Consent
Please note that it is the referring clinician’s responsibility to ensure that the patient/carer/family knows the purpose of the test and that the sample may be stored for future diagnostic testing.
For all germline genomic tests, a record of discussion must be retained within the patient record, but different tests require different forms which are detailed below.
For more information about consent and confidentiality in genomic medicine, please refer to guidance from the Joint Committee on Genomics in Medicine.
For all germline genetic tests, it is the responsibility of the referring clinician to ensure that patient consent is obtained before sending the sample to the Laboratory for testing. The Record of Discussion form for non-Whole Genome Sequencing results is below. The referring clinician should keep a copy of the signed form on the patient record (do not send this Record of Discussion form to the laboratory). If the appointment is conducted remotely, the Record of Discussion form can be completed virtually; tick the appropriate box at the end of the form to indicate remote consent.
Non-WGS NT record of discussion form
Somatic genetic testing does not require documentation of consent as the primary aim of the test is to detect changes in the DNA or RNA that will inform the diagnosis, treatment and management of an individual patient’s cancer. However, current recommendations do suggest that information about what the test is looking for should be provided to patients up front.
For all whole genome sequencing (WGS) tests, including those for solid tumours, there are specific consent forms which need to be completed. The WGS Record of Discussion form must be used and sent alongside the referral form.
WGS-Cancer-Record-of-Discussion.pdf
Record-of-Discussion-WGS-Rare-Disease.pdf
You may also need to complete:
- Consultee Declaration Form – This should be completed if a relative, friend or advocate needs to make the decision on behalf of someone who lacks the capacity. A consultee is someone who will only consider the likely views and interests of the person who lacks capacity. They must set aside their own personal views about participating in research and consider the person they represent. A consultee cannot be part of the person’s NHS clinical team or anyone else acting in a professional or paid capacity (e.g. a person’s solicitor).
- Young Assent Form – This should be completed by the patient if they are between the age of 6 and 15, to ensure they are informed about their involvement in the National Genomic Research Library (NGRL)
The record of discussion form for Whole Genome Sequencing includes information about whether or not patients consent to their data included in the National Genomic Research Library (NGRL), for use in research, and to be re-contacted regarding relevant research projects in the future. Patients’ choices regarding the NGRL can be recorded on page 3 of the record of discussion form, and, for those who lack capacity, on the consultee declaration form.
The NGRL is a comprehensive database that enables approved researchers to access de-identified genomic data, health data and samples. It is a partnership between NHS England and NHS Improvement (NHSE/I) and Genomics England. This central resource, linked to the GMS, aims to provide access to research opportunities to improve diagnoses and our understanding of health and disease, as well as accelerate the development of new biomarkers, diagnostics and therapeutic agents.
Please do try to discuss consent for research with your patients. Experience has shown that many people feel very positive about helping further research and using this kind of anonymised data can prove invaluable for researchers and often results in significant patient benefit.