Frequently asked questions
General project questions
Some of the most health deprived people in the UK are in East London, on the doorstep of our NHS hospital, primary care and medical school/university facilities.
Bangladeshi and Pakistani people in the UK have five times the rates of diabetes, and poor health by many other measures.
Bangladeshi and Pakistani people are the largest ethnic minority groups in East London.
We know the genetic make-up of South Asians differs, for example differences between Bangladeshi, Pakistani, and Tamil people can easily be seen at the genome level. Our article describes this further. In genetic studies, it is important to identify clearly defined ethnic groups, otherwise when comparing between conditions (for example people with and without diabetes) any differences seen might be due to changes in ethnicity rather than the condition being studied.
Many health research and genetic studies have focused more on other populations (for example, white European origin people). South Asian people are understudied, and so to enable local people to benefit from the coming genomics revolution in healthcare we have set up East London Genes & Health.
We already have excellent and joined-up primary care electronic health records on over a million people in East London. Soon other Boroughs will be joining. This will enable us to compare genetics and health conditions at a large scale, which is harder to do in other parts of the UK and other countries.
We know other people in East London, and in other parts of the UK are also health deprived. It is possible that the Genes & Health study may seek volunteers from other ethnic groups and other locations in the future. Please join our email letter if interested. However, for now, the study is recruiting only adult volunteers from across East London who regard themselves of Bangladeshi, British-Bangladeshi, Pakistani or British-Pakistani origin.
We take a very wide definition of East London. Of course, people in local boroughs (Tower Hamlets, Newham, Waltham Forest, Barking and Dagenham, Redbridge, Havering) can take part, but also other nearby London Boroughs and further afield.
Quite simply, if you would be willing to come to our Whitechapel centre (E1 2AT) if we were to invite you for recall at the second stage, we would welcome you taking part !
East London Genes & Health is recruiting adult volunteers (age 16 and over), with and without health problems, from across East London (see our FAQ: "I live east of the M25, is that East London?"), and who regard themselves as of Bangladeshi, British-Bangladeshi, Pakistani or British-Pakistani origin.
No, we are not creating a DNA database.
Information from these tests will not be used or made available for any purpose other than for health-related research and improvements in health care.
No. We will not sell or release any information that may identify you (e.g. your name, address, date of birth or contact details). Nor will we pass on identifiable information to other organisations (such as police or insurance companies).
To speed up developments of new diagnostic tests and better treatments, results of the studies will be made available to the public through scientific publications, including placing information on the internet, in press articles and project leaflets. This information may include part of your entire genetic code or the results of other tests performed with your samples and other relevant non-identifying information from the research database, e.g. your age in years, your gender etc. Under no circumstances would your name (or any identifying detail such as address, date of birth, etc) be disclosed in any media or publication.
Information from genetic tests will not be used or made available for any purpose other than for research and improvements in health care.
These studies are all quite different, although all involved in human genetics and genomics.
23andMe is a private genomics company that sells ancestry tests, and some very specific health related tests. It will sell a kit to anyone who pays for one. 23andMe does some high quality research, but different to what East London Genes & Health proposes. 23andMe will give you your own genetic information, whereas East London Genes & Health does not.
Genomics England is a company owned by the UK Department of Health (NHS, and accountable to the Secretary of State for Health who is the sole shareholder) and was set up to deliver the 100,000 Genomes Project. It is studying NHS patients who have certain cancers and rare inherited diseases, being cared for at one of the designated 11 NHS Genomic Medicine Centres. The project will sequence 100,000 whole genomes by 2017. The 100,000 Genomes Project is different to East London Genes & Health as it is a combined research project, clinical service and NHS transformation programme. The research component differs from that East London Genes & Health proposes in local South Asian people with recall for further studies over the next two decades.
However both Genomics England and East London Genes & Health may benefit from some of the research that each other is undertaking - for example, knowing what is normal genetic variation in Bangladeshi and Pakistani communities (provided by East London Genes & Health) will help genetic diagnosis of rare disease. Currently, Genomics England is also based at Queen Mary University of London - but at the Charterhouse Square campus - and is entirely separate of East London Genes & Health based at the Whitechapel Campus. Both projects are greatly increasing the healthcare genomics expertise around East London.
