This document provides an overview of medical ethics. It begins with definitions of ethics and discusses how ethics became important in medicine due to crimes against humanity in the 20th century. It then outlines the major developments in medical ethics codes and guidelines over time, including the Nuremberg Code, Declaration of Helsinki, and U.S. regulations. The document also covers ethical principles of beneficence, justice and respect for persons. It discusses types of ethics like professional, medical, bio and clinical ethics. Finally, it emphasizes the importance of ethical norms and codes in promoting responsible research and protecting subjects.

1. ..

2. Medica
l
ethics
Dr. Ibrahim A. Tolbah
Research Physician
University Diabetic Center
21/04/2015
Never
being
selfish
but
always
ready
to help
others

3. At the end of this lecture , all participants will be
able to know …
 What is EthicsWhat is Ethics
 Brief History of ethicsBrief History of ethics
 Ethical PrinciplesEthical Principles
 Types Of EthicsTypes Of Ethics
 Research Ethical Codes and PoliciesResearch Ethical Codes and Policies
 Importance Of Ethical Norms in ResearchImportance Of Ethical Norms in Research
Objective

4. When most people think of ethics (or morals), they think
of rules for distinguishing between right and wrong, such
as the Golden Rule ("Do unto others as you would
have them do unto you"), a code of professional
conduct like the Hippocratic Oath ("First of all, do no
harm"), a religious creed like the Ten Commandments
("Thou Shalt not kill..."), or a wise aphorisms like the
sayings of Confucius.
David B. Resnik, J.D., Ph.D.2011
Introduction

5. Case study
Dr. S is becoming increasingly frustrated with
patients who come to her either before or after
consulting another health practitioner for the
same ailment. she considers this to be a waste of
health resources as well as counter- productive
for the health of the patients. she decides to tell
these patients that she will no longer treat them
if they continue to see other practitioners for the
same ailment. she intends to approach her
national medical association to lobby the
government to prevent this form of misallocation
of healthcare resources.

6. What is Ethics?
Ethics is defined in the Webster dictionary as
“the philosophical analysis of human
morality and conduct that are established by
society” (Webster, 2005).
Ethics is The Norms for conduct that distinguish
between acceptable & unacceptable behavior
http://www.lib.uconn.edu/DoddCenter/ASC/dodphot1.htm

7. What is Ethics?
• Ethics are the standards of a particular
profession, occupation, institution, or group
within society. The word “Ethics”, when used
in this way, usually serves as a Modifier for
another word, e.g. Business ethics, Medical
ethics, Sports ethics, Military ethics, etc…. All
are professional ethics
http://www.lib.uconn.edu/DoddCenter/ASC/dodphot1.htm.

8. The Nuremberg Code , 1947.
As a part of the verdict, the Court
enumerated some rules for
Permissible Medical experiments",
now known as “Nuremberg Code”
Declaration of Helsinki ,1964
General principles and specific guidelines
(Recommendations) Guiding Medical
Doctors in Biomedical Research
Involving Human Subjects
“Concern for the interests of the subject
must always prevail over the interests
of science and society.”
History of ethics
www.bioethics.umn.edu

9. History of ethics
Public Health Service Policy
• National Advisory Health (NIH) Council Director and
Surgeon General requested that the Council review
human subject protections
• (NIH) Council recommended prior institutional review
for PHS supported research to:
– Protect of the rights and welfare of the subjects
– Assure appropriate methods of informed consent
– Determine acceptable balance of risks and benefits
• Adopted as Public Health Service policy in 1966
, Beginnings of the Institutional Review Board (IRB)
www.bioethics.umn.edu

10. History of ethics
National Research Acts
1 - 1973 Kennedy Hearings
Quality of Health Care - Human
Experimentation”
2 - 1974 National Research Act
Established the “National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research”
3 - The Belmont Report
Ethical Principles and Guidelines for the
Protection of Human Subjects of Research ,,
April 18, 1979
www.bioethics.umn.edu

