INTRODUCTION

  The Cancer Research Campaign (CRC) is a national medical research charity established in 1923. Its mission is the eradication of cancer. It is responsible for the support of the majority of cancer research undertaken in UK universities and medical schools as well as in four specialist cancer research institutes. Campaign funded scientists and clinicians have contributed to a number of significant "advances" in understanding the biology of cancer, its detection and its treatment.

  The CRC's current annual spend on research is £61 million set to rise to £78 million over the next three years. Funding is provided in the form of grants ranging from £10,000 to £5 million pa and in duration from one to six years.

  The Campaign raises all its money from its volunteers and supporters. It receives no Government funding directly, but all Campaign grants to universities are matched by an infrastructure component provided by Government.

1.  What current projects involve collecting genetic information on people in the UK? What other projects are about to start? Are there collections of material (eg tissue samples) that could be used to generate databases of DNA profiles?

  Cancer is known to have a genetic basis and therefore it will be essential for a proportion of CRC funded groups to collect tissue samples from patients in order to extract DNA and generate genetic information that can be studied.

  The scientific importance of appropriate sample collections has provided motivation for the development of a number of initiatives. In 1999 the CRC began to develop an initiative to establish a National Generic Tumour Bank. The MRC and ICRF were approached and recently agreed to provide joint funding for this sample collection. The Department of Health is aware of the proposed tumour bank and may agree to provide additional funding. As a result of the CRC/MRC/ICRF involvement in this initiative a Joint Sample Collections Working Group, with appropriate expertise and representation from the funding bodies involved, has been set up to discuss future developments.

  The aim of the National Generic Tumour Bank is to maintain a collection of 3,000 primary tumour samples representing 23 different types of adult cancer. Patient-matched normal tissue will accompany all tumour samples. Patient information will be limited to details of age, sex and site of the tumour.

  In addition, the CRC has agreed to provide joint funding with the MRC in order to establish the Dundee Tumour Bank. The aim of this collection is to store, administer and process patient specimens from Ninewells Hospital for use by groups interested in the p53 pathway. Panels of DNA and RNA will be generated from the tissue collection.

  Finally, the Campaign has recently provided funding for five years to support the UK Children's Cancer Study Group (UKCCSG) Tumour Bank. This was established in 1998 for storing frozen tumour material as well as matching normal tissue to facilitate biological studies to increase understanding of the molecular genetics of childhood cancers. Links to clinical phenotype and outcome data are retained through a coded storage system, allowing maximum research value while assuring anonymity of the donor.

  The CRC currently provides funding, through project grants and programme grants, for a number of tissue sample collections that are primarily used by single research groups.

  In 1998 both the MRC and the CRC independently established working groups to consider the ethical and operational guidelines for collections of biological samples. However, the CRC decided to carefully follow the workings of the MRC group as it planned very wide consultation on draft guidelines. When these provisional guidelines were produced the Campaign's Scientific Committee agreed to adopt them and recommend to all grantees that they should be followed. At the same time both agencies considered what other samples collections it would be appropriate to make. A starting point was felt to be the assessment of what collections already existed. A questionnaire was developed and was used by both organisations. Data received from CRC grantees is held on an MRC database. Table 1 [not printed] provides information on sample collections that have records held in the MRC database. A number of key CRC grantees have yet to provide information in response to the sample collection database survey. Information concerning their sample collections is provided in Table 2 [not printed].

2.  Why are these genetic databases being assembled? How are these activities funded? What practical considerations will constrain developments? Are there alternative ways of fulfilling the objectives?

  All cancers are due to abnormalities of DNA. Hence assembling such databases of genetic analyses from human tissues for research purposes helps us understand the origins and development of cancer. These databases may be used to identify the genes that make individuals highly susceptible to cancer. On the basis of this information efforts can be (and have successfully been) made to prevent cancer developing and limit cancer mortality. Detection of genetic abnormalities in cancer is also the starting point for research and development of new therapies and diagnostic tools which in time will also prevent cancer mortality.

  These activities are funded by Medical Research Charities (for example, the Wellcome Trust and Cancer Research Campaign) and other medical funding organisations such as MRC.

  Currently there is no other way of fulfilling these medical research objectives.

3.  What is the genetic information that is being collected? How is it being stored and protected?

  Among the data collected are general demographic features (age, sex), family tree with history of disease, nature of tumour types, and information from laboratory analyses. These could include DNA sequence information and information from patient samples relating to various types of genetic map.

  Named information is stored on computers that are isolated from networks and password protected and therefore cannot be accessed by external users. Some information is stored on disks stored locked.

  Samples from some studies are fully anonymised ie the data cannot be related back to the person from whom the sample originated. This protects privacy and is our preferred option where possible. However, some sample sets cannot be anonymised and for these information is stored as indicated above.

4.  How do the organisations involved see their responsibilities regarding privacy; consent; future use; public accountability and intellectual property rights?

  The protection of patient privacy is the responsibility of the custodian of the collection.

  Samples should only be used for medical research with the express consent of the patient (under such circumstances they are regarded as "gifted"). If samples for medical research are left over from, for example, surgical procedures carried out as part of clinical management, they can be regarded as "abandoned". However, if used under such circumstances the samples should be fully anonymised so that no link can be made back to the individual.

  Future unforeseen use of samples should require further consent from the individuals concerned. However, broad consent for a wide spectrum of medical research can be obtained if samples are anonymised.

  The MRC has recently produced guidelines concerning the use of human tissue and biological material. These guidelines are aimed to address the ethical, legal and management issues relating to the use of samples of human tissue for research. The CRC has agreed to adopt these guidelines and will ensure that they are adhered to in the future.

5.  How do they see their activities in the area of genetic databases developing in the future? What advances in sequencing, screening and database technology are they anticipating?

  With the advent of the human genome sequence it is anticipated that an increase in the number and/or size of databases containing genetic information, for medical purposes, would result. The methods used in DNA sequencing and other forms of sequence characterisation are likely to improve, further facilitating this process.

Dr Fiona Hemsley
Head of Science Funding (Institutes and Personal Awards)

Dr Emma Newman
Research Manager

12 October 2000