Table 4

Practical and process-related recommendations arising from this research

Issue raisedExemplar quoteRecommendations from this research
The CD forms are difficult to understand Suzanne: ’So I think your average person reading the form would go, I have no idea what that is… I am a teacher and university-educated, I don’t know whether the wording is a little bit too academic. So I got a gist, even I had a rudimentary understanding of what it was.’✓Use plain English and avoid technical jargon.
✓Explain how data are protected and who is accountable for the Registry information.
People see them as unimportant Kimberley says: “Because you are kind of just filling out forms all the time. They just kind of lose their importance which sounds a terrible thing to say but they do ultimately lose their importance.✓Provide examples of the types of studies that may be done, and why they are needed.
✓Clarify that the HFEA CD forms differ from other research consent (eg, trials) administrative paperwork (eg, finance), or consent forms for current treatment/storage.
Experience of receiving, completing and discussing the forms varies markedly by clinic Francis (consented): ’The nurse explained what the paperwork was for and told us to take it home and read it and then fill it in next time we went, at the second visit, she then went through it again and we signed it.'
Pat (consented): ’Discussed with senior lead in clinic what it meant, types of usage and what is used.'
Lee (refused): ’I was passed the paperwork by the receptionist. None of it was discussed with me.'
✓Patients benefit from having time to read and consider the paperwork in advance (a week or more).
✓An SMS/text reminder to complete the forms prior to their appointment may improve completion rates.
Clinical (rather than administrative) staff should check the forms and discuss patient queries.
Patients cannot recall what they signed Karen (patient): ’They don’t give you copies of the forms that you have signed. You never see them again whereas normally anything you sign, the bank or whatever, you get a copy of what you signed. They don’t do that, so I could not even refresh my memory about what I signed.'
Valerie (staff): ’All our forms that we get are carboned. The HFEA don’t say that we have to give them a copy but that is a decision we took because we think it is best practice really.'
Provide patients with a copy of these forms for their records (some, but not all, clinics do this already).
When staff are unclear about the paperwork, they do not always get adequate support Nina (patient): ’The nurses do not know any more than what is on the form and so they will look at the form and go ‘Oh, well’ and say it again and then you (think) ‘oh, well, I’ll just tick a box’. I don’t think that they know and I don’t suspect that they are that interested.'
Hayley (staff): ’When we have conferences, we will often have an HFEA representative who will come in and will say this is what is changing and this is what is happening.'
Michelle (staff): ’Sometimes, I think that the forms are hard for the patients to interpret, let alone… and I have been on the HFEA website and it doesn’t really give you any more information.'
Michelle (staff): ’Sometimes it can be quite scary to contact the HFEA because they are the regulator and it is usually only the consultants and the senior nurses who have any contact with them, so they can seem for me quite distant.'
Training and support should be provided for the staff who are explaining consent and checking the forms.
✓Provide a contact person to answer queries at the HFEA (or provide FAQs for staff).
Potential for completed forms to be inadvertently given to other patients, breaching confidentiality Valerie (staff): '(I think that the forms should) have the patient’s name on the front. I think that was a really bad thing… So when you pick up that form though, we have had before, not very often but not that long ago, someone had filled it in, left it in an outpatient room, then a healthcare assistant was tidying up thought it was an empty form, stuck it in a consent pack, do you know what I mean? I think that it needs to be quite clear that this is somebody’s form.'✓Revise the form to include something on the front cover which clearly indicates completion.
Concern about consenting for a ‘future’ child Michelle (staff): ’The couple who wanted Yes for the research and then said No for anything after, I know for him it was about……(the child)…. even though she wasn’t pregnant at that point.'✓Consider separating the patient and child consents, or providing a better explanation of why both are required.
  • CD, consent for disclosure; FAQ, frequently asked questions; HFEA, Human Fertilisation and Embryology Authority; SMS, short message service.

  • Bold text signifies emphasis.