Transcript What is research & P..

What is research &
Principles of research
ethics
Ayodele S. JEGEDE, PhD, MHSc
West African Bioethics Training Program
outline
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Objective
Learning outcomes
Research
Historical
Principles
Theory
Objective
 To introduce participants to the basic principles
guiding ethical practice
Learning Outcomes
 Participants understand principles guiding
research conduct
 Participants able to make reasoned decision(s)
about steps taken in conducting scientific
research
What is Research?
 human activity based on intellectual
application in the investigation of matter
 The primary purpose for applied research is:
discovering, interpreting, and the
development of methods and systems for the
advancement of human knowledge on a wide
variety of scientific matters of our world and the
universe.
 Research can use the scientific method
Scientific research
 Relies on the application of the scientific method, a
harnessing of curiosity
 It provides scientific information and theories for the
explanation of the nature and the properties of the
world around us
 It makes practical applications possible
 Scientific research is funded by
 public authorities
 charitable organizations
 private groups, including
Basic, Fundamental or Pure
Research
 Primary objective:
 advancement of knowledge and the theoretical
understanding of the relations among variables
 It is exploratory and often driven by the researcher’s
curiosity, interest, and intuition
 The terms “basic” or “fundamental” indicate that,
through theory generation, basic research provides
the foundation for further, sometimes applied
research
Research Process
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Formation of the topic
Hypothesis
Conceptual definitions
Operational definitions
Gathering of data
Analysis of data
Test, revising of hypothesis
Conclusion, iteration if necessary
Historical/Literature Review
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Identification of origin date
Evidence of localization
Recognition of authorship
Analysis of data
Identification of integrity
Attribution of credibility
Research Methods
 Exploratory research: structures and identifies
new problems
 Constructive research: develops solutions to a
problem
 Empirical research: tests the feasibility of a
solution using empirical evidence
 Research can also fall into two distinct types:
 Primary research
 Secondary research
 Is anything wrong doing research?
A history for concern
 Nuremberg & Japan
 Tuskegee
 The Project Camelot
Pfizer
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concerns
 Disturbing stories about routine use in research
without consent of
 Patient records
 Prenatal screening samples
 Tissue collected for treatment
 Deception
The response
 Nuremberg code
http://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htm
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Declaration of Helsinki www.wma.net
CIOMS Statement http://www.cioms.ch/
Tri-Council Policy Statement (Canada)
National Committee on Ethics in Human Research
(Canada) http://ncehr-cnerh.org/
 Belmont Report (US)
 Office of Human Research Protection (US)
http://ohrp.osophs.dhhs.gov/index.html
 MRC guidelines (http://www.mrc.ac.uk/ethics UK)
 British Sociological Society (UK)
 Nuffield Reports (UK)
http://www.nuffieldbioethics.org/home/index.asp
 Research Ethics Boards
Principles
Respect for human dignity
Beneficence / Non-Maleficence
Utility
Justice
Respect for human dignity
 Respect for autonomy
 Informed Consent
 Honesty
 Respect for privacy
 Fair recruitment procedures
 Follow up
 Collaborative research
Tallon D, Chard J, Dieppe P. Consumer
involvement in research is essential.
BMJ 2000;320:380-380
 “…consumer involvement will greatly enhance
the overall relevance of clinical research. It will
ensure that the most fruitful research questions
are addressed and the most appropriate
outcome measures used, thus maximising the
potential for the results to be relevant and
beneficial to research consumers. Furthermore,
it should lead to a more efficient use of
research resources.”
Ends, means, subjects and
objects
There is a danger of reducing research subjects
to research objects
Ends, means, subjects and
objects
 Be aware of the humanity in each person
 Treat persons as ends in themselves and
never solely as means to ends
 Includes honesty, consent
Beneficence / NonMaleficence
 Intentions
 Outcomes
 Balance the good of many with the good of few
M.H. Pappworth in 1967
 “No physician is justified in placing
science or the public welfare first and his
obligation to the individual, who is his
patient or subject, second. No doctor,
however great his capacity or original his
ideas, has the right to choose martyrs for
science or for the general good.”
 Pappworth M.H. Human Guinea Pigs; Boston: Beacon Press,
1967; pg. 27
Utility
 Make best use of scarce resources
 Research participants are a valuable resource
not to be exploited
 Ensure value of the research question
 Ensure quality of method
Justice
 Fairness as equity
 Equal access to benefits
 Equal share of burdens
 Deprived populations
 Global research
A challenging balance
Justice, risk and consent
Risk
Edwards SJ et al Research Ethics Committees and
paternalism, Jrl of Medical Ethics 2004;30:88-91
 Research entails risk
 Should we permit high risk research?
 Respect for persons + Beneficence
=
Paternalism or Disclosure of Risk
 But the risks associated with research are
mostly unknown and ...
US Hearings on Human
Experimentation, 1973
 “Those who have borne the brunt of
research – whether it is drugs or even
experimental surgery – have been the
more disadvantaged people within our
society; have been the institutionalised,
the poor, and minority members.”
 Sen. T Kennedy, prt 3, 7.3.1973, p. 841
Acceptable levels of risk?
 Baltimore Lead in Children study
 Relative to context and interpretation
 May imply that risky research is tolerable among
populations who live with high levels of risk in their day
to day existence
Spriggs M Canaries in the mines: children, risk, non-therapeutic
research and justice, Jrl of Medical Ethics 2004;30:176-181.
