Welcome to my web site.
I am Inge Balling-von Cappeln,
retired lecturer living in Copenhagen.
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 (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
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
emergency research without consent.
(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.
For more information please follow the following links:
- The Nüremberg Code
- Dr.Adil E. Shamoo: June 2006, consent in emergency research Excerpt from this link :.." There are
to benefit subjects more than current treatments. ...."
- Information from EU in general about the clinical trials directive
- Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
- Convention for the Protection of Human Rights and Dignity
- Reply from Inge Balling-von Cappeln, a Danish citizen
- (links in the above text no longer operative) substitute by: Convention on human rights and bioethics
- Reply from The Danish Commitee for Preventive Medicine and Patient Care
- Summary of the replies to the public consultation on the Concept Paper
- Revision of the "Clinical Trials Directive" 2001/20/EC Concept Paper submitted for public consultation (deadline for replies May 13th 2011)
- Roadmap for 2011 is clinical directive here ?
- Roadmap for 2012 ,It's possible the Danish Presidency will inform you here
- An American hospital informs people in its area before starting an emergency research project
- Other replies
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.
Source: Section 2, 12 of The Danish Act on Research Ethics Review of Health Research Projects
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: