REVIEW GUIDE FOR BELLBERRY HREC MEMBERS
It is the responsibility of all Bellberry HREC Members to familiarise themselves with each study
Protocol and other supporting documentation and consider whether the proposed research
meets the Values and Principles of Ethical Conduct detailed in Section 1 of the National
Statement.
Two themes must always be considered in human research: the risks and benefits of research,
and participants’ consent (National Statement Section 2).
The Human Research Ethics Committee conducts an independent review of research studies.
Their function is:







To decide whether each research project reviewed meets the requirements of the National
Statement on Ethical Conduct in Human Research (2007) (National Statement) and is
ethically acceptable.
To ensure that all research projects are reviewed in accordance with the National
Statement. The National Statement is based on values; respect for human beings, research
merit and integrity, justice and beneficence which help to shape the relationship between
researcher and participant as one of trust, mutual responsibility and ethical equality.
To protect the welfare, dignity, rights, safety and well-being of all participants in research
projects it reviews.
To consider local customs, cultural and social attitudes when evaluating research proposals.
To ensure appropriate informed consent is in place for any research project with particular
regard to those participants with reduced capacity to consent.
To confirm the legitimacy, experience and integrity of the investigator.
To provide independent, competent and timely review and monitoring of research projects.
The Committees must be satisfied that the above values have been addressed and met and
that the following main points have been considered:




Scientific design and conduct of the study. The ethics committee should be satisfied that
the risk benefit analysis is acceptable and should also consider the impact on the safety of
participants’ in the design of the study.
Recruitment of research participants. The ethics committee should examine how
participants are recruited.
Protection of research participants. The ethics committee must look at how the study
positively or negatively affects participants or their communities.
Informed consent. The ethics committee must decide if the consent forms and process are
adequate.
Review Bellberry policies, procedures and Terms of Reference for further guidance.
Participant Information Sheet and Consent Form (PIS)
(National Statement on Ethical Conduct in Human Research 2007 Chapter 2.2).
A Participant Information Sheet must accompany each Consent Form. It must not replace
personal communication between the investigator and the participant.
The Participant Information Sheet is one method of providing information to potential
participants to enable them to reach an informed decision regarding their involvement in the
research.
When preparing your comments, consider whether your concern is related to one of a personal
choice of words, or whether the existing wording may have a material impact on the
understanding of the study for the participant.
Comment Format
It would be appreciated if you could use the following format when submitting comments. This
will help provide clarity and consistency for the PI:
[Document type] [page]/[of number of pages in document] :
For example:
Protocol 3/123 : The protocol….
Questionnaire 1/2 : Please clarify…
PIS 1/12 : Under section….
If there is more than one PIS, please distinguish which PIS the comment relates to.
For example use the format PG PIS 1/12 : Under section…
Optional PIS 1/12 : Under section…
Common Comments:





The following may be used as the basis for common questions.
These are intended as a guide only, and can be edited as needed.
Please add the appropriate document reference at the beginning (per Comment Format
above).
If you have further suggestions for comments to be added to this list, please email Cathy
Stevens on cathystevens@bellberry.com.au
Please note this document will be updated from time to time. Please regularly check the
Committee Members pages of the Bellberry website for the latest version, as there may be
changes to some sections as a result of policy updates
WHEN COPYING COMMENTS FROM THIS WORD DOCUMENT AND PASTING INTO
EPROTOCOL, ANY APOSTROPHES AND QUOTATION MARKS WILL CREATE A RANDOM
SYMBOL ONCE PLACED IN EPROTOCOL. PLEASE CHECK FOR AND CORRECT ANY
UNUSUAL SYMBOLS THAT ARE CREATED PRIOR TO SUBMITTING YOUR COMMENTS.
WE APOLOGISE FOR THIS SYSTEM GLITCH.
Australian Law
Clause:
The Committee’s legal opinion is that this is an Australian trial
and should be governed by Australian Laws. If any information
goes overseas then it should not be exempted from Australian
Law, and any additional protection should apply.
Bellberry approval
The Bellberry Human Research Ethics Committee has reviewed
this study in accordance with the National Statement on Ethical
Conduct in Human Research (2007). Should you wish to discuss
the study or view a copy of the Complaint procedure with
someone not directly involved,
particularly in relation to matters concerning policies, information
or complaints about the conduct of the study or your rights as a
participant, you may contact the Committee chair, Bellberry
Human Research Ethics Committee on 08 8361 3222.
Compensation
Clause for NonSponsored Trials:
POLICYI014
Compensation
Clause for Sponsored
Trials
POLICYI014
Sample Compensation for Injury Clause for Participants For
Non-sponsored Trials
If, as a result of your participation in this study, you become ill or
are injured, immediately advise your study doctor of your
condition. In the first instance your study doctor will evaluate
your condition and then discuss treatment with both you and
your regular treating doctor.
Since you are participating in a non-sponsored trial any question
about compensation must initially be directed to your study
doctor who will advise their insurer of the matter.
It is the recommendation of the independent ethics committee
responsible for the review of this trial that you seek independent
legal advice.
Sample Compensation for Injury Clause for Participants
If you are injured as a result of your participation in this trial you
may be entitled to compensation.
Sponsors of clinical trials in Australia have agreed that the
guidelines developed by their industry body, Medicines Australia,
will govern the way in which compensation claims from injured
participants are managed by sponsors.
However, as guidelines, they do NOT in any way dictate the
pathway you should follow to seek compensation. The sponsor is
obliged to follow these guidelines.
These guidelines are available for your inspection on the
Medicines Australia Website (www.medicinesaustralia.com.au)
under Issues/Information – Clinical Trials – Indemnity &
Compensation Guidelines. Alternatively, your study doctor can
provide you with a hard-copy of the guidelines.
It is the recommendation of the independent ethics committee
responsible for the review of this trial that you seek independent
legal advice before taking any steps towards compensation for
injury.
Complementary
medicines
Wherever participants are asked about their medications, there
should be an additional statement that this includes
complementary medicines and vitamin supplements.
Consent Form (more
information required)
….Please refer to the Bellberry Sample Consent Form
(www.bellberry.com.au)
De-identified data:
The National Statement avoids the term ‘de-identified data’ as its
meaning is unclear. While it is sometimes used to refer to a
record that cannot be linked to an individual (‘non-identifiable’),
it is also used to refer to a record in which identifying information
has been removed but the means still exist to re-identify the
individual. Please clarify which of these meanings is intended.
GP notification
Please include in the consent that “I consent to my GP being
notified of my participation in this study and of any clinically
relevant”.
HIV/Hep C
Counselling
Please indicate that counselling will be provided both before and
after HIV/Hep C testing.
HIV Reproductive
Risks:
Please include the statement - As you are HIV-infected, the use
of a condom to reduce the risk of pregnancy and /or the risk of
transmission of HIV when having sexual intercourse must occur.
Ionising Radiation
POLICYI007
As part of every day living, everyone is exposed to naturally
occurring background radiation and receives a dose of about 2 to
3 millisieverts (mSv) each year. The effective dose from this
study is about (insert number) mSv. (Insert following
paragraph 1, 2, 3, or 4)
Choose one of the following paragraphs to be inserted
above as indicated:
1. Effective doses less than 2 mSv- At this dose level, no harmful
effects of radiation have been demonstrated and the risk is
negligible or
2. Effective doses between 2 and 20 mSv - At this dose level, no
harmful effects of radiation have been demonstrated and the risk
is low. The dose from this study is comparable to that received
from routine diagnostic medical x-ray and nuclear medicine
procedures or
3. Effective doses between 20 and 50 mSv – The dose from this
study is comparable to that received from several computed
tomography (CT) x-rays procedures. The benefits from the study
should be weighed against the possible detrimental effects of
radiation, including an increased risk of cancer.
In this particular study, the risk is moderate and the theoretically
calculated risk of contracting fatal cancer in the future is
considered acceptable.
The possible detrimental effects of radiation should be weighted
against the benefits from the study which are (state benefits to
the participant or to society).
If there are no perceived benefits from participating then state
this. or
4. Effective doses greater than 50 mSv - This research study
involves exposure to a significant amount ionizing radiation. The
benefits from the study should be weighed against the possible
detrimental effects of radiation, including an increased risk of
cancer. In this particular study, the risk is moderate and the
calculated risk of such harm is about 1 in.... (Calculate using the
ICRP risk coefficient for fatal cancer in the general population of5
x 10-2 per Sv. For studies in children or for persons over the age
of 50, the risk of radiogenic cancer should be calculated using
age- and sex-specific risk factors. The possible detrimental
effects of radiation should be weighted against the benefits from
the study which are (state benefits to the participant or to
society).
If there are no perceived benefits from participating then state
this.
You will be given a certificate that states the radiation dose you
have received from participating in this study. You should keep
the certificate for five years and show it if you are recruited for
any other research studies in that time.
Medical Record
Access by Bellberry
Where the PIS indicates Bellberry has access to medical
records:
…Please amend “medical records” to “study records”
Medicines Australia
website:
The hyperlink to Medicines Australia guidelines is incorrect.
Please replace with "These guidelines are available for your
inspection on the Medicines Australia Website
(www.medicinesaustralia.com.au) under Issues/Information –
Clinical Trials – Indemnity & Compensation Guidelines.