A modest proposal by M
Spriggs
 ‘My proposal is that researchers and reviewers
should be expected to contemplate and sign a
statement that says: ‘‘I would not hesitate to
submit myself, or members of my own family, or
anybody for whom I have any respect or
affection, if in circumstances identical to those
of the intended subjects’’’.
 Based on Papworth quote
Justice, Risk and REBs
 Safe mechanisms
 e.g. REBs, Monitoring, Audit
 Equal distribution of risks, harms and
benefits of research
Practical
considerations
Justice and the measurement of benefit and
burden in research
Considerations that might affect the
appropriateness of involvement of some
communities in research (Beyrer & Kass 2002)
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Vulnerability
Poverty
Human rights violations
Discrimination
Poor access to resources
Education
Coercion
Lack of trust
Problems
 They need to be interpreted
 Variability of application
Science is built upon a foundation of trust and honesty
Incorrect data or incorrect interpretation of data are usually (?) (often?
sometimes?) corrected by the continuing process of scientific
investigations. This is true whether the errors are caused by mistake or
misconduct.
Science tends to be self-correcting.
Most of the information and ideas in this presentation are from:
F. Macrina. Scientific Integrity, 2nd edition, ASM Press
and
Lucinda Peach. 1995. An Introduction to Ethical Theory. In: Research Ethics: Case and Materials, Robin Levin Penslar, ed. Bloomington, Indiana University Press)
Research ethics
The moral acceptability or appropriateness of specific conduct and
actions that moral agents take in particular situations
•Fraud
•Mistreatment of research subjects (human or animals)
•Accuracy and honesty in recording and reporting data
•Ownership and use of data
•Violations of intellectual property rights
•Interpersonal relationships
•Plagiarism and copyright violations
•Conflict of interest
How do you assess the acceptability or appropriateness of a
particular act?
Ethical Theory and Moral Reasoning
 No one theory can be used to evaluate every
situation
 All theories pay attention to all or some of six
factors
 Facts (?)
 Interpretations of the facts
 Consequences of the actions
 Obligations of the moral agents
 Rights of the players
 Virtues of the players
Moral Reasoning: Moral reasoning is individual or collective
practical reasoning about what, morally, one ought to do.
(from
Stanford Encyclopedia of Philosophy)
Two main theories
Teleological ethics (Consequentialist ethics, Utilitarianism;
rightness is dependent on the good or evil that results from the
action of the moral agents)
Deontology (rule-base ethics; rightness is independent of the
good or evil that results from the actions of the moral agents)
Two alternative theories that are widely applied
Virtue ethics
Casuistical ethics (evaluation by analogy)
Consequentialist ethics
•The course of actions is determined in accordance with its likely
consequences or outcomes rather than its inherent rightness or wrongness.
(Consequentialist conclusions that are especially based on an impartial consideration of
the interests or welfare of others are called utilitarian theories).
•We should strive to create the greatest possible balance of good over
evil.
•Promote human values by maximizing benefits and minimizing harm: the ends
justify the means and the greatest good for the greatest number.
•The order of priorities is the good before the right
•Generally focuses on a specific act, not what would be the best course of action for
someone in that kind of situation (telling the truth is generally the right thing to do for the
greatest good, but it may not be the right thing to do in a particular situation).
•General moral principals are guidelines, not binding rules.
Deontological ethics (rule-base ethics)
 Some acts are intrinsically right or wrong, regardless of the
consequences.
 Rule-based (judgments are made by reference to rules and rule
are based on principles.)
 Moral rules are binding regardless of the consequence (one
must do what is right, even if it does not result in the greatest
good; the ends do not justify the means)
 Deontologists are generally constrained by prohibitions; thus,
unintentional breaking of the rules is not necessarily unethical.
(if the standard is that plagiarism is the intentional use of
someone else’s work with out attribution then negligent failure
to cite the quoted work is not plagiarism).
 Deontologist do not base ethical judgments on the
consequence of the actions. Strict religious or legal
interpretations are deontological. There is one “right” way.
Casuistical ethics (evaluation by
analogy)
 Compare to less complex, similar cases that are
easier to evaluate and have a clear moral resolution,
i.e., casuistry.
 It analyzes particular moral problems by analogy to
prior paradigm cases (non controversial), rather than
as unique isolated cases.
 Requires practical wisdom; an ability to understand
when, and under what circumstances and conditions
the rules are relevant and should apply.
 Can help decide whether something is ethical and also
may give guidance on what to do about it (report the
plagiarizer or not)
Virtue ethics
 Focus on the character and moral qualities of the
players. What is their history, character, motives,
intentions. Do the player have the habit or disposition
to act morally and do what is right? There is less
concern with rules, standards and outcome.
 However, rules and outcome will reflect on the
character and virtuousness of the player.
 Virtue ethics can be important where there is a clear
violation of ethics or standards. Virtue ethics may be
most important in determining consequences in cases
of misconduct. (is this a person who made a mistake
or is there a pattern or wrongdoing from a person that
lacks virtue and good character?)
Summary/Conclusion:
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Consequentialist ethics
Deontological ethics (rule-base ethics)
Casuistical ethics (evaluation by analogy)
Virtue ethics
 In research, no one theory of ethics is appropriate all
the time and usually some aspect of all approaches
are necessary.
 Understanding the theories may be useful in making
final judgments about the ethics of a specific situation.
Acknowledgment
 Lisa Schwartz (na) “Principles of Research Ethics:
consent, risk and justice.” Arnold Johnson Chair in
Health Care Ethics, McMaster University
 Paul Patek & Sean Callahan
 FMOH (2006) National Code for Health
Research Ethics, National Health Ethics
Research Committee (NHREC).
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