Ethics in Research PDF

WE MAKE DOCTORS BLOCK VIII Neurosciences II Ethics in Research By Sergio Ramirez-Perez, PhD MSc WE MAKE DOCTORS Learning objectives a. Understand the historical development of research ethics and the fundamental principles that gui...

WE MAKE DOCTORS BLOCK VIII Neurosciences II Ethics in Research By Sergio Ramirez-Perez, PhD MSc WE MAKE DOCTORS Learning objectives a. Understand the historical development of research ethics and the fundamental principles that guide ethical decision-making in research. b.Identify and explain key ethical considerations in research design, including informed consent, risk-benefit analysis, and protection of participant confidentiality and privacy. c. Recognize and manage conflicts of interest in research and understand the importance of data integrity and honesty in research. d.Describe the ethical standards for reporting and publication in research, including the recent amendment to the Helsinki Declaration regarding post-trial access to treatment. Sergio Ramirez–Perez Ph.D. | Block V Musculoskeletal System  Introduction Agenda 1. Introduction and Historical Background of Research Ethics 2. Principles of Research Ethics 3. Ethical Considerations in Research Design 4. Informed Consent 5. Risk-Benefit Analysis 6. Confidentiality and Privacy 7. Conflict of Interest 8. Ethical Considerations in Data Collection and Analysis 9. Reporting and Publication Ethics 10. Obtaining Ethical Approval: Protocol Submission Process Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research What ethical considerations would you need to keep in mind during your research? Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction Overview What involves ethics? Research ethics involves the application of fundamental ethical principles to research activities It ensures that research is conducted in a manner that is respectful, responsible, and transparent Research ethics is crucial for maintaining public trust and confidence in the scientific enterprise, especially in the field of medicine where research directly impacts patient care and well-being Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction Historical Background Mengele researched dwarfism in wins with no regard for the health or safety of patients He was interested in people with different colored irises, and in the etiology and treatment of a gangrenous disease of the face endemic to the Gypsy prisoners in Auschwitz In the experiments, pairs of twins and persons with inherited anomalies were subjected to all imaginable medical examinations Josef Mengele As soon as these examinations were finished, they were killed with lethal injections of phenol to the heart so that the next phase of the experimentation could begin, autopsies and the comparative analysis of their internal organs Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction Historical Background https://www.youtube.com/watch?v=vs0s_upvFEo Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction The Nuremberg Code It is a document that was developed in response to the unethical human experimentation conducted by the Nazis during World War II and established ten principles to guide research involving human subjects (Shuster, 1997) Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction The Nuremberg Code https://www.youtube.com/watch?v=K1c26q0oxoE Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction The Declaration of Helsinki It was adopted by the World Medical Association It is a set of ethical principles for medical research involving human subjects developed originally in 1964 It has been revised multiple times (7 times) since its inception and remains one of the most influential documents in research ethics (World Medical Association, 2013) 11 ethical principles were established in 1964 but the number increased to 37 principles in the last version (2013) Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction The Declaration of Helsinki 7. Privacy and Confidentiality 1. Preamble 8. Informed Consent 2. General Principles 9. Use of Placebo 3. Risks, Burdens and Benefits 10. Post-Trial Provisions 4. Vulnerable Groups and Individuals 11. Research Registration and Publication and 5. Scientific Requirements and Research Protocols Dissemination of Results 6. Research Ethics Committees 12. Unproven Interventions in Clinical Practice Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Introduction The Belmont Report It was published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and outlines the ethical principles and guidelines for the protection of human subjects in research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Principles of Research Ethics Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Principles of Research Ethics Respect for Persons Participants should be treated as autonomous individuals, capable of making their own decisions about participation in research This includes obtaining informed consent and respecting participants' right to withdraw from the study at any time Example: The Tuskegee Syphilis Study, where participants were not informed of the true nature of the study and were denied treatment for their syphilis, highlights the importance of respect for persons in research (Jones, 1981). Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Principles of Research Ethics Beneficence Researchers should strive to maximize benefits and minimize harm to research participants This includes conducting a thorough risk-benefit analysis and ensuring that the potential benefits of the research outweigh any potential risks Example: The development of new cancer treatments often involves clinical trials that carry risks for participants, but the potential benefits of these treatments can outweigh the risks for many patients (Joffe et al., 2001). Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Principles of Research Ethics Justice The benefits and burdens of research should be distributed fairly among different groups in society This includes ensuring that vulnerable populations are not unfairly targeted or exploited in research Example: The use of a placebo in clinical trials for new cancer treatments raises ethical concerns about justice, as it may deny participants access to potentially life- saving treatments (Miller & Brody, 2003). Double-blind randomized controlled trial (RCT) Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Ethical Considerations in Research Design Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Ethical Considerations Overview Research design should be carefully planned to ensure that ethical principles are maintained throughout the research process This includes selecting research topics that are socially and scientifically valuable and designing protocols that minimize risks to participants Social and environmental impact Anticipate risks Ethical considerations in research design also include ensuring that research is conducted in a scientifically rigorous manner, with appropriate methods and controls to ensure the validity and reliability of the results Which ethical principle would you say is most important in research design: respect for persons, beneficence, or justice? Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research The Informed Consent Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Informed Consent Overview Informed consent is a fundamental ethical requirement for research involving human participants It involves providing participants with all the information they need to make an informed decision about whether to participate in the research The process of obtaining informed consent should include providing participants with information about: 1. The purpose, goals, and scope of the research 2. The procedures involved (colloquial vs. technical language) 3. The potential risks and benefits 4. Their rights as research participants Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Informed Consent Informed consent obtaining Should be obtained without coercion or undue influence, and participants should have the opportunity to ask questions and have their concerns addressed before deciding whether to participate in the research Example: The Tuskegee Syphilis Study What was the goal of the Tuskegee syphilis study? How did the lack of informed consent violate the principle of respect for persons? Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Risk-Benefit Analysis Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Risk-Benefit Analysis Overview Researchers have a responsibility to conduct a detailed risk-benefit analysis for their studies, weighing the potential risks to participants against the potential benefits of the research This involves identifying and assessing any potential risks to participants: 1. Physical harm 2. Psychological distress 3. Loss of privacy Finally, determining whether these risks are justified by the potential benefits of the research Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Risk-Benefit Analysis Minimize risks Researchers should take steps to minimize risks to participants wherever possible and ensure that the potential benefits of the research outweigh any potential harms Real-world Example: The development of new vaccines involves preclinical models but also clinical trials that carry risks for participants; however, the potential benefits of these treatments can outweigh the risks for many patients. Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Confidentiality and Privacy Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Confidentiality and Privacy Overview Confidentiality and privacy are essential components of research ethics, and researchers have a duty to protect the privacy of their participants and to keep their data confidential Researchers should also be transparent with participants about how their data will be used and shared, and obtain their consent for any data sharing or publication Real-world Example: The use of electronic health records has raised new challenges for protecting patient privacy, as these records can be easily accessed and shared (Kayaalp, 2018). Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Conflict of Interest Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Conflict of Interest Overview Conflict of interest occurs when a researcher's personal interests or relationships could unduly influence their research Researchers must disclose any potential conflicts of interest and take steps to manage them appropriately This may include declining from research activities where a conflict of interest exists or implementing safeguards to ensure that their research remains unbiased and impartial Real-world Example: The case of Dr. Andrew Wakefield, who had financial interests in the MMR vaccine and published a study linking the vaccine to autism, highlights the importance of managing conflicts of interest in research (Deer, 2011). https://doi.org/10.1136/bmj.c5347 Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Ethical Considerations in Data Collection and Analysis Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Ethical Considerations The importance of integrity and reliability Ethical considerations in data collection and analysis include: 1. Ensuring that data is collected and analyzed in a way that respects the dignity and privacy of research participants 2. The results are reported accurately and honestly Researchers should ensure the integrity and reliability of their data using appropriate methods and documenting their procedures in detail Researchers should be open to scrutiny and review of their methods and results Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Reporting and Publication Ethics Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Reporting and Publication Ethics Essential factors to ensure the integrity of the research process Researchers have an obligation to report their findings accurately and honestly and to give credit to others for their work This includes adhering to ethical standards for authorship, avoiding plagiarism and data fabrication, and disclosing any potential conflicts of interest Peer review plays a critical role in ensuring the quality and integrity of published research, and researchers should be open to feedback and criticism from their peers Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Obtaining Ethical Approval Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Obtaining Ethical Approval Protocol Submission Process Submitting a research protocol for ethical review is a crucial step in the research process The protocol submission process typically involves: 1. Preparing a detailed research plan and 2. Submitting it to the institutional review board (IRB), research committee (RC), and/or ethics committee of the institution for review 3. In some institutions the research protocol is also evaluated by the biosafety review board (BRB) Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Obtaining Ethical Approval Purpose of the review process The purpose is to ensure that the research is conducted in accordance with ethical principles and regulatory requirements, and that the rights of research participants are protected Researchers should be prepared to address any concerns or questions raised by the review board and may be required to make changes to their protocol before it is approved Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Conclusions Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research Conclusions 1. Research ethics is a complex and multifaceted field that requires careful consideration and attention to detail 2. By adhering to ethical principles throughout the research process, researchers can ensure that their work is conducted responsibly and with integrity 3. Ethical conduct in research is essential for maintaining public trust and confidence in the scientific enterprise 4. Researchers have a responsibility to maintain the highest standards of integrity and professionalism Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research References Angell, M. (1997). The ethics of clinical research in the third world. New England Journal of Medicine, 337(12), 847-849. Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics. Oxford University Press. Deer, B. (2011). How the case against the MMR vaccine was fixed. BMJ (Clinical research ed.), 342, c5347. Institute of Medicine. (2009). Conflict of Interest in Medical Research, Education, and Practice. The National Academies Press. Jones, J. H. (1981). Bad blood: the Tuskegee syphilis experiment. Simon and Schuster. Kayaalp, M. (2018). Patient privacy in the era of big data. Balkan medical journal, 30(3), 227-231. Miller, F. G., & Brody, H. (2003). What makes placebo-controlled trials unethical? American Journal of Bioethics, 3(2), 41-48. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Shuster, E. (1997). Fifty years later: the significance of the Nuremberg Code. New England Journal of Medicine, 337(20), 1436-1440. World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 310(20), 2191–2194. Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research  Questions? Sergio Ramirez–Perez Ph.D. | Block VIII | Ethics in Research