W12-L10 (DSA 458) Research Ethics Research Methodology (PDF)

Research Methodology (DSA 4580) Step 3: Designing a Study and Collecting Data Research Ethics Academic Year: 2023-2024 Fifth Year DSA 4580 WEEK 12 LECTURE 10 Abdulhamid Al Ghwainem, BDS, MSc, DClinDent Pediatric Dentistry Assistant Professor in Pediatric Dentistry [email protected] Thursd...

Research Methodology (DSA 4580) Step 3: Designing a Study and Collecting Data Research Ethics Academic Year: 2023-2024 Fifth Year DSA 4580 WEEK 12 LECTURE 10 Abdulhamid Al Ghwainem, BDS, MSc, DClinDent Pediatric Dentistry Assistant Professor in Pediatric Dentistry [email protected] Thursday, 9 November 2023 Copyright © 2023 by PSAU, Abdulhamid Al Ghwainem Disclaimer DISCLAIMER The information presented in this lecture is offered for educational and informational purposes and should not be construed as medical, dental, or research advice. While the amount of information in this handout is vast, and I make every effort to be as current and thorough as possible, the information cannot be taken as a reference manual or textbook. Please note that you should read the required textbooks as specified in the course curriculum and lecture references. 2 Notice WARNING Materials used in connection with this course or lecture may be subject to copyright protection. 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Do not remove this notice 3 Outline § Overview of research ethics. § Historical development of research ethics. § The four ethical principles. § Main ethical considerations. § Ethic committee and review. § Case study. 4 Lecture Objectives By the end of this session, you should be able to: § Define the term ethics and understand its importance in research. § Explain how history has now defined a moral imperative for ethics in research. § List ethical principles that must underpin all research. § Discuss the importance and implications of researcher integrity. § Describe why ethics review boards came into existence and explain their role in the research process. 5 Research Process/Steps Research: answering questions in logical and systematic ways Question Answer Research methodology: how to get from Question to Answer 6 Research Process/Steps Research: answering questions in logical and systematic ways Question Answer Research methodology: how to get from Question to Answer Identify study question Select study approach Design study and collect data 7 Analyse data Report findings Research Process/Steps Research: answering questions in logical and systematic ways Identify study question Select study approach Design study and collect data • Research Ethics 8 Analyse data Report findings Research Ethics: overview 9 Research Ethics: overview § Ethics: is a generic term for various ways of understanding and examining the moral life’ (Beauchamp and Childress, 2001). § Ethics is the systematic and logical analysis of different perspectives on moral questions of what is right and wrong. Is that enough? § Can be more complicated? humanistic obligation and scientific obligation. § All researchers are expected and required to follow certain ethical standards and guidelines that are outlined by associations, societies, and universities. § It is important to know the bigger picture of why decisions are being made about your research and how that bigger picture affects not only research but also wellbeing and health of the people/animals who are taking part in it. 10 Research Ethics: overview § Research is a serious business. § Not only must the research be undertaken with ethical standards, but § Also, researchers must personally have a strong set of ethical standards. § Researchers must ensure that their participants (human and animal) are treated ethically and that, in the case of human participants, their confidentiality is maintained. § They must also apply ethical principles in the design of their studies, as well as the collection, analysis, and presentation of the data. 11 Historical Development of Research Ethics § Modern research ethics has developed since the Second World War, driven largely from within biomedical research to protect the dignity and well-being of research subjects § Its progress has been marked by the publication of four key documents: 1. The Nuremberg Code 2. The Declaration Of Helsinki 3. The Belmont Report 4. The International Ethical Guidelines For Biomedical Research Involving Human Subjects 12 Historical Development of Research Ethics The Nuremberg Code (1947): § Mandated voluntary consent for experimental studies of humans. § No research could proceed on human subjects without ‘voluntary consent’, and this has remained unchanged in subsequent codes. 13 Historical Development of Research Ethics The Declaration Of Helsinki (1964): § Written by The World Medical Association, assisted by WHO. § Developed an expanded and revised code of ethics to guide doctors in research involving human subjects. § This was followed by a revised Declaration in 1975 (Helsinki II), which changed the emphasis from ‘clinical research’ to ‘biomedical research involving human subjects. § Most biomedical research’s processes of review that have been developed by governmental and institutional boards and committees are heavily based on the guidelines of the Helsinki codes. 