Storage of tissue and biological samples

Technical advances, particularly the ability to extract genetic material, have meant that the potential to use stored tissue or biological samples for research is increasing. It is not uncommon for such specimens to be collected from participants in a trial and stored centrally for possible future research [7]. This is not the place to discuss the legal and ethical issues raised by such research, but the implications for participants in a trial must be explained and their consent obtained for storage. Since consent to provide such samples might be refused by someone otherwise consenting to participate in the trial, it will usually be helpful (although not essential) to have a separate consent form. Indeed, having a separate patient information sheet as well may help to avoid confusion.

When a trial includes collection of such samples, the patient information sheet should make the following points, as appropriate.

♦ Description of the samples to be collected; in a cancer trial, these will usually be a single blood sample and a single tissue sample from the tumour.

♦ Patients in the study are being asked to consider donating samples because it will be useful for researchers to have access to samples from a wide cross-section of people with [type of] cancer.

♦ The samples can be obtained at the same time as samples for tests relevant to the study (if this is true - it usually is).

♦ The samples are not required for the present study, but are being collected and stored for future research.

♦ Giving samples is entirely voluntary, and declining to donate them does not affect the main study.

♦ The samples will be sent to a laboratory designated by [the sponsor], and will be kept as part of a store for possible future research; this research could include genetic (DNA) tests and studies of factors that predispose to [type of] cancer or that influence response to treatment.

♦ [The sponsor] will specify the arrangements for access to and control of the use of the collection.

♦ Access to the collection by the commercial sector as well as by academic researchers is not excluded, but no one commercial company will be given exclusive rights of access.

♦ Donors of samples will not be entitled to a share in any profits that might ensue.

♦ Personal information about donors of samples will be stored confidentially and will only be accessible to staff who have a duty of confidentiality to the donors. State if results of tests could have any implications for the patients and their families, and whether they will have access to the results.

♦ All research projects involving the stored samples will have to be approved by an independent ethics committee.

For further guidance, see the Medical Research Council's operational and ethical guidelines on human tissue and biological samples for use in research, available on their website (http://www.mrc.ac.uk).

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