School of Medicine Undergraduate eLearning School of Medicine Consent Policy Introduction This policy governs the use of any patient-identifiable data (including multimedia) in educational materials and the need to obtain patient consent before such materials can be used. This policy is supplementary to local Health Board policies and the acquisition and use of patient data must conform to local Health Board policies at all times. This includes local policy on Capacity to Consent and Data Protection, which are not directly addressed within this policy. What is Consent? Within a clinical and educational context, consent is the act of a patient granting permission to use information or media relating to their clinical history for the purposes of delivering medical education. Consent should be explicit i.e. should be acquired for a clearly defined purpose. Vague statements such as “for any other purpose” are not acceptable and are unlikely to hold up if challenged legally. Ideally, this requires the patient to be fully informed about where, when and how an item of data will be used. When using materials that require consent it is important to ensure that the original consent obtained is sufficient and appropriate for your current use of the materials. If consent is lacking it is vital that the patient is contacted and their consent is obtained for the new use of their data. You should not assume that consent will automatically transfer from one use to another. Withdrawal of Consent It is also very important to note that the patient has the right to withdraw consent to use their data in any fashion. If consent is withdrawn then any use of that data must cease immediately. The exception to this is where the patient has consented to use of their data in a uncontrolled manner, such as publication in a journal, or in education, within a freely shared Digital Learning Object. In such cases it would be impractical or impossible to withdraw all copies of the data, but for this reason it is vital that explicit, informed consent is obtained before using patient data in this fashion. In addition to withdrawal of consent the patient can demand that their patient record and all controlled derivatives are destroyed. Again, where the patient has consented to use of their data in a uncontrolled manner, this may not be practical. What Requires Consent? Last updated: 10th August 2010 (DRAFT) School of Medicine Undergraduate eLearning Consent is required to use almost any part of a patient record in educational materials. This includes patient data, multimedia (images, audio, video etc.). Under the Data Protection act, any recording taken as part of a patient’s health care treatment (i.e. while the patient is being examined or is receiving treatment) is considered a part of the patient’s record. (Ref. 1) In these cases the data almost always requires consent for use as an educational asset. Where the data is obtained outside of the course of assessment and treatment then the data is not considered part of the patient record and is not subject to consent. However, where media is requested from a patient outside of the course of normal treatment the patient is considered an actor and normal actor release agreements should be obtained for the media. Exceptions There are a number of exceptions where consent is not required, but these all come with caveats: ● The GMC consider certain images to be anonymous: ○ Images from pathology slides ○ X-rays ○ Laparoscopic images ○ Images of internal organs ○ Ultrasound images Such images can be used without consent provided any identifying marks have been removed from the images AND provided the condition depicted is not so rare that the patient identity could be deduced from details of the condition itself. ● Clinical images that pre-date 1997 The GMC accept that large amounts of clinical photography and slides will pre-date 1997, when consent became common practice. Many of these images will have significant educational value and may be very difficult to replace. In such cases these images may continue to be used provided the images are anonymised and provided all attempts are made to replace the images as soon as possible. Anonymising Images All images should be anonymised if at all possible, regardless of consent, however, anonymising images IS NOT a substitute for obtaining consent. The only exceptions for obtaining consent are those listed above. Obtaining and Tracking Consent In the case of images and other media, some form of consent is often obtained at the time the media is created. In many cases this will be have been done by the local Trust’s clinical photography department, and the consent will have been obtained and recorded there. When using patient data in educational materials it is important first to check that consent has been obtained and to ensure the consent obtained is appropriate for the intended use. For consent to be considered “informed” the patient should be fully aware of when, where and how their data is being used. This may require additional consent to be sought from the patient on a case-by-case basis. When contacting a patient to confirm or extend Last updated: 10th August 2010 (DRAFT) School of Medicine Undergraduate eLearning consent, be careful in the way the patient is contacted and “who” is contacting the patient. There has been at least one case where a Trust patient has been contacted on University headed paper and the patient in question has complained about a breach of Data Protection because the University appeared to have access to his medical records. Of particular importance is ensuring appropriate consent is obtained when media or data will be either shared with other institutions or made openly available across the Internet. In these circumstances the patient must be fully aware that these materials, when published in this fashion, are uncontrolled, meaning the patient’s ability to withdraw consent is removed. This excludes publication via Blackboard, which is a controlled environment. Responsibility for ensuring appropriate consent is in place lies with the author of the content. Where patient data is used in educational materials authors should, where possible, indicate from where the materials have been sourced and where the consent record is held. References Ref 1 Higher Education Academy, Medicine, Dentistry and Veterinary Medicine FAQ - What can you tell me aout obtaining patient consent for the use of audio/visual recordings (such as images and sounds) in leearning and teaching? http://www.medev.ac.uk/resources/faq/display_single/?autonum=66 Downloaded 14th June 2010 Last updated: 10th August 2010 (DRAFT)
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