Alternatively, your study doctor can provide you with a hard-copy
of the guidelines.”
Participant Complaint
Mechanism
The Bellberry Human Research Ethics Committee (A, B, C or D)
has reviewed and approved this study in accordance with the
National Statement on Ethical Conduct in Human Research
(2007). Should you wish to discuss the study or view a copy of
the Complaint procedure with someone not directly involved,
particularly in relation to matters concerning policies, information
or complaints about the conduct of the study or your rights as a
participant, you may contact the Chair, Bellberry Human
Research Ethics Committee on (08) 8361 3222 or Email:
bellberry@bellberry.com.au
Participant Payment
Details of the payments in situations where participants
withdraw, or, are withdrawn for non compliance or other reasons
must be described. Pro rata payment should be made to all
participants in all circumstances except where they are
withdrawn due to an adverse event. In this case they should
receive full payment for their participation.
POLICYI002
Participants
Please replace all references to “subject/s” with “participant/s”
per National Statement Section 1.
Pregnancy
(For Women)
Sample Clause for Participants and Partners of
Participants
USE ONLY RELEVANT SECTIONS AS APPROPRIATE FOR
EACH STUDY
POLICYI013
Because the experimental agents in this study may affect an unborn
baby, you should not be pregnant or become pregnant while on this
study and for …… months following the end of the study.
You must confirm to the investigator that, to the best of your
knowledge, you are not pregnant now, and that you do not intend to
become pregnant during the study.
You must use an accepted form of contraception and if currently
lactating, you should not breast feed your baby while on this study
and for 3 months after the last dose of study drug has been taken.
Examples of highly effective methods of birth control are:
(1) double barrier birth control including oral contraceptive or intrauterine device (IUD) together with a condom, or
(2) a diaphragm with spermicide together with condom.
If you are uncertain of what form of contraception is acceptable for
use during the study, then please ask your study doctor.
If you suspect that you have become pregnant during the study, you
must notify your study doctor immediately. You will not be able to
continue participation in the study if you become pregnant. In the
event you do become pregnant the Sponsor will request that you sign
a separate consent form to allow monitoring of your pregnancy and
the birth and the health of your child up to ……..years of age.
Pregnancy
(For men)
POLICYI013
Sample Clause for Participants and Partners of
Participants
USE ONLY RELEVANT SECTIONS AS APPROPRIATE FOR
EACH STUDY
Because the experimental agents in this study may affect an
unborn baby, you should not father a baby while on this study
and for …… months following the end of the study.
The effect the drug has on your fertility may not be known.
It is recommended that a condom be worn for all sexual relations
as the study medication may affect your sperm risking the
potential for an abnormal child being born.
It is also highly recommended that you inform your partner of
your participation in the study and that contraception has been
strongly recommended.
Further, you must agree that if your partner becomes pregnant
while you are on the study, you will advise the study doctor who
will then provide you with an authorisation form to present to
your partner. If she is in agreement, that authorisation will
function as consent to approve the study doctor’s access to
medical information to allow monitoring of the pregnancy, and
the birth and the health of the child up to ………years of age.
Registering the Trial:
Before beginning the clinical phase of the research, researchers
should register clinical trials in a publicly accessible register
(National Statement 3.3.12). Please comment on why the project
is not registered.
Seville Oranges
Seville oranges are a very sour citrus similar to grapefruits.
Some research has shown that Seville oranges contain
dihydroxybergamottin which can reduce or increase the activity
of some drugs.
Sexual Activity and
Medication Risks
It is recommended that a condom be worn for all sexual relations
as the study medication may cause harm to your partner through
the absorption of the study drug from the seminal fluid.
POLICYI013
Tissue Donation
Tissue Donation:- (All discussion of tissue donation must be
provided in this section only, using one of the following
statements as appropriate.)
i.
We are requesting the use of a sample of blood/tumour/etc for
studies related to how this drug works.
This will require……(provide details such as blood sample, extra
biopsy). It is optional/non-optional.
(If optional there must be a statement on the consent form with check
boxes to tick for opt in or opt out.)
ii. We are requesting the use of a sample of blood/tumour/etc for
storage for future studies that may or may not be related to
your condition or the drug used in this trial.
This will require……(provide details such as blood sample, extra
biopsy). The donation of tissue for this purpose is optional and
is covered in a separate Information Sheet and Consent Form.
Per Bellberry Sample Participant Information Sheet
(www.bellberry.com.au)
Typographical errors
Numerous typographical errors were noticed throughout the
documents. Please review and correct.
e.g………..
General reference to
Bellberry clauses/
policies/ procedures
….Please refer to the Bellberry sample… (www.bellberry.com.au)