Research Ethics by salman.pdf ethics considering

Research Ethics
Salman
Nursing Lecturer

Objectives
By the end of the session participants will be able to:-
1. Discuss the historical events influencing the development of ethical
codes and regulations
2. Identify ethical principles applicable in research process.
3. Evaluate the ethical dimensions of a research report.
4. Describe the role of the institutional review board
5. Understand the informed consent.

What is Ethics?
Definitions
 Ethics are the moral code which guides the members of the profession
in proper conduct of their duties & obligations.
 The philosophical study of moral values and rules.

Ethics in Research?
 Research Ethics provides guidelines for the responsible conduct of
biomedical research.
 In addition, research ethics educates and monitors scientists
conducting research to ensure a high ethical standard

Ethical vs. Unethical research
 Ethical studies protect subjects and are carried out using scientific principles.
Unethical research includes:
 Scientific misconduct
 Fraud, research protocol violations
 Untruth, falsification, duplicating of data
 dishonest manipulation of the designs and methods with protocols violations;
 Misrepresentative of findings
 Plagiarism
 Putting subjects at risk without consent. Failure to obtain permission to conduct
the trials or to inform and obtain informed consent from each subject.

Elements of Ethical Research
 Protecting human rights
 Understanding informed consent
 Understanding institutional review of research
 Balancing benefits and risks in a study

Historical events Influencing the development
of Ethical codes and regulation
1. Nazi medical experience.
2. Tuskegee Syphilis study
3. Willow brook Study
4. Jewish Chronic Disease Hospital Study
5. Nuremberg Code
6. Declaration of Helsinki

Unethical Studies
1. Nazi medical experiments
2. Tuskegee syphilis study
3. Willow brook study
4. Jewish chronic disease hospital study

Historical Events Influencing Ethics in Research
1. Nazi Trial (1935-1945)
 23 German Nazi physicians tortured (strenuous )
 Brutalized (abused) and murdered thousands of victims in the name
of research
 Exposing human bodies to extreme temperatures and altitudes
 To see how quickly a human could be euthanatized

2.Tuskegee Syphilis study for 40 years by the U.S. Public Health Service to
study the natural progression of untreated syphilis in poor, rural black men
who thought they were receiving free health care from the U.S. government.
 They were never told they had syphilis, nor were they ever treated for it.
 Over one hundred of the infected men died and others suffered from serious
syphilis related conditions.

3. Willow brook Study (1963-1966)
 Mentally retarded children were deliberately infected with hepatitis virus to
invent the vaccine for specific strains of hepatitis
4. Jewish Chronic Disease Hospital Study (1960)
 New York in 1960's, looking at patient's rejection responses to live cancer
cells, injected into patients that had been generated from human cancer
tissues
 Patients were not informed and no written informed consent was obtained
 Researchers thought that this research will bring upon extremely important
knowledge

Ethical Codes and Regulations
Codes of ethics have been developed in response to these violations of
human rights.
1. First internationally recognized efforts to establish ethical standards
is referred to as the Nuremberg code-1949
2. Declaration of Helsinki adopted in 1964 by the world medical
association and then later revised, in 2000.

Guidelines from Nuremberg Code 1949
1. Research participants must voluntarily consent to research
participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or
death are potential outcomes

Guidelines from Nuremberg Code
6. The degree of risk taken with research participants cannot exceed
expected benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at
any time
10. Scientists must be prepared to terminate the experiment if there is
cause to believe that continuation will be harmful or result in injury or
death

Declaration of Helsinki
Therapeutic research
 Results might benefit participants
Nontherapeutic research
 Results are not of benefit to participants, but might be in the future

National Commission for the Protection of
Human Subjects
The Belmont Report
In 1978 The National Commission for the protection of Human Subjects
of Biomedical and Behavioral Research was formed.
The goals of this commission were to:
a) Identify basic ethical principles that should guide the conduct of
research involving human subjects and
b) Develop guidelines based on principles that had been identified.

National Commission for the Protection of
Human Subjects
The report published by this commission in 1979 was titled “The
Belmont Report”
Three basic principles related to research subjects were identified
1. Respect for Persons – research subjects should have autonomy and
self determination
2. Beneficence – research subjects should be protected from harm
3. Justice – research subjects should receive fair treatment

Ethical principles necessary for conducting
research
• In undertaking research, certain ethical principles are used as a
framework to guide the researcher through the research process and its
subsequent use.
• They help to ensure the highest possible standards in every aspect of
research.
• The Belmont Report (1978) articulated three primary ethical principles
on which standards of ethical conduct in research are based:
1. Beneficence
2. Respect for human dignity
3. Justice.

