ESSEX PAPER 3: INITIAL GUIDANCE ON THE INTERPRETATION AND IMPLEMENTATION OF THE UN NELSON MANDELA RULES Rule 32(2) addresses informed consent in the context of participation in ‘clinical trials and other health research accessible in the community’. Informed consent is always critical for participation in clinical trials or research.245 It is magnified in the context of deprivation of liberty.246 As in the community, informed consent must be obtained through the provision of information to the prisoner-patient by those conducting the trials or research (such as a company or research institute). An ethics committee must also be involved in order to provide an independent view on whether the treatment would produce a ‘direct and significant’ benefit to health. The Essex Group noted that the prison authorities are under an obligation to ensure that the trial has been officially approved by an appropriate body and that this information and the means of conveying it to the prisoner must be the same as in the outside world. Confidentiality The Essex Group reiterated the overall principle of confidentiality as set out in the first Essex paper. In that paper, the experts stated that, the principle of medical confidentiality is a fundamental tenet of medical practice and derives from the right to privacy as recognized in the International Covenant on Civil and Political Rights. It has also been set out in Rule 8 of the Bangkok Rules, the World Medical Associations International Code of Medical Ethics 1949 (revised 2006), the World Medical Association Declaration of Lisbon on the Rights of the Patient, the Dual Loyalty Guidelines, Principle X of the Principles and Best Practices on the Protection of Persons Deprived of Liberty in the Americas, and the European Committee for the Prevention of Torture (CPT) Standards. The Essex Group recalled that confidentiality in prisons should be understood in the same way as in the community at large.247 Rule 32(1)(c) requires the confidentiality of medical information ‘unless maintaining confidentiality would result in a real or imminent threat to the patient or others’. The Essex Group noted that the exception to confidentiality in Rule 32(1)(c) should be understood narrowly and not as applying to the whole medical file. Rather, it requires an assessment of which specific pieces of information need to be communicated and at what level on a ‘need to know basis’.248 The exception does not imply that the whole medical file should be shared but depending on the situation, a summary of the pertinent issues (such as whether illness may have contributed to a particular behaviour) may be necessary. Similarly, the medical staff may communicate that certain action is needed without communicating that the prisoner has a particular disease or illness. An assessment of who receives the information will also be needed bearing in mind the sensitivity and confidentiality of medical information. Part of the obligation of confidentiality covers the storage of confidential records as set out in Rule 26. The Essex Group noted that these records should encompass a full medical file, not simply a summary. Standard 39 of the CPT Standards provides that, World Medical Association, Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects adopted at 18th WMA General Assembly, rev. at 64th WMA General Assembly, Fortaleza, Brazil October 2013, available at: (http://www.wma.net/en/30publications/10policies/b3 ) paras 25 – 32 on informed consent in research (WMA Declaration of Helsinki) 245  See WMA Declaration of Helsinki; CPT Standards; Council of Europe: Committee of Ministers, Recommendation No. R (93) 6 concerning prison and criminological aspects of the control of transmissible diseases including Aids and related health problems in prisons (1993) available at: https://bip.ms.gov.pl/Data/Files/_public/bip/prawa_czlowieka/ zalecenia/936.pdf; Council of Europe, Additional protocol Human rights to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Strasbourg 2005 (art 20), available at: https://www.coe.int/en/web/ conventions/full-list/-/conventions/rms/090000168008371a 246  CAT SMR revision observations, para.21 247  World Medical Association, Medical Ethics Manual (3rd edition 2015), available at: http://www.wma.net/en/30publications/30ethicsmanual/pdf/ethics_manual_en.pdf, at 53-56 248  Penal Reform International and the Essex Human Rights Centre | 68