1. Ethics in research involving human subjects
Public Health & Primary Care Unit
Paraclinical Sciences
Faculty of Medical Sciences
UWI, St Augustine, T&T
Ethics in research involving human subjects
presented by:
Celia M Poon-King
medical epidemiologist
lecturer in epidemiology

2. ethics in research involving human subjects
what do you know?
what do you think you need to know?
why?
WHAT DO YOU KNOW?
WHAT DO YOU THINK YOU NEED TO KNOW?
WHY?
4/19/2017
ethics in research involving human subjects

3. ethics in research involving human subjects
Outline
history
knowledge - principles, IRB
attitude
In conducting health related research involving human subjects, it is important to
appreciate that ethical practice is essential to conducting good research.
To do this you must be able to apply ethical principles to the actions you take while conducting your research.
To be able to apply ethical principles,
you need to appreciate why they are needed - HISTORY
you need to first know the principles and how their implementation is monitored, - PRINCIPLES AND IRB
then understand and appreciate them to ensure an ATTITUDE
that makes there use essential to your practice
4/19/2017
ethics in research involving human subjects

4. ethics in research involving human subjects
Outline
skills - application framework of principles
practice - learning objectives, research project
then know how to apply them – SKILLS using a framework
then Apply them – PRACTICE. You need to be able to learn to identify
what else you need to know in order to apply them
4/19/2017
ethics in research involving human subjects

5. ethics in research involving human subjects
History
Nuremberg code
To be able to appreciate where you are at any point in time,
a person must acknowledge and learn from the past
– good and bad - Or one is likely to repeat it.
In 1947, after World War II, at the Nuremberg trials,
the Nuremberg Code (
for ethical conduct of research involving human subjects
was developed. Why?
The trial highlighted highly unethical medical research conducted
by Nazi doctors on their many captives in the concentration camps in World War II.
– Much knowledge was gained from these studies. Should we not use this knowledge because of how it was gained?
e.g. information on hypothermia – how long a person can survive in cold water before dying?
4/19/2017
ethics in research involving human subjects

6. ethics in research involving human subjects
History
Helsinki declaration
Following this in 1964, the Helsinki Declaration released by the
World Medical Association further developed ethical guidelines for research involving human subjects.
It further highlighted the importance of informed consent. These are updated regularly (
Does this mean that after 1947, unethical medical research has not occurred?
No. What it does mean is the likelihood was decreased but not completely eliminated.
Tuskegee? What do you know about Tuskegee?
4/19/2017
ethics in research involving human subjects

7. ethics in research involving human subjects
History
Belmont report
In 1974, after Tuskegee and the debacle of the syphilis natural history
study conducted by the US Public Health Service on
the participants of ‘Tuskegee study of untreated Syphilis in the Negro Male’
which withheld appropriate treatment even after antibiotics became available,
the US enacted the National Research Act which established a National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research.
In 1979, this commission presented the Belmont Report (
The US President, Bill Clinton apologised on behalf of the government of the United States,
to the surviving black participants and their surviving relatives on May ,
65 years after the study was started.
4/19/2017
ethics in research involving human subjects

8. ethics in research involving human subjects
History
CIOMS
Internationally, the CIOMS (Council for International Organizations of Medical Sciences)
further developed guidelines for international research with human subjects. These are updated regularly (
4/19/2017
ethics in research involving human subjects

9. ethics in research involving human subjects
History
UNESCO
And in 2005, UNESCO presented the Universal Declaration on Bioethics and Human Rights (
4/19/2017
ethics in research involving human subjects

10. ethics in research involving human subjects
Knowledge
ethics
principles
professional conduct
What is ethics?
when you consider ethics principles in research involving human subjects,
Which are the groups of people you need to consider?
(1) the participants who will be in your studies, (2) the wider community – not in your study and (3) you - the researchers.
ETHICS PRINCIPLES
what are the ethics principles?
How do I as a researcher ensure that the participant’s interests
the communities’ interests? or my interests - are maintained?
Are there likely to be conflicts of interests?
and how do these ethics principles impact on my practice of research
or my professional conduct while conducting research?
PROFESSIONAL CONDUCT
what is professional conduct?
4/19/2017
ethics in research involving human subjects

