Training activity information
Details
Review the required consents for a variety of treatment cycles, including those involving donated gametes to ensure compliance with HFEA regulations
Type
Entrustable training activity (ETA)
Evidence requirements
Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion.
Reflection at multiple timepoints on the trainee learning journey for this activity.
Considerations
- Consent process and regulation including ensuring patient ability to give informed consent and referral to counselling has been offered
- HFEA consent forms
- Legal parenthood consent
- In-house consents
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
What does success look like?
- Identify what is expected of you in relation to reviewing consent forms, for example, checking specific elements of the consent forms and verifying full compliance with HFEA regulations.
- Consider how the learning outcomes apply, specifically how ensuring correct and complete consent forms facilitates the appropriate patient pathway.
- Discuss with your Training Officer to gain clarity of what is expected of you in relation to the different types of consent forms and the specific checks required for cycles involving donated gametes.
What is your prior experience of this activity?
- Think about what you already know about informed consent in a medical or fertility context. Have you seen different types of HFEA consent forms before?
- Consider possible challenges you might face during the activity, such as incomplete forms, conflicting information, outdated forms, or complex consent scenarios (e.g., withdrawal of consent), and how you might handle them.
- Recognise the scope of your own practice for this activity i.e. know when you will need to seek advice or help, and from whom. You will need to seek advice from your Training Officer when required, for example, if there is conflicting information regarding the withdrawal of partner consent.
- Acknowledge how you feel about embarking on this training activity, particularly given the legal and ethical significance of consent in fertility treatment and its regulatory requirements.
What do you anticipate you will learn from the experience?
- Consider the specific skills you want to develop, such as meticulous review of documentation, identifying key information and potential errors on consent forms, and applying specific sections of the HFEA Code of Practice related to consent.
- Identify the specific insights you hope to gain from engaging with the activity, such as a deeper understanding of the legal framework governing fertility treatment and the complexities of consent, especially in third-party reproduction.
What additional considerations do you need to make?
- Consult actions identified following previous experience with reviewing documentation or dealing with regulatory checks.
- Identify important information you need to consider before embarking on the activity, such as the specific treatment type the patient is undertaking, whether donor gametes are involved, and which HFEA consent forms are required for that scenario.
In action
Is anything unexpected occurring?
- Are you noticing anything surprising or different from what you anticipate whilst reviewing the consent forms?
- Are you encountering situations such as:
- Finding any sections of the consent form that were not signed or dated as expected?
- Noticing an inconsistency between different consent forms or patient details?
- Discovering that a consent period had expired, contrary to expectation?
How are you reacting to the unexpected development?
- How is this impacting your actions? For example, are you responding to the situation appropriately? Are you immediately recognising that the issue could lead to non-compliance with HFEA regulations?
- Consider the steps you are taking in the moment, such as immediately flagging the issue or halting the process requiring valid consent.
- How are you feeling in that moment? For instance, are you finding it difficult to adapt your plan to address the consent issue? Is it affecting your confidence in ensuring regulatory compliance?
What is the conclusion or outcome?
- Identify how you are working within your scope of practice. For example, did your immediate action prevent potential regulatory non-compliance? Or are you needing support because the consent issue involves legal complexity or expired donor forms requiring senior clinical authorisation?
- What are you learning as a result of the unexpected development? For example, are you gaining insight into common consent issues or how to identify documentation errors quickly?
On action
What happened?
- Begin by summarising the key steps you took when reviewing the consent forms, including the types of consent forms you reviewed (e.g., recipient, donor) and the process you followed.
- Consider specific events, actions, or interactions which felt important, such as checking the key consent requirements against HFEA regulations, especially for documentation related to donated gametes.
- Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, immediately flagging an incomplete signature or date field on a critical donor consent form and pausing the pathway review.
- How did you feel during this experience, e.g., did you feel acutely aware of the legal and ethical significance of the documentation or challenged by the complexity of third-party consents?
How has this experience contributed to your developing practice?
- Identify what learning you can take from this experience regarding reviewing consents for regulatory compliance. What strengths did you demonstrate, e.g., meticulous attention to detail in checking dates and necessary signatures?
- What skills and/or knowledge gaps were evident, e.g., unfamiliarity with specific requirements for different types of donor consents?
- Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in navigating the regulatory framework related to consent and donation?
- Identify any challenges you experienced, such as identifying missing information or dealing with ambiguity in the consent forms. Identify how you reacted to this, e.g., needing to seek advice or clarification on scope of practice regarding ambiguous consent forms.
What will you take from the experience moving forward?
- Identify the actions or ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you have received, with regards to improving your knowledge of specific HFEA consent forms and their mandatory fields.
- What will you do differently next time you approach reviewing consent forms for compliance, for instance, by proactively reviewing the patient’s file against a consent checklist specific to the type of treatment (e.g., fresh non-donor vs frozen donor cycle).
- Do you need to practise any aspect of the activity further, such as reviewing the HFEA Code of Practice section on consent or key learning outcomes related to practicing in accordance with the statutory framework?
Beyond action
Have you revisited the experiences?
- How have your subsequent experiences of reviewing patient consents, especially those involving donated gametes since completing this specific training activity led you to revisit your initial approach or decisions during that activity? For example, how an instance where a subsequent complex consent case involving legal capacity and HFEA forms forced you to re-evaluate the rigour of your validation process during your first attempt at this training activity.
- Considering what you understand about HFEA consent regulations for various treatment cycles, third-party reproduction consent complexities, and ensuring appropriate patient pathways now, were the actions or considerations you identified after your initial reflection on this training activity sufficient? How have you since implemented or adapted improvements in your consent review methodology based on further learning and experiences? For example, how you proactively developed a checklist specific to third-party consent documentation based on further learning.
- Has discussing ambiguous consent scenarios or the legal and ethical significance of valid consent with colleagues, peers, or supervisors changed how you now view your initial experience in this training activity? For example, how professional storytelling with a supervisor about a legal complication arising from incomplete donor consent documentation refined your understanding of the critical nature of upholding the regulatory framework.
How have these experiences impacted upon current practice?
- How has the learning from this initial training activity, in combination with subsequent consent review experiences, contributed to your overall confidence and ability in verifying complex consent forms and ensuring regulatory compliance, particularly in preparing for assessments like DOPS or OCEs? For example, how your accumulated familiarity with various HFEA consent forms, including those for donated gametes, enables accurate verification during a DOPS assessment (e.g., examining consents in the patient notes).
- How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to consent review? How does this evolved understanding help you identify when something is beyond your scope of practice or requires escalation? For example, how your evolved understanding helps you identify when incomplete forms or conflicting instructions, particularly regarding donor status, require immediate escalation to the Training Officer or PR due to the severe regulatory risk.
- Looking holistically at your training journey, how has this initial consent review experience, revisited with your current perspective, contributed to your development in meeting the learning outcomes related to practicing in accordance with the statutory and regulatory framework? For example, how this foundational experience has supported your development in practicing in accordance with the statutory and regulatory framework by meticulously maintaining the integrity of legal documentation.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Determine a patient’s pathway, including assisted reproduction options and stimulation regimens based on clinical presentation. |
| # 2 |
Outcome
Practice in accordance with the statutory and regulatory framework. |