90cd/9791E529F7789737CA25712A0019E79F/$FILE/06-003a.pdf
• Section 42T certificate
www.publicadvocate.vic.gov.au/file/file/Medical/interactive%20PDFs/42T_SectionNew_Int.pdf
For research that DOES NOT involve a “medical research procedure”:
Certain kinds of research may involve contact with participants but may not involve a medical
research procedure, e.g. observational studies, non-obtrusive examinations, and collecting or
using information.
Consent of next-of-kin
If you anticipate that participants will not be able to consent on their own behalf, and the project
does not involve a medical research procedure as defined within the Guardianship and
Administration Act 1986 (Vic), Participant Information should be provided for consideration by a
third party (e.g. next-of-kin/carer). Since next-of-kin/carer cannot legally give consent for
participation, but can object to participation, the next-of-kin/carer of an incapacitated person
should be asked to sign an Acknowledgment Form, acknowledging receipt of Participant
Information and indicating that they do not object to participation of their relative. Next-of-Kin
may include a participant’s spouse, nearest relative or legal guardian.
2.1 Consent
Before giving approval, the HREC must be satisfied as to how the researcher(s) will verify that a
participant has given valid consent to participate in the project. HRECs generally require that
written consent will be obtained from all participants and the signed Consent section of the PICF
is evidence that valid consent has been obtained. In some circumstances, it may be ethical to rely
on verbal or implied consent [National Statement 2.2.5]. Sometimes verbal consent may be valid
and formal written consent may be unnecessary or even undesirable. In these cases, consent
may be recorded by another means. Examples include video or audio taping or researcher’s notes
of a conversation, verbal consent given over the telephone before a telephone interview. Implied
consent may be expressed by the completion and return of a questionnaire.
(a) Indicate whether any participants will not have the capacity to give informed consent. If
“Yes”, that at least some of the participants will not have capacity to give informed consent,
indicate who will be asked to provide consent for those individuals in (i) and (ii). If 2.1 (a) is
“No”, identify in (iii) the procedure used to recruit patients.
(b) Explain how the person who will recruit participants will determine the competence of
individuals to give consent. This explanation should include information about how the decision
will be made, who will make it, the criteria being used to make the determination. [NS 4.5.9 (a)-
(c)]. See the discussion above for general considerations in relation to competence. This issue is
particularly important when potential participants are intellectually disabled, suffering from a
mental illness or another disease that may reduce the individual’s ability to understand the
research project.
(c) Within certain participant groups, the capacity to consent may fluctuate and may need to be
reassessed during the progress of the research. [NS 4.5.9 (d)] In such cases, a reassessment of
capacity should be designed into the research procedures.
2.2 Group of participants unable to consent
For all proposed participants who are incapable of giving consent, indicate which group best
describes them; check all that apply.
Guidelines for the Victorian-Specific Module 5 of 21 January 2015
2.3 Medical Research Procedure
Indicate whether the project involves a ‘medical research procedure’ (as defined above). If the
response is “No”, it is not necessary to complete the rest of Section 2, which solely relates to
medical research procedures. If the response is “Yes”, continue to question 2.4.
Questions 2.4 to 2.8 should only be completed if the project involves a ‘medical research
procedure’.
2.4 Urgent medical research procedure
If a ‘medical research procedure’ is necessary as a matter of urgency to save life, prevent serious
damage to health or prevent significant pain or distress then consent is not required, in
accordance with Section 42A of the Guardianship and Administration Act 1986. The researcher
must thoroughly explain that it may be necessary to perform a ‘medical research procedure’ in a
situation that may arise (refer to the Guardianship & Administration Act 1986 information paper).
If the response is “Yes”, it is not necessary to complete the rest of Section 2.
2.5 Recovery of capacity to consent
If patients are likely to recover capacity to consent to the ‘medical research procedure’ within a
reasonable timeframe then you must wait and seek the patients’ own consent before commencing
the ‘medical research procedure’.
2.6 Person responsible
The Guardianship and Administration Act 1986 is quite specific about who the person responsible
may be and researchers need to consider how the appropriate person will be identified. Careful
consideration should be given to how the person responsible will be approached, bearing in mind
that this may in some situations also be when the person responsible first learns of a relative’s
accident or health condition. In some cases, when the research is time-critical and the person
responsible is not present, they may need to be informed and provide consent by telephone.
Details of how this will be done and recorded should also be included, if relevant.
2.7 Procedural authorisation
The case for using procedural authorisation should be based on the criteria set out in Section 42T
of the Guardianship and Administration Act 1986 (Vic).
If the medical research procedure is to continue after a person responsible has been located or
after the participant themselves regains the capacity to consent, ‘continuing consent’ must be
obtained. If the procedure is already over, researchers should check whether their HREC requires
information to be given to the person responsible and/or participant after the event.
Submitting a Section 42T Certificate
Before, or as soon as practicable after the research procedure is carried out, the practitioner
supervising the conduct of the procedure must sign a Section 42T certificate (‘Medical research
procedure on a patient who is unable to consent and there is no person responsible to provide
consent’). The certificate is available at
www.publicadvocate.vic.gov.au/file/file/Medical/interactive%20PDFs/42T_SectionNew_Int.pdf
Copies of this certificate must be forwarded to both the Office of the Public Advocate and the
relevant HREC within a maximum of 2 working days of the medical procedure being carried out.
The original certificate should be filed in the patient’s medical record. A separate Section 42T
certificate must be submitted for each patient recruited under procedural authorisation. If the
procedure extends over more than one month, and it is still not possible to obtain person
responsible or participant consent, a further Section 42T certificate must be submitted (and
resubmitted every month for the duration of the procedure) as above.
2.8 Participant Information and Consent Form
Relevant Participant Information and Consent Forms (PICFs) for each site should be attached at
the end of the Victorian Specific Module. In question 2.8, indicate which PICFs are attached;
check all that apply. It is important to remember that PICFs designed for individuals who have
cognitive impairment, intellectual disability or mental illness must facilitate adequate
understanding of the research to those who are being invited to take part.
Guidelines for the Victorian-Specific Module 6 of 21 January 2015
Information for Victorian Specific Module Section 3:
Research Involving the Collection/Use/Disclosure of Information This section covers those aspects of the project proposal to which the various pieces of State and
Commonwealth privacy legislation relate. It is expected that all researchers will have to complete
at least some of the questions in this section, since every project will involve the collection, use or
disclosure of some piece of information.
