THE WAITEMATA BIOBANK
PARTICIPANT INFORMATION SHEET
(Place Patient Sticker Here)
REQUEST FOR INTERPRETER
English
I wish to have an interpreter.
Yes
No
Maori
E hiahia ana ahau ki tetahi kaiwhakamaori/kaiwhaka pakeha
korero.
Ka inangaro au i tetai tangata uri reo.
Ae
Kao
Ae
Kare
Au gadreva me dua e vakadewa vosa vei au
Fia manako au ke fakaaoga e taha tagata fakahokohoko kupu.
Io
E
Sega
Nakai
Samoan
Ou te mana’o ia i ai se fa’amatala upu.
Ioe
Leai
Tokelaun
Ioe
Leai
Tongan
Ko au e fofou ki he tino ke fakaliliu te gagana Peletania ki na
gagana o na motu o te Pahefika
Oku ou fiema’u ha fakatonulea.
Io
Ikai
Deaf
I wish to use sign language
Yes
No
Cook Island
Maaori
Fijian
Niuean
INTRODUCTION
You are being asked to participate in the Biobank. The purpose of this resource/biobank is to store
data within your electronic medical records and research the association between genes, drugs,
disease and the environment. We ask you to read this information sheet in order to decide if you
would like to participate. Before you decide, it is important for you to be aware of why the Biobank has
been set up, its aims and purposes, what research is likely to be done, and what your participation will
involve. Please take your time to read the following information carefully. Talk to others if you wish.
Ask us if there is anything that is not clear or if you would like more information. Take time to decide
whether or not you wish to take part.
WHAT IS A BIOBANK?
A Biobank is a resource that contains biological materials, such as DNA samples, and personal
information (data) on a large number of people. It has been set up so that it can be used as a
resource for researchers undertaking a wide range of medical research over time.
This resource/biobank has two main aims. The first aim is to gain a better understanding of the
interactions between genes, environment and the way we live that influence health or cause diseases.
The second aim is to use this understanding to develop new drugs, molecular tests and treatments
and to plan public health strategies that will benefit everyone. Taking part involves you giving a broad
consent. This means that you consent for your personal information and samples to be used for a
variety of medical research purposes. Other research will require a new consent. Also, your personal
data held in the Biobank will be updated by being linked to your electronic medical record and other
sources of administrative health information. If, after reading this information pamphlet, you are
unhappy about either of these aspects, you should not take part.
Waitemata Biobank Information and Consent Form. Version 1, 26th July 2014
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WHY HAVE I BEEN CHOSEN TO TAKE PART IN THE BIOBANK?
You have been chosen to take part in the Biobank because you are undergoing a diagnostic cardiac
investigation or procedure. This might be because:
-
You are healthy
You are suspected of having diabetes, high blood pressure, high cholesterol, atrial fibrillation
or coronary artery disease
You are undergoing a CT coronary angiogram
You are undergoing an invasive coronary angiogram or coronary stenting
You are undergoing a cardiac stress test
You are undergoing an echocardiogram
You are undergoing a direct current cardioversion
You are undergoing a Holter or Event monitor
You are having a pacemaker or defibrillating pacemaker implanted
DOES THE DECISION TO DONATE SAMPLES AFFECT MY CARE IN ANY WAY?
No. Your normal care and treatment is not affected by your decision.
HOW IS MY TISSUE COLLECTED?
If you are about to have a Blood Test, Ultrasound of your heart and an ECG:
We seek your consent to take 5 – 10mls of venous blood (if obtainable) and/or a fingerprick sample of
blood to store in the Biobank indefinitely in ethically approved medical research. In addition an
ultrasound and electrocardiogram may be performed on you.
HOW OFTEN WILL SAMPLES BE STORED?
Sometimes samples are removed on more than one occasion during the assessment and treatment
of your condition. We will seek renewed consent to collect a second tissue samples only if a second
procedure occurs. On each occasion your consent is entirely voluntary.
HOW ARE THE SAMPLES STORED?
All tissue samples are stored in a secured room in the Biobank. Your tissue sample(s) will be stored
indefinitely unless you withdraw your consent. Your electronic medical data will be stored securely in
a Cloud-based server and viewed remotely, by doctors involved in this study. This data will be deleted
after one year.
WHY DO YOU NEED INFORMATION FROM MY HEALTH RECORDS?