1. Beneficence
Encourages the researcher to do good and “above all, do no harm”. It contains multiple
dimensions.
1. Freedom From Harm: -
Physical (injury, fatigue), psychological (stress, fear), social (loss of friends), and
economic (loss of Wages).
2. Freedom From Exploitation: -
Participants need to be assured that their participation, or information they might
provide, will not be used against them in any way.
3. Benefits From Research:
Maximize benefits & to communicate potential benefits to participants
4. The Risk/Benefit Ratio
risks and benefits that individual participants might experience should be shared with
them so that they can evaluate whether it is in their best interest to participate.

2. Respect for Human Dignity
 People should be treated as autonomous agents with the right to self determination and
the freedom to participate or not in research.
 The right to self-determination and the right to full disclosure are the two major Elements
on which informed consent is based
The Right to Self-Determination
 The principle of self-determination means that principle of self-determination means that
prospective participants have the right to decide voluntarily whether to participate in a
study, without risking any penalty or prejudicial treatment
The Right to Full Disclosure
 Full disclosure means that the researcher has fully described the nature of the study, the
person’s right to refuse participation, the researcher’s responsibilities, and likely risks and
benefits.

3. Justice
 Human subjects should be treated fairly in terms of the benefits and
the risks of research
 It includes participants’ right to fair treatment and their right to
privacy.
1. The Right to Fair Treatment Study participants have the right to fair
and equitable treatment before, during, and after their participation in
the study.
2. The Right to Privacy Participants have the right to expect that any
data they provide will be kept in strictest confidence. This can occur
either through anonymity or through other confidentiality procedures.

Human Rights & how they protected during
research
 Human rights that require protection in research are as under.
1. Right to self-determination
2. Right to privacy
3. Right to anonymity & confidentiality
4. Right to fair treatment
5. Right to protection from discomfort and harm

Informed Consent Process
Informed consent concern subjects’ participation in research in which they
have full understanding of the study before the study begins
It is a conversations between study subject and the research team. In which
he/she decide to participate in the research study and consent by signing the
document.
 Participant will be given a copy of the informed consent document. He/she
can use it as an information resource throughout study.
 Both written consent and verbal consent for participation in research must
involve an informed consent process.
 Informed consent involves an education and information exchange that
takes place between the researcher and the potential subject.

Informed Consent
 Essential information for consent
 Comprehension of consent information
 Competence to give consent
 Voluntary consent

Essential Information for Consent
 Introduction of research activities
 Statement of research purpose
 Selection of research subjects
 Explanation of procedures
 Description of risks and discomforts
 Description of benefits
 Assurance of anonymity and confidentiality offer to answer questions
 Voluntary participation
 Option to withdraw
 Consent to incomplete disclosure

Role of the institutional review board in the
review of research proposals.
The Institutional Review Board (IRB) is an administrative body
established to protect the rights and welfare of human research
subjects recruited to participate in research activities conducted under
the auspices of the institution with which it is affiliated.
 The IRB is charged with the responsibility of reviewing, prior to its
initiation, all research (whether funded or not) involving human
participants.
 The IRB is concerned with protecting the welfare, rights, and privacy
of human subjects.

Role of the institutional review board in the
review of research proposals.
 The IRB has the authority to approve, disapprove, monitor, and
require modifications in all research activities.
 The IRB shall have at least five members of varying backgrounds in
order to provide complete and adequate review of human research
and its institutional, legal, scientific, and social implications.
 The IRB has several consultants who advise the Board and are
periodically involved in protocol review.

Evaluate the ethical dimensions of a research
report
1. Was the study approved by an Institutional Review Board (IRB)?
2. Was informed consent obtained from the subjects?
3. Is there information about provisions for anonymity or confidentiality.
4. Does it appear that subjects might have been coerced into acting as
subjects?

Evaluate the ethical dimensions of a research
report
6. Is it evident that the benefits of participation in the study
outweighed the risks involved?
7. Were subjects provided the opportunity to ask questions about the
study and told how to contact the researcher if other questions arose?
8. Were the subjects told how they could get the results of the study?

References
 Polit, D.F., and Bech, C.T. “Nursing Research; principles and Methods”
7th edition, LWW.
 Burns, N., and Grove, S.K. (2007). “Understanding Nursing Research;
 “Understanding Nursing Research; building an evidence based practice”
4th edition, New Delhi, Elsevier.
 University of Minnesota, Center for Bioethics. (2003). A guide to
research ethics.

Research Ethics by salman.pdf ethics considering

More Related Content

Similar to Research Ethics by salman.pdf ethics considering

Recently uploaded

Research Ethics by salman.pdf ethics considering