11. What are the ethical principles in research involving humans?
beneficence promotion of well being
maximize benefit
non-maleficence - do no harm (commission or omission)
minimize harm
BENEFICENCE – refers to promoting well being. In the context of research,
this refers to the responsibility of the researcher to maximise the potential benefits of the study for the participants.
NONMALEFICENCE – refers to the requirement to do no harm.
Applied to research, this refers to the researcher’s responsibility
to minimize the potential for harm – or the potential risks
4/19/2017
ethics in research involving human subjects

12. What are the ethical principles in research involving humans?
respect for persons
privacy, confidentiality
autonomy - make own decisions
informed consent
RESPECT FOR PERSONS – every person is an individual, with rights and individual dignity,
they are entitled to your respect just for being an individual.
In the context of research issues of privacy and confidentiality need to be
safeguarded to ensure this principle is upheld.
AUTONOMY – deals with the fact that individuals have the right to self determination
– make decisions that will affect them. In the context of research, in order to make decisions, what does and individual need to make an informed decision – information:
consent based on adequate information is essential.
4/19/2017
ethics in research involving human subjects

13. What are the ethical principles in research involving humans?
justice - fairness
risks and benefits
is it justifiable to …….
JUSTICE – Is about fairness. Applied to research consider whether those taking the risks are likely to benefit from the study findings?
Is it justifiable that the risks are taken by these individuals if they are unlikely to benefit from participating?
4/19/2017
ethics in research involving human subjects

14. ethics in research involving human subjects
Attitude
what are the attitudes that are needed?
ethics is essential to research and clinical practice
research should be a part of everyday clinical practice
know when to ask for help
see it, do it, teach it
What are the attitudes that are needed?
4/19/2017
ethics in research involving human subjects

15. ethics in research involving human subjects
Issue
HIV – It is 1970; developing world; vertical transmission: mother to child; clinical trials showing gain for intense Antiviral Treatment Regimes; A trial for a less intense regime
ethical issues
beneficence
non-maleficence
autonomy
justice
Consider, it is 1970, the developing world needs to find a feasible treatment regime
to limit vertical transmission of HIV: mother to child. Clinical trials showing gain
for intense Antiviral Treatment Regimes in have been published. These regimes
cannot be implemented in the developing world. A trial for a less intense regime is planned.
What are the ethical issues that need to be considered?
4/19/2017
ethics in research involving human subjects

16. ethics in research involving human subjects
Beneficence
maximize benefits
individual
family
community
researcher
What are the questions you need to ask yourself, the researcher,
so as to maximise the benefits of the study?
Are there benefits to the INDIVIDUAL?, FAMILY ? COMMUNITY? RESEARCHERr?
In considering benefits, one needs to consider the quality of a study.
Is the study scientifically sound? For study findings to be of use they must reflect the best science.
Does the study provide insight to the question asked?
Is the study design appropriate?
Is the method used appropriate?
Is the analysis, interpretation appropriate to the question?
Should benefits to one of these groups be of greater value than anothers?
4/19/2017
ethics in research involving human subjects

17. ethics in research involving human subjects
Non-Maleficence
minimize risk of harm
physical
psychological
social
individual vs community
What measures can you as a researcher take to minimise
the risk of harm in the study? If you are to minimize harm,
you first need to identify the types of harm possible
in the groups of people involved.
Risks can be considered in the realm of physical, psychological and social.
These can be identified in the context of the individual compared to the community.
In research clinical eqipoise needs to be present.
What is clinical equipoise?
4/19/2017
ethics in research involving human subjects

