Jan 25, 2018 - You are being invited to take part in a research study. Before you decide, it is important for ... This m
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School of Experimental Psychology 12a Priory Road BRISTOL BS8 1TU United Kingdom +44.117.9289943 t. +44.117.9288588 f. Carlos Sillero:
[email protected]
PARTICIPANT INFORMATION SHEET DNA methylation in e-cigarette users versus cigarette smokers and never-smokers Suzi Gage, Rebecca Richmond, Gemma Sharp, Matthew Suderman, Caroline Relton and Marcus Munafò 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 would 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 and remember that your participation is voluntary. What is the purpose of the study? We all receive genes from both our parents, and these genes determine a number of characteristics. It is now clear that environmental factors, such as whether or not you smoke, may regulate how genes work by stably turning them off or on. The study of this is a relatively new branch of biology called epigenetics. One form of epigenetic change involves a chemical modification of DNA called “DNA methylation”. Cigarette smoking is associated with distinctive DNA methylation patterns that may be linked to smoking-related health problems. We would therefore like to collect DNA from saliva samples of e-cigarette users, smokers and non-smokers in order to compare DNA methylation patterns between these groups. At present, there is no information on the patterns of DNA methylation seen in e-cigarette users. Exploring DNA methylation patterns in vapers, smokers and never smokers will help us to understand whether the patterns seen in vapers are more similar to those seen in smokers or never smokers, and therefore how much less harmful e-cigarettes may be than cigarettes. Why have I been invited? You have been chosen because you have enquired about our studies and requested to receive this further information following reading the summary version described in the letter of invitation or in a study advertisement.
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2 Do I have to take part? It is up to you to decide whether or not to take part. If you do decide to take part you would be asked to sign the accompanying consent form. If you decide to take part you are still free to withdraw your consent for us to use your sample without giving a reason. A decision to withdraw at any time, or a decision not to take part, would not be held against you in any way. It is also up to you to decide whether or not you consent to us storing your saliva sample and extracted DNA at the University of Bristol, where it could potentially be used in other studies. This may include it being sent to specialist research laboratories within the UK and abroad, in which case it will be anonymised and not connected to any personal information about you. Your decision on this will not affect your participation in this study. Once you have completed the questionnaire and sent your sample back to us you can still withdraw your saliva sample and extracted DNA, and also your questionnaire data up to one year after the study, or until the data are made open for sharing (see below). Am I eligible to take part? Please note you must be aged over 16 to volunteer. In order to take part you should; • • • •
Be aged between 16 and 35; EITHER have vaped at least weekly for the past 6 months AND have smoked less than 100 times in your lifetime (“vaper”); OR have smoked at least weekly for the past 6 months AND have used an e-cigarette less than 100 times in your lifetime (“smoker”); OR have never smoked or vaped, or have done so less than 100 times in your lifetime (“never smoker”).
Exclusion Criteria • • • •
Have current substance dependence (other than nicotine); Have significant current or past illness (including cancer, type 1/type 2 diabetes); Are currently pregnant or breast feeding; Have a related individual in sample (to the best of your knowledge).
What would I have to do? We would ask you to complete an online questionnaire, and depending on the results of this, send you a package in the post containing a kit to collect a saliva sample. We would require you to provide the saliva sample as instructed, then post it back to us in a provided pre-paid envelope. What will the researchers do with my saliva samples? We would extract DNA from the saliva sample that you provide. The DNA would be analysed for epigenetic markers. The extracted DNA would be stored securely in freezers at the University of Bristol (where we house thousands of samples from other such studies). With Information Sheet v1.4 25/01/2018
3 your permission we would store DNA and this may be used in future genetic or epigenetic studies (which would have received ethics approval). Your samples and questionnaire information could be shared with other scientists who are doing research (which would have received ethics approval), but your names or contact details would not be passed on, and you would not be identifiable from the shared data. We may ask for a fee from researchers outside Bristol to help cover the costs of storing your samples as well as the costs associated with sending them to other places. We would not make any profit from your sample. What are the possible disadvantages and risks of taking part? Your life insurance or private medical insurance could be affected by taking part and if you have private medical insurance you should check with the company before agreeing to participate. What are the possible benefits of taking part? You would not directly benefit from taking part in this research study and your participation is voluntary. However, the information we get from this study may help us to understand similarities or differences between smokers and vapers in terms of their DNA methylation, which may reflect health risks. What if there is a problem? Any complaint about the way you have been dealt with during the study or any possible harm you might suffer would be addressed. If you wish to complain or have any concerns about any aspect of the way you've been approached or treated during the course of this study, please contact Carlos Sillero (
[email protected]) on the study team. If you would like to speak to someone independent of the study please contact the Research Governance group at the University of Bristol (
[email protected]). Will my taking part in this study be kept confidential? Any personal information and research study documentation taken for this research study would remain confidential and would be available only to university research staff and government bodies that monitor whether research studies are performed properly. Samples would be given unique identification numbers so they could not be linked to any of your personal information. If you give permission for your samples to be stored the majority of research involving your samples would take place in Bristol, but other researchers (in universities, hospitals or other organisations) may apply to access them too. All samples would only be used in research that has received ethics approval, and your personal information would not be available. What would happen to the results of the research study? When the study has been completed, we would analyse the data we have collected and report the findings. This would be reported in an appropriate scientific journal or presented at a scientific meeting. You would not be identified in any way and if you would like a copy of the final report, you may request this. Your study data (the questionnaire and the saliva sample and extracted information) would be anonymised. This means that it would be given an identification number and any identifying Information Sheet v1.4 25/01/2018
4 information about you would be removed. Therefore, it would not be possible to identify you by name from any aspect of documentation or reporting for this research study. At the end of the study your transcribed data (information copied from the questionnaire and information extracted from your saliva sample) would become “open data”. This means that it would be stored in an online database so that it is publicly available. What is open data? Open data means that transcribed data are made available, free of charge, to anyone interested in the research, or who wishes to conduct their own analysis of the data. We would therefore have no control over how these data are used. However, all data would be anonymised before being made available and therefore there would be no way to identify you from the research data. Information relating to your whole genome would NOT be made open data, only the specific locations we are interested in. It is not possible to identify an individual from these. Why open data? Sharing research data and findings is considered best scientific practice and is a requirement of many funding bodies and scientific journals. As a large proportion of research is publicly funded, the outcomes of the research should be made publicly available. Sharing data helps to maximise the impact of investment through wider use, and encourages new avenues of research. Can I withdraw my study data after I have participated in the study? Yes. If you decide that you do not want your saliva sample, extracted DNA or questionnaire data to be used you can contact the study team and request that your sample is destroyed and/or your data are withdrawn. If you have agreed to your extracted DNA being stored for use in future studies you can withdraw this consent at any time and request that your sample is destroyed. The main stocks would then be destroyed. For study data, you can withdraw consent up to one year after the study ends or up until the point the transcribed data are shared as “open data” (whichever comes first). At this point links between your identity and your anonymised data set would be destroyed, and therefore we would no longer be able to withdraw your data as we would no longer be able to identify which data set is yours. Who is organising and funding the research? This research is funded by Cancer Research UK. It is being conducted within the MRC Integrative Epidemiology Unit and the Integrative Cancer Epidemiology Programme. Who has reviewed the study? This research has been approved by the Experimental Psychology ethics review board (approval code 06101642024). Who can I contact for further information? If you have any more questions about any part of this study please contact us and we will do Information Sheet v1.4 25/01/2018
5 our best to answer your questions. Carlo Sillero
[email protected] 0117 331 7495
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