We seek your consent for authorised Biobank staff and approved researchers to access relevant
clinical information from your health records for the purpose of ethically approved research. This will
contribute to building knowledge about your health and result in the best possible research using your
donated blood sample.
HOW WILL MY PRIVACY BE PROTECTED?
Your identity, tissue sample(s) and health information will remain confidential. Donors samples are
de-identified and given a coded number which only authorised Biobank staff can decode. Only
authorised Biobank staff and approved researchers will be permitted to have access to your health
records. Results from your sample will not be shared with governments, insurance agents, or the
police. All researchers will be required to ensure your privacy is protected. Your name will not be used
in any study reports or publications.
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HOW MIGHT THIS AFFECT MY WHAANAU/FAMILY?
You may hold beliefs about a sacred and shared value of all or any tissue samples removed. The
cultural issues associated with storing your tissue and/or undertaking genetic analysis on them should
be discussed with your whaanau/family as appropriate. There are a range of views held by Maori
around these issues; some iwi disagree with storage of samples and genetic testing citing whakapapa
and advise their people to consult prior to participation in research where this occurs. However it is
acknowledged that individuals have the right to choose.
WHAT TYPE OF RESEARCH WILL BE DONE WITH MY SAMPLES?
We cannot be specific about what tests might be done on your samples. However, they will only be
available for research studies approved by an accredited, New Zealand Ethics Committee or
equivalent and the Biobank Scientific Advisory Committee. Investigating your samples, may include
looking at your genetic information. Comprehensive molecular analysis of your sample may include
whole exome or genome sequencing, methylation analysis, DNA or RNA testing, proteomic and
metabolomic analysis.
This type of research will enhance the understanding of health and disease and may help to develop
new tests and/or better treatments. Samples may be used in a variety of research projects. If you
agree to donate your samples, then you cannot choose what type of research they will be used for or
where they will be sent.
You will not be notified of the results of research using your tissue. This is because results may not
be available for a very long time and are highly unlikely to be of relevance to you as an individual
patient. Research results are usually not linked back to the individual patients sample have come
from.
WILL MY SAMPLES BE SENT OUT OF NEW ZEALAND?
Future research may involve sending samples for study in overseas research institutions. Some
research could be carried out by commercial biomedical organisations. Both of these types of
research will have the same ethical, cultural and biological responsibilities. Samples that are sent
overseas will not be returned after testing and will be destroyed once testing has been completed. A
certificate of destruction will be issued as proof that they have been disposed of by the receiving
laboratory.
WHAT IF I CHANGE MY MIND?
You have the right to withdraw your consent at any time. If you wish to do so, please contact the
Biobank in writing (contact details below). You will be contacted to confirm the details of your request,
e.g., arrange the safe and respectful return or disposal of your tissue sample(s), including with an
appropriate blessing. You will receive written confirmation when your request has been actioned.
Please note, only samples and accompanying relevant clinical information that have not already been
released to approved research can be withdrawn. Your normal care and treatment will not be
affected if you change your mind.
HOW WILL MY SAMPLES BE DISPOSED OF?
Your sample(s) will not be disposed of unless you request this (as described above). If your sample
is given to a research project and there is some remaining at the completion of the research, the legal
contract signed by the researcher will require them to return any remaining samples to the Biobank to
be available for other approved research projects.
If you request your sample(s) to be disposed of, the Biobank will explain what options are available,
including with an appropriate karakia/blessing from the WDHB He Kamaka Waiora (Māori Health
Team).
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COMMERCIAL ISSUES
After studying your tissue sample(s) the information gained could lead to the development of new
tests or treatments. The intellectual property rights from this will be owned by the researchers,
governing institution and organisations that sponsor the research. This may include the Theranostics
Laboratory.
COMPENSATION
Procedures undertaken to collect samples for the Biobank will be part of standard care. No additional
procedures will be undertaken. Therefore there will be no compensation from the Biobank if an injury
occurs during one of these procedures.
ETHICAL APPROVAL
This information and consent form awaits ethical approval from the Northern X Regional Ethics
Committee.
WHERE IS THE WAITEMATA BIOBANK?
The Biobank is located at North Shore Hospital, Takapuna, Auckland.
WHO MAY I CONTACT IF I HAVE MORE QUESTIONS OR CONCERNS?