East London Genes & Health is not for profit and part of Queen Mary University of London.
There have been concerns about changes to English law e.g. over anti-terrorism legislation.
Queen Mary University of London will robustly fight any external attempts to access data. Keeping identifiable data on health research confidential is critical to the work of the entire medical school.
Another recent large scale genomics study, Genomics England, has obtained written agreement from the Home Office that no attempt will be made to access any data. We expect the same principle to cover our study, but will also be seeking this in writing.
Volunteer specific questions
We will look after your saliva sample and store it safely (most will be stored in the Blizard Institute, others securely at our partner the Wellcome Trust Sanger Institute).
We want to know how genes influence disease, and may use some of your sample to understand (sequence or genotype, or other lab test) your genetic code.
Samples collected as part of the present research project may be stored and used by Queen Mary University of London and for approved health research within a hospital, university, non-profit institution or a company laboratory within and/or outside the EU. All health research will be approved by our community and scientific advisory board.
Keeping your data secure is very important to us.
People who work for the study, and from Barts Health NHS Trust and Queen Mary University of London, who run the study, have volunteered for the study and trusted us with their data (for example, some of the First 46). These people can see from the inside that we are keeping data secure.
For increased security, we will store different types of data in separate places and servers, specifically :
- Laboratory samples will be tracked by location, with tube ID only. The server runs in a locked room on the QMUL intranet in the Blizard Institute.
- Volunteer questionnaire data, including any follow up (e.g. telephone calls, invites for and details of stage 2 studies) will be kept on a secure database accessible on the QMUL intranet only and run by QMUL Research IT Services on a dedicated server. This uses the REDCap mature, secure application in use by 1,376 active institutional partners in 90 countries. This data storage system has been approved by our research governance office (QMUL & Barts Health Joint Research Management Office). Volunteer questionnaire paper forms and electronic data access will be from different buildings to where laboratory samples and genetic data are stored.
- Sequencing data will be held at the Wellcome Trust Sanger Institute, Cambridge, along with study ID only. Additional genetic data (with study ID only) will be held on the QMUL Research IT Services Apocrita high performance compute cluster.
- Health record data will be accessed from the QMUL Clinical Effectiveness Group. Primary care data will have no identifiers (i.e. no names, dates of birth, addresses etc). The study ID will have been added to records at individual GP practices or NHS Trusts. It will be in the form of codes (e.g. C10 for diabetes). Health record data will be very securely stored at the Farr Institute of Healthcare Informatics Research London "safe haven". It will not be possible to export data from here without prior approval. Analyses will be done within the Farr Institute systems.
For additional security, members of staff who work directly in the laboratory or on genetic data will not have physical access or logins to volunteer questionnaire or health record data, and vice-versa.
We have adapted these security measures from the Cambridge BioResource, which has run successfully for over 10 years.
We are regulated by the Data Protection Act and the Department of Health Research Governance Framework.
Yes, absolutely. This is very important to us.
Best ethical and legal practice will be followed to ensure that all information collected about you will be handled in confidence. Your samples will be labelled with a unique sample study number (not your name) before being stored. Information from genetic and other tests and from your health records will be linked to this unique number but each stored in separate places from your personal details (surname, first name, contact details). Only the Chief Investigator of the study would be able to link data together, and then approval from our community and scientific advisory board for each research project would be required.
Please also see FAQs on How will you keep my data secure?, Will you sell or release my personal information? and Will you look in detail through my medical records with my name on?
No - once the funnel has been closed, the tube mixed, and the new cap put on - it is fine at room temperature and can be sent back using the business reply service at no cost to yourself.
Anyone aged 16 or over, with and without health problems, from across East London can take part.
Yes, in stage 1, we will not be doing any invasive procedures nor giving you any medicines to take.
We will only ask you to give a 2ml saliva (spit) sample at this stage of the study.
