Cancer Council NSW
Ethics Committee
STANDARD OPERATING
PROCEDURES (SOPs)
Contact information:
ethics@nswcc.org.au
Ms Angela Aston, Ethics Officer (02 9334 1889)
Ms Stephanie Deuchar, Ethics Secretary (02 9334 1708)
Updated February 2010
TABLE OF CONTENTS
Page
Acronyms and Definitions
Relevant Laws, Regulations & Guidelines
SOP001 –
Function of CCNSW Ethics Committee
6
SOP002 –
Membership composition of CCNSW Ethics Committee
7
SOP003 –
Appointment of members to CCNSW Ethics Committee
8
SOP003 Appendix 1 - Appointment to Ethics Committee
SOP004-
Orientation of new members to CCNSW Ethics Committee
11
SOP005-
Submission of new applications to CCNSW Ethics Committee
12
SOP006 -
Processing of applications for review by CCNSW Ethics Committee
13
SOP007 -
Preparation of agenda for CCNSW Ethics Committee
14
SOP008 -
Conduct of CCNSW Ethics Committee meetings
15
SOP009 -
Consideration of applications by CCNSW Ethics Committee
17
SOP010-
Attendance of Chief Investigator
19
SOP011-
External Expert Reviewers
20
SOP012 -
Preparation of minutes for CCNSW Ethics Committee
21
SOP013 -
Expedited review by CCNSW Ethics Committee
23
SOP014 -
Notification of decisions by CCNSW Ethics Committee
24
SOP014 Appendix 1 -
Format for NSWCC Ethics Committee letter granting ethical
approval for a project
SOP014 Appendix 2 –
Format for NSWCC Ethics Committee letter requesting further
information from investigator regarding the project.
Format for NSWCC Ethics Committee letter for projects not
approved
SOP014 Appendix 3 -
SOP015 -
Submission of amendments and extensions
SOP015 Appendix 1 SOP015 Appendix 2 -
30
Format for NSWCC Ethics Committee requested amendments
approved
Format for NSWCC Ethics Committee requesting further
information from an investigator regarding the change
SOP016 -
Handling of adverse events
33
SOP017 -
Monitoring of ethically approved projects
35
SOP017 Appendix 1 –
SOP018 -
NSWCC Ethics Committee Annual/Final Report Form
Complaints concerning the conduct of a research project
CCNSW Ethics Committee SOPs
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38
SOP019 -
Withdrawal of Ethical Approval/ Suspension of research
39
SOP019 Appendix 1 – Letter ordering immediate suspension of research
SOP019 Appendix 2 – Letter – ethical approval withdrawn
SOP019 Appendix 3 – Letter approving modified research proposal after ethical
approval withdrawn.
SOP020 -
Concerns and complaints relating to CCNSW Ethics Committee’s
ethical review process
44
SOP021-
Complaints concerning CCNSW Ethics Committee’s rejection of an
application
46
SOP022 -
Assessment of multicentre projects by CCNSW Ethics Committee
48
SOP023
Record keeping
49
SOP024-
Handling of conflicts of interest
50
SOP024 Appendix 1 – Declaration of interests form for Committee members
SOP025-
Reporting requirements of CCNSW Ethics Committee
52
SOP026 -
Review of Standard Operating Procedures and Terms of Reference
53
CCNSW Ethics Committee SOPs
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Acronyms
AHEC – Australian Health Ethics Committee
AVCC – Australian Vice-Chancellors’ Committee
CEO – Cancer Council NSW’s Chief Executive Officer
CCEC –Cancer Council NSW Ethics Committee
CCR – New South Wales Central Cancer Registry
CHO – NSW Health Department’s Chief Health Officer
HREC – Human Research Ethics Committee
NHMRC – National Health and Medical Research Council
CCNSW – Cancer Council NSW
Definitions
The following terms and definitions are used by the Committee. They are consistent with the
definitions contained in the NSW Health Privacy Manual, Version 2, 2005 and the NHMRC National
Statement on the Ethical Conduct of Research Involving Humans, 2007.
De-identified information – Data from which identifiers, for example, name, address, date of birth, have
been permanently removed, or where identifiers have never been included. Re-identification of data is not
possible.
Epidemiological Research – Epidemiological research is concerned with the description of health and
welfare in populations through the collection of data related to health and the frequency, distribution and
determinants of disease in populations, with the goal of improving health. Some epidemiological research
may require whole of population studies and be beyond an individual institution or organisation.
Epidemiological research is part of wider public health and health services research concerned with
improvements of health and welfare in human populations and with improving the efficiency and
performance of human health services. Public health and health services research are usually or often carried
out with human participants, or data or biological samples from them, and provide important new
knowledge that is not readily obtainable in other ways.
External – Outside the Cancer Council NSW
Health research - Systematic investigation undertaken for the purpose of adding to the body of
knowledge pertaining to human health.
Identifiable information – Any information characteristics or combination of information characteristics
concerning an individual that makes identification of that individual a reasonable possibility. Identifiable
information usually contains some elements of name, residential address or date of birth. For example, in
particularly small sets of data information such as postcode may be an identifier.
Internal – Inside the Cancer Council NSW
NSW Department of Health - The NSW Department of Health as established by section 6 of the
Health Administration Act 1982.
Potentially identifiable data - Data from which identifiers, for example, name, address, date of birth, may
have been removed and replaced by a code. In such cases it is possible to use the code or other means to reidentify the person to whom the data relate so that the process of de-identification is reversible. In addition,
cross-tabulations of data can produce small cell sizes from which it may be possible to identify the
individuals to whom the data relate, thus making the data potentially identifiable.
CCNSW Ethics Committee SOPs
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Public Health System – Under Section 6 of the Health Services Act 1997 consists of Area Health
Services, statutory health corporations and affiliated health organisations in respect of their recognised
establishments and services.
Relevant Laws, Regulations & Guidelines
In formulating applications, applicants should be aware of, and make reference as appropriate to, the
National Health & Medical Research Council (NHMRC) Guidelines on the ethical conduct of research and
relevant NSW Health policy including the Privacy Manual – Version 2 and the NSW Aboriginal Health
Information Guidelines. The following documents should be considered in the preparation of applications
to the Committee and consideration of applications by the Committee.







