Research Ethics

Courtesy: Prothom-Alo
 Objectives of the Session
It is expected that at the end of the session, the learners will be able
to demonstrate understanding of :

– Key elements of ethical issues

– Basic concepts of ethical issues
– Common terms used in research ethics
– Ethical committee
– How to take ethical clearance for the study
• Application
• Check list
• Abstract for ERC
 Why we should learn Ethics

• To take ethical clearance

• To protect myself from a sue.
• To get a good publication

Training and education in research ethics help reduce the

rate of misconduct in Research
 What is Research Ethics/ Bioethics

• Ethics is defined “a science of morals”.

• It is a branch of Philosophy that deals with moral principles, which

control or influence a person’s behavior.
 Basic Rights And Ethical Duties

Human
• Human Rights Dignity
• Access to health care
• Right to non-discrimination
• Right to privacy and confidentiality
• Right to environment that is not harmful to health or
well being
 What is Ethics????
In the narrow historical sense refers to a group of guidelines,
such as the Oath of Hippocrates; the physician’s ideal
relationship to his peers and to his patients.

In the modern sense, it refers to the application of general and

fundamental ethical principles to clinical practice situations,
including medical research.
 HISTORY

• Hippocratic Oath- Duty of Physicians

• During reign of Theodoric – 5th century
• Ishaq Ibn Ali al-Ruhawi- “Conduct of Physicians”- first book
on medical ethics
• Muhammad ibn Zakariya al-Razi
• Thomas Aquinas- catholic code of conduct
• Thomas Percival (England) 1794- medical ethics and medical
jurisprudence
• World Medical Association-Declaration of Geneva 1948
 Some ethical principles
• Honesty
• Objectivity
• Integrity
• Carefulness
• Openness
• Respect for intellectual property
• Confidentiality
• Responsible publication
• Responsible mentoring
• Respect for colleagues
• Social responsibility
Nuremberg Trial
 EVOLUTION

• Nazi human experimentation led to “Doctors Trial”-Trial of War

Criminals before the Nuremburg Military Tribunal (1947)
• Bone, muscle transplantation (without anaethesia), head injury
experiments, freezing experiments, malaria infection, mustard gas
poisoning etc.
• 23 defendants, 20 doctors including Lt Gen Karl Brandt, Lt Gen Karl
Gebhart; 7 death sentences
 Ethical issues in Bio-medical/Clinical
research( WMA/ CIOMS)
• Scientific Review Committee (G-1) and Ethical Review Committee (G-2)
• Duty of the Physician in medical research to protect the life, health, privacy
and dignity of the human subjects.
• Voluntary informed consent
• Inducement
• Confidentiality
• Autonomy
• Assessment of risk-benefit
• No deprivation of the medical facilities to the unwilling subjects who
previously used to get
Regulations for Research ETHICS
• The first international document on research ethics,
• The Nuremberg Code: The Code is designed to protect the
integrity of the research subjects.
• The code No-1: “the voluntary consent of the human subject is
absolutely essential”.
• To give the Universal Declaration of Human Rights, the General
Assembly of the U N adopted in 1966 :

Article 7: “No one shall be subjected to torture or to cruel,

inhuman or degrading treatment or punishment. In particular, no
one shall be subjected without his free consent to medical or
scientific experimentation”.
Ethical issues in Bio-medical/Clinical
research(WMA/CIOMS)

Basic principles of research ethics: 59th WMA declaration

of Helsinki’ 2008, WHO & CIOMS Guidelines.

– Respect for person/Autonomy

– Beneficence

– Non-maleficence

– Justice
 Basic principles (contd)
Respect for persons
• Recognizes the capacity and rights of all individuals to make their
own choices and decisions.
• Respect of the autonomy and self determination of all human
beings.
• Protection of person with impaired or diminished autonomy
(vulnerable persons).
• Respect for person during IC process.

“Participant” Versus “Subject”

“Participants” is thought to present a more respectful tone, while
“subject” may imply a subordinate relationship between the
 Basic principles (contd)

Beneficence
• Maximize possible benefits

• Minimize harms or wrongs

• Risk of research justified by experimental benefits

• Sound design

• Competent investigator(s)
 Basic principles (contd…)

Non-maleficence (Do No Harm)

• Guard against avoidable harm to research participants

 Basic principles (contd)
Justice
• Literally means Moral or Absolute Rightness

• Refers to the ethical obligation to treat each person in accordance

with what is morally right and proper, to give each person what is
due to him or her.

• Recruitment and selection of research participants should be done

in an equitable manner.

• It should be responsive to their health needs and priorities.

