Mr Ripple
Legend
- Joined
- Jun 2, 2017
- Messages
- 14,952
There was a link at the top of the page recently asking for people to take part in a questionnaire in return for Amazon vouchers.
I thought it would be pretty straightforward so went through the screening questions and was accepted but heard nothing of it till now.
I've recieved an email detailing what they want with a link to book in along with a pdf fact sheet copied and pasted below.
Firstly there was no mention of having to use an HNB device which i have no interest in doing at all and it turns out they want me to visit in person at my expense of travel to their clinic.
Bye bye.....
I thought it would be pretty straightforward so went through the screening questions and was accepted but heard nothing of it till now.
I've recieved an email detailing what they want with a link to book in along with a pdf fact sheet copied and pasted below.
Firstly there was no mention of having to use an HNB device which i have no interest in doing at all and it turns out they want me to visit in person at my expense of travel to their clinic.
Bye bye.....
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Title of Project: Comparative toxicological and psychopharmacological assessment of potential
reduced-exposure products and conventional cigarettes: a cross-sectional, cross-over study
Principal Researcher: Dr Lion Shahab
Address: Department of Behavioural Science and Health, UCL, 1-19 Torrington Place, London, WC1E
7HB
You are being invited to take part in a research study. Before you decide it is important for you to
understand why the research is being done and what it will involve. Please take time to read the
following information carefully and discuss it with 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. Thank you for reading this.
1. PURPOSE OF THIS RESEARCH STUDY
We are asking you to take part in a study to investigate the possible health effects of using novel
nicotine and tobacco-containing products compared with smoking conventional cigarettes and not
smoking at all. To do this, we want to assess what potentially harmful chemicals enter the bodies of
people using these products compared with those not using these products. For this reason, we will
collect urine from you to analyse levels of these chemicals and assess other health indices.
To be eligible to take part in this study, you must have smoked an average of five or more cigarettes
per day for at least six months but stopped using tobacco products at least three months ago and have
used heat-not-burn products (e.g. IQOS) for at least three months. If you have any heart- or lung-
related diseases or if you are a pregnant woman you will not be able to take part in this study.
2. PROCEDURES
If you decide to take part in this study we will ask you to visit the laboratory in the Department of
Behavioural Science and Health at University College London on a single occasion. This visit is expected
to last around 30-60 minutes.
We will ask you to avoid using the toilet and to refrain from drinking alcohol and eating one hour
before the visit. During the visit, we will ask you to fill out a short questionnaire to provide us with
some details about yourself, your health, your smoking history, your current smoking behaviour and
your use of other nicotine/tobacco-containing products (i.e. e-cigarettes and heat-not-burn). We will
also ask to see a packet of your cigarettes, e-cigarette or heat-not-burn product(s) that you are using
(depending on which product(s) you are currently using) so that we can verify the brand/type that you
smoke/use.
To verify whether you are smoking or not smoking, we will ask you to blow into a machine that
measures the amount of carbon monoxide in your breath. To do this, you have to take a deep breath,
hold it for 15 seconds and then blow into the machine. We will also ask you to blow as hard and fast
as you can into a Vitalograph, a small, hand-held device, intended for measuring lung function. We
will measure your heart rate using a smartphone app which will monitor the pulse rate in your
fingertip. These measures will be repeated up to three times to obtain accurate readings.
We will ask you to provide a urine sample before using your heat-not-burn device. This will be
temporarily stored in a secure laboratory at UCL and later sent overseas to a laboratory to be tested
for the levels of certain tobacco-related toxins and carcinogens that may be in your body. We will not
test your urine sample for anything else and we will not share any personal information with lab
personnel (all samples will be labelled with an anonymous code). Samples will be destroyed after
analysis. Following sample collection, you will be walked to an outside area and asked to use your
heat-not-burn product for 5 minutes.
After product use, you will be asked to provide heart rate and breath measurements again and
complete a short questionnaire regarding the product that you have used.
3. POSSIBLE RISKS OR DISCOMFORT
There is very little risk of taking part in this study. Providing a urine sample involves minimal risk. The
smartphone heart rate monitor, the carbon monoxide measurement machine and the Vitalograph
pose no risks. All of the methods used in this study have been used before. Coming to the laboratory
at the time you are scheduled is important and maybe inconvenient. We will do everything we can to
meet your schedule.
