Escolar Documentos
Profissional Documentos
Cultura Documentos
Subjects Research
Role of IRBs
I. Purpose of Human Subjects
Research
Understand Disease
Validate New Therapies
Understand Physiological Processes
Study Human Behavior
Evaluate Curricular Changes
Evaluate New Teaching Methods
Ethical Issues in Research
When using humans or animals for
research, important ethical issues must be
addressed
Historically,these issues were addressed by the
professional code of ethics
Codes of conduct have evolved and now have
been codified into law.
Ethical Issues in Research
World War II—The Nuremburg Trial
JosephMengele and unethical experiments
performed by Nazi doctors
Ethical Issues in Research
World War II-The Nuremburg Trial
20 doctors were charged with War Crimes and
Crimes against humanity
Joseph Mengele fled and was not tried
Lead to Nuremburg Code of 10 Principles
Nuremburg Code
Peer review
VI. Federal Oversight
Education on “Responsible Conduct of
Research”
Nine Areas:
Collaborative science
Human subjects
Research misconduct
Non-affiliated member
Veterinarian
Laboratory Research Animals
Functions of the IACUC
Review animal care and use program every six months
Inspect facilities for housing animals every six months
Prepare reports o reviews for Institutional Official
Review concerns involving animals at institution
Make recommendations regarding program to Official
Laboratory Research Animals
Functions of the IACUC
Review, approve, require modifications in
applications for animal use
Review, approve, require modifications of
proposed changes in approved animal projects
Suspend activities not adhering to approved
uses
Laboratory Research Animals
To approve animal use:
Procedures must avoid pain or discomfort and
have sound research design
Procedures involving minor discomfort or pain
must include sedation, analgesia, or anesthesia
Animals that would experience chronic pain
must be euthanized at the end of the procedure
Laboratory Research Animals
To approve animal use:
Living conditions must be appropriate for species
Medical care must be available from veterinarian
Personnel conducting procedures must be qualified
Methods of euthanasia must abide by AVMA rules
Studies approved by IACUC may be disapproved by
Institutional offices, however, unapproved studies may
not be approved by higher officials
Laboratory Research Animals
USDA and NIH have oversight
NIH does not have inspection arm
USDA makes periodic, unannounced visits to
assess compliance for “covered” species
Case Number 1
Social scientist
Observing 1st grade play activities
What level of review?
Exempt
Expedited
Full Review
Case Number 2
Psychologist
Interviewing 1st graders
Benign questions: no names or identifiers
What level of review
Exempt
Expedited
Full Review
Case Number 3
Behavioral Scientist
Interviewing 3rd graders
Questions regarding sexual behavior, parental
handling of bad behavior, etc.
What level of review?
Exempt
Expedited
Full Review
Nuremburg Code
The voluntary consent of the human subject is absolutely essential
The experiment should be such as to yield fruitful results for the
good of society, unprocurable by other methods or means of study,
and not random and unnecessary in nature.
The experiment should be so designed and based on the results of
animal experimentation and a knowledge of the natural history of
the disease or other problem under study, that the anticipated results
will justify the performance of the experiment.
The experiment should be so conducted as to avoid all unnecessary
physical and mental suffering and injury.
Nuremburg Code
No experiment should be conducted, where there is an a priori
reason to believe that death or disabling injury will occur; except,
perhaps, in those experiments where the experimental physicians
also serve as subjects.
During the course of the experiment, the human subject should be at liberty
to bring the experiment to an end, if he has reached the physical or mental
state, where continuation of the experiment seemed to him to be impossible.