Patient consent and confidentiality

BMJ’s policy is based on BMJ’s values, EU data protection law, the English common law of confidentiality, and guidance issued by the General Medical Council and the Committee on Publication Ethics (COPE).

Any manuscript containing patient personal data must comply with BMJ’s policy on anonymisation and patient consent and confidentiality. BMJ reserves the right to refuse to publish any manuscript which does not comply with the requirements set out in this policy.

BMJ’s patient consent policy

 

Any article that contains personal medical information about an identifiable living individual requires the patient’s explicit consent before we can publish it. We will need the patient to sign our consent form, which requires the patient to have read the article. If the patient has not seen a final version of the manuscript to be submitted to BMJ, the form must be amended to make clear what the patient has seen and that they have agreed to publication without having seen the final version of the manuscript. The consent form is available in multiple languages and the author must ensure that the form is in a language that the patient understands. When informed consent has been obtained it is indicated on the published article.

If consent cannot be obtained because the patient cannot be traced, then publication will be possible only if the information can be sufficiently anonymised*. Anonymisation means that neither the patient nor anyone else could identify the patient as detailed in our standard on anonymisation. A consequence of any anonymisation is likely to be the loss of information/evidence.

*This does not apply for BMJ Case Reports which requires a signed patient consent form for every case report submitted about a living individual, without exception.

Deceased patients

If the patient is deceased the UK data protection law does not apply, however BMJ requests that the author(s) seek permission from the next of kin as a matter of courtesy and medical ethics. Please use our BMJ deceased patient permission form for articles reporting on deceased patients, if this is relevant to your submission. If the relatives are not contactable we will balance the worthwhileness of the case, the likelihood of identification, and the likelihood of causing offence if identified in making a decision on whether we should publish without a relative’s consent.

For BMJ Case Reports, a document must be submitted confirming that exhaustive attempts have been made to contact the family and that the paper has been sufficiently anonymised not to cause harm to the patient’s family.

Children

If the patient is under the age of 18, we require parents or guardians to provide consent on behalf of the minor. Where the child has sufficient understanding of the consent process and its implications, the child must also sign the consent form. For younger children, even if parents consent, authors should consider whether the child might regret publication of his or her identifiable details in the future.

That ultimate decision to use material involving children (and those unable to legally consent for themselves) will rest with the editor of the journal. The editor will consider the possibility of future damage to an individual from publication of material about them as a minor. For controversial cases, additional advice will be sought from our ethics committee.

Patients who lack capacity

If the patient lacks the mental capacity to make a decision about publication our advice is that usually no one can give consent on behalf of the patient. Even if someone has this power, by means, for example of a health and welfare power of attorney, it has to be exercised in the best interests of the patient. There may be some benefit to the patient in having his or her case described in a publication, but usually this is not obvious or certain. In such cases we will normally require any personal information to be anonymised or will not be able to publish it.

Images of patients

Our policy on obtaining consent for publication of pictures or videos of patients is a subset of our general policy on patient confidentiality. If there is any chance that a patient may be identified from a photograph or other static or moving image, or from its legend or accompanying text, we need the patient’s written consent to publication by BMJ.

  • Images – such as x rays, laparoscopic images, ultrasound images, pathology slides, or images of undistinctive parts of the body – or multimedia files (e.g. video, audio) may be used without consent so long as they are anonymised by the removal of any identifying marks and are not accompanied by text that could reveal the patient’s identity through clinical or personal detail.
  • An exception to this policy of needing consent for recognisable photographs of individuals is when we use photographs from picture agencies to illustrate news stories and other articles. We state where these photographs have come from and we rely on the fact that the agencies and their photographers have obtained the relevant permissions from the people shown in the photographs. If we doubt that someone photographed could have given consent – owing for example to severe mental illness or learning disability – we will use our discretion and avoid using such images.

BMJ’s standard on anonymisation

 

It is BMJ’s view that patient confidentiality and “true anonymisation” can never be 100% guaranteed. We consider this to be particularly the case given the increasing general availability of data in the public domain including social media platforms. The objectives of this policy are therefore to ensure a balance between the protection of patient confidentiality whilst at the same time seeking to facilitate the serious communication of medical information in accordance with BMJ’s values.

This policy defines what BMJ considers to be “sufficient anonymisation” for the purposes of research publication. BMJ’s policy aims to ensure that patients are not directly identified and are unlikely to be identified through a combination of indirect data. This policy also seeks to safeguard patients by requiring that patients are fully informed of the risk of the potential disclosure of their personal data through research publication and have consented on this basis.

How to check an article is sufficiently anonymised

BMJ will consider an article to be sufficiently anonymised where there are NO DIRECT IDENTIFIERS and no more than TWO INDIRECT IDENTIFIERS. Conversely, BMJ will not consider an article to be sufficiently anonymised if it includes one or more direct identifiers, or three or more indirect identifiers as listed in BMJs standards of anonymisation checklist. In most cases, identifiers can be removed or generalized without affecting the readability or understanding of the study or the conclusions drawn.

The BMJ standards for anonymisation are followed by all BMJ editorial staff assessing identifiable data and should be followed by all authors wishing to submit an article containing patient identifiable information for publication with BMJ journals.

Anonymisation of images

BMJ do not accept images where facial features have been obscured (either by blurring or by black bars placed over the eyes) as it is considered to be an ineffective measure of preserving anonymity and could imply that the relevant permissions have not been obtained prior to publication. If a submitting author provides a signed BMJ consent form for full facial images, we will request an unobscured version so it is clear to our readers that the patient has consented for their image to appear in our publications. Please ensure all images are cropped to show only relevant clinical features.

Patient consent form

 

Please use our consent form for any image, multimedia file or description that needs consent to publication.

Please print out the form, fill in the details, ask the patient or next of kin to read and sign the form, sign it yourself and submit it with the File Designation “Supplementary file for Editors only”. Please note we do not accept forms that are electronically signed.

COVID-19 UPDATE: To account for the restrictive measures in place due to COVID-19, we will permit digital signatures where a handwritten signature is not possible.  If you are unable to obtain a digital signature, an audio recording of consent may be permitted where the patient expressly states they agree to the terms in the BMJ patient consent form.


Patient consent form (lang)