It is hoped that the process of completing this section of the application form will be educative for
researchers, as well as providing information that assists the HREC in assessing the project from
the perspective of privacy issues. While privacy legislation may seem complex, the underlying
principles are actually quite straightforward. Moreover, the principles are consistent between State
and Commonwealth legislation, so if the project is compliant with the privacy principles in Victoria,
in most cases, it will also be compliant with the Commonwealth legislation.
The first time researchers complete the questions in Section 3, they will be faced with issues that
they may not have considered in previous research projects. It is hoped that, once they are aware
of the issues that must be addressed, researchers will take these issues into account when they are
developing future research projects. Some of these issues include the source of the information and
the purpose for which the information will be used and how this relates to the purpose for which
the information was collected in the first instance. Researchers should also consider the nature of
the information (see definitions below) and why the collection, use or disclosure of that information
is justified.
The following is an overview of the State and Commonwealth privacy legislation that may impact
upon a project. Note that Table 3 helps the researcher identify which pieces of legislation (and
which Privacy Principles within that legislation) are relevant to the project.
Note: Most of the advice given in these Guidelines only relates to the Privacy Principles concerned
with collection, use or disclosure of information, since these are the Privacy Principles to which the
various sets of Statutory Guidelines apply. There are other Privacy Principles that deal with data
quality, data security, access to data, identifiers, trans-border data flows and other issues.
Researchers should review ALL Privacy Principles in the relevant legislation to ensure
that their project is fully compliant with all aspects of the law. Legislation and any relevant
guidelines can be downloaded from the websites listed below.
Researchers should be aware that HRECs have a statutory reporting requirement in relation to
information that is provided in this section of the application. Failure by the researcher to provide
all this information will delay the review of the application.
VICTORIAN LAW
Health information – where the collection, use or disclosure is by an organisation in
Victoria
The Health Records Act 2001 (Victoria) applies to all health information (see definitions below)
handled by the Victorian public sector and private sector. There are eleven Health Privacy Principles
(HPPs). HPP 1 and 2 govern the collection, use and disclosure of health information, including for
the purposes of research. This Act is administered by the Victorian Health Services Commissioner,
who may issue or approve Guidelines in relation to the HPPs. The Guidelines in relation to research
can be obtained from the Health Services Commissioner’s website: www.health.vic.gov.au/hsc. Any
researcher who considers that the HPPs might apply to their research should read these guidelines.
It is important to note that this Victorian Act applies generally to private sector organisations when
they handle health information in Victoria. Unlike the Commonwealth Privacy Act (see below), it
does not contain any exemptions for “small business”.
Other personal information - where the collection, use or disclosure is by the Victorian
public sector or a contracted service provider to the public sector
The Information Privacy Act 2000 (Victoria) sets out ten Information Privacy Principles (IPPs) that
regulate the responsible collection and handling of personal information – which includes “sensitive
information” but excludes health information (see definitions below) – by organisations in the
Victorian public sector, including universities set up by state legislation. The IPPs also apply to
agencies that provide services under contract to the Victorian Government. IPPs 1, 2 and 10 deal
with the collection, use and disclosure of this information for the purposes of research. There are
no separate Guidelines issued in relation to this Act. This Act is administered by the Victorian
Privacy Commissioner: www.privacy.vic.gov.au.
Guidelines for the Victorian-Specific Module 7 of 21 January 2015
Other laws
Other more specific laws may apply to particular categories of research. For instance, section 60 of
the Cancer Act 1958 regulates the disclosure of information from registries established under that
Act.
COMMONWEALTH LAW
The Privacy Act 1988 (Cth) applies to Commonwealth and ACT government agencies, and to certain
private sector organisations. It applies to private sector health service providers, and to private and
ACT universities. It does not apply to State or Northern Territory government agencies, including
state and territory public hospitals and health care facilities except in relation to Personally
Controlled Electronic Health Records and Individual Healthcare Identifiers in certain circumstances.
It does not cover ACT Government agencies handling health information or health records, nor
does it cover universities (other than private and ACT universities). It does not apply to public
schools (except ACT public schools) but does apply to private schools that have an annual turnover
of $3 million, or that provide a health service.
The Privacy Act 1988 (Cth) outlines thirteen Australian Privacy Principles, which establish
requirements for the collection, storage, use and disclosure of personal information and health
information. Sections 16A and 16B of the Privacy Act set out certain circumstances in which it is
permissible to collect, use and disclose personal information and health information for the
purposes of research.
Sections 95, 95A and 95A of the Privacy Act 1988 (Cth) provide for the NHMRC to issue guidelines
for the protection of personal information, health information and genetic information in research
the Guidelines, and establish that, if the Guidelines are approved by the Privacy Commissioner,
research that is carried out in accordance with the guidelines will not be in breach of the APPs.
Any researcher wishing to obtain information from a Commonwealth agency, and any researcher
who considers that that the APPs might apply to their research, should read the Guidelines under
Section 95, 95A and 95AA of the Privacy Act 1988, issued by the NHMRC (see
www.nhmrc.gov.au/publications/synopses/e26syn.htm).
GENERAL CONSIDERATIONS
All of the Guidelines described above provide very clear instructions as to the information that
researchers must include in their application.
Researchers are responsible for identifying the relevant Act and guidelines under which an
application for approval of a project is made.
If more than one Act (or set of guidelines) applies, all relevant legislative requirements will need to
be met, including the obtaining of any necessary approvals from a Human Research Ethics
Committee. The statutory guidelines referred to above are not identical, as they must reflect the
various statutes under which they are made and any different requirements must be adhered to.
There is nonetheless a high level of concordance in relation to the key requirements.
Researchers should note that this discussion about privacy laws is general information
intended to provide a starting point to assist them in understanding how the legislative
regimes may apply to their research activities. It does not constitute legal advice. If in
doubt as to their legal obligations, researchers should seek their own advice, or contact the
responsible Commissioner:
• Health Records Act: Victorian Health Services Commissioner (1800 136 066);
• Information Privacy Act: Victorian Privacy Commissioner (1300 666 444);
• Privacy Act: Office of the Australian Information Commissioner (1300 363 992).
Guidelines for the Victorian-Specific Module 8 of 21 January 2015
DEFINITIONS
Collection: an organisation or individual collects information if it gathers, acquires or obtains
information from any source and by any means, whether that information has been requested or
not. Questionnaires, surveys, interviews, focus groups and requests for information held in
databases, data sets or institutional records are all examples of how information may be collected.
Use: an organisation or individual uses information if it handles the information in any way. Use of
information includes any form of quantitative or qualitative analysis and any inclusion of the
information in any form of publication. Note that contacting a person based on contact details is
considered to be use of that information.
Disclosure: an organisation or individual discloses information when it releases information to
other organisations or individuals (that is, outside of those who collected the information in the first
instance). Giving individuals information about themselves does not constitute disclosure.
