NCMA 218 • Physician justify using patients by potential
value and ensure that research will not
Principles of Ethics and Research
adversely affect health
1. Nuremberg code of 1947
• Appropriate compensation and treatment for
Ethics principles for human experimentation
harm
resulting from Nazi doctors’ trial
RISKS, BURDENS, AND BENEFITS
Focus on human rights and welfare
• Pre-assess then monitor
10 principles of Nuremberg Code
• Importance of objectives outweigh R/B for
1. Voluntary free informed consent
participants
2. Good unprocurable by other means
o Benefits outweigh risks for participants and
3. Medically justified: prior animal trials, groups affected and managed
4. Proper design • Measures to minimize implemented
5. No unnecessary suffering or injury • Once risks outweigh the benefits or if there is
already a clear outcome: assess if research
6. No death or disability except if researcher is
subjected to risks never exceed humanitarian should be continued
purpose
VULNERABLE GROUPS AND INDIVIDUALS
7. Protection/safeguards in place
• Increased likelihood of wrong and harm
8. Qualified researcher
– Special protection
9. Participants can stop anytime
• Responsive to their health needs
10. Researcher ready to stop anytime
• Cannot be done on non-vulnerable
Declaration of Helsinki
• Stand to benefit from result
Statement of ethical principles for medical
SCIENTIFIC REQUIREMENTS AND RESEARCH
research involving human participants, including
PROTOCOLS
identifiable human material and data; doctors
doing medical research on patients • Conform to accepted scientific principles
For all involved in medical research • Respect animals
Basis for Good Clinical Practice (GCP)
• Complete protocol including addressed ethical
GENERAL PRINCIPLES considerations
• Purpose: understand disease, improve • Post-trial provisions indicated
interventions
RESEARCH ETHICS COMMITTEES
• Human participants necessary
• Transparent, independent, and qualified
• Primacy of patient’s best interest: health,
• Follow norms
well-being, rights
• Approve protocol
• Duty and responsibility of researcher even if
with consent of participants • Monitor study, approve amendments, and
receive final report
• Subject to ethical standards: International and
national guidelines cannot reduce Helsinki PRIVACY AND CONFIDENTIALITY
• Respect and protect participants • Protect
• Minimize harm to environment INFORMED CONSENT
, • option of being informed of general outcome 3. Justice: ensuring reasonable, non-
and study results exploitative, and well-considered procedures
are administered fairly — the fair distribution of
2. For not capable: legally authorized
costs and benefits to potential research
representative;
participants — and equally.
• consider vulnerable group
Ethical Issues Related to Evidenced Based
• assent if capable, dissent respected Practice
•condition vulnerable characteristic for Evidence- Based medicine or evidence based
research; if circumstances prevent Free and practice, is the judicious use of the best current
Informed Consent, REC approval, proxy; ASAP evidence in making decisions about the care of
the individual patient.
Belmont Report 1976
Evidence-base practice is a systematic inter
The Belmont Report is a report created by the connecting scientifically generated evidence
National Commission for the Protection of with the tacit knowledge of the expert
Human Subjects of Biomedical and Behavioral practitioner to achieve a change in a particular
Research. Its full title is the Belmont Report: practice for the benefit of a well-defined
Ethical Principles and Guidelines for the client/patient group.
Protection of Human Subjects of Research,
Report of the National Commission for the Evidence-based nursing it is a process by which
Protection of Human Subjects of Biomedical and nurses make clinical decisions using the best
Behavioral Research. available research evidence, their clinical
expertise and patient preference
The report was issued on 30 September 1978[1]
and published in the Federal Register on 18 Ethical issues
April 1979. [2] The report took its name from
Moral principles such as truth, fairness, and
the Belmont Conference Center where the
respecting autonomy lie at the heart of these
document was drafted in part. The Belmont
ethical concerns.
Conference Center, once a part of the
Smithsonian Institution, is in Elkridge, Maryland, Evidence based practice focuses on searching
10 miles south of Baltimore, and until the end and appraising available evidence on the
of 2010 was operated by Howard Community advantages and disadvantages of various
College. [3] interventions. Ethical issues include:
The Belmont Report [2] summarizes ethical Status of evidence- available evidence in health
principles and guidelines for research involving care areas consists mostly of expert opinions
human subjects. Three core principles are where despite important advance in research,
identified: respect for persons, beneficence, and only few have amassed sufficient data to enable
justice. Three primary areas of application are research-based confidence in treatment
also stated. They are informed consent, interventions.
assessment of risks and benefits, and selection
Client Autonomy- patient and family
of subjects. According to Vollmer and Howard,
participation in planning and intervention
the Belmont Report allows for a positive
(autonomy) is an important dimension of
solution, which at times may be difficult to find,
rehabilitation. This participation should also
to future subjects who are not capable to make
include decision making under difficult
independent decisions.
circumstances by the client when competing
The three fundamental ethical principles for interests are decided.
using any human subjects for research are:
Conflict of interest- May be represented when
1. Respect for persons: protecting the clinical trials are subjected to questions about
autonomy of all people and treating them with the validity of their contributions.