11. History of ethics
4 - Federal Regulations and Policy
Title 45, Part 46 from Code of Federal Regulations (45
CFR 46) Federal Policy for the Protection of Human
Subjects - “The Common Rule” June 18, 1991 The
regulations contain Three Basic Protections for human
subjects:
Basic Ethical Principles
A- Institutional Assurances
B- IRB Review (Institutional Review Board)
C- Informed Consent
http://206.102.88.10/ohsrsite/guidelines/45cfr46.html#46.101

12. A -Institutional Assurances
• Institutions bear full responsibility for all
research involving human subjects covered
under their Assurance
• All requirements of 45 CFR 46 must be met for
all federally-sponsored research
www.bioethics.umn.edu

13.  BENEFICENCE Risk/Benefit Analysis
Experimental Design
Qualifications of PI
 JUSTICE Subject selection
Inclusion/exclusion
Recruitment
 RESPECT FOR PERSONS
Informed consent
Protection of subjects
(especially vulnerable populations)
www.bioethics.umn.edu
B -IRB Review
Maximize
Benefits
and
Minimize
Harms
Respect for
Persons –
Privacy and
confidentiality
(Institutional Review Board) are Established
to protect and safeguard the interests, rights and
welfare of human subjects.

14. Role of IRB
• Shared responsibility for ensuring ethical standards
among investigators, peers, local community.
• Independent assessment of risks and benefits to
human subjects.
• Reflect values of local community
• Work collegially with PIs to safeguard subjects’ rights,
safety and welfare.
• Additional provisions for vulnerable subjects:
Prisoners, Children , Pregnant women and fetuses.

15. C -The Consent Process
Informed consent is not a single event or just a form to
be signed , rather, it is an educational process that
takes place between the investigator and the
prospective subject.
It means that people approached and asked to
participate in a research study must,
A.Know what they are getting involved with before they
commit;
B.Not to be manipulated in any way to participate,
C.Consent to participate in the project as a subject
Voluntarily.

16. Requirements For Informed ConsentRequirements For Informed Consent
The first requirement is that information disclosed to
research participants must include, “ procedure, their
purposes, risks and anticipated benefits, alternative
procedures and a statement offering the subject the
opportunity to ask questions and to withdraw at any
time from the research.
The second is comprehension, The concept of
comprehension requires researchers to adapt
information to be understandable to every participant.
taking into consideration different abilities, intelligence
levels, maturity, and language needs
The third requirement is voluntariness.
The Belmont Report of 1979
www.bioethics.umn.edu

17. 1.Professional Ethics1.Professional Ethics
2.Medical Ethics2.Medical Ethics
3.Bioethics3.Bioethics
4.Clinical Ethics4.Clinical Ethics
www.research.umn.edu/curriculumwww.research.umn.edu/curriculum
TYPES OF EITHICS
• Standards of conduct that apply to people who
occupy a professional occupation or role.
• A person who enters a profession acquires ethical
obligations because society trusts them to provide
valuable goods and services that cannot be
provided unless their conduct conforms to certain
standards.
• Professionals who fail to live up to their ethical
obligations betray this trust.
• Professional ethics studied by ethicists include
medical ethics.
www.research.umn.edu/curriculum

18. 1.Professional Ethics
• Standards of conduct that apply to people who
occupy a professional occupation or role.
• A person who enters a profession acquires
ethical obligations because society trusts them
to provide valuable goods and services that
cannot be provided unless their conduct
conforms to certain standards.
• Professionals who fail to live up to their ethical
obligations betray this trust.
• Professional ethics studied by ethicists include
medical ethics.
www.research.umn.edu/curriculum

19. 2.Medical Ethics
• A special kind of ethics, as it relates to a
particular realm of facts and concerns
• It is applied ethics, consists of the same
moral principles and rules that we would
appeal to, and argue for, in ordinary
circumstances, being applied to situations
peculiar to the medical world.
www.research.umn.edu/curriculum