Some unethical practices in Research

• Discussing with our colleagues regarding confidential data

• Failing to keep good research records
• Making a significant variation from the research protocol approved
by ERC & SRC
• Not reporting an adverse event in human research experiment
• Wasting animals in research
• Exposing research participants to biological risks
ETHICAL REQUIREMENTS IN THE REASEARCH ON
HUMANS

• Obtaining Informed Consent From The Potential Participants

• The Need For The Participants To Derive A Health Benefit
From The Research
• Keeping The Risk To The Participants As Small As Possible
• Publishing of research results
 Informed Consent (IC)

• IC is the process in which a person learns key facts about a clinical

trial, including potential risks and benefits, before deciding whether
or not to participate in a study. IC continues throughout the trial.

• IC is an essential prerequisite for starting a biomedical research

involving human participants. All research involving human
Participants should be conducted in accordance with three basic
principles that is - respect for person, beneficence and justice.
 Informed Consent Process
Informed Consent may be written or verbal.
Written
• Informed consent shall be documented in a consent form.
• Signed and dated by the research participant.

Verbal consent
• A person who understands and comprehend language but is
physically unable to talk.
• An impartial third party should witness and sign the consent
document.
 Some important points for IC

• Information Sheet
• Purpose of the research
• Type of Research Intervention
Participant selection

• State why this participant has been chosen for this research.
People often wonder why they have been chosen to participate
and may be fearful, confused or concerned.
• A sample of Informed consent will be given
 Some important points for IC
• Voluntary Participation

• Information on the Trial Drug [Name of Drug]

• give the phase of the trial and explain what that means. Explain to
the participant why you are comparing or testing the drugs.
• provide as much information as is appropriate- manufacturer,
location of manufacture, reason for its development etc.
• explain the known experience with this drug
• explain comprehensively all the known side-effects/toxicity of this
drug.
 Some important points for IC
• Procedures and Protocol
• Description of the Process
• Duration
• Side Effects
• Risks, Benefits
• Reimbursements
• Confidentiality
• Sharing the Results
• Right to Refuse or Withdraw
• CIOMS Guideline no-4 (CIOMS, Geneva 2002):

• For all biomedical research involving humans the investigator

must obtain the voluntary IC of the prospective subject or, in the
case of an individual who is not capable of giving IC, the
permission of a legally authorized representative in accordance
with applicable law.
• Waiver of IC is to be regarded as uncommon and exceptional,
and must in all cases be approved by an ethical review
committee.
 Confidentiality

• Researcher should be sensitive to the risks associated with breach

of confidentiality.

• Protection of privacy and confidentiality - individuals and

communities.

• Legal provisions to be used to protect confidentiality

• Practical approach to maintain confidentiality
 Intellectual property rights (IPR)
(Concept of patent and copyrights)

• IPR are the rights awarded by society to individuals organizations

principally over creative works.

• Intellectual property is an asset, and as such it can be bought, sold,

licensed, exchanged, or gratuitously given away like another form
of property
 Ethical review committee

• Consists of following odd number of members

– Scientist
– Social worker
– Layman
– Legal advisor
– Politician
– Religious leader
– Journalist
– A representative from female( Gender issues)
 Vulnerable subjects

• Insane person
• Children
• Elderly persons with some specific disease
• Unconscious person
• Persons of diminished autonomy
• Patients of slum area
• Student/ soldiers
 To identify ethical Issues:
A study of the relapse rate in typhoid fever on 408
charity patients

• 251 were treated with • Symptomatic treatment

chloramphenicol , of 20 was given , but
died chloramphenicol was
withheld in 157,of whom
36 died
 Starting in 1932 and continuing until 1972, the Tuskegee experiment
followed 600 poor black farmers in Alabama, 399 who had contracted
syphilis prior to the study. All believed they were receiving free
government medical care for “bad blood,” and although a cure for syphilis
was readily available since the mid 1940s via penicillin, treatment was
deliberately withheld to study the course of the disease. Many subjects
subsequently developed late-stage neuro-syphilis, infected their wives and
even children who were born with congenital syphilis. The horrors of the
Tuskegee syphilis experiment led to the establishment of the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research in 1979. Yet the damage from unethical tests had
already been done decades earlier. There were several other such
experiments involving syphilis in the United States. Another similar
experiment of note occurred in Guatemala from 1946 to 1948 when U.S.
researchers deliberately infected almost 700 prisoners with gonorrhea and
syphilis without their consent to study the effectiveness of new antibiotics.
The experiments left such a devastating legacy in that country that U.S.
Secretary of State Hillary Clinton publicly apologized on behalf of the
U.S. government in October 2010.