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The Declaration of Helsinki and 'The Role of Physicians' :

The Declaration of Helsinki and 'The Role of Physicians'

Aims of this presentation:

Aims of this presentation To care for and protect the Research ‘Subject’ Review some Codes of Practice Identify the underlying Ethical principles Illustrate how they are applied in the Declaration of Helsinki Discuss the specific role and responsibilities of the Physician Researcher

Protection of the Human Subject in Medical Research:

Protection of the Human Subject in Medical Research Cultural Mores Laws respecting Human Rights Consensus Guidelines Professional Codes of Conduct Individual Conscience Research Ethics Cttee

The Medical Conscience:

The Medical Conscience Conscientiousness is the readily identifiable mark of a good physician It reflects someone who is ‘habitually governed by a sense of duty ’ .

The Medical Conscience:

The Medical Conscience It is this ‘internal’ governance that is key to the trust, which patients continue to place in the medical profession worldwide irrespective of the system of healthcare

Codes and Guidelines:

Codes and Guidelines Nuremberg Code (1947) W.M.A’s Declaration of Helsinki (1964) Belmont Report (USA) (1979) C ouncil for I nternational O rganizations of M edical S ciences ( CIOMS) 1993 I nternational C onference on H armonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , in 1996 , Guideline on G ood C linical P ractice ,E6 (GCP)

Nuremberg Code (1947):

Nuremberg Code (1947) Voluntary & Informed Consent Experimentation on humans had to be necessary and yield benefit that overweighed the risk Right to withdraw without penalty Subject must be protected against possible injury, disability, or death Research only conducted by scientifically qualified personnel

1979 Belmont Report :

1979 Belmont Report Three ethical principles related to research on human subjects: Respect for Persons -Individuals should be treated as autonomous agents -Individuals with diminished autonomy are entitled to protections Beneficence -Do not harm -Maximum possible benefits, and minimize potential harms Justice -Fair distribution of burdens and benefits of research

Seven Ethical Pillars of Clinical Research:

Seven Ethical Pillars of Clinical Research Autonomy Beneficence Non malfeasance Fidelity Truthfulness Confidentiality Justice

Declaration of Helsinki 1964:

Declaration of Helsinki 1964 Potential benefits must outweigh hazards The need for informed consent A distinction between Scientific and Clinical Research

Declaration of Helsinki Revisions:

Declaration of Helsinki Revisions 1 st 1975 Tokyo 2 nd 1983 Venice 3 rd 1989 Hong Kong 4 th 1996 Somerset West. S. Africa 5 th 2000 Edinburgh 6 th 2004 Scotland

Declaration of Helsinki Autonomy :

Declaration of Helsinki Autonomy Consent Para 20 The subjects must be volunteers and informed participants in the research project. Para 22 After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent , preferably in writing

Declaration of Helsinki Beneficence:

Declaration of Helsinki Beneficence Para 5 In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society Para 18 Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject

Declaration of Helsinki Non Malfeasance :

Declaration of Helsinki Non Malfeasance Para 16 Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others.

Declaration of Helsinki Fidelity – duty of care:

Declaration of Helsinki Fidelity – duty of care Para 11 Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation

Declaration of Helsinki Fidelity – duty of care :

Declaration of Helsinki Fidelity – duty of care Para 15 Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent

Declaration of Helsinki Truthfulness - Honesty:

Declaration of Helsinki Truthfulness - Honesty Para 27 Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available

Declaration of Helsinki Confidentiality:

Declaration of Helsinki Confidentiality Para 21 Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

Declaration of Helsinki Justice:

Declaration of Helsinki Justice Para 30 At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study

Declaration of Helsinki Justice:

Declaration of Helsinki Justice Para 8 Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized .

Declaration of Helsinki Justice:

Declaration of Helsinki Justice Para 9 Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.

Declaration of Helsinki 2000 Revision:

Declaration of Helsinki 2000 Revision Changes made: 08 Research on people from vulnerable groups 13 Ethics Committees have right to monitor research conflicts of interest to be disclosed 16 Design of studies to be publicly available 21 Protection of Confidentially of information about patient

Declaration of Helsinki:

Declaration of Helsinki Para 29 The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists

Declaration of Helsinki :

Declaration of Helsinki Note of clarification on paragraph 29 of the WMA Declaration of Helsinki The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: - Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or - Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

Declaration of Helsinki:

Declaration of Helsinki ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE Para 30 At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study

Declaration of Helsinki:

Declaration of Helsinki Note of clarification on paragraph 30 of the WMA Declaration of Helsinki ‘The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.’

Duties of the Physician Researcher:

Duties of the Physician Researcher Para 2 “It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.”

The Ethical Responsibility of the Physician Researcher:

The Ethical Responsibility of the Physician Researcher Para 10 ‘ It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject’ Para 15 ‘The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent’ WMA Declaration of Helsinki

The Ethical Responsibility of the Physician Researcher:

The Ethical Responsibility of the Physician Researcher Para 15 ‘Medical Research involving human subjects should be conducted only by scientifically qualifies person and under the supervision of a clinically competent medical person’ WMA Declaration of Helsinki

Declaration of Helsinki:

Declaration of Helsinki Para 17 ‘ Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed.. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results

Declaration of Helsinki:

Declaration of Helsinki Para 22 ‘…after ensuring that the subjects has understood the information, the physician should then obtain the subjects freely-given informed consent, preferably in writing….’