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What is research & Principles of research ethics Ayodele S. JEGEDE, PhD, MHSc West African Bioethics Training Program outline 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 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 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 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 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) 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: 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). $