What UK clinics should know about a switch to electronic consent processes
In September of 2019, the Human Fertilisation and Embryology Authority (HFEA) officially updated the Code of Practice to include guidelines for the safe and effective use of electronic signatures for recording and storing informed consent. Up until that time, the HFEA had only addressed paper-based consenting for use in completing mandatory HFEA forms.
For UK clinics already using electronic signature capture for in-house forms, and even more so, for those still struggling with the inefficiencies and risks of an all paper-based consent process, this was welcome news.
As the leading platform for informed consent and electronic signature capture in the US and UK, we give these new guidelines our robust endorsement. The HFEA’s dedication to patient protection, privacy, and consistency in the use of new technologies in fertility clinics mirrors our own and continues to inform our commitment to clinics and patients in the UK.
If you’re considering adopting a more efficient electronic process to reduce the risks and inconvenience of paper-based consent, here’s a synopsis of the new guidelines and how our platform can help you address them as you make the transition.
All electronic forms must precisely replicate the current version of the relevant HFEA form wording including accompanying guidance, HFEA colours and logo, and the format and layout.
EngagedMD has already done this work and maintains a library of exact replicas of all current HFEA forms for you to use. We keep careful versioning of documents too! So if something does change, it’s just a simple upload and every patient going forward will get the most current version.
Our platform is flexible enough to handle all in-house forms as well, so you can be confident that any forms in your workflow can be digitized and accessible to you and your patients.
Where electronic methods for taking consent employ conditional logic or algorithms, clinics must have documented procedures in place to regularly test the conditional logic or algorithms.
For complex forms, we can use conditional logic to ensure patients are guided through the form correctly and no section or field is skipped.
We QA every form with practice staff during the onboarding of new clients before going live with your staff and patients. We also give practices the ability to perform periodic quality testing on their own.
Clinics are responsible for ensuring the correct consent form has been completed by a patient and for guiding patients to ensure that the appropriate sections or questions within a consent form are completed.
A missing, improperly completed, or incomplete form is not only a legal risk to the clinic but can also jeopardize the legal rights of patients and partners, especially in the case of consent to legal parenthood.
We take this responsibility as seriously as if it were for our own clinic, so our platform includes built-in safeguards that make it impossible for patients to advance to the next section until each field and section has the required initials or signatures attached.
For additional assurance, no submitted form is considered complete until someone in your clinic has reviewed it and marked it complete.
Licensed centres must have safeguards in place to ensure that the person completing and signing the consent form is, in fact, the person who is meant to be completing the form.
Patients’ favorite aspect of the EngagedMD platform is the flexibility it gives them to access educational video modules and review and sign forms from anywhere. This feature is only possible because we’ve given as much attention to security as we have to convenience. While our eSign was designed specifically for the fertility sector, we built it on DocuSign—the most trusted name in electronic signatures.
With EngagedMD, each patient’s personal email address is the primary patient identifier. We also offer three additional multi-factor authentication options for a second layer of confidence.
- Text message authentication (our most popular)
- ID verification
- Phone call authentication
Centres must obtain and retain consent in a way that ensures patient confidentiality and compliant record keeping.
EngagedMD takes data privacy and information security very seriously. As the platform of choice for some of the most prominent fertility groups and hospital systems in the world, we’ve had to pass rigorous security assessments.
Sure, we’re a cloud-based platform with endless storage capacity. But you can still access your patients’ records easily from your clinic’s dashboard. And because EngagedMD easily integrates with many fertility EMRs, you can even auto-transfer copies of completed consents directly to your patient’s medical record.
The centre should ensure that anyone giving consent has been given enough information to enable them to understand the nature, purpose, and implications of the treatment or donation.
This one is not an update, but we think it’s important enough to include here to remind you that HFEA forms can become invalid if you can not prove that you’ve provided the patient (and partner, if applicable) with the relevant information before requesting consent. So providing patient education and an accurate “paper trail” is more than just “best practice”, it’s essential.
When you use eSign for electronic signature capture along with EngagedMD’s eLearn video modules, consent forms are automatically linked to the completion of education modules you’ve assigned to patients and partners. Thus, ensuring that patients and their partners not only received but reviewed and understood the vital information that constitutes informed consent before giving consent. And there’s documentation to prove it!