The Declaration of Helsinki
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The Declaration of Helsinki



The Declaration of Helsinki

The Declaration of Helsinki



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The Declaration of Helsinki The Declaration of Helsinki Presentation Transcript

  • The Declaration of Helsinki
  • Plan of Presentation• Introduction: History, Scope & Development• Ethical Problems• Arguments in support of FDA decision to abandon DoH• Arguments against FDA decision• Conclusion
  • What is Declaration of Helsinki?• Set of ethical principles• Developed by WMA for medical community – human experimentation• Followed Nuremberg Code (1947)• Regarded as cornerstone document of human research ethics• Included within clinical trial protocols
  • History of DoH• Adopted in June 1964• Has undergone 6 revisions• 2 clarifications• First significant effort by medical community to regulate research• Prior to Nuremberg Code only specific countries had National policies (Germany for Example)• Forms basis of most subsequent documents
  • Scope of DoH• Developed 10 prinicples first stated in Nuremberg Code• Linked to Declaration of Geneva (1948)• Statement of physicians ethical duties• DoH specifically addressed clinical research• Relaxed need for IC which Nuremberg code deemed ‘absolutely essential’
  • Development of DoH• 18th WMA General Assembly. Helsinki, Finland, June 1964 1. 29th WMA – Tokya, Japan, Oct-1975 2. 35th WMA – Venice, Italy, Oct-1983 3. 41st WMA – Hong Kong, Sep-1989 4. 48th WMA – Somerset West, RSA, Oct-1996 5. 52nd WMA – Edinburgh, Scotland, Oct-2000 6. 59th WMA – Seoul, Oct-2008• Clarifications of Articles 29 & 30 in 2002 & 2004, 53rd & 55th WMA General Assembly
  • Basic Principles• Confirm to the moral and scientific principles• Based on laboratory and animal experiments• Conducted only by scientifically qualified persons• Objective Vs. Inherent risk• Special caution should be exercised by the doctor
  • First Revision 1975• 11 years after first adoption of DoH• Introduced idea of oversight by Independent Committee• Led to developments of IRBs/IECs• Issues relating to IC developed – more prescriptive• Duty to individual given greater weight over duty to society• Ideas of publication ethics introduced• Comparison of trial treatment to best available treatment• Access to treatment following trial completion• Mandatory for protocols to state they adhered to th DoH
  • 2nd & 3rd Revisions 1983 & 1989• Fairly minor revisions• Consent of minors• Further development – Independent committees• CIOMS & WHO published International Ethical Guidelines for Biomedical Research Involving Human Subjects Developed in 1982
  • 4th Revision 1996• Allowed for use of placebo controlled trials• Only in cases where no proven diagnostic or therapeutic method existed• Followed AIDS study publication 1994• Maternal-Infant HIV Transmission & effect of Zidovudine• Drug showed 70% reduction in transmission rate and became standard of care• Subsequent HIV studies – US patient had unrestricted access to AZT• Patients in developing countries still randomized to placebo controlled arms
  • 4th Revision cont..• Conflicting guidance• 1994 WHO “Placebo controlled trials offer the best option for a rapid and scientifically valid assessment of alternative antiretroviral drug regimens to prevent transmission of HIV”• CIOMS – Ethical standards in developing countries should be no less exacting than those adopted within country initiating research
  • Consequence of 4th Revision• FDA ignored this revision – continued to refer to 1989 version• EU cited fourth revision in clinical trial directive of 2001• Adopted into UK National law in 2004
  • 5th Revision 2000• Extensive revision to structure of document• Extensive debate, symposia & conferences• No reference to research where there is no potential benefit to participants• Article 29 – Placebo controlled studies• Article 30 – After care trial participants• Led to clarification points of 2002 & 2004
  • 6th Revision 2008• Followed general review• Comparatively minor revisions• Extensive debate & consultation re: 5th & 6th revisons led to concerns• ? Ethical strength of DoH weakened
  • Points of controversy• Article 29 states:- – “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or, Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”
  • Points of controversy cont..• Article 30 states:- – “At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits”
  • Potential Ethical Problems• Possibility that placebo controlled trials might be allowed in emerging countries• Concerns re: availability of optimal care of patients• Able to use argument that ‘standard’ treatments not normally available within emerging country• Financial incentives for Pharma companies• Ethical Hypocrisy
  • Arguments in support of FDA Decision (1)• DoH was designed for regulation of physicians but:• “Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles”• DoH morally binding but not legally enforceable• Subsequent guidelines likely to be just as effective
  • Arguments in against of FDA Decision (1)• Have to agree DoH was primarily aimed at physicians and not legally enforceable• So too was Hippocratic oath (revised in Declaration of Geneva)• None would doubt the moral weight this carries• “Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in the Declaration”
  • Arguments in support of FDA Decision (2)• Hasn’t prevented ‘unethical’ practices continuing• Tuskegee study ended 1972• US Radiation experiments ended 1974• CNEP studies in prembabies at North Staffs Hospital in1990s• Alder Hay late 1980s & early 1990s
  • Arguments in against of FDA Decision (2)• Continuing unethical practices – True but abandoning DoH and adopting other guidelines unlikely to cause such aberrations to miraculously stop• Development of other Guidelines – Fundamental concerns with ICH GCP
  • Arguments in support of FDA Decision (3)• Other guidelines/regulations have since been developed• WHO• CIOMS• ICH GCP (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice)
  • Arguments in against of FDA Decision (3)• ICH GCP Guidelines driven by ‘interested parties’• ICH consists of drug regulators from US, EU & Japan, reps from pharma from same 3 areas and 3 observers (WHO, EU Free Trade Committee & Health Canada)• Risk that guidelines may be relaxed to facilitate Clinical Research
  • Arguments in support of FDA Decision (4)• DoH is now outdated by newer guidelines• Developed from DoH• More Comprehensive Guidelines• Should not assume pharma companies are morally corrupt
  • Arguments in against of FDA Decision (4)• Guidelines not legally binding in all countries• ‘Slippery Slope Argument’• Adoption and reliance upon ICH GCP depends on pharma companies regulating themselves• Demanding concept given huge financial pressures and incentives• Remember Germany was leader in introducing national policy on medical research – afforded little protection to those who suffered in WW2
  • Ethical Hypocrisy• Major argument against FDA decision• Globalisation of Clinical Research due to prohibitive cost of studies within the western world & access to standard treatments• Unacceptable to allow differing standards as suggested by drug companies when they refer to best standard of care in that area• Ethical tenets should be consistent and universal• If study unethical in US then it would also be unethical in Brazil
  • Is the DoH still relevant for the ethical conduct of clinical Trials?• YES• Remains morally binding for physicians over and above national/local laws and/or regulations• Less influenced by interested parties than ICH GCP guidelines• Provides basis for conduct of CTs and has a focus on protection of subjects/participants• “In medical research involving human subjects, the well being of the individual research subject must take precedence over all other interests” (Paragraph 6)• Upholds Kantian respect for persons and view that individuals should not be treated simply as a means to an end
  • References• WMA - Declaration of Helsinki – 2000 version (including notes of clarification 2002 & 2004)• WMA - Declaration of Helsinki – 2008 version• Human, D. & Fluss, S. (July 2001) “The World Medical Association’s Declaration of Helsinki: Historical and Contemporary Perspectives”• The Social Medicine Portal (1st June 2008) “FDA Abandons Declaration of Helsinki for international clinical trials” (accessed 20 Feb 2009)
  • Thankyou