Ethics in biomedical research

Lecture 5
 Lecture objectives
1. Ethical Research. Abstract.
2. "Nuremberg Code" and "Declaration of Helsinki"
World Medical Association as a fundamental source of
modern moral standards of the experiments and
human clinical trials.
3. The role of research ethics committees in research
involving on human.
4. The ethics of scientific publishing results of tests
and experiments.
 Abstract

• Ethics, an essential dimension of human

research, is considered both as discipline and
practice.
• For clinical research, ethically justified criteria
for the design, conduct, and review of clinical
investigation can be identified by obligations to
both the researcher and human subject.
• Informed consent, confidentiality, privacy,
privileged communication, and respect and
responsibility are key elements of ethics in
research.
 Ethical Research
• Our knowledge on bioethics conduct in
biomedical research is guided by
international codes of ethics and
regulations such as the Nuremberg
Code, the Declaration of Helsinki,
Belmont Report and EU Convention on
Human Rights.
They are:
 Ethical Research
• Social and clinical value
• Scientific validity
• Fair subject selection
• Favorable risk-benefit ratio
• Informed consent
• Respect for potential and enrolled
subjects
 Nuremberg Code (1947)

In the nineteenth century, the

judgment of the trial of the Nazi
doctors at Nuremberg is the
commonly recognized starting event
for modern research ethics.
It contained ten paragraphs, referred
to as the Nuremberg Code
 Nuremberg Code (1947)

• voluntary consent to be based on sufficient

knowledge of the nature, duration, purpose,
methods, inconveniences, hazards, and
effects of the research
• the experiment should bring positive results
to society.
• experiment to be based on animal research
and prior knowledge
 Nuremberg Code (1947)

• all unnecessary physical or mental suffering

and injury to be avoided

• no experiment be conducted in which death

or disabling injury will occur (except where
physicians were also subjects)

• the research be conducted by scientifically

qualified persons and require the highest
degree of skills and care
 Declaration of Helsinki (1964)
• The Declaration emphasized the scientific standards that
should govern scholarly research, it allowed more
freedom to the physicians to omit the application of
consent procedures in special circumstances.
• Then came the revision of the Declaration of Helsinki in
1975 that required the assessment of research protocols
by an independent research ethics committee.
• Today, the Declaration of Helsinki is considered as a
document of ethical principles for medical research
involving human subjects, including research on
identifiable human material and data.
 Ethics of medical research
• on human subjects must be clinically justified
and scientifically sound.
• Informed consent is a mandatory component of
any clinical research.
• Investigators are obligated to design research
protocols that establish standards of scientific
integrity, safeguard ethical and legislative issues
of the human subjects, and follow the protocols
for prospective review by independent research
ethics committees.
 Ethics Committees
The main goal of bioethics, to train people in the
management of moral conflicts, in order to take wise
decisions and, in this way, improve the quality of health care.
Bioethics committees are platforms for deliberations, in
order to take wise decisions and to make policy
recommendations. There are different types of ethics
committees, as described in the «UNESCO Guides
Establishing Bioethics Committees» :
• Policy-Making and Advisory Committees (PMAs)
• Health-Professional Association (HPA) Bioethics
Committees
• Health Care Ethics Committees (HECs)
• Research Ethics Committees (RECs)
 Ethics Committees
Each of these committees has its own
characteristics. For instance, HEC committees
do important work in clinical bioethics. They
consist of physicians, nurses, social workers,
and lay members, both men and women.
Different backgrounds, expertise and
experiences allow a better understanding of
cases, enriching all the individual perspectives
and facilitating decision-making.
 Ethics Committees
HEC committees are not judicial bodies with the
responsibility of sanctioning wrong conduct and
imposing disciplinary measures. This is one of the
biggest differences between ethics committees and legal
tribunals.
The goal of ethics is not to compete with law, but to
promote wise decisions among people and professional
excellence.
Bioethics does not look for what is legally right but for
what is humanly best.
The goal of bioethics is to promote the best possible
action.
 Reference:

- C.M.Francis, Medical Ethics, New Delhi (178-189)

- Nuremberg Code (1947)
- Declaration of Helsinki (1964, 1975)
- UNESCO Guides Establishing Bioethics Committees» :

Video: «Ethics in biomedical research», «History of

Research Ethics»,
«What is Ethics in Research», «The Nuremberg Code
(1947)», «Declaration of Helsinki», «Research Ethics
Committees (REC)»,
«Standards and guidance for researchers» (Utube)