Personal Information: generally1 means information or an opinion (including information or an
opinion forming part of a database), whether true or not, and whether recorded in a material form
or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the
information or opinion.
Health Information: under the Victorian Health Records Act 2001 means:
(a) information or an opinion about:
i. the physical, mental or psychological health or a disability (at any time) of an individual; or
ii. an individual’s expressed wishes about the future provision of health, disability or aged care
services to him or her; or
iii. a health, disability or aged care service provided, or to be provided, to an individual;
(b) other personal information collected to provide, or in providing, a health, disability or aged care
service; or
(c) other personal information about an individual collected in connection with the donation, or
intended donation, by the individual of his or her body parts, organs or body substances; or
(d) personal information that is genetic information about an individual in a form which is or could
be predictive of the health (at any time) of the individual or any of his or her descendants.
Sensitive Information: means information or an opinion about an individual’s:
• racial or ethnic origin; or
• political opinions; or
• membership of a political association; or
• religious beliefs or affiliations; or
• philosophical beliefs; or
• membership of a professional or trade association; or
• membership of a trade union; or
• sexual preferences or practices; or
• criminal record;
that is also personal information; or (in the Commonwealth Privacy Act only): health information
about an individual.
OTHER RELEVANT INFORMATION
Other relevant Federal and State Government legislation includes:-
• The Public Records Act 1973 and Amendments (Victoria)
• Disposal Schedule for Public Health Services Patient Information Records “PROS 99/94” the
Health Services Act 1988 Victoria
Recommendations/Guidelines of national bodies include:
• The National Statement on Ethical Conduct in Human Research (2007), produced by the
National Health and Medical Research Council (NHMRC) under the National Health and Medical
Research Council Act 1992.
• The Australian Code for the Responsible Conduct of Research (2007)
• Guidelines for the Protection of Privacy in the Conduct of Medical Research Aspects of Privacy
in Medical Research (1995)
Note: The National Health & Medical Research Council requires original data to be kept at least
seven years for clinical research, 15 years for clinical trials and 23 years for clinical trials involving
children.
Guidelines for the Victorian-Specific Module 9 of 21 January 2015
GENERAL ADVICE FOR COMPLETION OF SECTION 3
There may be projects that involve more than one set of information, with each set being collected,
used or disclosed in a different manner. In these cases, researchers may find it difficult to answer
questions in this section unambiguously.
It is recommended in these situations that researchers duplicate Section 3 and distinguish each
repeated section with a number (e.g. Section 3-Part I, Section 3-Part II, etc) or title (e.g.
Information from Case Workers, Information from Department of Health and Human Services
datasets, etc). In this way, it will be clear which answers apply to each set of information.
An example of circumstances when this approach might be useful is if one set of information is to
be handled with the consent of the individual, while another set of information is to be individually
identifiable (or re-identifiable) but handled without consent. Another example is when the
researcher is handling more than one set of individually identifiable information without consent,
but the reasons for needing identifiable information or for not obtaining consent are different for
each set of information.
Individually identifiable, re-identifiable and non-identifiable information
The National Statement identifies three mutually exclusive forms of data identifiability, as follows
[NS 3.2]:
Individually identifiable data where the identity of a specific individual can reasonably be
ascertained. Examples of identifiers include the individual’s name, image, date of birth or address;
Identifying information can include other information, if that information is unique in some way or
highly specific. For example, “employee of the Victorian Department of Health and Human
Services” is not sufficient information to identify a person. However, “employee of organisation X”
which only employs three people may be sufficient information to identify someone, particularly in
conjunction with other information;
Re-identifiable data, from which identifiers have been removed and replaced by a code, but it
remains possible to re-identify a specific individual by, for example, using the code or linking
different data sets;
Non-identifiable data, which have never been labelled with individual identifiers or from which
identifiers have been permanently removed, and by means of which no specific individual can be
identified. A subset of non-identifiable data are those that can be linked with other data so it can be
know that they are about the same data subject, although the person’s identity remains unknown.
Consider the situation where health information is disclosed to a researcher without information
that could identify the individual, but coded so that it may be re-identified if necessary. If it would
be impossible for the researcher to access the link, then the information collected and subsequently
used by the researcher is non-identifiable. If the researcher is given the code, as well as the
information, then the information is re-identifiable, as long as the code remains associated with
the information. Potentially identifiable information is treated in the legislation in the same way as
identifiable information.
3.1 Collection of participants’ information
(a) If participants will not be aware of their inclusion in the research and are not being asked for
consent, do not answer any other parts of this question and move directly to question 3.2. If the
project does involve collection of information about individuals (either directly from the individual
or from a source other than the individual) with their knowledge and consent indicate which
categories of information will be collected in part (b).
(c) Indicate whether you are seeking consent from participants to use their data for this specific
research project (‘specific’ consent), future research that is closely related to the original project or
in the same general area of research e.g. cancer research (‘extended’ consent), or unspecified
future research (‘unspecified’ consent). Refer to the National Statement 2.2.14 for further
information about consent to future use of data.
(d) The National Statement defines databanks (which includes databases) as “[A] systematic
collection of data, whether individually identifiable, re-identifiable or non-identifiable.” (see
definitions above). If data are being collected, aggregated and stored with a view to use for future
related or as yet unspecified research, this may involve ‘banking’ the participants’ data. For more
information, refer to the National Statement Chapter 3.2.
(e) If information is being collected with the consent of the individual, the researcher is responsible
for informing the participants about how the information will be used, disclosed, stored and
Guidelines for the Victorian-Specific Module 10 of 21 January 2015
published and how the individual may access the information concerning them. If the participants
will not be informed about these matters in the Participant Information and Consent Form, give
reasons why this is the case.
(f). Failure to provide this information to the individual may be a breach of the applicable privacy
legislation.
3.2 Do other questions in this section have to be completed?
(a) If the project does not involve the collection or use or disclosure of individually identifiable or
re-identifiable (potentially identifiable) information (see definitions above), then you do not need to
answer most of the questions in this section. Go directly to question 3.7 and do not answer
questions 3.2(b), 3.3, 3.4, 3.5 or 3.6. Please remember that access to identifiable records for the
purpose of extracting non-identifiable data constitutes ‘use’ and ‘disclosure’ of identifiable data,
even if such data will not be ‘collected’ by the researcher. Therefore, the correct answer to this
question is “yes” and further questions in this section must be answered. That is, the answer to
part (a) is “yes” if any one of the possible activities (collection/use/disclosure) involves individually
identifiable or re-identifiable information.