14 Historical Development of Research Ethics The Belmont Report (1979): § Published by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. § Define key research principles and is a foundational document for the current U.S. federal policy for protecting human research participants (the Common Rule). 15 Historical Development of Research Ethics The International Ethical Guidelines For Biomedical Research Involving Human Subjects (1982) § Moved the focus away from Western societies and onto issues raised by research involving developing countries. § The social, cultural and legal traditions of developing countries can be very different from those of industrialized nations. § A document which advocates the application of “universal” ethical principles in a diverse and multicultural world. 16 Ethical Principles §Beauchamp and Childress’ Four Principles approach is one of the most widely used frameworks and offers a broad consideration of medical ethics issues generally, not just for use in a clinical setting. §The Four Principles provide a general guide and leave considerable room for judgement in specific cases. 1. Beneficence 2. Non-maleficence 3. Respect for persons (autonomy) 4. Justice 17 Ethical Principles 1. Beneficence Means that the study should do good by maximizing possible benefits and minimizing possible harms. 2. Non-maleficence Means that the study should do no harm. 18 Ethical Principles 3. Respect for persons (autonomy) Emphasizes autonomy, informed consent, voluntariness, and protection of potentially vulnerable individuals. – Autonomy: only an individual (or his or her legal guardian) is authorized to decide whether to volunteer to participate in a research study. – Enabling individuals to make reasoned informed choices. 4. Justice The principle of justice requires an equitable and fair selection of subjects and a fair and equitable distribution of risks and benefits of research. 19 Ethical Principles 20 Eight Central Consideration (8 Cs) in Research Ethics 21 Research Ethics: incentives and coercion § The desire to reward or thank participants must be balanced with the need for participation in any research project to be voluntary. – Voluntariness is a decision made of an individual’s own free will without undue outside influence. – Coercion involves compelling an individual to participate in a research study in violation of the principles of autonomy and respect for persons. § Researchers must be transparent about what participants will gain from participation in a research study and what they will not gain. 22 Research Ethics: informed consent § Informed consent is an individual’s voluntary decision to participate in a research study after reviewing essential information about the project. § Informed consent statements provide crucial information about research projects to potential research participants so that they can make a thoughtful decision about whether to enroll in a study. § The statement must use clear, simple language that the reader understands. 23 Research Ethics: informed consent 24 Research Ethics: informed consent § Informed consent is intended to be a process, not merely a piece of paper. § The lines of communication between researchers and participants must remain open during and even after the data collection process. § The researcher should ensure that participants understand the research process and the consent document. § Understood consent requires evidence that a potential study participant comprehends the study benefits, risks, and procedures and knows his or her rights as a study participant prior to agreeing to participate. 25 Research Ethics: informed consent § For most research studies, the expectation is that each study participant will sign a printed copy of the informed consent statement. § When the source population has a low literacy rate, signatures may not be the best way to document consent: – A thumbprint or some other mark. – Oral consent, also called verbal consent: informed consent for participation in a study that is spoken and witnessed rather than requiring a participant’s signature. 26 Research Ethics: confidentiality and privacy § Privacy is the assurance that individuals get to choose what information they reveal about themselves. § Confidentiality is the protection of personal information provided to researchers. 27 Research Ethics: sensitive issues § Researchers asking questions about sensitive issues must decide ahead of time how to handle disclosures (such as disclosures of participation in illegal activities). § The research team can apply for a certificate of confidentiality that protects the identity of participants in a study of sensitive topics from being subject to court orders and other legal demands for information. 28 Research Ethics: cultural considerations § Culture is a way of living, believing, behaving, communicating, and understanding the world that is shared by members of a social unit. § Cultural competency is the ability to communicate effectively with people from different cultures and backgrounds. § A research protocol must be appropriate to the culture or cultures of the expected study participants. § It may be helpful to have a local advisory board facilitate communication between the community and the research team. 29 Research Ethics: vulnerable populations § Children and some adults with cognitive impairments may not be considered competent to make an informed decision. § Assent is the expressed willingness to participate in a study by a child or another person who is deemed not legally competent to provide his or her own consent. § Whenever possible, in addition to having the legal representative’s consent, potential participants should assent to their own participation. 