18. ethics in research involving human subjects
Autonomy
informed consent
sufficient information
Applied to research, with the principle RESPECT FOR PERSONS:
you should consider privacy,….
Confidentiality….
and autonomy
Specifically applied to AUTONOMY-
WHAT DO YOU AS A RESEARCHER NEED FROM the individual – potential participant?.....
Answer: The individual needs to CONSENT to participate – to become a participant.
what do YOU as an individual need to make a decision about anything-such as to participate in a study?-
INFORMATION – INFORMED CONSENT.
What are the 3 components to informed consent?:
SUFFICIENT INFORMATION: enough information about the project –
the research procedure, and purpose
about the risks, about the benefits –
other procedures (where therapy is involved),
and the opportunity to ask questions, and the ability to withdraw from the research.
Belmont Report
4/19/2017
ethics in research involving human subjects

19. ethics in research involving human subjects
Autonomy
capacity
understand
appreciate consequences of participation
free power
You now have the information, what else do YOU need to make your decision?
YOU- the potential participant needs to be able to not only understand what is being consented to,
but also to appreciate the consequences of participating - CAPACITY.
You have the information, you understand and appreciation the consequences,
what else does the person need to be able to make a decision?: you need FREE POWER, the ability to say know.
FREE POWER : refers to the ability to choose to participate or not to participate.
Belmont Report
4/19/2017
ethics in research involving human subjects

20. ethics in research involving human subjects
Autonomy
actions:
ethics committee - community
investigators
participants
Enter the 3 potential players we started with:
In order to have informed consent, there are ACTIONS that need to be taken
by the ethics committee, the investigators and by the participants.
The ethics committee assesses the actions of the investigator.
The investigator needs to implement informed consent,
And the participant must take part in the process.
In considering the participant in relation to informed consent, if any of these components is absent –
that population is ? vulnerable.
Paddi O’hara
4/19/2017
ethics in research involving human subjects

21. Vulnerable populations (sufficient knowledge, capacity, free power)
children (assent)
mentally disabled
In such cases, what do you think will be needed?
Would Additional procedures be needed to provide informed consent?
what procedures?
In children, when capacity may be an issue, -Parental consent would be required.
But, together with parental consent, assent of the child is also sometimes required.
Assent-the child must agree.
In MENTALLY DISABLED individuals, where capacity may also be an issue,
guardian consent. Sometimes a history of the request of the individual in the past
may also be assessed – Living wills, or consent before loss of capacity.
4/19/2017
ethics in research involving human subjects

22. Vulnerable populations (sufficient knowledge, capacity, free power)
prisoners
with PRISONERS – free power may be an issue.
In all these cases, the role of the ethics committee is intrinsic to ensuring that
these individuals rights are protected.
4/19/2017
ethics in research involving human subjects

23. ethics in research involving human subjects
Justice
fairness
share risks → share benefits
JUSTICE is about fairness. Is a study fair? Is a study just?
What do I mean by fair or just?
Is it likely that the participants, in the same way that the risk was shared,
will the benefits of the study also be shared?
4/19/2017
ethics in research involving human subjects

24. ethics in research involving human subjects
Role of EC/IRB
ethics committee (EC)
institutional review board (IRB)
safeguard - dignity rights, safety and well being
What is the essential function of the IRB/EC?
To safeguard the dignity, rights and wellbeing of the research participants.
4/19/2017
ethics in research involving human subjects

25. Ethics committee Institutional review board
review & approval
beneficence, autonomy, justice, non-maleficence
How does the IRB/EC do this?
By the process of review and approval of potential research protocols submitted by researchers.
Review – considers the implementation of the ethical principles in the study.
The objective of the IRB/EC is to apply the principles in the LOCAL CONTEXT.
What does this mean?
4/19/2017
ethics in research involving human subjects

26. Ethics committee Institutional review board
membership
non-scientist, community participant
The membership of the IRB/EC
needs to reflect the LOCAL CONTEXT – i.e include non-scientists and community participants
as well as the research community.
4/19/2017
ethics in research involving human subjects

27. Ethics committee Institutional review board
scientifically sound research?
scientific review board
All ethics committees do not necessarily have the
expertise to consider scientific validity. so there is usually
a separate scientific review board.
Is it ethical to conduct a study that is not scientifically sound?
4/19/2017
ethics in research involving human subjects

