Research ethics

• At the end of the lecture, students should be able to: 1. Explain the term research ethics, 2. Explain what is given in the Hippocratic oath, 3. Explain the development of research ethics, giving historical examples of unethical human experimentation and the principles of research ethics given in Nuremberg code and Belmont report, 4. Explain what the Helsinki Declaration is and principles stated in it, 5. Discuss the main ethical principles of autonomy, beneficence, justice and non-maleficence and how they are applicable to human experiments, 6. Discuss the significance of obtaining informed consent and maintaining confidentially, 7. Explain the necessity for ethics review of research projects and the functions of Ethics Review Committees
• Ethics


  Standards of conduct (or behavior) that distinguish between right/wrong, good/bad, etc. The study of standards of conduct.
• Research ethics


  Governs ethical principals involved in conducting Research, primarily involving humans. Objectives include protecting human participants and ensuring research serves interests of individuals, groups and/or society.
• Code of ethics for Physicians
• Hippocratic Oath


  An oath historically taken by physicians, requiring a new physician to swear, by a number of healing gods, to uphold specific ethical standards. One of the earliest expression of medical ethics, establishing principles of confidentiality and non-maleficence.
• World Medical Association Declaration of Geneva
• Why Research Ethics?
• Nazi Medical War Crimes


  • Medical Research involving human beings have created a lot of potential pitfalls that led to tragedies in the last century.
• Tuskegee Syphilis Study - Alabama


  • The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment. In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families.
• Other Major Violations to Human Research Subjects


  • 1963 - Brooklyn - Jewish Chronic Diseases Hospital: Cancer cells were injected into debilitated elderly patients to see if they would immunologically reject the cells. 1972 - Willowbrook State Hospital in New York: Retarded children were deliberately infected with viral hepatitis to study its natural history.
• Codes of ethics
• Nuremberg Code


  Voluntary informed consent, Likelihood of some good resulting, Based on prior research (animal models), Avoidance of physical or psychological injury or harm, Benefits should outweigh risks, Proper experience of researcher, Right to withdraw consent, Research must stop if harm is resulting (no specific mention of children, unconscious people, or others who may not be competent to give consent)
• Belmont Report


  Respect for persons, Beneficence, Justice
• Helsinki Declaration


  The World Medical Association (WMA) has developed the Declaration of Helsinki, first version adopted in 1964, amended seven times since, most recently in 2013 (version 7). Principles include respect for the individual, subject's welfare must always take precedence over the interests of science and society, protection of vulnerable groups, their right to self-determination and make informed decisions, careful assessment of risks and benefits, studies should be stopped if the available information indicates that the original considerations are no longer satisfied, information regarding the study should be publicly available.
• Other Ethical Guidelines
• Autonomy


  Ability of the person to make his or her own decisions. Voluntary Decision, No influence, Fully informed decision, Researcher respects the right of participants to decide.
• Beneficence (do Good)


  Researchers should have the welfare of the research participant as a goal of a research study. Doing good for others.
• Non-maleficence (do NO harm)


  Requires the researcher to be clear about risk and probability by assessments of harm of the research intervention. A medical practitioner has a duty to do no harm or allow harm to be caused to a patient through neglect.
• Justice


  Fair Treatment, Treat equally, Distribute resources fairly.
• Consent


  Voluntary informed consent is a prerequisite for a subject's participation in research. It is a voluntary agreement to participate in research, subject need to have an understanding of the research and its risks/benefits, respects patients autonomy, ensured by providing an information sheet and an informed consent form.
• Confidentiality


  The obligation to keep some types of information confidential or secret. Treatment of information that an individual has disclosed in a relationship of trust. Violation of confidentiality violates the trust that personal information will not be divulged to others without permission or originally consented for. Researcher must protect information from unauthorized access, use, disclosure, modification, loss or theft.
• Researcher must protect the rights of the Patients/Subjects and welfare and humane treatment of test animals. This is ensured by Institutional Ethics Review Committees (ERC).
• Institutional Review Board (IRB) / Ethics Committee


  A committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.
• What Ethics Review committees do: Review Research Proposals before Research Commence, Grant or Reject Ethics Approval, Monitor Approved Projects
• Responsibilities of IRB/IEC: Risks to study participants are minimized, Risks are reasonable in relation to anticipated benefits, Selection of study participants is equitable, Informed consent is obtained and appropriately documented for each participant, Adequate provisions for monitoring data collection to ensure safety of the study participants, Participant privacy and confidentiality is protected
• The IRB/IEC should obtain the following documents: Trial /research protocol(s), Written informed consent form(s), Information Sheets, Data Collection Tools, CVs of Investigators
• "No Risk" Exempt from Ethics Review, "Minimal Risk" Expedited Review, "Greater than Minimal Risk" Full Committee Review
• ERC decisions
• Glossary: https://www.niehs.nih.gov/research/resources/bioethics/glossary/index.cfm