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Ethics

Principles of Ethics

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Dr.mittal rathod
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8 views

Ethics

Principles of Ethics

Uploaded by

Dr.mittal rathod
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Ethics

Dr.Mittal Rathod
Associate Professor
Community Medicine
AIIMS, Jammu
Introduction
• The study of what is right and wrong.
• beliefs about what is morally correct or
acceptable.
• Bioethics is the study of ethical, social, and legal
issues that arise in biomedicine and biomedical
research.
• Any research involving human participants
Nazi crime or Hitlerite crime
• NAZI (1919)
• The Holocaust (1933)
• first concentration camp at
“Dachau
THE NAZI EXPERIMENT (1942)
• 11 million people were killed.
• Concentration camps (Labor and death camps)
• Constant torture and starvation (Mass killing
through gassing chambers)
MEDICAL EXPERIMENTS (Nazi Human
Experimentation
1. Experiment on Twin :-
2. Bone, muscle and nerve transplantation experiments :
3. Head Injury Experiment :-
4. Freezing experiments :
5. Malaria experiments:
6. Immunization experiments:
7. Epidemic experiments:
8. Mustard gas experiment
9. Sulfonamide experiments
10. Sea water experiments :
11. Sterilization and fertility experiment:
12. Experiments with poison
13. High Altitude experiment
14. Blood coagulation experiments
NUREMBERG TRIALS(1945 – 1949)
• The Nuremberg trials were a series of military tribunals held
following World War 2 by the Allied forces under international
law and laws of war.
 Military tribunals – is a special court or committee that is
appointed to deal with particular problems. (Trials were held
before an International Military Tribunal (IMT).
 Allied forces – are two or more individuals,
organizations, or countries who are working
together towards the same purpose as a
result of a mutual agreement.
 The decisions marked a turning part between classical and
contemporary international laws.
 The Nuremberg trials were conducted according to the laws
of not only one country, a group of four powers, (France,
Britain, The Soviet Union and The United States) with
different legal traditions and practices.
 Nuremberg trials were held for the purpose of bringing Nazi
war criminals to justice; to force Nazi leaders to answer for
war crimes.
 Nuremberg trials were a series of 13 trials

carried out in Nuremberg, Germany between


1945 – 1949.
Evidence Room War Crime Executive Committee
Tuskegee Study –Syphilis study
• The U.S. Public Health Service (USPHS) Syphilis
Study at Tuskegee was conducted between
1932 and 1972 to observe the natural history
of untreated syphilis.

• As part of the study, researchers did not


collect informed consent from participants
and they did not offer treatment, even after it
was widely available.
• the subjects were completely unaware and
were instead told they were receiving
treatment for bad blood when in fact, they
received no treatment at all.

• Even after penicillin was discovered as a safe


and reliable cure for syphilis, the majority of
men did not receive it.
• THE DECLARATION OF HELSINKI: World
Medical Association (WMA), established to
address the ethical challenges arising from the
German tragedy.
E V O L U T I ON O F E T H IC S C O DE

INTERNATIONAL
1947, Nuremberg Code Initiated discussion on rationale and justification of
research, risk benefit analysis, competence of investigators
and voluntary consent in research
1964, Helsinki Declaration, Commitment to individual rights to make informed decisions,
Revised 1883, 1989, 1996, investigators’ duties, research participants’ welfare,
2000, vulnerability
2008, 2013
1978-79, Belmont report Described the basic ethics principles of autonomy,
justice and beneficence, emphasized informed consent
and review by ethics committee
1992-93, CIOMS guidelines Reporting of adverse drug reactions and safety of
[Council for International research participants, benefit-risk balance, need
organizations on Medical and principles of pharmacovigilance,
Sciences and WHO],
Revised 2002

1996, ICH [International Good Clinical Practice


Council on
Harmonization]
Indian Council of Medical Research introduced
Ethical Guidelines for Research on Human
Participants
NATIONAL GUIDELINES
2000, ICMR guidelines All institutions in the country which carry out
any form of biomedical research involving
2006, Revised ICMR human beings should follow these guidelines in
guidelines letter and spirit to protect safety and well being
http://www.icmr.nic.in of all individuals.

There are several Genome Policy and Genetic Research [2000],


other national Indian GCP [2001], Amendment of Drugs and
guidelines available Cosmetics Act [2002], Assisted Reproductive
Technology [2005], Stem Cell Research and
Bio-banking [2006]
What is informed consent?

• Informed consent is the process of informing the potential


participants about the proposed research in a systematic
manner and empower them to take an informed decision to
participate in the research study
• Understand study procedures and risks and benefits
• Get all questions and concerns answered
• Take a learned and informed decision to [or not to] participate

• This process can be repeated several times during the


research study if necessary

• Although group consent is desirable [e.g. tribal studies], it


cannot replace individual consent
Range of ethical issues that need to be
addressed in health research
• Competence of the researchers and the research team
• Provisions for protection of human rights and ethical issues:
vulnerable populations, women, children
• Measures for protecting confidentiality and non-
discriminatory practices
• Appropriateness of Informed consent and study specific
educational material
• Mechanisms for reporting and management of adverse events and
serious adverse events
• Care and support for research participants: standard of care, long-
term care,
• post-trial access to care and product
• Reimbursement and compensation
• Continuing review of progress of the study
Thank You

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