4. POSSIBLE BENEFITS
It is not expected that taking part in this study will benefit you directly. Other people may benefit from
you taking part in this study. For example, if the study finds that long-term use of novel
nicotine/tobacco-containing products may be harmful, warnings can be given to people who use (or
are considering using) these products.
If you would like to receive a report of the results of this study when they are available, you can
request this by contacting the principal researcher.
5. FINANCIAL CONSIDERATIONS
In appreciation for the time given to take part in this study and any inconvenience caused by taking
part, you will receive a £40 Amazon gift voucher at the end of your visit, and up to £5 to reclaim travel
expenses (if receipt provided). Alternatively, you will have the option to donate this sum to Cancer
Research UK. Other than the cost of transport to the laboratory, no aspect of taking part in this study
is expected to result in any additional cost to you.
6. CONFIDENTIALITY
All data collected during this study will be collected and stored in accordance with the Data Protection
Act 1998 and the General Data Protection Regulation, May 2018. To protect your confidentiality, we
will assign you a unique number or code that will be used to label the information and sample that
you provide. Any personal information that you provide, such as your name and contact details, will
be kept separately and locked away. Only the researchers will have access to any of the information
you provide. None of your personal information will be on the samples or questionnaire responses
you provide. The results of this study may be published for scientific purposes but no information that
could identify you will be included in these reports.
7. TERMINATION OF RESEARCH STUDY
You do not have to take part in this study if you do not want to. You are free to decide whether or not
you want to take part and you will not be penalised in any way if you decide not to take part. You can
choose to stop participating at any point during the study. If you would like to withdraw your consent
for the storage and analysis of any information or samples you have provided, you can do so by
contacting the Principal Investigator. You can do this at any time prior to the analysis but will be unable
to do so once any information or samples have been analysed.
8. ETHICS REVIEW
This study has been approved by the UCL Research Ethics Committee (Project ID Number: 12621/001).
9. AVAILABLE SOURCES OF INFORMATION
All participants will be given a copy of this information sheet and their signed consent form to keep.
If you have any questions later on or would like any additional information about the study and your
rights as a participant, please feel free to contact the Principal Investigator (Dr Lion Shahab) by
telephone on 020 7679 1805, or by email at [email protected].
Transparency Information
University College London (UCL) is the sponsor for this study based in the United Kingdom. We will be
using the information provided by you in order to undertake this study and we will act as the data
controller for this study. This means that we are responsible for looking after your information and
using it properly. We will keep identifiable information about you (i.e. your email address) for the
duration of the study and, with your permission, will retain this until the end of the study to share
with you the finished results of the study (expected end date: July 2019). This information will be
stored on a secure and encrypted data system within UCL.
Your rights to access, change or move your information are limited, as we need to manage your
information in specific ways in order for the research to be reliable and accurate. If you withdraw from
the study, we will keep the information about you that we have already obtained. To safeguard your
rights, we will use the minimum personally-identifiable information possible.
UCL will use your contact details to contact you about the research study. Individuals from UCL may
look at your research records to check the accuracy of the research study. The only people at UCL who
will have access to information that identifies you will be people who need to contact you to arrange
appointments for the data collection process. The people who analyse your information will not be
able to identify you and will not be able to find out your name or contact details. We will ask for
personal data relating to ethnicity and details about your health. Please note, this information will not
be directly personally-identifiable as it will be linked to your pseudonymous ID number. UCL will use
such data to analyse whether there are individual/group differences in the research outcomes.
Once you have provided your urine sample, it will be rendered acellular using a machine in the
laboratory. Therefore, your sample is not personally-identifiable. Instead, the sample is labelled with
a pseudonymous number so the people analysing your urine overseas will not be able to identify you
and will not be able to find out your name, contact details or other personal information.
You can find out more about how we will use your information by contacting the Research Assistant,
Humairah Arshad [email protected]. If you wish to raise a complaint on how we have
handled your personal data, you can contact our Data Protection Officer who will investigate the
matter. If you are not satisfied with our response or believe we are processing your personal data in
a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
Our Data Protection Officer is Lee Shailer and you can contact them at [email protected].
