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  • Findings of the Cumberlege Review: informed consent (July 2020)

    PatientSafetyLearning Team
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    Chaired by Baroness Julia Cumberlege, the Independent Medicines and Medical Devices Safety Review report, First Do No Harm, examines how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices. In this blog, Patient Safety Learning reflects on one of the key patient safety themes featured in the Review – informed consent. 


    In our recent blog Analysing the Cumberlege Review; Who should join the dots for patient safety? we identified a number of key patient safety issues which were reflected in the Review’s findings. One theme running throughout the Review was a failure to engage patients in their care, most noticeably around the issue of informed consent.

    What is informed consent?

    The NHS definition of informed consent is that “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead”.[1] The landmark UK Supreme Court judgement Montgomery v Lanarkshire Health Board case in 2015 reaffirmed this principle in law, setting out the legal duty of doctors to disclose information to patients regarding risks.[2]

    Review findings

    Patients being unable to make decisions on the basis of informed consent was a recurring theme in the review, manifesting itself in several ways:

    1. Patients’ consent not being sought - the Review heard from patients where consent was not given for the procedure carried out, particularly in cases for implanting pelvic mesh. The authors of the Review state that they were “appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”.[3]
    2. Patients lacking information – this was a consistent issue concerning patients regarding the three interventions considered by the Review: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One specific example of this is the case of pregnant women taking sodium valproate as an epilepsy treatment without knowing that doing so could harm their unborn child. Despite efforts to make patients aware of this, it remains an issue, with women who are taking sodium valproate as a epilepsy treatment “still becoming pregnant without any knowledge of the risks”, lacking the information to make the decision about whether to continue with this medication.[4]
    3. Patients not being involved in decision making – the Review also heard from patients who raised concerns about the failure of informed consent as a result of doctors choosing not to share relevant information with patients for their decision-making. They refer to cases where doctors did not discuss the risks with women taking sodium valproate prior to pregnancies and “gave advice based on their own assumptions, without involving patients in the decision-making process”.[5]

    Concerns around the absence of informed consent go beyond the procedures focused on in the Review. On the hub, we have featured community discussions and patient accounts of these issues in relation to hysteroscopy procedures, while earlier in the year the Paterson Inquiry highlighted concerns about this, recommending that a short period should be introduced into surgical procedures to allow for patients to provide their consent.[6]

    How can we ensure informed consent is gained?

    The Cumberlege Review notes that, since the Montgomery ruling in 2015, there has been a significant increase in patient safety leaflets sharing information on risks of specific treatments, but that the sheer variety of these and differing consent forms can be “bewildering and a major source of confusion”.[7] The Review is supportive of an approach where information is conveyed in a clear and direct way, and where  patient decision aids are used in complex conversations to support the consent process.[8]

    At Patient Safety Learning, we believe it is important that patients are not simply treated as passive participants in the process of their care. Informed consent is vital to respecting the rights of the patient, maintaining trust in the patient-clinician relationship and ensuring safe care. We have identified three calls for action which we believe are needed to tackle the failure of informed consent:

    1. All patient information should be co-produced with patients to ensure that it meets patient needs for decision-making.
    2. Repositories of information and good practice are put in place so that organisations don’t have to re-invent the wheel but instead can learn from experience.
    3. Patient information for medication and medical devices should be reviewed and signed off by the NHS to ensure that it is not solely the responsibility of manufacturers.

    What are your thoughts on this issue? Have you had an experience where you feel that you have not given informed consent before receiving medical care? Are you a healthcare professional who can share resources for good practice? Let us know in the comments below to ensure our calls for action are informed by your experience and insights.


    1. NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/
    2. UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015. https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf; Lee, Albert. “'Bolam' to 'Montgomery' is result of evolutionary change of medical practice towards 'patient-centred care'.” Postgraduate medical journal vol. 93,1095 (2017): 46-50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5256237/#R3
    3. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
    4. Ibid.
    5. Ibid.
    6. Campaign Against Painful Hysteroscopy, Patients Stories Essay, September 2018. https://www.hysteroscopyaction.org.uk/wp-content/uploads/2018/10/sept-2018.pdf; The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf
    7. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
    8. Ibid.
    1 reactions so far


    Recommended Comments

    All the 3 recommendations made above are very important and are in line with the current review/recommendations of patients being at the center of patient safety.

    Coming from a research background, the importance of informed consent is vital and some of the principles used during informed consent within a clinical trial setting should be the norm throughout the whole healthcare system. 


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    @HelenH They are normally included in the Good Clinical Practice(GCP) guidelines which everyone involved in research has to do inform of a face to face learning day or a refresher course online if you have done a face to face one before. 

    Here is a link: Good Clinical Practice 

    Will try and upload some content around it as well. 

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    @HelenH @Steph O'Donohue I have found a Module summary that i did a couple of years back on 'The process of Informed Consent' and have attached it below.

    The process of informed consent in clinical research is thorough:

    • Its an ongoing process 
    • Voluntary participation
    • informed decision
    • process is well documented
    • The person is at the centre of the process

     and i think would be of benefit to patients and their safety if applied in the wider clinical setting as patients should be participants in their own care and their choice to participate in any aspect of their care should always be confirmed and affirmed every step of the way.

    Let me know your thoughts please and if it is useful.



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    Hi @Shamim Odera RN thank you for posting this, really very interesting and useful.

    Do you know if there is a version online or if you would have permission to reuse? Or perhaps you are the author? If you do have permission, you could add it to the hub via the 'Share' option. Any problems sharing resources and just get int ouch - one of our team will chat you through the process. 

    Also, I have now added the GCP to the hub - thank you for the recommendation. 

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