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The North Cumbria Community Genetics Project J Med Genet: First Published As 10.1136/Jmg.35.5.413 on 1 May 1998

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The North Cumbria Community Genetics Project J Med Genet: First Published As 10.1136/Jmg.35.5.413 on 1 May 1998 JMed Genet 1998;35:413-416 413 The North Cumbria Community Genetics Project J Med Genet: first published as 10.1136/jmg.35.5.413 on 1 May 1998. Downloaded from Diana S Chase, E Janet Tawn, Louise Parker, Patricia Jonas, Claire 0 Parker, John Burn Abstract through classical genetic family studies, but The aim of the North Cumbria Commu- requires an epidemiological approach to the nity Genetics Project is to establish a store study of large, preferably unselected, popula- of DNA, plasma, and viable cells from a tion cohorts. This necessitates a source of cohort of around 8000 Cumbrian infants. DNA and cells from a normal population and To meet this objective, specimens of um- also the ability to link results of DNA analysis bilical cord blood and tissue will be with important lifestyle factors and disease collected with maternal consent from outcome over an extended period of time. babies born at the West Cumberland Hos- To date there has been only one attempt to pital, Whitehaven over a five year period do this, in a study where the emphasis was pri- from January 1996. These samples will be marily on child development, and although used in a series of genetic and epidemio- placental samples were collected DNA was not logical studies investigating the interaction initially extracted and no viable cells were between genes, the environment, and obtained.5 The North Cumbria Community health. There is little population move- Genetics Project aims to store samples of ment in West Cumbria and so it will be DNA, plasma, and viable cells collected from possible to follow many of the babies babies born at the West Cumberland Hospital, throughout their childhood and to investi- Whitehaven and to use them as a resource for gate the relationship between their genetic future genetic epidemiological research. The constitution and health outcome. West Cumbrian population is ideal for this type (7Med Genet 1998;35:413-416) of research resource because not only is it rela- tively stable, but the study builds on the exper- Keywords: population; gene/environment interaction; tise in child health epidemiology and genetics genetic and epidemiological research; DNA resource already established in the area. From the beginning it was recognised that for this innovative study, ethical debate, both An international effort is under way to with professionals and the public, would be sequence the whole of the human genome required to gain the goodwill and support nec- (Human Genome Project) and there are confi- essary for success. Before the project could Genetics Unit, dent predictions that by the year 2005 the http://jmg.bmj.com/ Westlakes Research proceed it required careful planning and entire genome will be mapped and all the genes preparation. Information leaflets, consent Institute, Moor Row, (about 80 000 in total) will be identified.' The Cumbria CA24 3JZ, forms, and questionnaires were produced and UK next task will be to assign functions to the the logistics of distributing these and collecting D S Chase genes. Mutations in some genes will be samples were established with regard to E J Tawn sufficient in themselves to cause disease; antenatal care and midwifery practices operat- C 0 Parker however, many diseases, including most can- ing in the area. Technical aspects of sample cers, are the result of interactions between sus- Sir collection and storage were devised and proce- on October 1, 2021 by guest. Protected copyright. James Spence ceptibility genes and factors in environ- Institute of Child the dures developed to ensure that confidentiality Health, University of ment. These multifactorial diseases affect a of the data was safeguarded at all times. In the Newcasde, Newcasde large proportion of the population. Heart event it was not until January 1996, several upon Tyne NEI 4LP, disease, for example, affects about half of the years after the idea was initially conceived, that UK population over 65 years of age and is the sin- sample collection began. L Parker gle most common cause of death in this age group.2 Asthma is an cause Department of Human increasing of Genetics, University of morbidity in childhood and in 1986 affected Public and professional consultation and Newcastle, Newcastle 6.5% of children by the age of 16 years, an ethical approval upon Tyne NE2 4AA, increase of 70% since 1974.3 In contrast, cystic The North Cumbria Community Genetics UK fibrosis, which is the most common autosomal Project was first conceived in autumn 1993 at P Jonas recessive disorder in European populations, meetings between the University of Newcastle J Burn affects about 1 in 2500 people.4 Identification (Department of Human Genetics and the Sir Maternity Department, of susceptibility genes may enable population James Spence Institute of Child Health) and West Cumberland screening programmes to be considered, thus Westlakes Research Institute (Genetics Unit