Dr. Patrick Gladding, Cardiologist, Prinicpal Investigator
Ph +649 4861491
patrick.gladding@waitematadhb.govt.nz
If you are unsure of your legal rights you should seek legal advice. This can be free from your community law
centre, or your lawyer which would include a fee.
If you have any questions or complaints about your rights as a research participant, you may wish to contact an
independent health and disability advocate:
Free phone: 0800 555 050
Free Fax: 0800 2 SUPPORT (0800 2787 7678)
Email: advocacy@hdc.org.nz
Cultural support
If you require Māori cultural support talk to your whānau in the first instance. Alternatively you may contact the
administrator for He Kamaka Waiora (Māori Health Team) by telephoning 09 486 8324 ext 2324
Questions and complaints
If you have any questions or complaints about the study you may contact the Auckland and Waitematā District
Health Boards Maori Research Committee or Maori Research Advisor by telephoning 09 4868920 ext 3204
Waitemata Biobank Information and Consent Form. Version 1, 26th July 2014
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WAITEMATA BIOBANK
CONSENT FORM
(Place Patient Sticker Here)
REQUEST FOR INTERPRETER
English
I wish to have an interpreter.
Yes
No
Maaori
E hiahia ana ahau ki tetahi kaiwhakamaori/kaiwhaka pakeha
korero.
Ka inangaro au i tetai tangata uri reo.
Ae
Kao
Ae
Kare
Au gadreva me dua e vakadewa vosa vei au
Fia manako au ke fakaaoga e taha tagata fakahokohoko kupu.
Io
E
Sega
Nakai
Samoan
Ou te mana’o ia i ai se fa’amatala upu.
Ioe
Leai
Tokelaun
Ioe
Leai
Tongan
Ko au e fofou ki he tino ke fakaliliu te gagana Peletania ki na
gagana o na motu o te Pahefika
Oku ou fiema’u ha fakatonulea.
Io
Ikai
Deaf
I wish to use sign language
Yes
No
Cook Island
Maaori
Fijian
Niuean
Tick one of the boxes below

Consent has been given previously and I agree to consent again.
(If so, only fields in this box need to be completed)
Patient Name:
Signature:
Date:
Consent reconfirmed by:(print name):
Role:

Signature:
Date:
This is the first time consent has been given.
(If so, patient must read everything after this box, including page 2 and complete all applicable fields after this box)
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 I have read the Information Sheet Version 1, dated 26th July 2014 about the Waitemata Biobank.
 I have been asked to give permission for any of my blood/tissue sample to be stored indefinitely in
the Biobank at North Shore hospital, accompanied by relevant clinical information for use in future,
ethically approved medical research, in New Zealand or overseas.
 I have been asked to give permission for up to 5-10mL of venous blood (if obtainable) to be taken,
and/or a fingerprick sample and/or saliva.
 I understand that the genetic material may be studied and used in research for cardiovascular
disease
 I understand my sample(s) and accompanying relevant clinical information can be removed from
the Biobank at any time at my request, if not already given to an approved research project. I
understand however, any information obtained from my sample(s) before my request for removal
will not be able to be claimed by me.
 I have had enough time to consider whether to donate my blood including enough time to discuss
the opportunity to donate with my family/whanau.
 Any questions I have had about this proposal have been answered to my satisfaction.
 I understand donating my blood and accompanying relevant clinical information for research is
voluntary (my choice).
 I understand if I choose not to donate my blood to the Biobank, or if I request it to be removed after
donating it, this will not affect my diagnosis or present or future treatment.
 I consent to my tissue(s) and accompanying relevant clinical information being stored in the
Biobank, for later use in research which must be approved by an accredited, New Zealand Ethics
Committee or equivalent and those approved researchers and authorised Biobank staff to have
access to my health records for that research.
YES / NO
 I consent to being re-contacted about future research projects on my tissue samples (Optional)
YES / NO
ETHNICITY: (as asked in the 2006 census)
Which ethnic group do you belong to?
Mark the space or spaces that apply to you.
 New Zealand European
 Maaori
 Samoan
 Cook Island Maaori
 Tongan
 Niuean
 Chinese
 Indian
 Other (such as DUTCH, JAPANESE, TOKELAUAN). Please state:
Patient Name:
Patient Signature:
Date:
Alternate Contact Name & Address (optional):
Information for consent given by (print name):
Role:
Signature:
Date:
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