27 September 2019
CH(19)01 - Electronic methods for taking consent
Informed consent is central to our ethical and regulatory framework; licensed centres must obtain fully informed consent from a person as required under the Human Fertilisation and Embryology Act 1990 (as amended). The fundamental consent principles that have since been enshrined in law, were outlined in the Warnock Report in 1984, and include:
- It is important for time and consideration to be devoted to explaining fully to prospective patients and, where necessary, to their partners the details of any infertility treatment they undergo
- no such treatment should be undertaken without the fully informed consent of the patient
- the process of explaining and describing prospective treatment should be embarked upon as far in advance as possible, so that patients and partners have plenty of time to discuss and consider the treatment.
Consent has historically been recorded via ink signature on paper only and although many clinics still use paper consent forms, the HFEA acknowledges that electronic methods for taking consent are now being adopted by clinics. In principle we consider this to be an acceptable and appropriate means of consenting provided clinics comply with the updated General Directions 0007 (version 8) on consent and the Code of Practice. Electronic methods for taking consent can be used to supplement the traditional paper-based approach or, as a routine replacement for it, where appropriate. Clinics must retain the option for paper-based consent for use at a patients’ request and to serve as a back-up method to the electronic component.
Electronic methods for taking consent
Obtaining informed consent involves a process of information provision and discussion and includes completion of the relevant consent form(s). Some of this process can now be offered or provided electronically to the patient. Electronic methods that may be include, but not be limited to:
- completing and signing a consent form in an editable PDF format
- a more sophisticated platform/programme for patients to record their specific consent decisions (where relevant) and to sign the record of consent
- use of generic videos or other means of electronic information provision
- consent information entered electronically to other systems for data processing, use or storage eg they interface with the clinic’s own records system
Guidance on the use of electronic methods for taking consent
The HFEA will update guidance note 5 (Consent to treatment, storage, donation, training and disclosure of information) of the Code of Practice to include guidance on the requirements that must be met where clinics intend to use electronic methods of recording consent and to expand on the particular issues it raises. Existing guidance note 4 (Information to be provided prior to consent) and guidance note 5 of the Code of Practice on good practice on informed consent-taking should be applied whatever the format of information-giving and consent taking you use in your clinic. Each clinic has a responsibility to make sure that informed consent is given and recorded correctly whether you are working with paper-based or electronic methods of consent taking. In the interim, please refer to the updated General Directions 0007 (version 8), which clinics must comply with when using electronic consenting methods. As with any form of consent, the onus is on clinic staff to assure themselves that best practice is always followed.
Please speak with your inspector(s) if you have further questions on the use of electronic consent. We will continue to monitor this developing area of practice and provide updated guidance in due course.
Yours sincerely
Sally Cheshire
Chair, Human Fertilisation and Embryology Authority