courtesy and respect and allowing for informed
ETHICO-MORAL OBLIGATIONS OF THE NURSE IN
consent. Researchers must be truthful and
EVIDENCE-BASED PRACTICES
value and ensure that research will not
Principles of Ethics and Research
adversely affect health
1. Nuremberg code of 1947
• Appropriate compensation and treatment for
Ethics principles for human experimentation
harm
resulting from Nazi doctors’ trial
RISKS, BURDENS, AND BENEFITS
Focus on human rights and welfare
• Pre-assess then monitor
10 principles of Nuremberg Code
• Importance of objectives outweigh R/B for
1. Voluntary free informed consent
participants
2. Good unprocurable by other means
o Benefits outweigh risks for participants and
3. Medically justified: prior animal trials, groups affected and managed
4. Proper design • Measures to minimize implemented
5. No unnecessary suffering or injury • Once risks outweigh the benefits or if there is
already a clear outcome: assess if research
6. No death or disability except if researcher is
subjected to risks never exceed humanitarian should be continued
purpose
VULNERABLE GROUPS AND INDIVIDUALS
7. Protection/safeguards in place
• Increased likelihood of wrong and harm
8. Qualified researcher
– Special protection
9. Participants can stop anytime
• Responsive to their health needs
10. Researcher ready to stop anytime
• Cannot be done on non-vulnerable
Declaration of Helsinki
• Stand to benefit from result
Statement of ethical principles for medical
SCIENTIFIC REQUIREMENTS AND RESEARCH
research involving human participants, including
PROTOCOLS
identifiable human material and data; doctors
doing medical research on patients • Conform to accepted scientific principles
For all involved in medical research • Respect animals
Basis for Good Clinical Practice (GCP)
• Complete protocol including addressed ethical
GENERAL PRINCIPLES considerations
• Purpose: understand disease, improve • Post-trial provisions indicated
interventions
RESEARCH ETHICS COMMITTEES
• Human participants necessary
• Transparent, independent, and qualified
• Primacy of patient’s best interest: health,
• Follow norms
well-being, rights
• Approve protocol
• Duty and responsibility of researcher even if
with consent of participants • Monitor study, approve amendments, and
receive final report
• Subject to ethical standards: International and
national guidelines cannot reduce Helsinki PRIVACY AND CONFIDENTIALITY
• Respect and protect participants • Protect
• Minimize harm to environment INFORMED CONSENT
, • option of being informed of general outcome 3. Justice: ensuring reasonable, non-
and study results exploitative, and well-considered procedures
are administered fairly — the fair distribution of
2. For not capable: legally authorized
costs and benefits to potential research
representative;
participants — and equally.
• consider vulnerable group
Ethical Issues Related to Evidenced Based
• assent if capable, dissent respected Practice
•condition vulnerable characteristic for Evidence- Based medicine or evidence based
research; if circumstances prevent Free and practice, is the judicious use of the best current
Informed Consent, REC approval, proxy; ASAP evidence in making decisions about the care of
the individual patient.
Belmont Report 1976
Evidence-base practice is a systematic inter
The Belmont Report is a report created by the connecting scientifically generated evidence
National Commission for the Protection of with the tacit knowledge of the expert
Human Subjects of Biomedical and Behavioral practitioner to achieve a change in a particular
Research. Its full title is the Belmont Report: practice for the benefit of a well-defined
Ethical Principles and Guidelines for the client/patient group.
Protection of Human Subjects of Research,
Report of the National Commission for the Evidence-based nursing it is a process by which
Protection of Human Subjects of Biomedical and nurses make clinical decisions using the best
Behavioral Research. available research evidence, their clinical
expertise and patient preference
The report was issued on 30 September 1978[1]
and published in the Federal Register on 18 Ethical issues
April 1979. [2] The report took its name from
Moral principles such as truth, fairness, and
the Belmont Conference Center where the
respecting autonomy lie at the heart of these
document was drafted in part. The Belmont
ethical concerns.
Conference Center, once a part of the
Smithsonian Institution, is in Elkridge, Maryland, Evidence based practice focuses on searching
10 miles south of Baltimore, and until the end and appraising available evidence on the
of 2010 was operated by Howard Community advantages and disadvantages of various
College. [3] interventions. Ethical issues include:
The Belmont Report [2] summarizes ethical Status of evidence- available evidence in health
principles and guidelines for research involving care areas consists mostly of expert opinions
human subjects. Three core principles are where despite important advance in research,
identified: respect for persons, beneficence, and only few have amassed sufficient data to enable
justice. Three primary areas of application are research-based confidence in treatment
also stated. They are informed consent, interventions.
assessment of risks and benefits, and selection
Client Autonomy- patient and family
of subjects. According to Vollmer and Howard,
participation in planning and intervention
the Belmont Report allows for a positive
(autonomy) is an important dimension of
solution, which at times may be difficult to find,
rehabilitation. This participation should also
to future subjects who are not capable to make
include decision making under difficult
independent decisions.
circumstances by the client when competing
The three fundamental ethical principles for interests are decided.
using any human subjects for research are:
Conflict of interest- May be represented when
1. Respect for persons: protecting the clinical trials are subjected to questions about
autonomy of all people and treating them with the validity of their contributions.
courtesy and respect and allowing for informed
ETHICO-MORAL OBLIGATIONS OF THE NURSE IN
consent. Researchers must be truthful and
EVIDENCE-BASED PRACTICES