(b) If the project does not involve collection or use or disclosure of information without the consent
of the person to whom the information relates, then you do not need to answer most of the
questions in this section. Go directly to question 3.7 and do not answer questions 3.3, 3.4, 3.5 or
3.6. Please note that the answer to part (b) is “yes” if any one of the possible activities
(collection/use/disclosure) will be conducted without consent.
3.3 Type of activity proposed
Indicate all types of activity for which this proposal is seeking approval. You may be seeking
approval for more than one type of activity, for example, collection and use of information. Note
that disclosure may occur in two directions: an organisation may disclose information to a
researcher (which the researcher, in turn, collects from that organisation) and/or the researcher
may disclose information to other organisations or in the form of a publication.
If you are collecting information about individuals from a third party (i.e. not directly from the
individuals themselves), then you should consider whether this application for ethical approval is to
cover the disclosure of the information from the third party, as well as the collection and use of the
information by yourself and your colleagues. (Note: You will be asked about this issue specifically in
Question 3.4(c)) There is no legal requirement for a separate application to be made by the
disclosing organisation providing the application covers disclosure, if applicable. Therefore, it is
important for the application to cover disclosure, collection and use of information. This issue is
most relevant in cases where the disclosing organisation does not have its own HREC. In such
situations, the disclosing organisation would probably prefer to have its disclosure activities
reviewed as part of the application to collect and use the information.
3.4 Collection of information about individuals from a third party
The italicised instruction at the start of this question is a reminder to researchers that if they
answered “no” to either part (a) or part (b) of question 3.2, then they should not be answering this
question.
(a) Specify the source of the information that is to be collected. Check as many boxes as are
relevant (i.e. if information will be collected from multiple sources).
In the case of health information, researchers should note that some organisations that are not
health service providers (such as the YMCA or child care centres) (see definition below) do collect
and hold health information. If such an organisation is the source of the health information to be
used in the research project, researchers should check the box corresponding to “An organisation
other than a health service provider”.
Carers are sometimes used as the source of information about an individual they are caring for. If
the carer is managed representative (whether as paid or unpaid worker) of an organisation that
provides services to assess, maintain or improve a person’s health, or to treat or diagnose a
person’s illness, injury or disability, they are a health service provider for the purposes of the
Health Records Act 2001. If the carer is providing care in a private capacity (for example as a
family member or friend), then the carer is not a health service provider and the researcher should
check the box for “Others”.
Definition of “Health Service Provider”
Guidelines for the Victorian-Specific Module 11 of 21 January 2015
For the purposes of the Health Records Act 2001, a health service provider means a person or an
organisation that provides a health service in Victoria. A health service means an activity that is
intended or claimed to assess, maintain or improve a person’s health, or to diagnose or treat
illness, injury or disability, and includes a disability, palliative care or aged care service.
Definition of “Commonwealth Agency”
For the purposes of the Privacy Act 1988, a Commonwealth agency is a minister, department,
statutory corporation or other body established for a public purpose by Commonwealth legislation.
This covers virtually all Commonwealth departments. The main exceptions are companies,
incorporated societies, intelligence organisations and trade unions. Some of the organisations and
government departments defined as Commonwealth record keepers are listed below. This list is a
guide to the agencies most commonly approached by researchers (from the AHEC Report on Use of
Section 95 Guidelines)
• Aboriginal and Torres Strait Islander
Commission (ATSIC)
• Australian Electoral Commission (not State
Electoral Offices)
• Australian Archives • Australian National University
• Australian Bureau of Statistics • Australian Sports Commission
• Australian Institute of Health and Welfare • Health Insurance Commission
In the table at the end of part (a), list the categories of individuals or organisations from which
information will be collected and clearly indicate precisely what information will be obtained from
each source.
(b) Indicate whether the organisations from which you intend to collect information have agreed to
provide that information. Please supply written evidence of the agreement to disclose information.
If the agreement of the disclosing organisation has not yet been obtained, explain why not and
how/when the agreement will be obtained.
(c) As discussed above in Question 3.3, indicate whether the organisation(s) from which
information will be collected will be seeking separate HREC approval for disclosure of the
information. If separate approval is sought by the disclosing organisation, researchers should
supply a copy of that approval when it is available. If separate approval will not be sought by that
organisation, then the researcher should supply a copy of this HREC’s approval (and any conditions
associated with it) to the organisation disclosing the information.
(d) Indicate whether the person collecting the information routinely has access to the information.
An example would be a psychiatrist who routinely accesses the RAPID database (a Department of
Health and Human Services database) for clinical purposes, but wishes to use the database for a
research purpose.
(e) If you are answering this question, it is because individually identifiable (or re-identifiable)
information will be collected without the consent of the individual to whom the information relates.
In this case, Guidelines may have to be applied, depending upon which Privacy Principles apply.
This part of Question 3.4 assists researchers to identify which Privacy Principles apply to the
collection of information. This will be determined by:
• The type of information being collected;
• The type of organisation that will be collecting the information (i.e. the researcher’s
organisation or institution).
List all of the Privacy Principle Codes (from Table 3) that apply. Remember that health information
includes personal information (such as name, address, date of birth, Medicare number, etc) that is
contained within the health record. Therefore, if health information is being collected, it is not
necessary to record “personal information” codes as well in relation to that information. “Personal
Information” codes only need to be recorded if personal information that is not part of a health
record is being collected. Remember that these Privacy Principles only relate to the
collection of information and other Privacy Principles in that Act may also apply.
The relevant Guidelines are:
• For Health Privacy Principles (HPPs) – Statutory Guidelines on Research issued for the purposes
of Health privacy principles 1.1 (e)(iii) & 2.2(g)(iii).
• Download from the Health Services Commissioner’s website:
www.health.vic.gov.au/hsc/downloads/guideres.doc
Guidelines for the Victorian-Specific Module 12 of 21 January 2015
• For Information Privacy Principles (IPPs) – Guidelines Under Section 95 of the Privacy Act 1988.
Download from: www.nhmrc.gov.au/publications/synopses/e26syn.htm
• For Australian Privacy Principles (APPs) – Guidelines Approved under Section 95A of the Privacy
Act 1988. Download from: www.nhmrc.gov.au/publications/synopses/e43syn.htm
(f) Identifiable data may not be collected for deposit in a databank without participants’ consent
unless an HREC gives permission. By ticking the ‘yes’ box here, you are asking the HREC to waive
the need to seek consent from participants to ‘bank’ their data for possible use in future research
National Statement 3.29 (c)(ii).
