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ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN SUBJECTS

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Title: ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN SUBJECTS


1
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON
HUMAN SUBJECTS
2
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

3
BACKGROUND
4
  • 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)

5
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

6
Vulnerable Populations
  • Children.
  • Individuals with questionable capacity to
    consent.
  • Prisoners.
  • Foetuses and pregnant women.
  • The terminally ill.
  • Students/employees.
  • Comatose patients.

7
Shortfall
  • Prisoners
  • Employees
  • Illiterates
  • Handicapped persons
  • Women in general (illiterate, widows)
  • Children (orphans, children of prisoners,
    mentally handicapped children)

8
BASIC FACTORS ENSURED IN A MEDICAL AND RELATED
RESEARCH USING HUMAN BEINGS.
9
  • THE PURPOSE
  • HOW TO CONDUCT
  • EVALUATION

10
THE GENERAL PRINCIPLES OF A MEDICAL RESEARCH.
11
  • PRINCIPLES OF ESSENTIALITY.
  • PRINCIPLES OF VOLUNTARINESS, INFORMED CONSENT AND
    COMMUNITY AGREEMENT.
  • PRINCIPLES OF NON-EXPLOITATION.
  • PRINCIPLES OF PRIVACY AND CONFIDENTIALITY.

12
  • 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.

13
  • PRINCIPLES OF INSTITUTIONAL ARRANGEMENTS.
  • PRINCIPLES OF PUBLIC DOMAIN.
  • PRINCIPLES OF TOTALITY OF RESPONSIBILITY .
  • PRINCIPLES OF COMPLIANCE.

14
  • INSTITUTIONAL ETHICS COMMITTEE IEC
  • OR
  • INSTITUIONAL REVIEW BOARD IRD

15
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.

16
  • RESPONSIBILITIES OF IEC.

17
  • 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

18
  • 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

19
GENERAL ETHICAL ISSUESBELMOND REPORT
  • AUTONOMY
  • BENEFICENCE
  • NON-MALEFICENCE
  • JUSTICE

20
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.

21
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.

22
Non - Maleficence
  • Research must not cause harm to the participants
    in particular and to people in general.

23
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.

24
THANK YOU
  • Dr.K.Narayana Pai
  • Director,
  • IHMA School of Homoeopathy
  • E- Mail knpaidr_at_yahoo.co.in
  • Mob 9388184433
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