Table 3

Factors that may influence the representativeness of the data available to researchers

Characteristic influencing responseExemplar quotes
Educational attainment and literacy: Where patients do not understand the forms or the point of disclosure they are less likely to give consent to disclose PII. Mark (staff): ‘Some patients they say that if they do not understand or they are hesitant, they just tick, no, no, no.’
Language barriers: For patients who do not speak English, staff focus on explaining treatment and have little time to devote to explaining the consent for disclosure forms. Barbara (staff): 'we do have a lot of people who we need to have interpreters or we need to use language line with and that can be quite stressful for the patient because they have got a stranger in the room talking about their very personal business and in fact I had a very lovely couple but he was, because of his religion he had great difficulty using words like sperm and egg. It was very hard.
To be honest with you, we don’t probably talk about research in that situation because it would be too difficult and confusing for them, I think.’
Cultural attitudes to infertility: Differences in uptake across some BME groups; men may be less likely to agree to disclose their information than women. Valerie (staff): '(British Asians) are very protective about their confidentiality and they always think that it is going to link in even if we are saying, this is just data, and it is numbers. I find them very much more private.’
Nicola (patient): ’I think it stems from this very basic fact, in the beginning that conception is normally a sexual act and it is something very private and you don’t normally discuss that with your grandmother and your aunt and everybody else, you just announce the happy news and everyone pretends they don’t know how it happens.’
Individual clinics: Consent rates vary by clinic. Some spend more time and effort explaining the forms (eg, text message prompts to complete clinic-specific information sheets). Clinics where research is part of their culture may have better rates. Mark (staff): ’Our nurse co-ordination time is 1 hour… Now when I was at the NHS, they (had) group co-ordination. Ten couples do one night to discuss about the treatment and things and then they will be seen individually after the co-ordination, so the individual appointment will be just like 15 minutes.’
NHS versus private setting: NHS patients may not get as much time with staff as private patients, and in some settings they have initial nurse consultations (to explain timing, drugs and forms) as a group. Self-funded patients do not even have to tell their GP that they are receiving ART, and may also be less likely to disclose PII for research. Alex: ’we were so grateful to have the opportunity to receive IVF treatment through the NHS. We almost felt that we were helping research by providing data.’
Mark (staff): ’Because this is a private clinic, most of the patients don’t want to disclose their information to their GP…. you just have to explain why do I have to give information to my GP. That is the most common question. Why do I have to tick this?’
Diagnosis: Stephen (staff): ’The thing is the patients that want to keep it more private tend to also want to put restrictions on other things as well. I mean I would say, it’s probably a bit more likely (to refuse consent) if they are using donor gametes.’
Successful outcome of treatment: Can work both ways. Refusing consent after treatment could be important if opt-outs are applied retrospectively. Jude: ’The first time I agreed because I believe in the value of sharing information for research purposes. However, the second time I completed the forms, I had a child (born from successful first treatment) and I did not feel happy with the clause that noted agreeing to disclose information meant that my child’s identifying information would automatically be disclosed as well. It felt inappropriate and intrusive to my child’s privacy. After much agonising, I refused, even though I regretted having to hold back my own information.’
Karen, who completed the forms more than once, described how she had changed her mind: ’I don’t think that you fully appreciate what is being asked of you…We have a son, we have benefited from other people participating in research. So, it put a different perspective on it as we could see why it was important to actually be included in the future.’
  • ART, assisted reproductive technology; BME, black and minority ethnic; GP, general practitioner; IVF, in vitro  fertilisation; NHS, National Health Service; PII, patient identifiable information.

  • Bold text signifies emphasis on the issue identified and the individuals who are quoted to support the findings.