Parts (g), (h) and (i) are key issues. The answers provided by the researcher to these questions
will in large part determine whether the HREC comes to the conclusion that the public interest in
the project (whether it is research or another activity) substantially outweighs the public interest in
protecting the privacy of individuals.
In answering part (g), researchers are asked to explain why the information will not be collected in
a non-identifiable form, e.g. because identifiers are required for data linkage, etc. This question is
not requesting an explanation of why the information is considered to be individually identifiable or
re-identifiable (e.g. because names and birth dates will be included).
Similarly for part (h), the researcher should explain why consent will not be obtained, e.g. because
the number of records is so large that obtaining consent is not practicable, or because not
obtaining consent from all relevant individuals would impact on the scientific rigour of the research,
or because of the negative impact that an attempt to obtain consent might have on individuals.
This question is not seeking an explanation of why the researcher’s actions constitute ‘not seeking
consent’ (e.g. because the researcher won’t be contacting the individuals).
3.5 Use of information about individuals
The italicised instruction at the start of this question is a reminder to researchers that if they
answered “no” to either part (a) or part (b) of question 3.2, then they should not be answering this
question.
(a) If you are answering this question, it is because individually identifiable (or re-identifiable)
information will be used without the consent of the individual to whom the information relates. In
this case, Guidelines may have to be applied, depending upon which Privacy Principles apply. This
part of Question 3.5 assists researchers to identify which Privacy Principles apply to the use of
information. This will be determined by:
• The type of information being used;
• The type of organisation that is using the information.
List all of the Privacy Principle Codes (from Table 3) that apply. For example, if health information
and other non-health personal information are being used, record all relevant codes. Remember
that these Privacy Principles only relate to the use (and disclosure) of information and
other Privacy Principles in that Act may also apply.
The relevant Guidelines are as listed above for question 3.4(e).
(b) Specify how the information is to be used.
(c) If the information is to be used for a purpose (the “secondary purpose”) other than the primary
purpose for which the information was collected, the secondary purpose may be directly related to
the primary purpose and the individual might reasonably expect that their information would be
used for that purpose. If this is the case, state how the secondary purpose is related to the primary
purpose.
Parts (d), (e) and (f) are key issues. The answers provided by the researcher to these questions
will in large part determine whether the HREC comes to the conclusion that the public interest in
the project (whether it is research or another activity) substantially outweighs the public interest in
protecting the privacy of individuals. Please refer to Question 3.4 parts (g) and (h) for guidance
about the information sought from researchers in response to these questions. Researchers who
have already answered similar questions in Question 3.4 (g), (h) and (i) may refer to their earlier
answers, if those answers are relevant.
3.6 Disclosure of information
Guidelines for the Victorian-Specific Module 13 of 21 January 2015
The italicised instruction at the start of this question is a reminder to researchers that if they
answered “no” to either part (a) or part (b) of question 3.2, then they should not be answering this
question.
Question 3.6 examines “disclosure” from two different perspectives, since disclosure may occur at
the start of the process (i.e. an organisation discloses information to the researcher) and/or at the
end of the process (i.e. the researcher discloses information to another organisation), but does not
include publication (which is considered to be a “use” of information, not a “disclosure”).
(a) If you answer “yes” to this question, it is because individually identifiable (or re-identifiable)
information will be disclosed by an organisation to the researcher without the consent of the
individual to whom the information relates. In this case, Guidelines may have to be applied,
depending upon which Privacy Principles apply. This part of Question 3.6 assists researchers to
identify which Privacy Principles apply to the disclosure of information. This will be determined by:
• The type of information being disclosed;
• The type of organisation that is disclosing the information.
List all of the Privacy Principle Codes (from Table 3) that apply. For example, if health information
and other non-health personal information are being disclosed, record all relevant codes.
Remember that these Privacy Principles only relate to the disclosure (and use) of
information and other Privacy Principles in that Act may also apply.
The relevant Guidelines are as listed above for question 3.4(e).
(b) If you answer “yes” to this question, it is because individually identifiable (or re-identifiable)
information will be disclosed by the researcher to another organisation without the consent of the
individual whose information it is. As for part (a) above, Guidelines may have to be applied,
depending upon which Privacy Principles apply. This will be determined by:
• The type of information being disclosed;
• The type of organisation that is disclosing the information (i.e. the researcher’s organisation).
List all of the Privacy Principle Codes (from Table 3) that apply. For example, if health information
and other non-health personal information are being disclosed, record all relevant codes.
Remember that these Privacy Principles only relate to the disclosure (and use) of
information and other Privacy Principles in that Act may also apply.
Identify the individuals or organisations to which the information will be disclosed, if applicable. List
the organisations by name (or by category if there are a large number, e.g. “child care centres”)
and clearly indicate what information will be disclosed to each one.
Parts (c), (d) and (e) are key issues. The answers provided by the researcher to these questions
will in large part determine whether the HREC comes to the conclusion that the public interest in
the project (whether it is research or another activity) substantially outweighs the public interest in
protecting the privacy of individuals. Please refer to the guidelines for Question 3.4 parts (f) and
(g) for guidance about the information sought from researchers in response to these questions.
Researchers who have already answered similar questions in Questions 3.4 or 3.5 may refer to
their earlier answers, if those answers are relevant.
3.7 General issues
These questions assist the HREC to determine whether other Privacy Principles have been adhered
to.
(a) Provide an indication of the number of records that will be collected, used or disclosed in this
project. A record is a set of information about an individual. If the information is only to be
collected directly from the person to whom the information relates, then the number of records will
be equal to the total number of participants in the project. If the information is to be collected from
a hospital or a Department of Health and Human Services held dataset, then the number of records
will be equal to the number of separate individuals, whether identifiable or non-identifiable, whose
information is collected. If information is to be collected from participants and from datasets, then
the number of records will be the sum total of the two. Provide approximate numbers if exact
numbers are not known. Also specify the type of information that will be collected. Note that this
question is part of the mandatory reporting requirement for HRECs.
(b) The use of unique identifiers and the adoption of identifiers assigned by another agency or
organisation is dealt with in privacy legislation. Researchers should ensure that the use of
identifiers is done in accordance with Privacy Principle dealing with Identifiers in any relevant
privacy legislation (e.g. HPP 7 in the Health Records Act 2001 (Vic), IPP 7 in the Information
Privacy Act 2000 (Vic), APP 9 in the Privacy Act 1988 (Cth)).
Guidelines for the Victorian-Specific Module 14 of 21 January 2015
(c) Trans-border data flow occurs if, for example, a researcher in Victoria sends data to a colleague
interstate or overseas. Researchers should ensure that such data transfers of personal and/or
health information are carried out in accordance with the Privacy Principle dealing with Trans-
border Data Flows in any relevant privacy legislation (e.g. HPP 9 in the Health Records Act 2001
(Vic), IPP 9 in the Information Privacy Act 2000 (Vic), APP 8 in the Privacy Act 1988 (Cth)).