NSW Health’s Privacy Manual – Version 2 - 2005
NSW Aboriginal Health Information Guidelines
NSW Health’s Research - Model for Single Ethical & Scientific Review of Multi-Centre Research 2007.
NHMRC Australian Code for the Responsible Conduct of Research, 2007
NHMRC National Statement on the Ethical Conduct of Research Involving Humans, 2007
NHMRC Guidelines Under Section 95 of the Privacy Act 1988, 2000
CPMP/ICH135/95 Note for Guidance on Good Clinical Practice, 2000
NHMRC Guidelines are available from the NHMRC, ph: 1800 020 103 or www.nhmrc.gov.au. The
NSW Health Privacy Manual is available at the NSW Health website at www.health.nsw.gov.au, and
the NSW Aboriginal Health Information Guidelines are available at http://www.ahmrc.org.au.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP001
Subject:
Date: February 2010
Function of the Cancer Council NSW Ethics Committee.
Purpose: To describe the function of the Cancer Council NSW Ethics Committee
Overall Function
1. The primary objective of the Ethics Committee is to protect the mental and physical
welfare, rights, dignity and safety of participants of research, to facilitate ethical research
through efficient and effective review processes, to promote ethical standards of human
research and to review research in accordance with the NHMRC National Statement on
Ethical conduct in Research Involving Humans (National Statement).
Scope of Responsibilities
1. The functions of the Ethics Committee are:
i.
To provide independent, competent and timely review of research projects
involving humans in respect of their ethical acceptability.
ii. To provide ethical oversight, monitoring and advice for research projects
involving humans.
iii. To prescribe the principles and procedures to govern research projects
involving human subjects, human tissue and/or personal records.
2. Research projects may include, but are not limited to, epidemiological and public health
research and research involving social, and psychological investigations in relation to
cancer
3. The Committee will assess projects submitted to it for review in accordance with the
National Statement (and any other legal requirements) in order to determine their ethical
acceptability.
4. The Committee may review projects involving quality assurance when required. In
determining whether or not quality assurance proposals require review, the Committee
will refer to the NHMRC document ‘When does quality assurance in health care require
independent ethical review?’ and the ‘Health Records and Information Privacy Act 2002:
Statutory Guidelines on Management of Health Services’.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP002
Date: February 2010
Subject:
Membership composition of the Cancer Council NSW Ethics Committee.
Purpose:
To describe the composition of members of the Cancer Council NSW
Ethics Committee.
1.
The Committee will have a minimum of eight members. The core membership of the
Committee will be in accordance with NHMRC guidelines and any amendments to them
as issued from time to time.
2.
The core membership comprises:
(a)
a chairperson;
(b)
two lay people, one man and one woman, not affiliated with the Cancer Council,
and not currently involved in medical, scientific or legal work;
(c)
a person with knowledge of, and current experience in, the areas of research
regularly considered by the Committee;
(d)
a person with knowledge of, and current experience in, the professional care,
counseling or treatment of people;
(a)
a minister of religion or a person who performs a similar role in a community and
(e)
a lawyer.
(f)
At least one third of members must be from outside CCNSW.
3.
To ensure the membership will equip the Committee to address all the relevant
considerations arising from the categories of research likely to be submitted, some or all
of the above categories may be represented by more than one person.
4.
Additional members may be appointed to ensure the Committee has the expertise
required to assess the proposals regularly submitted for its consideration. If additional
members are appointed the composition of the HREC shall continue to reflect the
diversity and balance of its members, including gender and the relative proportion of
institutional and non-institutional members.
5.
Where required, the Committee may seek advice and assistance from experts to assist
with consideration of a project. The Committee must however, be satisfied that such
experts have no conflicts of interest in relation to the project under consideration, arising
from any personal involvement or participation in the project, any financial interest in the
outcome of the project or any involvement in a competing project.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP003
Subject:
Date: February 2010
Appointment of members to the Cancer Council NSW Ethics Committee.
Purpose: To describe the appointment and terms of appointment of members of the
Cancer Council NSW Ethics Committee.
.
1.
Members will be recruited through appropriate means, such as spontaneous
expressions of interest, objective nominations and externally advertised calls for
expressions of interest. Prospective members shall be asked to provide a copy of their
Curriculum Vitae to the selection committee. Members must agree to their name and
profession being made available to the public, including being published on the Cancer
Council NSW website.
2.
Members are appointed as individuals for their expertise rather than in a representative
capacity.
3.
A selection committee, consisting of the Chairperson, the Ethics Officer and at least one
other Committee member shall interview the prospective applicant, consult with the
Committee members and make a recommendation to the CEO. Prospective members
may be invited to attend a meeting of the Committee as an observer.
4.
Members of the Committee are appointed by the Board of the Cancer Council NSW and
will be sent a letter of appointment. Members will be advised by the Board when their
term has expired. Members are appointed for a term of two years and may serve three
consecutive terms.
5.
The Chairperson and the Deputy Chairperson will be appointed by the Board. The
Committee may nominate candidates for the position of Deputy Chairperson. In the
absence of the Chairperson, the Deputy Chairperson will perform the role and duties of
the Chairperson.
6.
The letter of appointment shall include the date of appointment, length of tenure,
assurance that indemnity will be provided in respect of liabilities that may arise in the
course of bona fide conduct of their duties as a Committee member, the circumstances
whereby membership may be terminated and the conditions of their appointment.
7.
Members will be required to sign a confidentiality undertaking upon appointment, stating
that all matters of which they become aware during the course of their work on the
committee will be kept confidential; that any conflicts of interest, which exist or may arise
during their tenure on the Committee will be declared; and that they have not been
subject to any criminal conviction or disciplinary action, which may prejudice their
standing as a Committee members.
8.
Upon appointment, members shall be provided with the following documentation:
- Cancer Council NSW Ethics Committee Terms of Reference;
- Cancer Council NSW Ethics Committee Standard Operating Procedures;
CCNSW Ethics Committee SOPs
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- up-to-date list of members’ names and contact information including that of the
Secretary;
- NHMRC National Statement on Ethical Conduct in Research Involving Humans
2007;
- a copy of the NHMRC Human Research Ethics Handbook
- Health Records and Information Privacy Act (HRIPA) 2002
- Statutory guidelines under HRIPA as appropriate, specifically the “use or disclosure
of health information for research purposes”.
- any previous reports on the Committee’s activities; and
- any other relevant information about the Committee’s processes, procedures and
protocols.
9.
To ensure that the Committee remains current and up-to-date in approach, the
Committee will aim to replace a minimum of one person per year.
10. The Cancer Council NSW indemnifies members when they are acting in good faith for
the purposes of discharging their roles as Committee members.
11. Members are not offered remuneration. Members will be reimbursed for legitimate
expenses incurred in attending Committee meetings, such as parking expenses.
12. Membership will lapse if a member fails to attend three (3) consecutive meetings of the
Committee without apology, unless exceptional circumstances exist. The member will
be notified of such lapse of membership by the Chair in writing.
13. Members may seek a leave of absence from the Committee for extended periods, and
steps may be taken to fill the vacancy.
14. Members will be asked to participate in relevant specialised working groups as required.
15. The Board may terminate the appointment of a member at any time.
16. New members are expected to attend NSW Health and NHMRC education and training
sessions as soon as practicable after their appointment. All members are expected to
attend education and training sessions. Reasonable costs associated with attendance at
training and education sessions will be met by the Cancer Council NSW.
17. A member may resign from the HREC at any time upon giving notice in writing to the
Chairperson. Steps shall be taken to fill the vacancy of the former member.
CCNSW Ethics Committee SOPs
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SOP003 Appendix 1
<<Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Title and name>>,
Re:
Appointment to Ethics Committee
Following our Board meeting on [date], it gives me great pleasure to appoint you as a [position]
on the Cancer Council NSW Ethics Committee.
The appointment of a [position] is in accordance with the NHMRC Guidelines for Institutional
Ethics Committees (IEC), which stipulates a requirement for “at least one member who is a
[position]”, and members of the Cancer Council NSW Ethics Committee are appointed for a term
of two years and may serve a maximum of three consecutive terms.
The Cancer Council NSW looks forward to the contribution you will make as a member of the
Ethics Committee.
As per our Standard Operating Procedures, you will be presented with a range of information to
assist you in your role on the Ethics Committee, including the National Statement on Ethical
Conduct in Research Involving Humans 2007; the Health Records and Information Privacy Act
2002; the Cancer Council Ethics Committee Standard Operating Procedures and Terms of
Reference and other additional information as necessary.
Please be assured that in your role as a Committee member on the Ethics Committee, you are
indemnified against any liabilities that may arise in the course of bona fide conduct of your
duties.
If you have any queries please contact the Ethics Committee [Insert best contact] on [(XX) XXXX
XXXX]
Yours sincerely,
Andrew Penman
Chief Executive Officer
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP004
Subject:
Date: February 2010
Orientation of new members to the Cancer Council NSW Ethics Committee
Purpose: To describe the procedure for the orientation of new members
1. New Committee members must be provided with adequate orientation including
reference materials as per Point 8. of SOP003.
2. Orientation may involve all or some of the following:
-
Introduction to other Committee members prior to the meeting.
Informal meeting with Chair and Ethics Officer to explain their responsibilities as
a Committee member, the Committee processes and procedures.
An opportunity to sit in on Committee meetings before their appointment takes
effect.
‘Partnering’ with another Committee member in the same category.
Priority given to participate in training sessions.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP005
Subject:
Date: February 2010
Submission procedure for new applications for ethical assessment by the
Cancer Council NSW Ethics Committee.
Purpose: To describe the procedure for the submission of new applications to the
Cancer Council NSW Ethics Committee must be made.
1. All proposals submitted to the Committee for ethical assessment must be made on the
National Ethics Application Form (NEAF) available at www.ethicsform.org/au which has
been designed by NHMRC and will include documentation as specified in the application
form. The NEAF application form is accessible via the above website link.
2. Instructions for completing the NEAF application form are also on the same website and
will assist in the proper completion of the application.
3. The Committee will require all sections of the application form to be completed.
Incomplete application forms will generally be returned to the applicant for completion.
However, minor omissions may, at the discretion of the Secretary, be remedied by the
applicant within a specified time frame.
4. The applicant will be required to submit as many copies of the application and supporting