No. You do not receive any money for joining East London Genes & Health (stage 1, providing a saliva sample).
If you are invited back for any stage 2 studies you may be offered payment for participating in studies to cover your time and any inconvenience and travel costs. For participation in a stage 2 study the amount of payment is calculated based on the level of volunteer involvement in the study and what the study asks you to do. For some stage 2 studies there may be no payment at all or the payment will be minimal. This reflects the fact that we are funded purely for health research on a charity and not-for-profit basis. We are also regulated by research ethics which does not allow large payments.
Most of our volunteers take part as an act of generosity rather than for financial reward.
We have translations of the consent form and questionnaire available in Bangla and Urdu. You can assist or fill in the English version of the forms on their behalf provided the answers are a true reflection of theirs.
It is a study requirement that volunteers sign and date the Volunteer Consent form themselves.
Yes, more than one family member can take part. Your genetics will be different. Even for identical twins, healthcare outcomes are not the same, and we would like both to participate.
We will take account of any relatedness in the statistical analysis.
No, the reason you have been invited is that you fit the inclusion criteria for the study - usually a combination of your specific genetic make-up and something (or absence of something) specific in your health records.
We are doing research. This means we are often trying to work out what things mean, and do not have the answers to "what does this mean for me?".
We will not provide genetic or other laboratory results obtained from any sample. This is made clear in the information sheet. The MRC and Wellcome Trust have issued recent advice in this area, and we comply with their guidance. The exception is that at stage 2 (see below) you may, if you wish, ask for the reason you were invited.
However in the unlikely event that a result obtained from your sample indicates that you require immediate medical treatment, we would contact you and your GP. This would not usually occur with a saliva or genetic sample. However with a blood sample, very occasionally it is obvious that a sample is anaemic or very rarely a blood cancer can be seen.
If you are invited for further medical studies (stage 2), then you may ask to know why you were invited. Alternatively you may ask not to be told. Invitation will be because you meet the criteria for inclusion in a stage 2 study, usually the combination of some specific information in your genetic code and in your health records. This combination of information will be of interest to a researcher but usually of unknown health significance.
No.
The type of research we will mainly do will be to do with codes for diagnosis and a code number for your genome information.
For example, we might search for those people with a code of C10 (diabetes) in their health record, and then look at different types of variation in a gene to do with sensitivity to insulin. None of this involves a name or any identifiable information. No-one looks in detail through your named medical records.
We will access health record data as and when needed. We will not keep a copy (and this would soon be out of date anyway).
The health record data will not have any personal identifiers attached (no NHS number, no names, no dates of birth, no addresses etc).
There are a number of recognised "sensitive" health record codes e.g. termination of pregnancy or gonorrhea. We will block these from coming into our systems.
If a researcher wanted individual-level detailed medical information and a physical examination, then we would invite you back for this as a stage 2 study. You would be completely free to accept or decline this invitation having been given full information and informed consent, independent of the stage 1 East London Genes & Health study. Only a qualified and regulated doctor or research nurse would be using this information.
There may be other research studies you could take part in that need your further involvement. In that case we will contact you to invite you to take part in these separate studies. We call this Stage 2 of East London Genes & Health.
You may be asked to participate in studies on the basis of genetic results obtained from your sample as described above and other information given to us or obtained from your medical records. You will be provided with full information regarding each of these studies and you will be free to decide whether or not to take part in each study. Only some selected volunteers will be invited to Stage 2, and the maximum number of invitations to studies will be 4 per year.
At the beginning of East London Genes & Health (March 2015) we have one approved stage 2 study "Blood cell biology and genetic variation". This study involves giving a single small (50ml) blood sample.
We expect many more stage 2 studies over the next decade or more. Each stage 2 study will be different. Some will be simple, for example a questionnaire, others more complicated. If invited, you will be provided with full information regarding each of these studies and you will be free to decide whether or not to take part in each further study.
Absolutely not, your sample will not be used, and would be impossible to use, in any form of cloning or genetic engineering.