20. 3.Bioethics
• Bioethics could be defined as the study of
ethical issues and decision-making associated
with the use of living organisms
• Bioethics includes both medical ethics and
environmental ethics.
Bioethics is learning how to balance different
benefits, risks and duties.
www.research.umn.edu/curriculum

21. 4.Clinical Ethics
Clinical ethics is a practical discipline that
provides a structured approach for
identifying ,analyzing, and resolving ethical
issues in clinical medicine.
Clinical ethics focuses on the doctor-patient
relationship including such issues as honesty,
competence, integrity, and respect for persons
www.research.umn.edu/curriculum

22. 4.Clinical Ethics
• Clinical ethics aims to improve patient care
and patient outcomes by focusing on reaching a
right and good decision in individual cases.
• Clinical ethics include specific issues such as
truth-telling, informed consent, end of life care,
palliative care, allocation of clinical resources,
and the ethics of medical research.
www.research.umn.edu/curriculum

23. Research Ethical Codes and Policies
• Honesty… Strive for honesty in all scientific
communications. Honestly report data, results,
methods and procedures, and publication status.
• Do not fabricate, falsify, or misrepresent data.
• Do not deceive colleagues, granting agencies, or the
public.
• Objectivity… Strive to avoid bias in experimental
design, data analysis, data interpretation, peer review,
personnel decisions, grant writing, expert testimony,
and other aspects of research where objectivity is
expected or required.
Avoid or minimize bias or self-deception.
Disclose personal or financial interests that may affect
research environmental health sciences
http://www.niehs.nih.gov/index.cfm

24. Research Ethical Codes and Policies
• Integrity … Keep your promises and agreements; act
with sincerity; strive for consistency of thought and
action.
• Confidentiality … Protect confidential communications
such as papers or grants submitted for publication,
personnel records, trade or military secrets, and patient
records.
• Carefulness … Avoid careless errors and negligence;
carefully and critically examine your own work and the
work of your peers.
Keep good records of research activities, with agencies
or journals.
• Openness … Share data, results, ideas, tools,
resources. Be open to criticism and new ideas
http://www.niehs.nih.gov/index.cfm

25. Research Ethical Codes and Policies
• Respect for Intellectual Property ... Honor patents,
copyrights, and other forms of intellectual property.
Do not use unpublished data, methods, or results
without permission. Give credit where credit is due.
Give proper acknowledgement or credit for all
contributions to research.
• Responsible Publication … Publish in order to
advance research and scholarship, not to advance just
your own career. Avoid wasteful and duplicative
publication
• Responsible Mentoring … Help to educate, mentor,
and advise students. Promote their welfare and allow
them to make their own decisions.
http://www.niehs.nih.gov/index.cfm

26. Research Ethical Codes and Policies
• Respect for colleagues … Respect your colleagues
and treat them fairly
• Social Responsibility … Strive to promote social good
and prevent or mitigate social harms through research,
public education, and advocacy
• Non-Discrimination … Avoid discrimination against
colleagues or students on the basis of factors that are
not related to their scientific competence and integrity.
• Competence … Maintain and improve your own
professional competence and expertise through lifelong
education and learning; take steps to promote
competence in science as a whole.
http://www.niehs.nih.gov/index.cfm

27. Research Ethical Codes and Policies
• Legality … Know and obey relevant laws and
institutional and governmental policies.
• Animal Care … Show proper respect and care for
animals when using them in research. Do not conduct
unnecessary or poorly designed animal experiments
• Human Subjects Protection … When conducting
research on human subjects, minimize harms and risks
and maximize benefits; respect human dignity, privacy,
and autonomy; take special precautions with vulnerable
populations; and strive to distribute the benefits and
burdens of research fairly.
http://www.niehs.nih.gov/index.cfm
What is Ethics in Research & Why is it Important .html