documentation as the Committee considers necessary to enable it to carry out a proper
review.
5. A levy will not be charged for applications submitted for assessment by the Committee.
6. The Secretary will undertake an administrative review of the application prior to
acceptance onto, and distribution of, the agenda, to ensure that the application has been
completed and that there are no obvious omissions.
7. Applications must be received by the Secretary at least twelve working days before each
scheduled Committee meeting. The scheduled meeting dates and corresponding
application closing dates should be available from the Committee’s Secretary and from
the Cancer Council NSW website. The Committee will consider completed applications
at its next available meeting provided that the application is received by the relevant
closing date.
8. It is incumbent on the Committee to satisfy itself, and where uncertain to request the
Secretariat to make investigation, as to the bona fides and qualifications of the
researchers making application to the Committee.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP006
Subject:
Date: February 2010
Processing of applications for review by the Cancer Council NSW Ethics
Committee.
Purpose: To describe the process of each application once it has been received for
ethical assessment by the Cancer Council NSW Ethics Committee.
1. The Secretary will assign an identification number, known as the Project Number, to
each application. The Project Number is assigned according to the next available
sequential number in the Ethics database, which records Projects submitted in order of
receipt. The date of the meeting at which the project is discussed, as well as the agenda
item number is also recorded on the Ethics database.
2. The Secretary will open and maintain a confidential file for each application, including the
original application and all subsequent information and correspondence relevant to the
application.
3. The Secretary will record the application on the Cancer Council NSW Ethics Committee
database, including NHMRC prescribed items of information, eg: Project Identification
Number, the name of the responsible institution or organisation, name of the Chief
Investigator, title of the project and whether the project is multi-centre.
4. The Secretary will acknowledge acceptance of the application for ethical review by
issuing an acknowledgement email (or letter if no email address is provided) to the
principal investigator within 7 days of receipt of the application. The acknowledgement
communication shall include the date of the meeting at which the application will be
reviewed, as well as the unique project identification number given by the HREC to the
project.
5. The application will be included on the agenda of the Committee’s next scheduled
meeting, provided that the application is received by the relevant closing date.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP007
Subject:
Date: February 2010
Preparation of agenda for the Cancer Council NSW Ethics Committee.
Purpose: To describe the process and format of agenda for a meeting of the Cancer
Council NSW Ethics Committee.
1.
The Secretary will prepare an agenda for each Committee meeting.
2.
All completed applications and relevant documents received by the Secretary by the
closing date will be included on the agenda, for the Committee’s consideration at its next
available meeting.
3.
The meeting agenda and associated documents will be prepared by the Ethics Officer
and Ethics Secretary and circulated to all Committee members at least 7 days prior to
the next meeting.
4.
Correspondence and other documents received after the closing date will be included
on the agenda at the discretion of the Chair/Secretary. Under no circumstances shall
new applications for research be tabled at the meeting.
5.
The agenda format will include the following items:
-
6.
Attendance
Minutes of the previous meeting
Business arising from previous minutes
Conflicts of interest
New applications
Amendments to proposals previously given ethics approval
Progress reports
Completed projects
Correspondence
Other business
Next meeting
To ensure confidentiality, the agenda is to be distributed by hand delivery, courier, or
express post, to those members external to the Cancer Council NSW and shall remain
confidential.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP008
Subject:
Date: February 2010
Conduct of Cancer Council NSW Ethics Committee Meetings.
Purpose: To describe the format of meetings of the Cancer Council NSW Ethics
Committee.
1. The Committee will meet at least bi-monthly, from February to December. The scheduled
meeting dates and corresponding application closing dates should be publicly available
from 1 January and can be obtained from the Committee’s Secretary.
2. Meetings will be held in the Debbie Thake Room, Level 6, Cancer Council NSW, 153
Dowling St, Woolloomooloo, NSW 2011.
3. The Chairperson may cancel a scheduled meeting if it has been determined that there
are insufficient agenda items to warrant a meeting or a quorum cannot be achieved
(Refer to Point 8). Should this occur, the Committee will convene within 5 working days
of the cancelled meeting to ensure all agenda items are considered.
4. Meetings will be scheduled initially for two hours. If the Committee’s business has not
been completed within the 2 hour period, then the Committee may either continue the
meeting until all agenda items have been considered, defer consideration until the next
scheduled meeting or schedule an additional meeting. If an additional meeting is called
for, then the meeting should be held as soon as possible.
5. The Committee meeting should be conducted in private, to ensure confidentiality and
open discussion. Members should be encouraged to raise any concerns.
6. Attendance by Committee members at a meeting should be in person or in some
circumstances may be via telecommunications link.
7. Members who are unable to attend a meeting may contribute prior to the meeting
through either written or oral submissions to the Secretary or Chairperson. These should
normally be received at least 3 working days prior to the meeting so that copies may be
made available in advance to members. The minutes should record these submissions.
8. A quorum must be present in order for the Committee to reach a final decision on any
agenda item. A quorum shall exist when a representative of each of the following
categories is present:
-
-
a chairperson;
at least two members who are lay people, one man and one woman, who
have no affiliation with the institution or organisation, and who are not
currently involved in medical, scientific, or legal work;
at least one member with knowledge of, and current experience in, the areas
of research that are regularly considered by the HREC;
at least one member with knowledge of, and current experience in, the
professional care, counseling or treatment of people;
CCNSW Ethics Committee SOPs
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-
at least one member who is a minister of religion, or a person who performs a
similar role in the community;
at least one member who is a lawyer
At a third of these members must be external to the Cancer Council NSW, and at least
two must not be medically or scientifically trained.
9. In the event of a representative of a core category not being in attendance at a meeting,
an ethical determination cannot be made without either oral or written comment from the
absent representative prior to the meeting, or by their ratification of the decisions of the
Committee. In such circumstances, there must be at least 5 members physically present
to achieve a quorum, including one of each of the following categories:
Chairperson/Deputy Chairperson, lay person, researcher familiar with the types of
proposals that are normally reviewed by the HREC.
10. Any member of the Committee who has any interest, financial or otherwise, in a proposal
or other related matter considered by the Committee, should as soon as practicable
declare such interest. The Committee will determine if this results in a conflict of interest
for the member and if so the member will withdraw from the meeting until the
Committee’s consideration of the relevant matter has been completed. All declarations of
interest and the absence of the member concerned will be minuted.
11. The Committee will endeavor to reach a decision concerning the ethical acceptability of a
proposal by unanimous agreement. Where a unanimous decision is not reached, the
decision will be considered to be carried by a majority of two-thirds of members who
examined the proposal, provided that the majority includes at least one layperson. Any
dissenting view will be noted in the minutes.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP009
Subject:
Date: February 2010
Consideration of applications for ethical assessment by the Cancer Council
NSW Ethics Committee.
Purpose: To describe the process of the Cancer Council NSW Ethics Committee’s
consideration of applications for ethical assessment.
1.
The Committee will consider a new application at its next available meeting provided
that the application is received by the relevant closing date.
2.
The application will be reviewed by all members of the Committee present at the
meeting or providing written or oral submission in lieu of attendance.
3.
The Committee will deal with multi-centre research applications in accordance with
SOP022.
4.
The Committee will ethically assess each application in accordance with the NHMRC
National Statement on Ethical Conduct in Research Involving Humans 2007. The
Committee must ensure that it is sufficiently informed on all aspects of a research
protocol, including its scientific validity, in order to make an ethical assessment.
5.
The Committee will consider whether an advocate for any participant or group of
participants should be invited to the Committee meeting to ensure informed decisionmaking.
6.
Where research involves the targeted recruitment of persons unfamiliar with the English
language, the Committee will ensure that the participant information sheet is translated
into the participant’s language and that an interpreter is present during the discussion on
the project.
7.
The Committee, after consideration of an application at a meeting will make one of the
following decisions:
- It will approve the project as being ethically acceptable, with or without
conditions.
- It will defer making a decision on the project until the clarification of
information or the provision of further information to the Committee.
- It will request modification of the project.
- It will reject the project.
8.
The Committee will endeavour to reach a decision concerning the ethical acceptability of
a project by unanimous agreement. Where a unanimous decision is not reached, the
decision will be considered to be carried by a majority of two-thirds of members who
examined the project, provided that the majority includes at least one layperson. Any
significant minority view (i.e. 2 or more members) shall be noted in the minutes.
CCNSW Ethics Committee SOPs
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9.
In order to facilitate consideration of an application, the Committee may invite the
applicant to be present at the relevant meeting for its discussion and to answer
questions.
10. For projects where the Committee has requested clarification, the provision of further
information, or modification of the project, the Committee may choose to delegate the
authority to review that information and approve the project between meetings to one of
the following:
- chairperson alone; or
- chairperson, in oral or written consultation with one or more named members
that were present at the meeting or who submitted written comments on the
application; or
- a sub-committee of the Committee.
In such circumstances, the Committee shall be informed at the next available meeting, of
the final decision taken on its behalf, including the applicant’s response and the reason
for the decision taken.
11. Exceptionally, the Committee may decide that the information should be considered at a
further meeting of the HREC.
12. The Committee may conduct expedited review of projects in accordance with SOP011.
13 . A member of the Committee is designated as the ‘spokesperson’ for the project, for the
purpose of discussion of the project at the Committee’s meeting. The spokesperson is
required to give a verbal summary of the project and highlight any issues of concern. It
should be noted that the spokesperson’s role does not involve a more in depth review of
the proposal than that conducted by other members. The spokesperson simply reminds
other members of key issues involved. The spokesperson is designated to a project via
a consecutive listing of Committee members. A spokesperson is not designated a
proposal based on their relevant expertise. New Committee members are incorporated
into this system after four meetings. If the designated spokesperson cannot attend the
meeting then the next member from the consecutive listing is approached.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP010
