Introduction
Using forms to document consent
Methods
Setting
Design
Procedure
Quantitative content analysis
Sample size
IFs study interview schedule | Consent and confidentiality study topic guide |
---|---|
• What sort of genetic tests are you organising and what range of results will these give? • How often do you order genetic tests? • What are the lab protocols for reporting results? • What are your ‘usual’ processes of seeking consent for genetic tests? • What is your experience of gene panels and how do you seek consent for these types of tests? What do you include/exclude in this discussion? • If consent is sought by non-geneticists, are there any issues this raises? • What is your understanding of the term IF? • Can you give any examples from practice where IFs have been discovered? What happened in these cases? • Are you aware of any available guidelines to help direct practice? • How do you see this issue developing in the future as genetic technologies continue to develop? • What measures would you like to see/ find useful to assist in your practice? • Is the issue of managing IFs being addressed in training of HCPs? | • What is your role? • What kinds of patients do you see? How many per week? • What other departments do you work with? Is confidentiality important in the area of medicine that you are working in? • Why do you think it is important from a patient’s point of view? • And why from a healthcare professionals’ (HCPs’) perspective? What aspects of the medical consultation should be kept confidential? • Probe about personal versus familial genetic information • Probe about confidentiality in genetic medicine versus other areas of medicine Are there guidance documents or protocols you follow for confidentiality? • What do they say? • Are they widely read? • Do people agree with them? What does/should the consent process involve when a person has a genetic test? • Is there an official consent process in your department? • How, if at all, do you talk about the limits of confidentiality in the consent process? • What do you consider these limits to be? Have you ever had a patient tell you that they were not going to inform their family of a risk? Or been unsure whether a patient had told? • To what extent do you feel like you have a responsibility to ensure patients’ family members know their risk? • What, if any, limits does this responsibility have? Regarding these issues, do you feel like you have enough support and training? Who do you talk to about ethical issues? |
Recruitment
Analysis
Findings
Quantitative content analysis
(How) do genetic services’ forms mention the use of test results to benefit relatives?
(How) do forms mention IFs?
Aside from the JCGM statements, what else do forms mention?
Statement | No. of services that included them (and response options) |
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Opportunity to name an individual to receive result if patient is unable | 9 |
Patient can change mind about receiving results | 8 |
Understand sample will be used anonymously to develop new testa
| 7 (one gave choice) |
Choice whether to receive results | 6 |
Confirmation that written information has been given | 6 |
Confirmation that patient understands the implications | 5 |
Confirmation that patient has been given opportunity to ask questions | 4 |
Option to not allow General Practitioner or speciality doctor to obtain result | 4 (all gave choice) |
Name of interpreter | 3 |
Possibility for “no answers to be found” from the genetic test | 3 |
Understand sample will be used anonymously for research | 2 (one gave choice) |
Understand may be contacted for research studies | 2 |
Possibility that testing could impact insurance premiums | 2 |
Choice of route to receive results (e.g. phone, clinic, letter) | 2 (both gave choice) |
Understand result will be part of electronic medical record | 1 |
Qualitative thematic analysis
HCPs views on how forms facilitated good practice
FG12P6 “[Some clinicians] weren’t really aware consent was needed. [Mainstreaming means this has] become more of a problem recently.”
P26 “People stop and think this is a different type of test to others, because you don’t normally sign a consent form when you have a blood test.”FG15P5 “The number of boxes they have to read and initial might encourage people to think about it.”
FG16P3 “[We’re not] breaching confidentiality then, because [we’]ve got permission.”
FG10P1 “It’s like a legal document but it’s not legally verified: it’s just for our peace of mind.”P31 “You may think the [NHS] organisation would require it to protect them, but I’m not sure written consent would achieve that.”
HCPs views on how forms constrained, or had limited use in, facilitating, good practice
FG8P2 “Our [form] is very much longer and more complicated than anyone else’s. I’m sure patients think, ‘oh my god’ when they see it, the amount of words. People often question the wording: are we going to write to their doctors first? Are we going to be writing to [or] contacting their family members? There’s a bit of anxiety.”
FG8P4 “It’s only because we’re asking them to tick something that it becomes a major issue. They think there’s a hidden agenda…that we’re going to find all their family members.”
P31 “We [seek written consent] for taking photos of a child because we want to define for the family what we might use those photos for. There is a parallel there with what the blood might be tested for.”
FG8P2 “[Forms are already] unnecessarily long, laborious, wordy, in the smallest print, complicated, [with] umpteen questions.”
FG6P3 “Most patients don’t know they’ve had a genetic test, even though they’ve signed a form. It’s sometimes not worth the paper it’s written on. It’s more important that that patient actually understands, that you’ve communicated that to them.”
FG8P4 “You don’t want such tight consent that you can’t use it”
FG7P3 “[Testing] can be ongoing: the reason to not discuss that [possible] diagnosis first is because [parents]’ll go straight on the internet, look it up, join a support group and then it’s not [the right diagnosis.]”
P27 “We specify the condition we’re testing for, or the genes relating to [it]. You’d expect therefore only to feed back results relating to that condition. To give them the IF is outside of that written consent.”