Hospital, Whitehaven, allowing subjects potentially at risk to be given and the Department of Occupational Health Cumbria CA28 3JG, appropriate lifestyle advice and regular moni- and Medical Statistics). It was clear from the UK toring, with the objective ofreducing morbidity start that it required the full backing ofthe local P Jonas from disease, enhancing quality of life, and health professionals and the support of the Correspondence to: reducing premature mortality. This preventa- local community. Initial discussions with pae- Dr Chase. tive approach has implications for a more diatric and obstetric staff at the West Cumber- effective use of limited health care resources. land Hospital concentrated on the practicali- Received 13 October 1997 The identification of Revised version accepted for gene-disease associations ties of fitting the project into the current publication and the impact of environmental factors on antenatal care programme operated by the 2 December 1997 these associations will not be established midwifery staff. 414 Chase, Tawn, Parker, et al Early in the development of this project a of any impact its activities could potentially presentation was made to the West Cumbria have on the local environment. Following the Local Research Ethics Committee to ensure report by Gardner et af showing a statistical were no objec- association between paternal preconceptional that there fundamental ethical J Med Genet: first published as 10.1136/jmg.35.5.413 on 1 May 1998. Downloaded from tions. The scientific justification was accepted irradiation received occupationally at the Sell- by the committee who encouraged the develop- afield reprocessing plant and the development ment of a full, detailed protocol. Three months of childhood leukaemia, considerable effort later such a protocol was presented to the was expended in developing child health stud- committee. This encompassed methodology ies in the area. Some of these studies have been for the collection and storage of samples from reported8 9 and are consistent with the realisa- newborns at the West Cumberland Hospital tion that the association does not represent a subject to informed maternal consent, together plausible causal mechanism.'" Factors related with a short lifestyle questionnaire to be to the nuclear industry will of necessity be part completed by the mother. The project was of the environmental and occupational charac- given approval subject to a consultation period teristics of the local population, but the project coordinated by North Cumbria Health Au- has a much wider remit and will focus on gene- thority. This took the form of three meetings. environment interaction in the aetiology and The first for health professionals was chaired pathogenesis of disease. BNFL have no role in by a general practitioner and was addressed by the management of the project and have not members of the project team. The second two sought such a role. were public meetings chaired by the Chief Because of the unique nature of the project Executive of the North Cumbria Health and the lack of published guidelines, a number Authority. These were poorly attended despite of recognised UK experts with experience in associated media coverage including a brief the ethics of genetic and epidemiological stud- television broadcast, a radio "phone in", as well ies were invited to form an Ethics Advisory as newspaper coverage both nationally and Group. This group meets regularly and has locally. The project was also discussed by the provided valuable insight. With this input we North Cumbria Health Authority, the West have established a project which matches the Cumbria Health Care Trust Board, and the recommendations outlined in the Statement on West Cumbria Community Health Council. the Principled Conduct of Genetic Research, Feedback from the consultation period re- devised by HUGO Ethical, Legal, and Social sulted in a revised protocol which was given full Issues Committee and adopted by the HUGO approval by the North Cumbria Health Council in March 1996." Authority in December 1994. A project liaison midwife was appointed in April 1995 to inter- Confidentiality face between the midwives and the research From the outset, confidentiality was identified team and to develop the infrastructure for as being of major importance. The project is a recruitment of mothers. collaboration between the University of New- http://jmg.bmj.com/ In all the consultations, concern centred pri- castle and Westlakes Research Institute and marily around aspects of confidentiality and a this allows the separate storage of personal public concern about the dangers of eugenics. information and biological specimens. All the The rapid advances in genetic knowledge bring personal information is sent to Newcastle with them a potential danger that genetic where it is stored encrypted on a stand alone information could be used to disadvantage computer with restricted access, while all the people in such areas as life assurance.6 To allay biological specimens are stored at Westlakes on October 1, 2021 by guest. Protected copyright. such fears, full information was provided about Research Institute.
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