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

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

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

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

ethics in research involving human subjects History 1947 - 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 (http://www.cirp.org/library/ethics/nuremberg/) 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

ethics in research involving human subjects History 1964 - 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 (http://www.wma.net/e/policy/b3.htm, http://www.wma.net/e/ethicsunit/pdf/manual/ethics_manual.pdf) 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

ethics in research involving human subjects History 1979 - 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 (http://ohsr.od.nih.gov/guidelines/belmont.html) 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 16 1997, 65 years after the study was started. 4/19/2017 ethics in research involving human subjects

ethics in research involving human subjects History 1993 - CIOMS Internationally, the CIOMS (Council for International Organizations of Medical Sciences) further developed guidelines for international research with human subjects. These are updated regularly (http://www.cioms.ch/frame_guidelines_nov_2002.htm) 4/19/2017 ethics in research involving human subjects

ethics in research involving human subjects History 2005 - UNESCO And in 2005, UNESCO presented the Universal Declaration on Bioethics and Human Rights (http://unesdoc.unesco.org/images/0014/001461/146180E.pdf) 4/19/2017 ethics in research involving human subjects

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 (http://www.cumc.columbia.edu/dept/gsas/ac_programs/bio.htm) A self study course (http://www.fhi.org/training/en/Retc/intro.htm) (http://ec.europa.eu/european_group_ethics/docs/tb1oc_en.pdf) (http://www.who.int/tdr/publications/publications/pdf/ethics.pdf) (http://unesdoc.unesco.org/images/0014/001473/147392e.pdf) 4/19/2017 ethics in research involving human subjects

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

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