medical ethics with research

Medical Ethics

Dr. Ibrahim A. TolbahResearch Physician

University Diabetic Center21/04/2015

Never being selfish but always ready to help others

At the end of this lecture , all participants will be able to

know …

What is EthicsWhat is Ethics

Brief History of ethics Brief History of ethics

Ethical Principles Ethical Principles

Types Of EthicsTypes Of Ethics

Research Ethical Codes and PoliciesResearch Ethical Codes and Policies

Importance Of Ethical Norms in Research Importance Of Ethical Norms in Research

Objective

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

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.

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

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.

The Nuremberg Code , 1947.As a part of the verdict, the Courtenumerated some rules for Permissible Medical experiments",now known as “Nuremberg Code”Declaration of Helsinki ,1964General 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

History of ethicsPublic 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)


History of ethicsNational 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


History of ethics4 - 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 AssurancesB- IRB Review (Institutional Review Board)

C- Informed Consent

http://206.102.88.10/ohsrsite/guidelines/45cfr46.html#46.101

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


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.

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.

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.


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


1.Professional Ethics1.Professional Ethics

2.Medical Ethics2.Medical Ethics

3.Bioethics 3.Bioethics

4.Clinical Ethics4.Clinical Ethics

www.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

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

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.


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.


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


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.


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

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


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.


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.


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

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.


Importance Of Ethical Norms in Research

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 Laws


What is Ethics in Research & Why is it Important .html

• 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

• Three basic protections for human subjects called basic ethical principles (Institutional assurances, IRB review, informed consent)

• Ethical Norms are Important in Research , as itPromote 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

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.

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 osteoarthritisShe 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: [email protected] • www.wma.net

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, Franceemail: [email protected] • www.wma.net

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, Franceemail: [email protected] • : www.wma.net

The Golden RuleThe Golden Rule

("Do unto others as you would have them do unto you“)

medical ethics with research

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