Subject:
Date: February 2010
Attendance of the Chief Investigator
Purpose: To describe the process of the Cancer Council NSW Ethics Committee’s inviting
the Chief Investigator to attend a meeting to give a formal presentation.
At the request of a HREC member the Chief Investigator may be invited to make a formal
presentation or respond directly to requests from the HREC for further information,
clarification or reassurance.
Where the Chief Investigator is unable to attend, another key investigator or collaborator will
attend if appropriate. Representatives of any sponsors will not attend. Other members of the
research team may attend with the Chief Investigator.
The Chief Investigator may also attend meetings via speakerphone or teleconference
facilities.
Confidentiality agreements will be signed by attending investigator’s before a meeting
whether in person by telephone.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP011
Subject:
Date: February 2010
External Expert Reviewers
Purpose: To describe the process of the Cancer Council NSW Ethics Committee’s seeking
the advice of an external expert reviewer.
If the CCNSW HREC is unable to make a decision on an application or without the
necessary expertise is able to seek the advice of an External Expert Reviewer through the
Standing Committee on Scientific Assessment Committee or through experts identified in the
area by the Chairperson and/or the Ethics Officer.
The advice of External Expert Reviewers will be sought using the following procedure;
 The Ethics Officer or Chairperson will ensure that the opinion of the researcher is
sought concerning objections to potential reviewers;
 Expert Reviewers declare any conflict of interest and signs the Declaration for
Committee members;
 The Ethics Officer or Chairperson will write to the Expert Reviewers seeking written
advice prior to the meeting;
 A copy of the advice received will be made available to HREC members,
subcommittee or other appropriate members, prior to the meeting or tabled at the
meeting. The advice will be recorded in the minutes.
Where the Committee decides that it cannot give an opinion until it has obtained further
advice from an expert reviewer the following procedures will be adopted;
Notification will be sent to the applicant following the meeting advising that a final decision
will not be made on the application until advice is obtained from an expert reviewer. The
letter will notify the applicant of the issues of concern to the HREC, but not request further
information or clarification. In circumstances where expert scientific opinion is sought, the
researcher will be given the option to identify experts to whom they object.
The Committee will select a suitable expert reviewer during the meeting and record the
decision in the minutes or the Chairperson or the Ethics Officer will identify a suitable expert
following the meeting.
The Chairperson or Ethics Officer will initially contact the prospective expert reviewer(s) by
phone or e-mail to establish whether they are available to provide expert advice within the
required time frame. The Chairperson or Ethics Officer will establish the nominated reviewer
does not have any connection with the research that might give rise to a conflict of interest.
The Chairperson or Ethics Officer will advise the expert reviewer about confidentiality
requirements and obtain a signed confidentiality agreement and declaration of interest forms
prior to obtaining advice.
The Ethics Officer specifies in writing the issues of concern to the Committee and the expert
advice required. A copy of the application form will be provided together with any supporting
documentation required by the expert reviewer. The request will be made within 10 working
days of the meeting. The Expert Reviewer will be asked to respond in writing within 10
working days of receiving the documents.
It will be made clear to the applicant the opinion of the Committee on the research
application is the independent opinion of the Committee.
CCNSW Ethics Committee SOPs
20
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP0012
Subject:
Date: February 2010
Preparation of minutes for the Cancer Council NSW Ethics Committee.
Purpose: To describe the process and format for minutes of a meeting of the Cancer
Council NSW Ethics Committee.
1.
The Secretary will prepare and maintain minutes of all meetings of the Committee.
2.
The format of the minutes will include the following items:
- Apologies
- Attendance
- Minutes of the previous meeting
- Business arising from previous minutes
- Conflicts of interest
- New applications
- Amendments to Proposals Previously Given Ethics Approval
- Progress reports
- Completed projects
- Correspondence
- Other business
- Next meeting
3.
The minutes should include the recording of decisions taken by the Committee as well
as a summary of the Committee’s discussion. This includes reference to views
expressed by absent members.
4.
In relation to the review of new applications or amendments, the minutes shall record a
summary of the main ethical issues considered, including any requests for additional
information, clarification or modification of the project.
5.
In recording a decision made by the Committee, any significant minority view (i.e. 2 or
more members) shall be noted in the minutes.
6.
To encourage free and open discussion and to emphasise the collegiate character of
the Committee, particular views should not be attributed to particular individuals in the
minutes, except in circumstances where a member seeks to have his/her opinions or
objections recorded.
7.
Declarations of conflicts of interest by any member of the Committee and the absence of
the member concerned during the Committee’s consideration of the relevant application
will be minuted.
8.
The minutes should be produced as soon as practicable following the relevant meeting
and should be checked by the Chairperson, Deputy Chairperson or a member of the
Committee, for accuracy.
9.
The minutes should be circulated to all members of the Committee as an agenda item
for the next meeting. All members will be given the opportunity to seek amendments to
the minutes prior to ratification of the minutes.
CCNSW Ethics Committee SOPs
21
10. The minutes will be formally ratified at the next Committee meeting.
11. The original signed copy of each meeting’s minutes will be retained in a confidential
‘Minutes’ file.
12. A report will be prepared for the Board meeting following the Ethics Committee meeting
and the minutes of each Committee meeting shall be made available to the Board.
CCNSW Ethics Committee SOPs
22
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP013
Subject:
Date: February 2010
Expedited review by the Cancer Council NSW Ethics Committee
Purpose: To describe the procedure for the expedited review of research by the HREC
1. The Committee may establish an Executive, consisting of at least the Chairperson and
the Ethics Officer. The Executive may undertake expedited review of research projects
in the following circumstances:
- questionnaires on non-controversial, non-personal issues
- research which is being conducted primarily at another institution/Health
Service and has been approved by another HREC, but which involves a
minimal risk component at the Cancer Council NSW.
Expedited review of research projects may be undertaken between scheduled meetings
at the discretion of the Chairperson. The Executive may seek advice from other
Committee members or suitably qualified experts, as appropriate, before reaching a
decision. The decision of this review must be tabled for ratification at the next
Committee meeting.
The Executive may consider other items of business that are considered to be of minimal
risk to participants such as appropriate adverse events, project reports, minor
amendments and the like.
2. The minutes of Executive meetings will be tabled for ratification at the next Committee
meeting.
3. Research with the potential for physical or psychological harm should generally not be
considered for expedited review. This includes clinical trials, research involving invasive
physical procedures and research exploring sensitive personal or cultural issues.
4. Where the Chairperson considers that research may involve a departure from the ethical
principles of integrity, respect for persons, beneficence and justice, the protocol must be
considered by the full Committee and cannot be dealt with by expedited review.
CCNSW Ethics Committee SOPs
23
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP014
Subject:
Date: February 2010
Notification of decisions by the Cancer Council NSW Ethics Committee for
new applications.
Purpose: To describe the process of notifying applicants of the outcome of the Cancer
Council NSW Ethics Committee’s ethical assessment.
1.
The Committee will report in writing to the applicant, advising whether the proposal is
ethically acceptable and any conditions imposed by the Committee, within 10 working days
of the meeting unless otherwise notified.
2.
Notification of the Committee’s deliberation should include reference to the meeting date at
which the project was considered.
3.
If the Committee determines that further information, clarification or modification is required
for the consideration of a proposal, the correspondence to the Chief Investigator should
clearly set out the information, clarification or modification that is required and reasons for
this determination. The format for a letter of this nature is set out in SOP014 Appendix 2.
Where possible, requests for additional information/clarification/modification should refer to
the NHMRC National Statement on Ethical Conduct in Research Involving Humans or other
relevant pieces of legislation.
4.
If the requested information, clarification or modification is not received from the Chief
Investigator within 3 months or two meetings (whichever occurs later), the proposal will be
dismissed and the investigator will be required to re-submit the proposal at a later date.
5.
The Committee shall endeavor to openly communicate with applicants to resolve
outstanding requests for further information, clarification or modification of projects relating
to ethical issues. The Committee may nominate one of its members to communicate
directly with the applicant or by inviting the applicant to attend the relevant meeting.
6.
If a proposal is approved, the approval letter (see SOP014 Appendix 1) should include
reference to the following:
- title of the project
- name of the principal investigators
- unique project identification number, assigned by the Committee
- the version number and date of all documentation reviewed and approved by the
Committee including Patient Information Sheets, Consent Forms, advertisements,
questionnaires etc.
- date of the meeting at which the project was first considered
- date of approval
- the requirement for the project to be conducted in accordance with the NSW Health
Information Privacy Code of Practice 1998 and (where applicable) the NHMRC National
Statement on Ethical Conduct in Research Involving Humans, 2007;
- the length of time the approval is valid;
CCNSW Ethics Committee SOPs
24
-
the conditions outlined below and any other conditions of approval the Committee has
set;
i) The project will be carried out as described in the application and in accordance with
ALL subsequent correspondence.
ii) The Chief Investigator will advise the Committee of any changes to the project or its
conduct, if any unforeseen events that might affect continued ethical acceptability of
the project or adverse events take place, or if the project is abandoned for any
reason. New ethical approval must be sought for substantially altered or revised
research protocols.
iii) In order to fulfill monitoring requirements of the Committee and the NHMRC, a
report is required annually and at completion of the study. The report should be
received by the Committee by the date specified (Refer to SOP017 for determining
due date) for its consideration. Ethical approval may lapse unless the report is
received.
iv) any other information the Committee deems necessary.
7.
If the Committee determines that a project is ethically unacceptable, the notification of
the Committee’s decision should include the grounds for rejecting the project with
reference to the National Statement or other relevant pieces of legislation. A format for a
letter of this nature is set out in SOP014 Appendix 3.
8.
The status of the project is updated on the Cancer Council NSW Ethics Committee
database.
CCNSW Ethics Committee SOPs
25
SOP014 Appendix 1
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for submitting the above project, which was considered by the Cancer Council
NSW Ethics Committee at its meeting on <<date>>. I am pleased to advise that the
Committee has recommended that ethical approval be granted.
Please note that approval is valid for x year from the date of this letter.
The following documentation has been reviewed and approved by the Ethics Committee