(d) Indicate the period of time for which the information will be retained. Note that the Australian
Code for the Responsible Conduct of Research (2007) recommends that data should be retained for
at least 5 years from the date of publication, but in the case of clinical research, 15 years may be
more appropriate. (see Australian Code 2.1.1). Note also that certain organisations in Victoria are
subject to the Public Records Act 1973 (Vic).
(e) Describe the security arrangements for storage of the information, including who will have
access to the information.
(f) If the research data will be ‘banked’ in a databank for possible use in future research, this
additional information about how data will be stored and made available for future use should be
provided. Researchers should be familiar with the requirements in the National Statement -
Chapter 3.2: Databanks.
(g) Explain how the publication of results from this project will be handled in terms of the privacy
of the individuals whose information has been used.
3.8 Other ethical issues
Provide details of any other ethical issues (with respect to the collection, use or disclosure of
information) not described above and how these issues will be addressed. Issues may include:
• Identification and reporting of illegal activities;
• Consequences of the findings of the project for indigenous or other special community or
cultural groups (see National Statement Chapters 4.7 and 4.8).
Guidelines for the Victorian-Specific Module 15 of 21 January 2015
Information for Victorian Specific Module Section 4:
Use of Ionising Radiation
GUIDELINES
These guidelines provide information and instructions on how best to answer the questions in the
Section Four: Use of Ionising Radiation. Please refer to these guidelines when answering each
of the questions in the application form.
The application forms and guidelines are modified and updated from time to time. Please go back
to the website each time you make a new application, to ensure that you have the latest version.
It is important to include all essential information so that your application can be promptly
assessed for approval. It is also important to give all information in clear, everyday English so that
it can be easily understood by the members of HREC who may not have a science or health
industry background. Clearly define all terminology and abbreviations.
Research protocols need to follow the recommendations of:
• Radiological Protection in Biomedical Research of the International Commission on
Radiological Protection, 1992, Publication 62; and
• Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) RPS 1.
Recommendations for Limiting Exposure to Ionizing Radiation (1995) and National Standard
for Limiting Occupational Exposure to Ionising Radiation (republished 2002); and (ARPANSA)
RPS 8. Code of Practice - Exposure of Humans to Ionizing Radiation for Research Purposes
Radiation Protection Series Publication No. 8 (May 2005).
In Victoria, The Radiation Act 2005 and Radiation Regulation 2007 control all uses of ionising
radiation, and include a system requiring the licensing of operators and ionising apparatus.
There are specific licensing requirements related to research involving humans who are exposed to
radiation which is additional to that received as part of their normal clinical management, either
diagnostic or therapeutic.
With the Use of Ionising Radiation Form, you must also include:
• the National Ethics Application Form (NEAF); and
• Other documents relevant to your research project.
Project Details
Project Title, Principal Researcher and HREC number(s) (if known)
Please state the full title of the research project, the name of the principal researcher and the HREC
number, if one has been allocated for the research project.
4.1 Identification of Participants
A volunteer is any person that voluntarily enrols in a research project that results in them
undergoing an examination that involves the use of ionising radiation which is additional to that
typically received as part of their standard clinical care* and is not specifically treating a disease or
symptom.
This includes research involving volunteers and/or patients and includes, but is not restricted to,
research with diagnostic/therapeutic agents and procedures, including Phase I, II, III and IV clinical
trials and novel procedures on selected groups of research participants. It does not apply to the use
of radiation outside a research project even if it involves the use of a novel procedure.
*Standard clinical care is defined as the typical or routine management of the patient with an
identical condition that is not part of this clinical trial. When considering whether the management
is 'standard clinical care' the following items need to be taken into account:
• The number of radiation procedures being performed.
• The frequency or time interval between the radiation procedures.
• The body part region being exposed to radiation.
The test that needs to be applied is: “If a participant were not enrolled in this clinical trial, would
they still receive the same number of examinations involving the use of ionising radiation at the
specified intervals as stated in the research protocol?” If the answer is NO then the ionising
radiation procedures should be considered as being in addition to standard care.
4.2 Participants
Guidelines for the Victorian-Specific Module 16 of 21 January 2015
Number of participants
As ionising radiation has the potential for risk, restrict the number of participants to the minimum
number necessary for statistically meaningful results.
Age of the research participants
The research participants should, where practicable, be over 40 years of age, and preferably over
50; and the exposure of children must only be permitted if the condition under study is related to
the age of the participants and the information sought cannot be obtained using adult participants.
Pregnancy in the research participants
Pregnant women must be excluded except when conditions specific to this group are being
investigated. In studies on pregnant women, the dose to the foetus must also be evaluated and
advice provided to the Human Research Ethics Committee on the associated risks. Where some
participants are women of reproductive age, the possibility that a woman may be pregnant must be
taken into account; and where the pregnancy status is uncertain and the radiation dose to the
uterus is likely to exceed 0.1 mSv, premenopausal women should have a biochemical pregnancy
test to exclude pregnancy before the radiation exposure. Finally, the use of ionising radiation
should only be undertaken when the information sought cannot be obtained by other means.
Research participants who are breastfeeding
In the case of studies involving the administration of radioactive substances, research participants
who are breastfeeding must be excluded unless conditions specific to this group are being
investigated.
Life expectancy of volunteers
The radiation dose constraints that are applied to the research and advice given in the participant
information documentation depend on the life expectancy of the volunteers. The median life
expectancy of the participating volunteers should be quoted as either below or above 5 years.
4.3 Procedures involving the use of ionising radiation
All procedures involving ionising radiation in your project need to be listed in the table. Include and
identify procedures deemed to be ‘standard care’ and those procedures that are additional to
standard care that are required purely because of the volunteer’s inclusion in this research. As
indicated above, standard clinical care is defined as the typical or routine management of the
patient with an identical condition that is not part of this clinical trial.
If you are unsure as to the category (standard care or not) for a particular ionising radiation
procedure you should consult either the principal researcher or an approved medical physicist.
Finally, where the exact number of examinations is not known, please indicate the anticipated
average and maximum number likely to be performed over the duration of the research. And,
indicate “(Avg)” & “(Max)” next to the value stated.
