How to complete a record of discussion form

Overview

Whenever any medical test is being considered, it is important to speak with your patient or, where appropriate, their parent or guardian, about the suggested investigation and any implications that may arise from the result, and to gain their consent for the test.

In genomic medicine this is a vital discussion, given the potential impact of test results on the individual in question and possibly other members of their family. There are also other considerations, which should be explained in advance, such as uncertain or unexpected results, as well as data governance issues.

What is a record of discussion form?

For all genomic tests undertaken, a record of discussion (RoD) form will need to be completed to demonstrate that the discussion outlined above has taken place. All forms will be available on your local Genomic Laboratory Hub (GLH) website – direct links below. There may be slightly different forms for different tests (for example, there is a special form for discussing whole genome sequencing), but they should all follow a standard structure.

You will need to complete an RoD form for every family member to be tested. For example, for a trio whole genome sequencing (WGS) test, three RoD forms will need to be completed.

What is the usual structure?

Each form is likely to comprise at least two sections.

A series of statements that should be covered in the discussion between the patient (or parent or guardian) and the clinician. This will comprise the following subsections:
- family and wider implications;
- uncertainty;
- unexpected information;
- DNA storage;
- data storage; and
- health records.
A section in which the patient and clinician complete demographic information and agree to the above statements.

In some cases, there will be a third section in which the patient (or parent or guardian) can elect to participate in research.

How do I complete an RoD form?

The forms can be completed digitally or by hand. You must ensure that the demographic information is complete and correct. If the form is being completed as part of a remote consultation, the clinician can sign it on behalf of the patient.

In some cases, when the patient (or parent or guardian) is not able to complete the form, the clinician may wish to proceed in the best interests of the patient.

For an adult with learning difficulties, it is important to complete a Mental Capacity Act assessment to establish whether they have the capacity to consent to testing. Support in completing these forms can be provided by Trust safeguarding and adult learning support teams.

If a patient is of adult age and has capacity to consent, they must complete the form directly. If the form is being completed on behalf of another person (such as a child who is not Gillick competent, or an adult who does not have capacity to consent), this must be recorded appropriately.

You must go through each section of the form, ensuring that the patient understands each section and answering any questions they may have.

Working through the sections of an RoD form

Some people will read through the form verbatim with their patient, or paraphrase as they get more confident. It is important to cover each section of the form, all of which are summarised in the table below.

Section	Statement	Description
Family and wider implications	‘The results of my test may have implications for me and members of my family. I understand that my results may also be used to help the healthcare of members of my family and others nationally and internationally. This could be done in discussion with me or through a process that will not personally identify me.’	This section informs the patient that the results could reveal information relevant to family members. In such cases, we may need to pass information on to other family members or their clinicians.
Uncertainty	‘The results of my test may have findings that are uncertain and not yet fully understood. To decide whether findings are significant for myself or others, my data may be compared to other patients’ results across the country and internationally. I understand that this could change what my results mean for me and my treatment over time.’	We all carry variation within our genes that makes us different, and it can sometimes be difficult for scientists and clinicians to determine whether a specific variant is disease causing or part of normal variation. It is important to inform the patient that there could be a situation in which the testing reveals a variant of uncertain significance, by which we mean that the clinical significance of a result is not yet known. This uncertainty can be challenging for patients, so it is important to explain the possibility of delivering such a result.
Unexpected information	‘The results of my test may also reveal unexpected results that are not related to why I am having this test. These may be found by chance and I may need further tests or investigations to understand their significance.’	There is also a chance that a finding unrelated to the initial reason for testing (an incidental finding) is uncovered, and it is important to inform the patient that this is a possibility. They would only be informed of incidental results that are clinically actionable – for example, results that have management or screening implications.
DNA storage	‘Normal NHS laboratory practice is to store the DNA extracted from my sample even after my current testing is complete. My DNA might be used for future analysis and/or to ensure that other testing (for example that of family members) is of high quality.’	It is standard practice for genetic material to be stored by the local GLH. If further testing is required, this DNA can be used – reducing the need to obtain further samples and avoiding the delays associated with this process. If testing of other family members is indicated, this sample can also be used as a control.
Data storage	‘The data from my genomic test will be securely stored so that it can be looked at again in the future if necessary.’	As with storage of physical DNA samples, digital storage of genetic data is also becoming standard. This allows the team to re-examine the data if new information becomes available.
Health records	‘Results from my genomic test will be part of my patient record, a copy of which is held in a national system only available to healthcare professionals.’	The information extracted from the genomic test will form part of the patient’s health records.
Research	‘I understand that I have the opportunity to take part in research, which may benefit myself or others, now or in the future. An offer to join a national research opportunity is available on the following page.’	Should the patient wish to participate in research, any research RoD forms should also be completed.

How is the RoD form for WGS different?

The RoD form for WGS differs slightly from the form for general genomic tests. You can access this form through your local GLH website.

The form follows the same points outlined above; however, it contains a second consent form inviting patients to contribute to a research project called the National Genomic Research Library, which is managed by Genomics England (a publicly funded company owned by the Department of Health and Social Care). This is optional, and deciding not to participate will not affect a patient’s care.

Where testing includes a comparison of an individual’s DNA with that of their parents (such as in trio WGS), it is also important to counsel families that this type of testing may identify unexpected parental relationships, such as non-maternity or non-maternity. When taking consent, it is important to ask specifically about donor egg or sperm donation in relation to pregnancies conceived through IVF.

What if the patient has questions or concerns?

Some individuals may have further questions about a particular section of the RoD form. Your local GLH or clinical genetics team may be able to provide advice. Guidance should be sought in accordance with the clinical urgency of the test in question.

What next?

When the RoD form is complete, a copy should be retained in the patient records and a copy given to the patient for their own records.

Resources

For clinicians

NHS England: Genomic Laboratory Hubs
NHS England Genomics Education Programme: Facilitating Genomic Testing series (online courses)
NHS England Genomics Education Programme: Requesting whole genome sequencing: Information for clinicians