[insert the version number and date of all documentation reviewed and approved
by the HREC including protocols, information sheets, consent forms,
advertisements, questionnaires etc]
The project should be conducted in accordance with the NHMRC National Statement on
Ethical Conduct in Research Involving Humans, 2007 and the NSW Health Information
Privacy Code of Practice 1998, NSWCC Guidelines Ethical approval is conditional upon
adherence to these guidelines and the conditions outlined below.
i) The research project will be carried out as described in the application and in
accordance with ALL subsequent correspondence.
ii) The Chief Investigator will advise the Committee of any changes to the project or its
conduct, of any unforeseen events that might affect continued ethical acceptability of
the project, of any serious or unexpected adverse events that take place, or if the
project is abandoned for any reason. New ethical approval must be sought for changes
to the research protocol, conduct of the research or length of ethics approval, from the
Ethics Committee, in the specified format.
iii) In order to fulfill monitoring requirements of the Committee and the NHMRC, a report is
required annually and at completion of the study. A form for reporting to the Committee
is attached. Your report should be received by the Committee by <<date>> for its
consideration. If a report is not received, ethical approval may be withdrawn.
iv) <<Include any other conditions the Committee may have set>>
[insert if research is being carried out within an external organization]. Although it is within
this Ethics Committee’s Terms of Reference to review research which takes place within
sites that fall under the NSW Health Single Ethical Review of Multi Centre Research
system, we note that other organisations within this system are not part of the Cancer
Council NSW. This approval does not have the effect of conferring any insurance or
indemnity coverage on the external organisation by the Cancer Council NSW in relation
to this project, and any liabilities arising from the conduct of the project are entirely the
responsibility of the organisation at which the research is conducted.
Should you require any additional information regarding the Committee’s consideration of
the proposal, please contact the [Insert best contact] on [(XX) XXXX XXXX] or at
ethics@nswcc.org.au.
CCNSW Ethics Committee SOPs
26
Please quote Project No. xxxx in all correspondence.
Yours sincerely
Andrew Penman
CEO
Cancer Council NSW
CCNSW Ethics Committee SOPs
27
SOP014 Appendix 2
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for submitting the above project which was first considered by the Cancer
Council NSW Ethics Committee at its meeting on [insert date].
In order to make a determination of ethical acceptability of your project, please respond to
the following request for additional information/modification/clarification [delete whichever
is not applicable]:
 [list each request separately]
In order to facilitate the Committee’s consideration of your project, please provide the
requested information as soon as possible. Your response may be emailed to the Ethics
Secretary at ethics@nswcc.org however this should be accompanied by a hard copy.
Please note that if a response is not received within 3 months the project will be
dismissed and you will be required to re-submit the project for review at a later date.
Should you have any queries about this response please contact the [Insert best contact]
on [(XX) XXXX XXXX] or at ethics@nswcc.org.au.
Please quote Ethics ID xxxx in all correspondence.
Yours sincerely,
A/Prof Bettina Meiser
Chair
Cancer Council NSW Ethics Committee
CCNSW Ethics Committee SOPs
28
SOP014 Appendix 3
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for submitting the above project, which was first considered by the Cancer
Council NSW Ethics Committee at its meeting held on [insert date].
The Ethics Committee has determined that this project does not satisfy the necessary
requirements for ethical approval for the following reasons:
 [list each reason separately. Each reason will refer to the relevant paragraph/s of
the National Statement, relevant legislation or other applicable guidelines].
Should you wish to discuss the Ethics Committee’s decision, please contact the [Insert
best contact] on [(XX) XXXX XXXX] or at ethics@nswcc.org.au.
Yours sincerely,
Andrew Penman
CEO
Cancer Council NSW
CCNSW Ethics Committee SOPs
29
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP015
Subject:
Date: February 2010
Submission of amendments and extensions to approved projects
Purpose: To describe the procedure for the submission and HREC review of requests
for amendments and extensions to approved protocols.
1. Proposed changes to approved research projects, conduct of the research, or
requests for extensions to the length of Ethics approval, are required to be reported
by the principal investigator to the Committee for review.
2. Requests shall outline the nature of the proposed changes and/or request for
extension, reason/s for the request, and an assessment of any ethical implications
arising from the request on the conduct of the research. All amended documents
must have the changes highlighted and contain revised version numbers and dates.
3. Expedited review of requests for minor amendments and extensions may be
undertaken by the Committee Executive between scheduled meetings at the
discretion of the Chairperson and in accordance with SOP 011, on the condition that
it be ratified at the next Committee meeting. Where an urgent protocol amendment is
required for safety reasons, the Chairperson may review and approve the request. In
such circumstances, the Committee will review the decision at its next available
meeting.
4. All other requests for amendments shall be reviewed by the Committee at its next
available meeting, provided the request has been received by the Ethics Officer by
the agenda closing date.
5. The Committee will report in writing to the principal investigator, advising of the
ethical approval of the proposed amendment and/or request for extension, within 10
working days of the meeting at which the request was considered (this may be the
full HREC meeting or the Executive meeting). The Committee may inform the
applicant in writing that the amended research may commence.
6. A standard response will be issued, in the format set out in SOP013 Appendix 1
7. If the Committee determines that further information, clarification or modification is
required for the consideration of the request for amendment or extension, the
correspondence to the investigator should clearly articulate the reasons for this
determination, and clearly set out the information, clarification or modification that is
required. A format for a letter of this nature is set out in SOP013 Appendix 2. Where
possible, requests for additional information/clarification/modification should refer to
the National Statement or relevant pieces of legislation.
8. All reviewed and approved requests for amendments and extensions shall be
recorded, and the status of the project shall be updated on the Committee’s register
of received and reviewed applications.
CCNSW Ethics Committee SOPs
30
SOP015 Appendix 1
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for your submission of a request for an amendment/extension to the above
project, which was considered by the Cancer Council NSW Ethics Committee at its
meeting of <<date>>.
I am pleased to advise that the Committee has granted ethical approval for the requested
amendments, as follows:
 [insert summary of amendment request including the version number and date of
all documentation reviewed and approved by the Committee including protocols,
information sheets, consent forms, advertisements, questionnaires etc]
Please note the following conditions of approval:
 The Chief Investigator will advise the Committee of any changes to the project or
its conduct, of any unforeseen events that might affect continued ethical
acceptability of the project, of any serious or unexpected adverse events that take
place, or if the project is abandoned for any reason. New ethical approval must be
sought for changes to the research protocol, conduct of the research or length of
ethics approval, from the Ethics Committee, in the specified format.
 [list any other conditions of approval imposed by the Ethics Committee]
Should you require any additional information regarding the Committee’s consideration of
the proposal, please contact the [Insert best contact] on [(XX) XXXX XXXX] or at
ethics@nswcc.org.au.
.
Please quote Project No. xxxx in all correspondence.
Yours sincerely
Andrew Penman
CEO
Cancer Council NSW
CCNSW Ethics Committee SOPs
31
SOP015 Appendix 2
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for your submission of a request for an amendment to the above project,
which was considered by the Cancer Council NSW Ethics Committee at its meeting of
<<date>>.
In order to make a determination of ethical acceptability of your amendment, please
respond to the following request for additional information/modification/clarification [delete
whichever is not applicable]:
 [list each request separately]
In order to facilitate the Committee’s consideration of your project, please provide the
requested information as soon as possible. Your response may be emailed to the Ethics
Secretary at ethics@nswcc.org however this should be accompanied by a hard copy.
Please note that if a response is not received within 3 months the project will be
dismissed and you will be required to re-submit the project for review at a later date.
Should you require any additional information regarding the Committee’s consideration of
the proposal, please contact the [Insert best contact] on [(XX) XXXX XXXX] or at
ethics@nswcc.org.au.
.
Please quote Project No. xxxx in all correspondence.
Yours sincerely
A/Prof Bettina Meiser
Chair
Cancer Council NSW Ethics Committee
CCNSW Ethics Committee SOPs
32
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP016
Subject:
Date: February 2010
Handling of adverse events.
Purpose: To describe the process for the reporting and handling of adverse events for
projects ethically approved by the Cancer Council NSW Ethics Committee.
1. The Committee shall require, as a condition of approval of each project,
researchers to immediately report serious or unexpected adverse events to the
Committee, including those that have occurred at other institutions participating in
the study.
2. Notifications of adverse events must be submitted in the appropriate format as
determined by the Committee, and shall include all documentation as required
listed below. This documentation shall include as a minimum:
-
-
Advice from the principal investigator as to whether, in his/her opinion, the
adverse event was related to the protocol.
Advice from the principal investigator as to whether, in his/her opinion, the
adverse event necessitates an amendment to the project and/or the
Patient Information Sheet/Consent Form.
Advice from the principal investigator regarding the frequency of the event
in relation to the total number of participants, for the trial in which the event
occurred.
3. The procedures and format for notification of adverse events to the Committee
shall be readily available to investigators.
4. Adverse events may be reviewed by an Executive or Subcommittee of the
Committee, which shall determine the appropriate course of action. This may
include:
-
notation on file of the occurrence;
increased monitoring of the project;
request for an amendment to the protocol and/or Patient Information
Sheet/Consent Form;
suspension of ethical approval; or
termination of ethical approval.
Any such adverse events shall be reported to the Committee at the next available
meeting.
5. Chief Investigators should immediately report all adverse events to the
Committee. Reporting should be made in writing and directed to the Chair of the
Committee. The reporting should include comment from the investigator on
whether, in his/her opinion, the adverse event was related to the project.
6. For adverse events deemed by the Chair as serious and requiring immediate
attention, the Chair will take such action as considered necessary. This may
include:
- Referral to the scientific/technical subcommittee
CCNSW Ethics Committee SOPs
33
-
Immediate request for additional information
Immediate suspension of ethical approval
Immediate termination of ethical approval
7. The Committee shall inform the investigator that it has received notification of the
serious or unexpected adverse event, and the course of action it has deemed
necessary to take.
CCNSW Ethics Committee SOPs
34
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP017
Subject:
Date: February 2010
Monitoring of ethically approved projects.
Purpose: To describe the monitoring procedures of the Cancer Council NSW Ethics
Committee for proposals it has ethically approved.
1.
The Committee will monitor the progress of all proposals for which it has granted
ethical approval. In doing so, the Committee may request and discuss information on
any relevant aspects of the project with the investigators at any time.
2.
Monitoring responsibilities will include, at a minimum, obtaining an annual report on
the progress of the project and a final report at the project’s completion. Reports
must be made in the format set out in SOP015 Appendix 1. Report Forms should be
available from the Secretary and the Cancer Council NSW web site.
3.
The Committee may withdraw ethical approval if reports are not received.
4.
To ensure a project is monitored annually, reports should be received in time for
consideration by the Committee at the meeting preceding the 12 month anniversary
of the date of the ethical approval letter. Example: For a project granted ethical
approval late April 1999, the annual report should be received by the closing date for
the meeting preceding the end of April 2000.
5.
Additional monitoring responsibilities include ensuring that the Chief Investigator
advises the Committee of anything which might warrant review of ethical approval of
the project, including:
(a) any proposed changes to the project or its conduct;
(b) any serious or unexpected adverse events that take place;
(c) any unforeseen events that might affect continued ethical acceptability of the
project; or
(d) if the project is abandoned/discontinued for any reason.
An explanation or the rational for any changes are expected as part of the notice.
Changes will not be automatically approved. Investigators are not to change any
aspect of a project prior to ethical approval of the change.
6.
If a project has not commenced within two years from the date of ethical approval,
then ethical approval will lapse. If the investigator is still planning to undertake the
project then a new submission to the Committee is required.
7.
The Committee may adopt any additional appropriate mechanism for monitoring,
including performing random audits of ‘active’ projects to ensure compliance with
approval, for example: security of storage of data; the level of identification of data;
and the existence of signed consent forms.
8.
The Committee will determine if any additional forms of monitoring are required for a
project, based on its consideration of the risk to participants in the project.
CCNSW Ethics Committee SOPs
35
SOP017 Appendix 1
Cancer Council NSW Ethics Committee (CCNSWEC)
Annual/Final Report
1. Project Number:
(Please circle)
Chief Investigator:
2. Title of Project:
3. Date of Project Approval by CCNSWEC:
4. Name of Cancer Council NSW data collection(s) used (if applicable):
5. Name of Custodian(s) of the data collection(s) (if applicable):
6. Project Status: 