4.4 Radiation Assessment
Consult the institution’s radiation safety officer/medical physicist about the research protocol at the
preparatory stage. If the radiation safety officer is not an approved medical physicist, then he/she
must consult a ‘medical physicist’ as defined in the research code. The Radiation Team of the
Department of Health and Human Services has compiled a list of medical physicists approved to
perform radiation dosimetry assessments for research projects involving the exposure of human
volunteers to ionising radiation. You should verify that the medical physicist is approved to perform
the calculations. If you are unsure of the medical physicist’s status the contact details for Radiation
Team can be found in the ‘Useful Contacts’ section of this document.
The medical physicist will:
Make an assessment of the radiation dose;
Determine the relevant category of risk;
Produce the recommended statement outlining the risks associated with the radiation
exposure to be included in the participant information and consent form;
Advise on the appropriate approvals required, for example, licence approvals from the state
or territory regulators; and
Obtain verification of the estimated doses to participants, when the radiation dose exceeds
the dose constraints, from an independent second medical physicist.
Note: The radiation doses to the research participants must be kept to the minimum level
practicable. Wherever possible, the total effective doses and organ doses to adults and
children should conform with the dose constraints as tabulated below. If these dose
Guidelines for the Victorian-Specific Module 17 of 21 January 2015
constraints are exceeded the Human Research Ethics Committee should give particular
attention to the justification for the radiation exposure, and if necessary, seek further
independent authoritative advice before approving the proposal.
Table 1: Dose Constraints for Participants in Researcha
Participant Category Dose
Constraintb
Adults
Total effective dose in any year 5 mSvc
over 5 years 10 mSv
Total effective dose in adult with life expectancy less than five years in any year 50 mSv
Equivalent dose to skin averaged over 1 cm2 in any year 200 mSvd
Equivalent dose to any other organ or tissue in any year 100 mSve
Children and foetuses
Total effective dose to age 18 years, 5 mSv
- Subject to:
• Effective dose from conception to birth; and
• Effective dose in any year from birth to 18 years.
0.1 mSv
0.5 mSv
Total equivalent dose to age 18 years to any organ or tissue 100 mSv a A dose constraint for research participants specifies a maximum dose with which it should be
possible to comply in normal circumstances and it is intended to apply to radiation which is in
addition to that received as part of normal clinical management. Dose constraints apply to
diagnostic investigations not radiation therapy. b The dose constraint applies to the sum, over the relevant period, of doses received from external
exposure and the 50-year committed dose (to age 70 years for children) from intakes over the
same period. c When all the research participants are within the following specified age limits, the following total
effective dose constraints apply:
- for adults 60 years or more – in any year – 8 mSv and
- for adults 70 years or more – in any year – 12 mSv. d Derived from Table 3.1 of ICRP85 – factor of 10 below the threshold of 2 Sv for early transient
erythema. e Derived from Table 3.1 of ICRP85 – factor of 10 below the threshold of 1 Sv for detectable lens
opacity.
4.5 Procedure Description
In this section you must list only the procedures involving the use of ionising radiation that are
additional to 'standard clinical care'.
When requesting a report on the radiation dose and associated risk from the radiation safety
officer/medical physicist, include a copy of the research protocol and proposed participant
information and consent form. Other information that can be useful to provide to the radiation
safety officer/medical physicist is to identify the ionising radiation procedures that are additional to
that of standard care of the patient, the age, gender and pregnancy status of the participants.
Furthermore, you should also include any relevant referenced material relating to the procedure
and/or radiation dose received by the participant. Hence, it is advisable that you attempt to
complete as much as possible of Section Four prior to meeting with the radiation safety
officer/medical physicist.
Finally, the medical physicist will be able to assist you with the nuclear medicine & PET terminology
and determination of the organ and effective doses for the ionising radiation procedures listed in
the table.
4.6 Categories of Risk & Dose
Based on the estimated dose received by the volunteer the medical physicist will be able to assist
you with the completion of this table. Consequently a level of societal benefit expected will be
derived based on the calculated effective dose, which will determine the level of justification
Guidelines for the Victorian-Specific Module 18 of 21 January 2015
required and provided to the ethics committee to enable the research application to be thoroughly
reviewed.
4.7 Expected Societal Benefit
The risk categories for stochastic effects in adults1, differing by an order of magnitude from each
other and associated information are given below:
Category I (risk less than 1 in 100,000)
The dose range for this project category is less than 0.2 mSv which is the dose delivered by natural
background radiation in a few weeks. It is considerably less than the variations in annual dose from
natural background radiation to persons living in different locations, and the risk level is considered
minimal. The level of benefit needed as the basis for approval of research with doses in this
category will be minor and will include those investigations expected only to increase knowledge.
Category II
The dose range for this category includes the annual doses received by essentially all radiation
workers in the course of their employment and the annual doses received by members of the public
from the totality of naturally occurring sources to which they are exposed, apart from some of the
doses from radon where the radon contribution to the annual doses is somewhat higher.
Category IIa (risk less than 1 in 10,000) represents a very low level of risk. The dose
range of 0.2 to 2 mSv covers the allowable annual dose to the public from controlled sources.
To justify risks in this category the benefit will probably be related to increases in knowledge
leading to health benefit.
Category IIb (risk less than 1 in 1,000) represents a low level of risk. The dose range of 2
to 20 mSv covers the annual doses received by most radiation workers in the course of their
employment, and most diagnostic radiological procedures. To justify the risks a moderate
benefit will be needed. The benefit will be more directly aimed at the diagnosis, cure or
prevention of disease.
Category III (risk greater than 1 in 1,000)
The dose range for this category is tens of mSv or more, which is greater than the annual dose
limit of 20 mSv for occupational exposure and is comparable to that received from several CT
procedures together. To justify research involving doses or risks in this category, the benefit will
have to be substantial and usually directly related to the saving of life or the prevention or
mitigation of serious disease.
In terms of the justification, researchers MUST provide as much information as possible specifically
related to the ionising radiation procedures to allow the ethics committee to assess the application
thoroughly. This should include information on why the ionising radiation procedures are required
and where the results from these procedures will be used to assist in the objectives of the
research. The researchers should also provide information about the benefits that can be expected
to be accrued from this research either to the individuals participating or society overall. The ethics
committee will examine the ionising radiation procedures in the context of the risk associated
versus the benefits expected to be obtained from conducting the research.
4.8 Participant Information Risk Statements
Communication Of The Risk To The Research Participant
The main risk from low levels of ionising radiation is the induction of cancer some time in the
future. It is particularly important that information about this risk and other risks are
communicated in a manner that will be understood by the research participant. It is recommended
that a consistent approach be used by researchers for the ‘lay language’ description of risk.
