ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN SUBJECTS

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ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON
HUMAN SUBJECTS
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Definition

• Ethics
• A set of principles of right conduct.
• A theory or a system of moral values
• The rules or standards governing the conduct of a
  person or the members of a
  profession medical ethics.
• Principles of proper professional conduct
  concerning the rights and duties of physician,
  patients and physicians actions in the care of
  patients
• Moral principles defining right and wrong

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BACKGROUND
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• Nazi war crimes (1939 45)
• Tuskegee Syphilis Study (1932 72)
• Jewish Chronic Disease Study (1963-66)
• Willow brook Study (1963-66)
• Uterine Cervical Dysplasia (1976 88)
• In R.C.C (1999,2005)

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Codes of Ethics

• The Nuremberg Code 1947
• Universal Declaration of Human Rights 1948
• Declaration of Helsinki 1964
• Belmont Report 1979
• FDA Regulations (21 CFR 50) 1980
• CIOMS Guidelines 1982
• The Common Rule 1992
• OHRP 2000
• ICMR Guidelines - 2000

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Vulnerable Populations

• Children.
• Individuals with questionable capacity to
  consent.
• Prisoners.
• Foetuses and pregnant women.
• The terminally ill.
• Students/employees.
• Comatose patients.

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Shortfall

• Prisoners
• Employees
• Illiterates
• Handicapped persons
• Women in general (illiterate, widows)
• Children (orphans, children of prisoners,
  mentally handicapped children)

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BASIC FACTORS ENSURED IN A MEDICAL AND RELATED
RESEARCH USING HUMAN BEINGS.
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• THE PURPOSE
• HOW TO CONDUCT
• EVALUATION

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THE GENERAL PRINCIPLES OF A MEDICAL RESEARCH.
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• PRINCIPLES OF ESSENTIALITY.
• PRINCIPLES OF VOLUNTARINESS, INFORMED CONSENT AND
  COMMUNITY AGREEMENT.
• PRINCIPLES OF NON-EXPLOITATION.
• PRINCIPLES OF PRIVACY AND CONFIDENTIALITY.

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• PRINCIPLES OF PRECAUTION AND RISK MINIMISATION.
• PRINCIPLES OF PROFESSIONAL COMPETENCE .
• PRINCIPLES OF ACCOUNTABILITY AND TRANSPARENCY.
• PRINCIPLES OF THE MAXIMISATION OF THE PUBLIC
  INTEREST AND OF DISTRIBUTIVE JUSTICE.

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• PRINCIPLES OF INSTITUTIONAL ARRANGEMENTS.
• PRINCIPLES OF PUBLIC DOMAIN.
• PRINCIPLES OF TOTALITY OF RESPONSIBILITY .
• PRINCIPLES OF COMPLIANCE.

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• INSTITUTIONAL ETHICS COMMITTEE IEC
• OR
• INSTITUIONAL REVIEW BOARD IRD

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I R B / I E C

• It is recognized that Investigators alone may not
  ensure compliance with ethical norms.
• IRBs comprise sufficiently qualified individuals
  who have no vested interest in the research study
  or its outcomes. Their responsibility is to
  ensure that all research studies are ethical and
  justified.

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• RESPONSIBILITIES OF IEC.

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• CHAIRPERSON
• 1-2 BASIC MEDICAL SCIENTISTS.
• 1-2 CLINICIANS FROM VARIOUS INSTITUTES
• ONE LEGAL EXPERT OR RETIRED JUDGE
• ONE SOCIAL SCIENTIST/REPRESENTATIVE OF
  NON-GOVERNMENTAL VOLUNTARY AGENCY
• ONE PHILOSOPHER/ETHICIST/THEOLOGIAN
• ONE LAY PERSON FROM THE COMMUNITY
• MEMBER SECRETARY

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• INFORMED CONSENT PROCESS
• COMPENSATION FOR PARTICIPATION
• SELECTION OF SPECIAL GROUPS AS RESEARCH SUBJECTS
• ESSENTIAL INFORMATION ON CONFIDENTIALITY FOR
  PROSPECTIVE RESEARCH SUBJECTS
• COMPENSATION FOR ACCIDENTAL INJURY
• INTERNATIONAL COLLABORATION/ASSISTANCE IN
  BIO-MEDICAL/HEALTH RESEARCH
• RESEARCHERS RELATIONS WITH THE MEDIA AND
  PUBLICATION PRACTICES

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GENERAL ETHICAL ISSUESBELMOND REPORT

• AUTONOMY
• BENEFICENCE
• NON-MALEFICENCE
• JUSTICE

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Autonomy

• Respect for persons demands that each individual
  taking part in research does so with voluntary
  consent and with information. This is the basis
  of Informed Consent.
• Special protection needs to be given to persons
  with limited autonomy.

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Beneficence

• Human participants are treated in an ethical
  manner, respecting their decision, protecting
  them from harm, and make efforts to secure their
  well being.
• The researcher is obliged to maximize benefits
  and minimize risks to participants.

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Non - Maleficence

• Research must not cause harm to the participants
  in particular and to people in general.

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Justice

• Difficult issue.
• Distribution of risks and benefits fairly.
• Participants should not be chosen on the basis
• of availability and vulnerability.
• Equal opportunity and risk irrespective of
  gender, skin colour, economic status or any
  other such basis.

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THANK YOU

• Dr.K.Narayana Pai
• Director,
• IHMA School of Homoeopathy
• E- Mail knpaidr_at_yahoo.co.in
• Mob 9388184433