28. Responsible conduct of research scientific misconduct
to maintain honesty & integrity
examples of failure - plagiarism, fabrication, falsification
regulation: professions, legal
outcome of failure:
damage science, society
credibility
Given that the IRB/EC safe guards the participant, what about the researcher?
What does the researcher have to do to ensure good research is implemented?
The researcher should conduct research with honesty and
integrity. Examples of failure to display this behaviour are:
plaigarism, fabrication and falsification.
Regulation is by the profession. In some countries there are legal
Regulatory mechanisms for scientific misconduct – United States.
However, the major outcomes of failure
of responsible as well as ethical conduct of research is
damage to science, society, and loss of credibility and
trust by the community served by the research.
Tuskegee ………..
4/19/2017
ethics in research involving human subjects

29. ethics in research involving human subjects
Learning objectives
principles
beneficence, non-maleficence, justice, respect for persons (including autonomy)
The Learning Objectives are at the end, because having driven the course,
your now need to be able to see where you have been
and knowing what you should be able to do, please consider
what else you need to explore and find out.
At the beginning, I gave you an outline of where we were going.
Part of the journey has been trying to figure out all the turns and ups and downs.
What are the questions you must constantly ask yourself to be the best possible researcher?
Should You be able to discuss the principles for the ethical conduct of research involving human subjects?
What should you be able to do if you have to implement these principles?
Should you be able to describe and implement a framework to use to apply ethics specifically to research?
Keeping in mind that this framework is transferable to other situations in clinical practice.
as well.
4/19/2017
ethics in research involving human subjects

30. ethics in research involving human subjects
Learning objectives
informed consent
components, deception - procedures
INFORMED CONSENT – is a good example of a component of the framework that is easily
transferable to clinical practice. Should You be able recognize and discuss the components of
both informed consent and deception?
Should You be able to implement procedures to ensure informed and valid consent is obtained?
Should this be intrinsic to your conduct of both good research and clinical practice?
4/19/2017
ethics in research involving human subjects

31. ethics in research involving human subjects
Learning objectives
institutional review board/ethics committee
responsibilities, composition
responsible conduct of research
Should You be able to discuss the role of the ethics committee or institution review board?
- the composition and their responsibilities and the part you must play in the responsible conduct of research?
4/19/2017
ethics in research involving human subjects

32. Implication - research project
protocol
undertaking study
interpretation
making recommendations
presenting your findings
what does this mean for you and your research project?
At all the stages of conducting research,
designing the study and writing the protocol,
undertaking the study, interpreting the findings, making recommendations
and presenting your findings - writing the report, making the oral presentation and poster
– you should let ethical principles guide your practice for the responsible conduct of research
4/19/2017
ethics in research involving human subjects

33. ethics in research involving human subjects
Summary
ethical conduct of research with human subjects
responsible conduct of research
this lecture has been an introduction to these 2 topics.
First consider doing your research with you as the participant –
and let that be your guide to ensure that your practice is ethical and in your interest as the participant.
Then as a researcher consider the trust the community and society
has given you by participating in your study.
Entrusting sometimes very sensitive information to you,
the participants give you a privilege they would not give sometimes even intimate partners.
You are responsible for your conduct in research. Please make it responsible.
The framework presented identifies areas with each principle
to be considered, A listing of US resources for ethical practice in research (
A self study course ( ( ( (
4/19/2017
ethics in research involving human subjects

34. ethics in research involving human subjects
Issue
use of statins
diabetics
your country
2007
a clinical trial to examine the efficacy of statins in the treatment regimes in diabetics
Using the framework presented, consider the following issue:
In 2007, in your country, you would like to design a trial to examine the efficacy
of statin use in the treatment regimes in diabetics.
What are the ethical issues you must consider?
4/19/2017
ethics in research involving human subjects

35. ethics in research involving human subjects
the end
thank you
4/19/2017
ethics in research involving human subjects