The researchers must ensure that the participant is provided with sufficient written information
about the purpose, methods, radiation dose, associated risks and any discomforts of the radiation
exposure to enable the research participant to give informed consent. The ARPANSA research code
includes numerous model statements that can be incorporated into the participant information and
consent form. Each version is applicable to the level of exposure indicated, and is in keeping with
the risk categories described above. In addition, as the long-term risks from radiation exposure are
minimal in patients who have a very short life expectancy, these statements of risk may be
inappropriate and are not required for research studies involving such patients.
1 See RPS 8 Annex 1
Guidelines for the Victorian-Specific Module 19 of 21 January 2015
In Victoria, the Radiation Team of the Department of Health and Human Services has its own
specific requirements with respect to the inclusion of appropriate risk communication statement.
The approved medical physicist should be familiar with these requirements. For physicists
generating reports, advice regarding the inclusion of an appropriate risk communication statement
may be obtained by contacting the Radiation Team of the Department of Health and Human
Services.
4.9 Regulatory Authorisations
The institution must hold a radiation management licence that authorises research involving the
exposure of humans to ionising radiation before a specific project can be authorised.
The radiation safety officer/medical physicist will be able to advise you as to whether the institution
already holds a radiation management licence and whether the radiation source is appropriately
licensed for use and the operators are appropriately authorised to use the equipment.
If the project proposes radiation doses that are below the dose constraints and approval has been
given by the HREC, the project may commence. The Department of Health and Human Services
does not need to be notified of these projects.
If the project proposes radiation doses that will exceed the dose constraints and has been approved
by the HREC, then the licence holder needs to notify the Department of Health and Human Services
of the details of the project using the notification form available at:
www.health.vic.gov.au/radiation
The project may commence without having to wait for the notification being submitted to the
Department of Health and Human Services.
The form requires a management licence number which appears on the management licence that
must be held by the Institution. The radiation safety officer or medical physicist within your
institution should be able to verify that your Institution has a management licence and provide the
management licence number.
Useful Contacts
• Your Institution’s Human Research Ethics Committee
• Your Institution’s Radiation Safety Officer/Medical Physicist
• Department of Health and Human Services
Radiation Team
Level 14
50 Lonsdale St
MELBOURNE VICTORIA 3000
Phone: 1300 767 469
Facsimile: 1300 769 274
Email: [email protected]
Useful Links
• Department of Health and Human Services, Radiation Team
www.health.vic.gov.au/radiation
• Department of Health and Human Services Human Research Ethics Committee
www.health.vic.gov.au/ethics
• ARPANSA
Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes
www.arpansa.gov.au/Publications/codes/rps8.cfm
• ARPANSA
Recommendations for Limiting Exposure to Ionizing Radiation (Printed 1995 - Republished 2002)
and
National Standard for Limiting Occupational Exposure to Ionizing Radiation (Printed 1995 -
Republished 2002)
www.arpansa.gov.au/pubs/rps/rps1.pdf
Guidelines for the Victorian-Specific Module 20 of 21 January 2015
Information for Victorian Specific Module Section 5:
Research Involving the Use of Human Tissues or Blood, or Performance of Post Mortem
The Human Tissue Act 1982 (Vic) contains specific requirements about the consent for the removal
of tissue or blood and the donation of human tissue after death, where the removal or donation is
for medical and scientific purposes.
It is an offence to remove tissue from a person without the consent or authorisation that is
required under the Human Tissue Act 1982 (Vic).
5.1 Regenerative tissue
Definition of ‘regenerative tissue’
“Regenerative tissue” means tissue that, after injury or removal, is replaced in the body of a living
person by natural processes.
“Non-regenerative tissue” means tissue other than regenerative tissue.
(a) An adult may consent in writing to the removal of regenerative tissue for the purposes of
transfer to another living person or for therapeutic, scientific or medical purposes. A medical
practitioner may then issue a certificate of consent. The certificate will be sufficient authority to
allow another medical practitioner to remove the tissue.
A consent or agreement given under the Human Tissue Act 1982 (Vic) may be revoked. A
certificate will not be sufficient authority for the removal of the tissue or blood if the consent has
been revoked or if the medical practitioner who is removing the blood or tissue has reason to
believe that the certificate of consent contains a false statement.
(b) A parent may give written consent for the removal of regenerative tissue from a child but only
for the purposes of transplanting the tissue to a sibling or parent of the child. It is not lawful to
remove non-regenerative tissue from the body of a living child for the purpose of the
transplantation of the tissue to the body of another living person. Note that ‘parent’ does not
include reference to any other guardian of a child.
Definition of ‘child’
For the purposes of regenerative tissue removal, a ‘child’ is a person who has not attained the age
of 18 years and is not married (see Section 2, Human Tissue Act 1982 (Vic)).
5.2 Removal of blood
(a) As detailed in the Human Tissue Act 1982 (Vic), an adult may consent to the removal of blood:
• for the purpose of a blood transfusion to another person; or
• for the purpose of using the blood or any of its constituents for other therapeutic purposes or
for medical or scientific purposes.
(b) A parent of a child under 16 may consent to removal of blood from the child for the above
purposes, provided the child agrees and a medical practitioner advises that the removal will not be
prejudicial to the health of the child.
Definition of ‘child’
For the purposes of blood removal, a ‘child’ is a person who has not attained the age of 16 years
(see Section 20, Human Tissue Act 1982 (Vic)).
5.4 Removal of tissue from a deceased person
Where a body is in a hospital, tissue may be removed from it for the purposes of the
transplantation of the tissue to the body of a living person, or for use of the tissue for other
therapeutic purposes or for medical or scientific purposes, on the authority of a designated officer
of the hospital. That authority is only given if:
• certain consents have been obtained from the deceased or their senior available next of kin;
or
• the designated officer cannot locate the senior available next of kin after reasonable
enquiries, and has no reason to believe that the deceased expressed an objection to the
removal of the tissue for the proposed purpose.
Where a body is in a place other than a hospital, a registered medical practitioner may remove
tissue from the body if:
Guidelines for the Victorian-Specific Module 21 of 21 January 2015
• the deceased consented or;
• the senior available next of kin have consented; or
• the registered medical practitioner cannot locate the senior available next of kin after
reasonable enquiries, and has no reason to believe that the deceased expressed an objection
to the removal of the tissue for the proposed purpose.
Authority shall not be given and tissue shall not be removed if the designated officer or registered
medical practitioner has reason to believe that the deceased expressed an objection to tissue being
removed.
When tissue is removed the senior available next of kin must be notified.
5.5 Fees
Unauthorised sale or purchase of tissue is prohibited. The Minister may in writing authorise a
person to buy tissue or take tissue from the body of another person, subject to conditions set out
in the permit.