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East Genomics

Patient choice and consent

An appropriate discussion of genomic testing and the possible implications for a patient and their family members must take place before testing is requested.

It is the responsibility of the referring clinician to ensure appropriate consent has been obtained for all genomic tests, other than certain (non WGS) tests on cancer tissue.

A record of this discussion must be retained within the patient record when a genomic test is ordered.

Training

The discussion with the patient, which can be taken remotely, must take place according to the Consent and Confidentiality in Genomic Medicine guidelines. Training has been developed to support the Patient Choice Consent Framework, which is available online.

For Whole Genome Sequencing (WGS) tests, clinicians must complete this training prior to placing an order.

Protecting patient information

We follow Trust policies and Caldicott principles to safeguard all patient information.

DNA from all referrals is currently retained for quality assurance purposes and may be used anonymously for the development of new tests unless consent for this is expressly denied.

Record of discussion form - non WGS tests

For all genomic tests, a record of discussion must be retained within the patient record.

For non WGS tests, where there is no written consent on request forms the assumption is made that the appropriate health care professional has obtained informed consent prior to obtaining samples. We will act on the understanding that samples have only been taken under the direction of medical staff acting in the best interest of the patient.

Please refer to the appropriate test for the relevant form.

Whole Genome Sequencing (WGS) forms

There are specific consent forms which need to be completed for all whole genome sequencing tests (including those on solid tumour).

The WGS Record of Discussion form must be used and sent alongside the referral form. The patient choice conversation can be performed remotely.

Additional forms you may need to complete:

i) 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).

ii) 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).

To access the relevant forms, please refer to the appropriate test from our referral index page.

This Record of Discussion form is available in several languages including: Arabic, Chinese (simplified), Gujarati, Polish, Portuguese, Punjabi, Spanish, Urdu, Bengali and Welsh. These forms can be downloaded here.

Patient information leaflets

Various patient information leaflets (for cancer and rare disease tests) have been created for patients considering whole genome sequencing. These, as well as versions in several other languages, can be found here and should be given and/or discussed with the patient or their parent/carer.