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Principles of Ethical Research

Principles of Ethical Research. DR. M. RAZA SHAH INTERNATIONAL CENTER FOR CHEMICAL AND BIOLOGICAL SCIENCES CENTER FOR BIOEQUIVALENCE STUDIES AND BIOASSAY RESEARCH. Ethics. Greek word “ ethos” which means custom or character. Regulations = Ethics.

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Principles of Ethical Research

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  1. Principles of Ethical Research DR. M. RAZA SHAH INTERNATIONAL CENTER FOR CHEMICAL AND BIOLOGICAL SCIENCES CENTER FOR BIOEQUIVALENCE STUDIES AND BIOASSAY RESEARCH

  2. Ethics • Greek word “ethos” which means custom or character

  3. Regulations = Ethics

  4. Translation of Ethical Principles into Regulations • Risks are reasonable relative to the anticipated benefits • Selection of subjects is equitable • Informed consent will be obtained and documented • Data safety monitoring is adequate • Risks are minimized through a sound research design • Privacy and confidentiality provisions are adequate • Appropriate safeguards are included for vulnerable subjects

  5. Historical Perspective • 18th Century: Scientists were the human subjects. Ralph M. Steinman • 19th and 20th Century: subjects were poor patients and/or prisoners.

  6. Examples of Unethical Trials • Tenofovir trials on HIV transmission (2004-2005) • Hepatitis E vaccine trial in Nepal (2001-2003) • Nevirapine PMTCT trials in Uganda (1997-2003) • SFBC Miami test centre (2000-2005) • Letrozole trials in India (2003) • Streptokinase trials in India (2003) • Alosetron trials after marketing withdrawal (2000) • Fortified ORS trials in Peru (2004-2005) • Risperidone trials in India (2003

  7. Examples of Unethical Trials • TGN 1412 trials in London (2006) • VGV-1 trials in China (2003) • Imatinib trials (2000) • Ragaglitazar trials in India and other countries (2002) • Trovafloxacin trials in Nigeria (1996) • Cilansetron trials in India (2000) • Zoniporide trials in India (2000) • Trials on foster care children in New York (1997-2002) • Maxamine trial in Russia (2000) • Cilostazol trials in India (1999) • NDGA trials in India (1999-2000) • Cariporide trial in Argentina (1997)

  8. Unethical Conduct • Nuremberg Code 1947 • Declaration of Helsinki 1964 • The Belmont Report 1979 • International Conference on Harmonization “ICH” 1990

  9. Nuremberg Code 1947 • Voluntary consent • Anticipate scientific benefits • Benefits outweigh risks • Animal experiments first • Avoid suffering • No intentional death or disability • Protection from harm • Subject free to stop • Qualified investigators • Investigator will stop if harm occurs

  10. The Declaration of Helsinki 1964 • It is a LIVING DOCUMENT that attempts to take into accountthe evolving nature of scientific research. • It was first adopted by the World Medical Assembly in 1964 and revised in 1975,1983, 1996, 2000, 2004 and last updated in 2008 (Seoul).

  11. Basic Principles for all Medical Research 1. It is the duty of PI to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of subjects. 2. Research on Human subjects must be based on a thorough knowledge of the scientific literature, adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

  12. Basic Principles for all Medical Research 3. The design and performance of each research study involving human subjects must be clearly described in a research protocol. 4. The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee.

  13. What is the ICH It is the International Conferenceon Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Initiated in 1990.

  14. What For? • Rationalize and harmonizeinternational regulations to address: • Rising costs of health care; • Rising costs of Research & Development and Public expectation of minimum delay in availability of safe and effective new treatments.

  15. ICH Guidelines These guidelines covers: • Safety (non-clinical); • Efficacy (clinical safety); • Quality (GMP); • Multidisciplinary topics.

  16. Relevant ICH Guidelines & Topics

  17. Relevant ICH Guidelines & Topics

  18. Objective of ICH-E6 This guideline should be followed when executing clinical trial and generating datathat are intended to be submitted to regulatory authorities.

  19. Contents of ICH-E6 guideline 1. Glossary 2. Principles of ICH-GCP 3. IRB/IEC 4. Investigator 5. Sponsor 6. Clinical Trial Protocol & Protocol Amendment 7. Investigator’s Brochure 8. Essential Documents for Clinical Trial Conduct

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