CONSENT ADVANCE DIRECTIVES RESEARCH
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1 CONSENT ADVANCE DIRECTIVES RESEARCH 24TH ALZHEIMER EUROPE CONFERENCE SCOTLAND, GLASGOW, OCTOBER 2013 Maria do Rosário Zincke dos Reis
2 IN 2012 THE PORTUGUESE PARLIAMENT APPROVED THE ADVANCE DIRECTIVES LAW. SINCE THEN, ADVANCE DIRECTIVES ARE LEGALLY BINDING IN PORTUGAL. THEY MAY BE IN THE FORM OF A LIVING WILL OR IN THE FORM OF A HEALTHCARE PROXY.
3 Act of Parliament n.º 25/2012 of Regulates advance directives in the form of a living will and in the form of a healthcare proxy, creates the Living Will National Registration (Registo Nacional do Testamento Vital (RENTEV))
4 Ordinance n.º 96/2014 of Health Ministry Regulates the Living Will National Registration (RENTEV) Ordinance n.º 104/2014 of Health Ministry Adopts the living will registration form +uteis/testamento+vital/testamento+vital.htm
5 ACT OF THE PARLIAMENT Nº 21/2014 OF on the conduct of clinical trials on medicinal products for human use and medical devices
6 DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
7 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (partially adopted)
8 Article 8º Incapacitated adults not able to give informed consent nº 2 inclusion in clinical trials of incapacitated adults who have not given or not refused informed consent before the onset of their incapacity shall be allowed only if:
9 a) the informed consent of the legal representative has been obtained and the consent must respect the participant presumed will; b) The person not able to give informed consent has received information according to his/her capacity of understanding regarding the trial, the risks and the benefits; c) The explicit wish of the person who is capable of forming an opinion has been respected by the investigator;
10 Article 8º, nº 3 The clinical trial with intervention* in adults incapable of giving informed consent can be conducted only if: a) nº 2 conditions has been fulfilled; *the clinical trial with intervention is any investigation which would include a change, influence or programming of health care, behavior or knowledge of participants and caregivers in order to discover or verify health effects.
11 Article 8º, nº 3 The clinical trial with intervention in adults incapable of giving informed consent can be conducted only if: b) The clinical trial with intervention is essential to validate data obtained in cliniacl trials on persons able to give informed consent or by other research methods and relates directly to a life threatening or debilitating clinical condition from which the incapacitated adult concerned suffers;
12 Article 8º, nº 3 The clinical trial with intervention in adults incapable of giving informed consent can be conducted only if: c) The clinical trial with intervention has been conceived to prevent the disease, discomfort, fear, to reabilitate, and any other foreseeable risk related to the disease and developmental stage; both the risk threshold and the degree of distress shall be specially defined and constantly monitored.
13 In clinical trial without intervention, the limitations provided for in nº 3 of Article 8º do not apply but only those referred to in nº 2 of this Article do.
14 *A clinical trial without intervention is i) a study where the medicinal products are prescribed or the medical devices are used in the usual manner in accordance with the terms of the marketing authorisation or in the assessment and compliance proceedings, respectively; ii) The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice;
15 iii) the prescription of the medicine is clearly separated from the decision to include the patient in the study; iv) No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data.
16 If the person has given her/his informed consent before the onset of the disability, there are no limitations specified in nº2 a), b) and c) or nº 3 of Article 8º of the Act of the Parliament nº 21/2014 of 04.16: (remember: nº 2 inclusion in clinical trials of incapacitated adults who have not given or not refused informed consent before the onset of their incapacity shall be allowed only if.. )
17 WHAT DOES THIS MEAN?
18 This means that: if the participant had made a living will expressing her/his will to participate in clinical trials or made a health care proxy, the wishes expressed in advance have to be respected in the light of the Act nº25/2012 which regulates the advance directives in Portugal.
19 IT IS IMPORTANT TO NOTE THAT If informed consent has been provided by the legal representative (a guardian appointed by the court in the framework of an interdiction process) it is necessary to respect the limitations provided in nº 2 b) and c) (study without intervention) and nº 3 (study with intervention) of the same Article 8º.
20 IN CONCLUSION: ADVANCE DIRECTIVES (LIVING WILL OR HEALTHCARE PROXY) MAY GIVE A VERY IMPORTANT AND USEFUL CONTRIBUTION TO RESEARCH IN THE FIELD OF DEMENTIA ALLOWING TO OVERCOME THE INFORMED CONSENT BARRIERS.
21 For a society that really involves people with dementia and respects their rights.
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