28. Ethical norms in research can,,,
Promote the Aims of Research. such as knowledge, truth,
and avoidance of error ( prohibitions against fabricating,
falsifying, or misrepresenting research data.)
Promote the Values that are Essential to Collaborative
Work, such as trust, accountability, mutual respect, and
fairness.
 Help to Ensure that researchers can be held
accountable to the Public, to build public support for
research .
Promote a variety of other Important Moral and Social
Values , such as social responsibility, human rights, animal
welfare, compliance with the law, and health & safety.
http://www.niehs.nih.gov/index.cfm
Importance Of Ethical Norms in Research

29.  Ethical lapses(mistakes) in research can significantly
harm human and animal subjects, students, and the
public
 The study of ethics prepares medical students to
recognize difficult situations and to deal with them in a
rational and principled manner.
Importance Of Ethical Norms in Research
It Is Important to remember
that ethIcs and Law are not
the same, ethIcaL norms tend
to be broader and more
InformaL than LawsWhat is Ethics in Research & Why is it Important .html

31. • Ethics is the norms for conduct , but not general standards of
conduct it is the standards of a particular profession, occupation,
institution, or group within society.
• Ethics become a must because of several medical crimes against
humanity that occurs at the last century (Nuremberg ,,,,, )
• Ethical principles and guidelines for the protection of human
subjects of research was done through several steps started at
1947 and continue until now.
Summary

32. • Three basic protections for human subjects called basic
ethical principles (Institutional assurances, IRB review,
informed consent)
• Ethical Norms are Important in Research , as it
Promote the Aims of Research.
Promote the Values that are Essential to Collaborative Work
 Help to build public support for research .
Promote a variety of other Important Moral and Social
Values .
Ethical lapses can significantly harm human and animal
subjects, students, and the public
• Ethics and Law are Not The Same
Summary

33. Back To The Case Study
• According to the analysis of the physician- society
relationship , dr. S. is right to consider the impact on
society of her patient's behavior.
• even if the consultations with the other health
practitioner occur outside of the health system in which
dr. s works , the patient is taking up Dr. Ss’ time that
could be devoted to other patients in need of her
services. However, dr. s must be cautious in dealing
with situations such as this.
• Patients are often unable to make fully rational
decisions and may need considerable time and health
education to come to an understanding of what is in the
best interests of themselves and of others.
• Dr. s is also right to approach her medical association
to seek a societal solution to this problem.

34. Case Study
Dr. R, GP in a small rural Town , is approached by a
Contract Research Organization (C.R.O.) to participate
in a clinical trial of anew (NSAID) drug for osteoarthritis
She is offered a sum of money for each patient that she
enrolls in the trial. The C.R.O. representative assures
her that the trial has received all the necessary
approvals , including one from an ethics review
committee.
Dr. R has never participated in a trial before and is
pleased to have this opportunity, especially with the
extra money. She accepts without inquiring further
about the scientific or ethical aspects of the trial
?????????????????????????
The World Medical Association Ferney-Voltaire Cedex, France
email: wma@wma.net • www.wma.net

35. Back to the Case Study
• Dr. R should not have accepted so quickly. She should
first find out more about the project and ensure that it
meets all the requirements for ethical research.
In particular, the protocol that was submitted to the
ethics review committee and any comments or
conditions that the committee put on the project.
• She should only participate in projects in her area of
practice, and she should satisfy herself about the
scientific merit and social value of the project.
• She should ensure that she acts in the best interests
of her patients and only enrolls those who will not be
harmed by changing their current treatment to the
experimental one or to a placebo.
The World Medical Association Ferney-Voltaire Cedex, France
email: wma@wma.net • www.wma.net

36. Back to the Case Study
• She must be able to explain the alternatives to her
patients so they can give fully informed consent to
participate or not to participate.
• She should not agree to enroll a fixed number of
patients as subjects since this could lead her to
pressure patients to agree, perhaps against their best
interests.
• She should carefully monitor the patients in the study
for unexpected adverse events and be prepared to
adopt rapid corrective action.
• Finally, she should communicate to her patients the
results of the research as they become available.
The World Medical Association , Ferney-Voltaire Cedex, France
email: wma@wma.net • : www.wma.net

37. The Golden RuleThe Golden Rule
("Do unto others as
you would have them
do unto you“)