History of research ethics Learning outcomes: ➔ Identify the ethical code of principles for clinical research that has been adapted worldwide ➔ Describe 3 key principles of clinical research identified in the Nuremberg Code ➔ List the 4 ethical principles included in the 1964 Declaration of Helsinki (beyond the Nuremberg Code) ➔ Describe what the 1966 NIH Ethical Review Policies obligated US research institutions to develop and institute. Institutional review board (IRB) and informed consent Learning outcomes: ➔ Discuss which types of clinical studies need institutional review board approval ➔ List 5 purposes of informed consent ➔ Discuss how the Facebook case used or did not use the informed consent process ➔ Discuss current problems with informed consent process and forms ➔ Discuss 3 common misconceptions that participants may have even after the completing informed consent process ➔ Discuss 3 different types of informed consent that might be used for studies with genetic materials. Data and safety monitoring Learning outcomes: ➔ Identify potential safety issues related to your study ➔ List at least three important duties of a quality control coordinator and/or data and safety monitor ➔ Describe the function and operation of a Data and Safety Monitoring Board (DSMB).
Ethics aspects of study methods Learning outcomes: ➔ Why and how ethics issues can affect study methods
➔ How international guidelines on research ethics can affect study methods ➔ How to report ethics aspects in the methods section of a research paper ➔ Why medical journals mandate prospective registration of clinical trials, protection of patient confidentiality, and other ethics issues that affect study methods. Data and safety monitoring Learning outcomes: ➔ Identify potential safety issues related to your study ➔ List at least three important duties of a quality control coordinator and/or data and safety monitor ➔ Describe the function and operation of a Data and Safety Monitoring Board (DSMB).
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