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: radiation.safety@health.vic.gov.au

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.