Not Started
Abandoned
In Progress
Completed
Expected Completion Date:
Completion Date:
7. If the project has been abandoned or not started, please give reasons why:
8. Has the project protocol been changed since approval in any way that might affect
participant involvement or change the information collected? (If yes, give details and
indicate which changes have already been notified to the CCEC).
9. Have the ethical issues in the project changed? (If yes, indicate the changes):
10. List conditions imposed by the CCEC and indicate how each has been complied with.
11. Have any problems, complications or adverse events affecting human subjects arisen
during, or as a result of, the study? (If YES, state what they were and what action was
taken to resolve them):
CCNSW Ethics Committee SOPs
36
12. Do procedures for data handling and storage protect privacy in accordance with
NHMRC guidelines? If not, in what way do they vary from these standards?
(All data security must satisfy NHMRC guidelines)
13. Person responsible for data storage:
14. Medium of data storage: Paper / Computer / Microfiche / Other (Please specify):
15. Preliminary results, including any publications:
(Relevant abstracts, articles etc. may be attached)
(Maximum half a page)
Name of Chief Investigator:
Signature of Chief Investigator:
Date:
For Office Use Only:
Comments:
CCNSW Ethics Committee SOPs
37
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP018
Subject:
Date: February 2010
Complaints concerning the conduct of a research project.
Purpose: To describe the mechanism for receiving, handling and responding to
complaints concerning the conduct of a project approved by the Cancer
Council NSW Ethics Committee.
1.
A person, whether he/she is a project participant, researcher or other interested
person, with a complaint about the conduct of a project, should bring the complaint to
the attention of the Secretary of the Committee in the first instance, detailing the
grounds of the complaint.
2.
The Secretary in conjunction with the Chair of the Committee, will investigate the
complaint. The Chief Investigator of the project shall be notified of the complaint.
Further information from all relevant persons may be sought during the investigation
of the complaint. In some cases, the Chief Investigator may be required to attend a
Committee meeting to explain the situation. The Committee must respond urgently
where there is any suggestion of harm to participants, researchers or any other
persons.
3.
The Committee, having considered the matter, will make a recommendation on the
appropriate course of action.
4.
The CEO of the Cancer Council NSW will, on the advice of the Committee, inform the
Chief Investigator in writing, of the result and the actions arising from the
investigation. These actions may include:
(i)
a caution;
(ii)
increased monitoring by the Committee;
(iii)
the requirement for amendments to the project;
(iv)
suspension of ethical approval; or
(v)
termination of ethical approval.
5.
The complainant will be advised in writing of the outcome of the investigation of the
complaint.
6.
If the complainant is not satisfied with the outcome of the Committee’s investigation,
then he/she can refer the complaint to the Board of the Cancer Council NSW.
7.
Contact details of the Secretary must be provided to participants as part of the
information provided on entering a project, as a component of the Committee’s
mechanism for receiving complaints.
8.
At the Committee’s discretion, anonymous complaints received will follow the same
process.
9.
All complaints received, and the relevant action taken, will be reported to the Board.
CCNSW Ethics Committee SOPs
38
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP019
Subject:
Date: February 2010
Withdrawal of Ethical Approval/ Suspension of research
Purpose: To describe the procedure for the withdrawal of ethical approval of a research
project and/or the immediate suspension of research.
1. Where CCEC finds reason to believe that continuance of a research project will
compromise participants’ welfare, or that the research project is not being
conducted in accordance with its ethical approval, it should immediately seek to
establish whether ethical approval for the project should be suspended or
withdrawn. This process should ensure that researchers and others involved in
the project are treated fairly and with respect.
2. In such circumstances, the Committee will immediately notify the co-ordinating
investigator and local principal investigators. This notification must be confirmed in
writing within three working days.
3. CCEC cannot withdraw ethical approval from multi-centre studies that are
governed by lead committee; however it may withdraw ethical approval from
studies for which it is the primary reviewing Committee in NSW (for example, this
may include, but is not limited to, research being done in partnership between
Cancer Council NSW and a University).
4. In the event that ethical approval is withdrawn by CCEC for a project that is
operating in multiple States, or Countries CCEC with notify the other approving
bodies of the withdrawal within three working days of the determination.
5. An investigator cannot continue with the research if ethical approval has been
suspended or withdrawn and must comply with any special conditions imposed by
CCEC. The research may not be resumed unless either:
a. The investigator subsequently establishes that continuance will not
compromise participants’ welfare; or
b. The research is modified to provide sufficient protection for participants,
the modification is ethically reviewed, and the modified research is
approved by the Committee.
6. It is the responsibility of the Ethics Officer of the Committee to update the
Research Ethics Database accordingly.
CCNSW Ethics Committee SOPs
39
SOP019 Appendix 1
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
The above project was first approved by the Cancer Council NSW HREC on [date].
However in recent discussion the Cancer Council NSW HREC have concluded the ethical
acceptability of this project is questionable and consequently the conduct of this research
is to be suspended immediately until such a time that the Cancer Council NSW HREC
believe the research is being conducted in an ethical manner. The following reasons have
been given for this suspension;
1. [List each reason separately. Each reason must refer to the relevant
paragraph/s of the National Statement, relevant legislation or other
applicable guidelines].
This suspension includes all aspects of the research project. In order to re-obtain ethical
approval for this project the identified issues must be dealt with. Should you wish to
continue this research you will need to write to the Committee systematically addressing
each of the issues above. You will also need to resubmit any affected documentation.
Please confirm receipt of this notice including your planned approach to this suspension
and what measures have been taken to ensure all aspects of the research project are
ceased until further notice.
Should you wish to discuss the HREC’s suspension of your project, please contact [insert
name and contact details of HREC Ethics Officer or Chairperson].
Please quote Project No. xxxx in all correspondence.
Yours sincerely
Andrew Penman
CEO
Cancer Council NSW
CCNSW Ethics Committee SOPs
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SOP019 Appendix 2
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<Date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for your letter dated [date]. The Cancer Council NSW Ethics Committee has
reviewed your submission of the above project [or response to the Committee’s
concerns], following the projects’ suspension on the XXXX. The Committee does not
believe you have adequately addressed the issues identified and ethical approval has
therefore been withdrawn.
The following reasons have been given for this withdrawal;
1. [List each reason separately. Each reason must refer to the relevant
paragraph/s of the National Statement, relevant legislation or other
applicable guidelines].
Should you require any additional information regarding the Committee’s withdrawal of
the ethical approval for this project please contact the [Insert best contact] on [(XX) XXXX
XXXX] or at ethics@nswcc.org.au.
Please quote Project No. xxxx in all correspondence.
Yours sincerely
Andrew Penman
CEO
Cancer Council NSW
CCNSW Ethics Committee SOPs
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SOP019 Appendix 3
<<Chief Investigator’s Title and Name>>
<<Address>>
<<Address>>
<<Suburb State Postcode>>
<<date>>
Dear <<Chief Investigator>>,
Re:
Project No: xxxx
Project Title
Thank you for your letter dated [date]. The Committee is satisfied that you have
adequately addressed all the changes requested to the above project when ethical
approval was initially withdrawn on the [date].
Please note that approval is valid for x year from the date of this letter.
This approval includes the use of the following documents:

