A brief explanation of the Four Principles of research ethics and History

1. HEALTHCARE ETHICS
SCHOOL OF HEALTH SCIENCE
MASTER OF PUBLIC HEALTH
2016/2017

2. CONTENTS
1. INTRODUCTION
2. HISTORY
3. PRINCIPLES
4. CASE-STUDY
5. SUMMARY
6. REFERENCES

3. INTRODUCTION
Ethics is concerned with moral principles, values and
standards of conduct. The field of health and health care
raises numerous ethical concerns, related to, for example,
health care delivery, professional integrity, data handling,
use of human subjects in research, and the application of
new techniques, such as gene manipulation.

4. HISTORY
Prior to 1906, when the Pure Food and Drug Act was passed,
there were no regulations regarding the ethical use of
human subjects in research. There were no consumer
regulations, no Food and Drug Administration (FDA), no
Common Rule, and no Institutional Review Board (IRB). What
follows is a brief discussion of why federal rules and
regulations were established and why the IRB became a
necessity.

5. Nuremberg Trials
 A well-known chapter in the history of research with human
subjects opened on December 9, 1946, when an American
military tribunal opened criminal proceedings against 23
leading German physicians and administrators for their
willing participation in war crimes and crimes against
humanity. Among the charges were that German physicians
conducted medical experiments on thousands of
concentration camp prisoners without their consent. Most
of the subjects of these experiments died or were
permanently crippled as a result.
 As a direct result of the trial, the Nuremberg Code was
established in 1948, stating that "The voluntary consent of
the human subject is absolutely essential," making it clear
that subjects should give consent and that the benefits of
research must outweigh the risks.

6. Declaration of Helsinki.
 In 1964, the World Medical Association established
recommendations guiding medical doctors in biomedical research
involving human subjects. The Declaration of Helsinki (DoH) is a
set of ethical principles regarding human experimentation
developed for the medical community by the World Medical
Association (WMA). It is widely regarded as the cornerstone
document on human research ethics. The Declaration of Helsinki
was revised in 1975, 1983, 1989 and 1996 and is the basis for
Good Clinical Practices used today.
Issues addressed in the Declaration of Helsinki include:
 Research with humans should be based on the results from
laboratory and animal experimentation
 Research protocols should be reviewed by an independent
committee prior to initiation
 Informed consent from research participants is necessary
 Research should be conducted by medically/scientifically
qualified individuals
 Risks should not exceed benefits

7. The Belmont Report
 A report created by the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research. Its full title is
the Belmont Report: Ethical Principles and Guidelines for the Protection
of Human Subjects of Research, Report of the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral
Research.
 The Belmont Report was first written by the National Commission for
the Protection of Human Services of Biomedical and Behavioral
Research. Prompted in part by problems arising from the Tuskegee
Syphilis Study (1932–1972) and based on the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral
Research (1974–1978). The Belmont Report is one of the leading works
concerning ethics and health care research. It allows for the protection
of participants in clinical trials and research studies.

8. Indian Council of Medical Research Guidelines on Code of Conduct
for Research Scientists engaged in field of Life Sciences
 Guidance on transfer of human biological material for
research/commercial purposes
 'ICMR-DBT' Guidelines for evaluation of probiotics in food
 Knowledge Management policy for Health - Service, Education
and Research (Draft)
 Ethical Guidelines for Biomedical Research on Human
Participants
 Intellectual Property Rights Policy

9. PRINCIPLES
The four principles of health care ethics developed by Tom
Beauchamp and James Childress in the 1985 Principles of
Biomedical Ethics provide medical practitioners with
guidelines to make decisions when they inevitably face
complicated situations involving patients
1. AUTONOMY: In medicine, autonomy refers to the right of
the patient to retain control over his or her body. A health
care professional can suggest or advise, but any actions that
attempt to persuade or coerce the patient into making a
choice are violations of this principle. In the end, the
patient must be allowed to make his or her own decisions –
whether or not the medical provider believes these choices
are in that patient’s best interests – independently and
according to his or her personal values and beliefs.

10. 2. BENEFICENCE: This principle states that health care
providers must do all they can to benefit the patient in each
situation. All procedures and treatments recommended must
be with the intention to do the most good for the patient. To
ensure beneficence, medical practitioners must develop and
maintain a high level of skill and knowledge, make sure that
they are trained in the most current and best medical
practices, and must take their patients’ individual
circumstances into account: what is good for one patient will
not necessary benefit another.

11. 3. NON-MALEFICENCE: Non-maleficence is probably the best
known of the four principles. In short, it means, “to do no
harm.” This principle is intended to be the end goal for all of
a practitioner’s decisions, and means that medical providers
must consider whether other people or society could be
harmed by a decision made, even if it is made for the benefit
of an individual patient.

12. 4. JUSTICE: The principle of justice states that there should
be an element of fairness in all medical decisions: fairness in
decisions that burden and benefit, as well as equal
distribution of scarce resources and new treatments, and for
medical practitioners to uphold applicable laws and
legislation when making choices.

13. CASE STUDY
A Closer Look: Case Study
 One hypothetical case study involves a patient who has an ovarian cyst
that, left untreated, will result in kidney failure. An operation to remove
the cyst is the best treatment, but the patient is frightened of needles
and is against the surgery which would require a needle to give her
anesthesia. The doctor must work with the patient to respect the fact
that she dislikes needles and doesn’t want the operation (her autonomy),
and needs to find a solution that would prevent her from going into kidney
failure, which is in her best interest (beneficence). Although the surgery
is the best choice, forcing the patient to accept the needle would be
harmful to her (non-maleficence). Finally, the doctor needs to consider
the impact that the patient’s choices might have on others if she starts to
go into preventable kidney failure, she’ll need dialysis, which affects
other people who need the same treatment (justice). So before making
the final decision the doctor must consider all four principles of health
care ethics which will help the physician make the choice that will have
the best possible benefits for both the patient and society.

14. SUMMARY
 Nazi atrocities in World War II drew attention to the lack of
international standards on research with human subjects and led to
the formulation of the Nuremberg Code, the first international
document which advocated voluntary participation and informed
consent.
 The Declaration of Helsinki is the basis for Good Clinical Practices
used today..
 The National Research Act codified the requirement that human
subjects in research must be protected and set the stage for the
issuance of the Belmont Report.
 Research ethics govern the standards of conduct for scientific
researchers. It is important to adhere to ethical principles in order to
protect the dignity, rights and welfare of research participants. As
such, all research involving human beings should be reviewed by an
ethics committee to ensure that the appropriate ethical standards are
being upheld. Discussion of the ethical principles of beneficence,
justice and autonomy are central to ethical review.

15. REFERENCE
http://www.who.int/ethics/research/en/
http://online.sju.edu/resource/health-human-services/four-principles-of-
health-care-ethics-improve-patient-care
http://ors.umkc.edu/research-compliance-(iacuc-ibc-irb-rsc)/institutional-
review-board-(irb)/history-of-research-ethics
Health Care Ethics: Lessons from Intensive Care By Kath M Melia