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ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

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jyothibhat21

This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India. The viewers are requested to give their feedback on the utility of the presentation.

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ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS By: Jyothi Bhat 20 Nov 2009 Indian Council of Medical Research, 2006
Definition BIOETHICS = BIO + ETHICS Study of ethical issues and decision-making associated with the use of living organisms Learning how to balance different benefits, risks and duties
Bioethics Started… ,[object Object],[object Object],[object Object]
Indian Council of Medical Research ,[object Object],[object Object],[object Object],[object Object],[object Object]
The Beginning….. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],1980
Bio-Medical Ethics
ICMR Code ,[object Object],[object Object],[object Object],[object Object],[object Object]
GENERAL STATEMENT ,[object Object],[object Object],[object Object],[object Object],[object Object],These Statements of General and Specific Principles may be varied, amended, substituted and added from time to time.
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object],[object Object],[object Object]
STATEMENT OF GENERAL PRINCIPLES ,[object Object],[object Object],[object Object]
ETHICAL REVIEW PROCEDURES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BASIC RESPONSIBILITIES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
COMPOSITION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
COMPOSITION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
COMPOSITION Judge Clinician Social worker Philosopher Layman Chairman Secretary
COMPOSITION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TERMS OF REFERENCE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],TERMS OF REFERENCE
TRAINING ,[object Object],[object Object],[object Object],[object Object]
REGULATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
REVIEW PROCEDURES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],REVIEW PROCEDURES
[object Object],[object Object],[object Object],REVIEW PROCEDURES
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],REVIEW PROCEDURES
Decision making process… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Interim Review
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Record Keeping
 

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ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

  • 1. ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS By: Jyothi Bhat 20 Nov 2009 Indian Council of Medical Research, 2006
  • 2. Definition BIOETHICS = BIO + ETHICS Study of ethical issues and decision-making associated with the use of living organisms Learning how to balance different benefits, risks and duties
  • 3.
  • 4.
  • 5.
  • 7.
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  • 12.
  • 13.
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  • 16.
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  • 19.
  • 20.
  • 21. COMPOSITION Judge Clinician Social worker Philosopher Layman Chairman Secretary
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
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  • 34.