Welcome to my web site. 

                                                             I am Inge Balling-von Cappeln, 
                                                          retired lecturer living in Copenhagen.
                                                   
                                                         http://www.ingeballing.dk/publikationer   


                                                        The Revision of the directive became a REGULATION 
             
                                    Please see below what´s new  especially about  emergency research :


                                    (36) This Regulation should provide for clear rules concerning informed consent in emergency situations. Such situations relate to cases where for example a patient has suffered a sudden life-threatening medical condition due to multiple traumas, strokes or heart attacks, necessitating immediate medical intervention. For such cases, intervention within an ongoing clinical trial, which has already been approved, may be pertinent. However, in certain emergency situations, it is not possible to obtain informed consent prior to the intervention. This Regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions. In addition, the said clinical trial should relate directly to the medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative. Any previously expressed objection by the patient should be respected, and informed consent from the subject or from his or her legally designated representative should be sought as soon as possible.
 


                                                  regulation of 2014 

 REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products  for human use, and repealing Directive 2001/20/EC      
            
                                                     draft regulation 

                                  
                                        Clinical trials in EU
         The aim of the site was to inform and to encourage debate during the revision period-

                     Revision of the Clinical Trials Directive was  planned  for a long time 
                    and was  intended to take place under the Danish Presidency  spring 2012

                   This site concentrates on EU´s  proposal and  later acceptance of 
                                                             legalising

                 emergency research without consent.
 
      


ABSTRACT from  Macklin, R. (2003), Bioethics, Vulnerability, and Protection. Bioethics, 17: 472–486. doi: 10.1111/1467-8519.00362

" What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics?A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. The type of multinational research likely to raise the most ethical concerns is that in which the investigators or sponsors are from a powerful industrialised country or a giant pharmaceutical company and the research is conducted in a developing country......"



                      

(You´ll find little information  from EU about emergency research without consent !)

              


                   
            Emergency research without consent from the research subject  !
                   How to make it ethically acceptable? Click on the link below.

You can make contact to the Commitee for Preventive Medicine and Patient Care,click here.

(see updates)
For more information please follow the following links:




Here is what in accordance with the  Danish Law L169 of June 1st 2011 is planned to become legal in EU:

Trial guardian: A unit consisting of two doctors who in acute situations, cf. Section 12, may give proxy consent on behalf of the trial subject for participation in a health research project that concerns clinical trial of medicines. The trial guardian must safeguard the trial subject’s interests and be independent of the investigator’s interests and interests in the research project otherwise.


This is an excerpt from a reply from the Danish Ministry of the Interior and Health. If you would like to read the full reply please click here to download the PDF document (81 KB)


Transparency under the Danish Presidency? Not quite. The forerunner for the revision of  the clinical trials directive:, click below:

Updates
  • John Dalli
    Tekst xxxx
    Posted Jul 30, 2012, 7:52 AM by Inge Balling-v. Cappeln
  • JOHN Dalli´s speech March 7th 2012 on the revision
    March 7th 2012 John Dalli´s important speech about the revision

    John Dalli 
    Member of the European Commission, responsible for Health and 
    Consumer Policy 
    Commissioner Dalli delivers speech on 
    "Clinical Trials Directive – Meeting 

    Revison of the directive  will be a  REGULATION.
    Posted Mar 26, 2012, 4:55 AM by Inge Balling-v. Cappeln
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