[insert the version number and date of all documentation reviewed and approved
by the HREC including protocols, information sheets, consent forms,
advertisements, questionnaires etc]
The project should be conducted in accordance with the NHMRC National Statement on
Ethical Conduct in Research Involving Humans, 2007 and the NSW Health Information
Privacy Code of Practice 1998, NSWCC Guidelines Ethical approval is conditional upon
adherence to these guidelines and the conditions outlined below.
i) The research project will be carried out as described in the application and in
accordance with ALL subsequent correspondence.
ii) The Chief Investigator will advise the Committee of any changes to the project or its
conduct, of any unforeseen events that might affect continued ethical acceptability of
the project, of any serious or unexpected adverse events that take place, or if the
project is abandoned for any reason. New ethical approval must be sought for changes
to the research protocol, conduct of the research or length of ethics approval, from the
Ethics Committee, in the specified format.
iii) In order to fulfill monitoring requirements of the Committee and the NHMRC, a report is
required every six months and at completion of the study. A form for reporting to the
Committee is attached. Your report should be received by the Committee by <<date>>
for its consideration. If a report is not received, ethical approval may be withdrawn.
iv) <<Include any other conditions the Committee may have set>>
[insert if research is being carried out within an external organization]. Although it is within
this Ethics Committee’s Terms of Reference to review research which takes place within
sites that fall under the NSW Health Single Ethical Review of Multi Centre Research
system, we note that other organisations within this system are not part of the Cancer
Council NSW. This approval does not have the effect of conferring any insurance or
indemnity coverage on the external organisation by the Cancer Council NSW in relation
to this project, and any liabilities arising from the conduct of the project are entirely the
responsibility of the organisation at which the research is conducted.
CCNSW Ethics Committee SOPs
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Should you require any additional information regarding the Committee’s consideration of
the proposal, please contact the [Insert best contact] on [(XX) XXXX XXXX] or at
ethics@nswcc.org.au.
Please quote Project No. xxxx in all correspondence.
Yours sincerely
Andrew Penman
CEO
Cancer Council NSW
CCNSW Ethics Committee SOPs
43
Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP020
Subject:
Date: February 2010
Concerns and complaints relating to the Cancer Council NSW Ethics
Committee’s ethical review process.
Purpose: To describe the procedure for receiving and handling concerns or complaints
from investigators about the Cancer Council NSW Ethics Committee’s review
process
1.
Any concern or complaint about the Committee’s review process should be directed
to the attention of the Secretary of the Committee, detailing in writing the grounds of
the concern or complaint. Complaints may also be made to the CEO.
2.
The Secretary will inform the Chairperson and the CEO as soon as possible of any
complaints received by him/her. The CEO will inform the Chairperson as soon as
possible of any complaints received by him/her. The CEO will send a letter of
acknowledgement to the complainant, outlining the following mechanism.
3.
The Chairperson will instigate an investigation of the complaint and its validity, and
make a recommendation to the Committee on the appropriate course of action. This
investigation shall take no longer than 2 weeks from the time of notification of the
complaint or concern, unless exceptional circumstances exist.
4.
If the complainant is not satisfied with the outcome of the Chairperson’s investigation,
then he/she can refer the complaint to the CEO, or his/her nominee, or request the
Chairperson to do so.
5.
The Chairperson of the Committee will provide the CEO with all relevant information
about the complaint/concern, including:
- the complaint;
- material reviewed in the Chairperson’s investigation;
- the results of the Chairperson’s investigation; and
- any other relevant documentation.
6.
The CEO will determine whether there is to be a further investigation of the
complaint.
7.
If the CEO determines there is to be a further investigation, then he/she will establish
a panel to consider the complaint/concern. Where there is to be no further
investigation, the CEO will inform the application and the Chairperson of this.
8.
The panel will include, at least, the following members:
- The CEO or his/her nominee as Convener of the panel.
- Two nominees of the CEO (not members of the Committee).
9.
The panel will afford the Committee and the complainant the opportunity to make
submissions.
10. The panel may access any documents relating to the project. The panel may
interview other parties, and seek any other internal and/or external expert advice. In
conducting its review, the panel shall be concerned with ascertaining whether the
Committee acted in accordance with the NHMRC National Statement on Research
CCNSW Ethics Committee SOPs
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Ethical Conduct in Research Involving Humans, its Terms of Reference, Standard
Operating Procedures, or otherwise acted in a fair and unbiased manner.
11. The CEO will notify the complainant and the Committee of the outcome of the
investigation. The outcomes of this process may include:
- The complaint/concern is dismissed.
- The complaint/concern is referred back to the Committee for consideration,
bearing in mind the findings of the panel.
12. The panel may also make recommendations about the operation of the Committee
including such actions as:
- Review Terms of Reference and Standard Operating Procedures;
- Review committee membership;
- Take other such action as appropriate.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP021
Subject:
Date: February 2010
Complaints concerning the Cancer Council NSW Ethics Committee’s rejection
of an application
Purpose: To describe the procedure for receiving and handling complaints from
investigators about the Cancer Council NSW Ethics Committee’s rejection of
an application.
1.
A person with a concern or complaint about the Committee’s rejection of their
application should detail the grounds of the concern or complaint in writing and bring
it to the attention of the Ethics Officer of the Committee. Complaints may also be
made to the CEO.
2.
The Ethics Officer will bring any complaints to the attention of the Chairperson and
the CEO as soon as possible after receipt by him/her. The CEO will inform the Ethics
Officer and the Chairperson as soon as possible of any complaints received by
him/her. The CEO will send a letter of acknowledgement to the complainant,
outlining the following mechanism.
3.
The Ethics Officer will instigate an investigation of the complaint and its validity,
confer with the Chair of the Committee and make a recommendation to the
Committee on the appropriate course of action. This investigation shall take no
longer than 2 weeks from the time of notification of the complaint or concern, unless
exceptional circumstances exist.
4.
If the complainant is not satisfied with the outcome of the Chairperson’s investigation,
then he/she can refer the complaint to the CEO or the Board of The Cancer Council
NSW, or request the Chairperson to do so.
5.
The Chairperson will provide the CEO with all relevant information about the
complaint, including:
- the complaint;
- material reviewed in the Chairperson’s investigation;
- the results of the Chairperson’s investigation; and
- any other relevant documentation.
6.
The CEO will determine whether there is to be a further investigation of the complaint.
7.
If the CEO determines there is a case to be investigated, then he/she will establish a
panel to consider the complaint and will report the matter to the Cancer Council
Board.
8.
The panel will include, at least, the following members:
- The CEO or his/her nominee as convenor of the panel
- Two nominees of the CEO (not members of the Committee)
- An expert/s in the discipline of research of the project under consideration
9.
The panel will afford the Committee and the complainant the opportunity to make
submissions.
CCNSW Ethics Committee SOPs
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10. The panel may access any documents relating to the project. The panel may
interview other parties, and seek any other internal and/or external expert advice.
11. The CEO will notify the complainant, the Board and the Committee of the outcome of
the investigation. The outcomes of this process may include:
- The complaint/concern is dismissed.
- The complaint/concern is referred back to the Committee for consideration,
bearing in mind the findings of the panel.
12. Should the Committee be requested to review its decision, then the outcome of this
review by the Committee will be final.
13. The panel or CEO cannot substitute its approval for the approval of the Committee.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP022
Subject:
Date: February 2010
Assessment of multi-centre projects by the Cancer Council NSW Ethics
Committee.
Purpose: To describe the Cancer Council NSW Ethics Committee’s role in assessing
multi-centre projects.
1. To facilitate the review of multi-centre research the Committee may:
- communicate with any other HREC;
- accept a scientific/technical and/or ethical assessment of the research by
another HREC;
- share its scientific/technical and/or ethical assessment of the research with
another HREC.
2. The Committee will abide by NSW Health’s Single Review System of Multi-centre
research as outlined in Research - Model for Single Ethical & Scientific Review of
Multi-Centre Research 2007.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP023
Subject:
Date: February 2010
Record keeping
Purpose: To describe the procedure for the preparation and maintenance of records of
the Cancer Council NSW’s activities
1. The Secretary will prepare and maintain written records of the Committee’s activities,
including agendas and minutes of all meetings of the Committee.
2. The Secretary will prepare and maintain a confidential electronic and/or paper record
for each application received and reviewed and shall record the following information:
-
unique project identification number;
the principal investigator(s);
the name of the responsible institution or organisation;
title of the project;
ethical approval or non-approval with date;
approval or non-approval of any changes to the project;
the terms and conditions, if any, of approval of the project;
whether approval was by expedited review; and
action taken by the Committee to monitor the conduct of the research.
The paper file shall contain a hard copy of the application, including signatures, and
any relevant correspondence including that between the applicant and the
Committee, all approved documents and other material used to inform potential
research participants.
3. All relevant records of the Committee, including applications, membership, minutes
and correspondence, will be kept as confidential files in accordance with the
requirements of the Health Records and Information Privacy Act 2002 and the State
Records Act 1998.
4. To ensure confidentiality, all documents provided to Committee members, which are
no longer required, are to be disposed of in a secure manner, such as shredding or
placed in confidential bins. Members who do not have access to secure disposal
should leave their documents with the Secretary for disposal.
5. Data pertaining to research projects shall be held for sufficient time to allow for future
reference. The minimum period for retention for non-clinical research is at least 5
years after the date of publication or completion of the research or termination of the
study. Retention periods shall comply with the Australian Code for the Responsible
Conduct of Research.
6. A register of all the applications received and reviewed shall be maintained in
accordance with the NHMRC National Statement on Ethical Conduct in Research
Involving Humans 2007.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP024
Subject:
Date: February 2010
Handling of conflicts of interest
Purpose: To describe the procedure for the handling of conflicts of interest of Cancer
Council NSW members
1. Before beginning a term on the Committee applicants will read the Conflicts of
Interest Policy and Guidelines for the Cancer Council Ethics Committee and
subsequently declare any ongoing conflict interest they have with the ethical review
of projects at the Cancer Council NSW.
2. A Committee member shall, as soon as they are aware of a potential conflict of
interest in a project or other related matter(s) considered by the Committee, inform
the Chairperson and Ethics Officer and complete an additional Declaration of
Interests Form describing the conflict.
3. The Committee will determine if this results in a conflict of interest for the member
and if so, the member will withdraw from the meeting until the Committee’s
consideration of the relevant matter has been completed. The member shall not be
permitted to adjudicate on the research.
4. In the event of an ongoing conflict of interest the Committee in conjunction with the
Board will establish a procedure to deal with the conflict.
-
If the conflict becomes apparent after the initial review the Committee’s
Chair will review the conflict and how it may have affected the review
of the project concerned. Appropriate action will then be taken.
5. All declarations of conflict of interest and the absence of the member concerned will
be minuted.
CCNSW Ethics Committee SOPs
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SOP024 Appendix 1
Declaration of interests form – Committee Members
Before beginning a term on the Cancer Council NSW Ethics Committee nominated
persons should declare any ongoing interests in the outcome of research proposals and
in the future declare any conflict of interest in the review of projects as they arise. An
interest can include financial gain or personal interest in the review of a project. An
interest in the review of projects may stem from being directly involved in the project,
closely affiliated with the organisation conducting the research or being in close
relationship with researchers involved in the project. If you are unsure whether certain
circumstances could be considered a conflict of interest, you should discuss this with the
Ethics Officer.
Failure to declare interests may result in the termination of your position on the
Committee and/or projects reviewed whilst you had a conflict of interest may need to be
re-reviewed.
After reading the above information, please sign the declaration below;