30 Research Ethics: academic integrity § Ethical researchers do not plagiarize or claim credit for the work of others. § They do not misreport sources, invent data, or fake results. § They do not submit data whose accuracy they do not trust, unless they say so. § They don't hide objections that they can't answer. § They don't think poorly of or misrepresent different points of view. § They do not destroy data or conceal sources important for those who follow. 31 Research Ethics: ethics committee § An institutional review board (IRB), sometimes called a research ethics committee, is a group responsible for protecting people who participate in research studies § Three primary goals 1. Protect the “human subjects” who will participate in research 2. Protect researchers by preventing them from engaging in activities that could cause harm 3. Legally protect the researcher’s institution from the liability that could occur as a result of research activities 32 Research Ethics: ethics committee The major functions of ethics review boards are to: § Review new and revised research proposals. § Approve or disapprove of those proposals. § Ensure that informed consent is documented (if required). § Conduct continuing review of long-term research projects. 33 Research Ethics: ethics committee § Ethics review is required for almost every research that will involve living human subjects, whether those people will be directly contacted by the research team, or their existing personal information will be analyzed. § For primary studies, the required documentation typically includes a protocol along with any recruiting materials, the informed consent statement, and any relevant additional or required materials. § For secondary analyses, the application typically includes evidence that the data are in the public domain or that appropriate individuals or organizations have granted the researcher permission to analyze the data. 34 Research Ethics: ethics committee § Before conducting any human research, the researcher must have the study approved by the IRB. § Once the written proposal is completed, it is submitted to the appropriate IRB along with any additional materials needed (e.g., consent forms, test materials, and questionnaires). § This proposal will be sent to reviewers who will provide detailed feedback pertaining to the ethical conduct of the study. § Upon receiving the reviews, the IRB committee will meet to reach a final decision. § Researchers are responsible for complying with all IRB decisions, conditions, and requirements. § Upon granting approval to the investigators, the research project could be initiated. 35 Break Out Session Instructions: Search and read about the Tuskegee syphilis study § Explain and summarise the study § What were the ethical problems with this study? 36 Break Out Session Feedback § The Tuskegee syphilis study was an American public health study that violated research ethics throughout its 40-year run from 1932 to 1972. In this study, 600 young black men were deceived into participating with a promise of free healthcare that was never fulfilled. § In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses, or the research aims. § Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care. § When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death. § By the end of the study, 128 participants had died of syphilis or related complications. The study ended only once its existence was made public and it was judged to be “medically unjustified.” 37 References Required: Neale, J., 2020. Research methods for health and social care. Bloomsbury Publishing. Jacobsen, K.H., 2020. Introduction to health research methods: A practical guide. Jones & Bartlett Publishers. Additional: Bowling, A., 2014. Research methods in health: Investigating health and health services. Maidenhead, United Kingdom: Open University Press. Creswell, J.W. and Creswell, J.D., 2018. Research design: Qualitative, quantitative, and mixed methods approaches. Sage publications. World Health Organization. Regional Office for the Western Pacific, 2001. Health research methodology : a guide for training in research methods. 2nd ed.. WHO Regional Office for the Western Pacific. https://apps.who.int/iris/handle/10665/206929 World Health Organization. Regional Office for the Eastern Mediterranean. (2004). A practical guide for health researchers. https://apps.who.int/iris/handle/10665/119703 References Cited references: § Beauchamp, Tom L., and James F. Childress. Principles of biomedical ethics. Oxford University Press, USA, 2001. Next Lecture: Step 3: Designing a Study and Collecting Data Sampling Techniques Identify study question Select study approach Design study and collect data Thank you! Any questions [email protected] Analyse data Report findings