Principles of research ethics

Prepared by:
Assist. Prof. Dr. Yassin A. Asaad
 Learning objectives
By the end of this presentation, students should be
able to recognize:
• History of developing universal research ethics.
• The principles of research ethics.
• The ethical conduct of research.
• Special ethical issues in research.
 Case Study
Dr. R, a general practice in a small rural town, is approached
by a contract research organization (C.R.O.) to participate in
a clinical trial. He is offered a sum of money for each
patient that he enrolls in the trial. The C.R.O. representative
assures him 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.
He accepts without inquiring further about the scientific or
ethical aspects of the trial.
 Introduction
• Medicine is not like mathematics, due to new changes and
developments.
• All aspects of medical practice should be validated by
research.
• Comparing and evaluating drugs is the clinical trials.
• Four steps, or phases, of clinical research:
1. Small number of healthy volunteers
2. Group of patients
3. Clinical trial
4. After the drug is being licensed and marketed
 Foundations of research ethics
• The Nuremberg Code 1947
• The Declaration of Helsinki 1964 recently revised in 2000
• The Belmont Report 1978
• The U.S. Code of Federal Regulation (The common Rule)
1991
• Council for international organizations of Medical
Sciences (CIOMS) Guidelines 1993
• International Conference on Harmonization (ICH) 1996
• National Bioethics Advisory Committee (NBAC) 2001
 Ethics and research Ethics
• Ethics are moral principles that that govern a
persons behavior or the conduction of an activity.

• Research ethics is specifically interested in the

analysis of ethical issues that are raised when
people (or even animals) are involved as
participants in the research.
 Why research ethics is important?
• It is a reflection of respect of those who take part in the
research.
• It ensures that sufficient knowledge is shared by others.
• It has become a norm as an expectation for research
activity.
• A professional requirement in the academic discipline.
• It is one of the requirements to obtain fund.
 Principles of research ethics
1. Respect for persons
– Respect people’s autonomy ‫ا‬Protect those with diminished
autonomy

2. Beneficence and Non-maleficence

– Maximize benefits and minimize risks
– Minimize harm and whenever possible remove the causes of
harm

3- Justice
– Treat individuals Fairly
 Principles of research ethics- Contin.
4- Informed consent
5. Confidentiality and data protection
6. Integrity
Research should be designed, reviewed and undertaken to ensure
recognized standards of integrity are met, and quality and
transparency are assured.

7. Conflict of interest
 Ethical conduct of research
• Responsibilities
– Research institute
– Researcher
– Community
– Sponsor
– Ethical committee

• Ethical aspects
– Quality of research
– Participants’ rights
– Informed consent
 Ethics committee
• Review the research protocol for ethical issues

• Ensures the protection of participants

• Ensures administration of an informed consent

• Works on maximizing benefits and minimizing harm

• Supervises the research to make sure of ethical conduct

• Responds to changes in the protocol, addition of new research

implementation sites, changes in recruitment procedures and
problems encountered that could impact the safety of participants
 Quality of research

• Scientifically sound
• Respects social values
• Assures equitable benefits to respondents
• Assures a balance between risk/benefit
 Participants’ rights

Informed Consent
• Voluntary participation
• Inducement to participate
• Right to consent
• Right to withdraw
• Anonymity
• Privacy
• Confidentiality
 Special issues in research
• Consenting
• Data collection
• Conflict of interest
• Scientific misconduct
 Ethical issues in consenting
• Women
• Children
• Parentless/homeless children
• Young adolescents
• Sick people
• Mentally ill
• Prisoners
 Ethical issues in data collection
• Recording
• Filming
• Providing services
 Conflict of interest
A conflict of interest is a situation in which a person or
organization is involved in multiple interest, financial or
otherwise and serving one interest could involve working
against another.
• The Institution
– bring in research funds
– publish on a regular basis
• Research Sponsors
– implement studies
– produce favorable results
• The Researcher
– desire private/ financial gain
– earn prestige/respect of peers
 Scientific research misconduct
• Falsification ‫التزييف‬
- Making up of data or results or it is changing or omission of research
results (data) to support claims, hypotheses, other data, etc.
• Fabrication ‫التلفيق‬
- The construction and/or addition of data, observations, or
characterizations that never occurred in the gathering of data or
running of experiments.
• Plagiarism ‫الغش‬
-The most common form of research misconduct. Researchers must
be aware to cite all sources and take careful notes. Using or
representing the work of others as your own work.
 Conclusion
• Research is an honest, and transparent tool
to promote human wellbeing.

• All stakeholders should work hand-in-hand

to secure the ethical conduct of research.