I [NAME] of [ORGANISATION, where appropriate] do not have any ongoing conflict of
interest in the ethical review of projects as a [POSITION ON COMMITTEE] for the
Cancer Council NSW Ethics Committee. I understand the circumstances (as
described above) that could be considered a conflict of interest in the outcome of
ethical review.

I declare that should a conflict of interest arise in the course of my involvement with
the Cancer Council NSW Ethics Committee I will declare this interest as soon as it
arises so the necessary arrangements can be made.

I acknowledge that my term on the Committee may be suspended and that any
projects reviewed whilst I had a conflict of interest may need to be re-reviewed.
Signed:
..............................................................................................
in the presence of
(name):
..............................................................................................
(signature):
..............................................................................................
(position):
..............................................................................................
Date:
..............................................................................................
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP025
Subject:
Date: February 2010
Reporting requirements of the Cancer Council NSW Ethics Committee.
Purpose: To describe the reporting requirements of the Cancer Council NSW Ethics
Committee.
1. Reporting to the Cancer Council NSW
The Committee will provide a report to the Board at the next meeting following the
Ethics meeting, and annually to the NHMRC, on its activity and its compliance with
the NHMRC reporting and monitoring requirements. The report should include
information on membership, members’ attendance, the number of proposals
reviewed, status of proposals, and a description of any complaints received and
general issues raised.
2. Reports to the National Health and Medical Research Council
The Committee will provide reports to the CEO at the end of each calendar year, in
accordance with the requirements of the NHMRC. This includes reporting annually
information relevant to the Committee’s procedures such as:

membership/membership changes;

number of meetings;

number of projects reviewed, approved and rejected

description of any research where ethical approval has been withdrawn
and general reasons for the withdrawal of approval

confirmation of participation by required categories of members;

the number of protocols presented, the number approved, and the
number rejected;

monitoring procedures in place and any problems encountered; and

complaints procedures and number of complaints handled.
3. The Committee will provide reports to the Australian Health Ethics Committee
(AHEC) in accordance with the requirements of the NHMRC.
4. The Committee will provide reports to the NSW Privacy Commissioner in accordance
with the requirements of the Health Records and Information Privacy Act 2002
(NSW).
5. The Committee Terms of Reference, Standard Operating Procedures and
membership will be available upon request to the general public, and will be posted
on the Cancer Council NSW website.
CCNSW Ethics Committee SOPs
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Cancer Council NSW Ethics Committee
Standard Operating Procedures
Reference Number: SOP026
Subject:
Date: February 2010
Review of Standard Operating Procedures and Terms of Reference
Purpose: To describe the procedure for the approval of amendments to Cancer Council
NSW Ethics Committee’s Standard Operating Procedures and Terms of
Reference.
1. The Standard Operating Procedures and Terms of Reference shall be reviewed at
least every two years and amended as necessary.
2. The Standard Operating Procedures and Terms of Reference may be amended by
following the procedure below:
For those proposals made by a Committee member:
a. The proposal must be in writing and circulated to all Committee members for
their consideration.
b. The views of the members should be discussed at the next scheduled
Committee meeting, and a vote taken at that meeting. Any member unable to
attend such a meeting may register his or her views in writing.
c. The proposal shall be ratified if two thirds of the members agree to the
amendment.
d. The Chairperson shall send the amendment to the CEO for review and
approval if appropriate.
For those proposals made by the CEO:
e. The CEO will send the proposal to the Committee and seek the views of any
relevant person.
CCNSW Ethics Committee SOPs
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