ETHICS AND LAW IN BIOMEDICAL RESEARCH
,ETHICS IN BIOMEDICAL RESEARCH
HISTORY OF UNETHICAL AND ATROCIOUS HUMAN MEDICAL
RESEARCH AND EXPERIMENTATION
Clinical context Research context
- Pt’s initiative - Researcher’s initiative
- Goal: health of PT - Goal: knowledge increase
- Best effort based - Minimal harm
Screening context
- health care initiative
- population focus
- benefit/outcome based
WHAT IS RESEARCH ETHICS
- Research ethics involves a balance between two values
└ The pursuit of scientific knowledge
└ Protecting the rights of research participants
à potential benefits such as advancing of our understanding of health and
determinants of health, gaining generalizable knowledge or helping research
participants must be weighted against potential costs/harm to the study
participants
MAIN OBJECTIVES OF RESARCH ETHICS
- To protect human participants
└ This is in line with the ethical principle of Non-maleficense – first, do no
harm (Hippocratic oath)
└ Human subjects are essential to the conduct of research intended to
improve human health, as such the relationship between investigators
, and human subjects is critical and should be based on honesty, trust and
respect
└ Concern over the treatment of research subjects arouse after the
revelation of gross violations of basic human rights in the name of science
└ There are accounts of unethical, atrocious and infamous research
practices in the past
- To ensure that research serves the interests of individuals, groups and/or society
as a whole
└ This objective can be linked to the emphasis on the social value of
research and benefit sharing
- To examine the ethical soundness of research and ensure that they conform to
ethical norms and standards with respect to risk management, confidentiality,
informed consent etc
HISTORIAL PERSPECTIVES OF ATROCIOUS RESEARCH
- Many unethical human research and experimentation
- Selected few that were well documented in literatures
└ Nazi human experiments
└ Tuskegee Syphilis study
└ Guatemala Syphilis study
└ Willowbrook hepatitis experiment
└ Kano Pfizer Trovan trial
NAZI HUMAN EXPERIMENTS
- Nazi doctors conducted as many as 30 different types of experiments of
concentration camp inmates
└ Without consent of the victims who suffered indescribable pain,
mutation, permanent disability, or in the case of many … death
- Goal
└ Very nobel
- Experiments
└ (bv. High altitude experiment)
└ Freezing
└ Twins
§ How to create more ubermensch
└ Bone, muscle and joint transplant
└ Seawater
- Aftermath of nazi experimentation
└ Nuremberg doctors trial
- Nuremberg code
, └ Set of guiding principles for the conduct of research involving human
subjects
§ Emphasizes on the voluntary consent of all research subjects in
any experiment
§ Avoidance of unnecessary physical and mental suffering
§ Option to quit/responsibility to terminate
§ Other safeguards
TUSKEGEE SYPHILIS STUDY
- Experiments
└ On black man for syphilis à non therapeutic research
§ Only black man
§ Poor man
- Nobel goal
└ Develop treatment programs for syphilis
§ Penicillin could heal syphilis, but people in this trial didn’t receive it
- Apologies
- Belmont report = you can say it is the start of biomedical ethics
└ Identified three principles essential to the ethical conduct of research
with humans, these serve as the foundation of the current guidelines for
ethical conduct of human subjects research
§ Respect for persons
§ Beneficence
§ Justice
,ETHICS IN BIOMEDICAL RESEARCH
HISTORY OF UNETHICAL AND ATROCIOUS HUMAN MEDICAL
RESEARCH AND EXPERIMENTATION
Clinical context Research context
- Pt’s initiative - Researcher’s initiative
- Goal: health of PT - Goal: knowledge increase
- Best effort based - Minimal harm
Screening context
- health care initiative
- population focus
- benefit/outcome based
WHAT IS RESEARCH ETHICS
- Research ethics involves a balance between two values
└ The pursuit of scientific knowledge
└ Protecting the rights of research participants
à potential benefits such as advancing of our understanding of health and
determinants of health, gaining generalizable knowledge or helping research
participants must be weighted against potential costs/harm to the study
participants
MAIN OBJECTIVES OF RESARCH ETHICS
- To protect human participants
└ This is in line with the ethical principle of Non-maleficense – first, do no
harm (Hippocratic oath)
└ Human subjects are essential to the conduct of research intended to
improve human health, as such the relationship between investigators
, and human subjects is critical and should be based on honesty, trust and
respect
└ Concern over the treatment of research subjects arouse after the
revelation of gross violations of basic human rights in the name of science
└ There are accounts of unethical, atrocious and infamous research
practices in the past
- To ensure that research serves the interests of individuals, groups and/or society
as a whole
└ This objective can be linked to the emphasis on the social value of
research and benefit sharing
- To examine the ethical soundness of research and ensure that they conform to
ethical norms and standards with respect to risk management, confidentiality,
informed consent etc
HISTORIAL PERSPECTIVES OF ATROCIOUS RESEARCH
- Many unethical human research and experimentation
- Selected few that were well documented in literatures
└ Nazi human experiments
└ Tuskegee Syphilis study
└ Guatemala Syphilis study
└ Willowbrook hepatitis experiment
└ Kano Pfizer Trovan trial
NAZI HUMAN EXPERIMENTS
- Nazi doctors conducted as many as 30 different types of experiments of
concentration camp inmates
└ Without consent of the victims who suffered indescribable pain,
mutation, permanent disability, or in the case of many … death
- Goal
└ Very nobel
- Experiments
└ (bv. High altitude experiment)
└ Freezing
└ Twins
§ How to create more ubermensch
└ Bone, muscle and joint transplant
└ Seawater
- Aftermath of nazi experimentation
└ Nuremberg doctors trial
- Nuremberg code
, └ Set of guiding principles for the conduct of research involving human
subjects
§ Emphasizes on the voluntary consent of all research subjects in
any experiment
§ Avoidance of unnecessary physical and mental suffering
§ Option to quit/responsibility to terminate
§ Other safeguards
TUSKEGEE SYPHILIS STUDY
- Experiments
└ On black man for syphilis à non therapeutic research
§ Only black man
§ Poor man
- Nobel goal
└ Develop treatment programs for syphilis
§ Penicillin could heal syphilis, but people in this trial didn’t receive it
- Apologies
- Belmont report = you can say it is the start of biomedical ethics
└ Identified three principles essential to the ethical conduct of research
with humans, these serve as the foundation of the current guidelines for
ethical conduct of human subjects research
§ Respect for persons
§ Beneficence
§ Justice
