Ensuring and reporting research ethics

Ethical considerations in research

Learning outcomes:

  • Discuss a brief history of research oversight
  • Review ethical principles and federal regulations
  • Explain institutional review board (IRB) approval
  • Define informed consent
  • Discuss scientific misconduct, authorship, conflicts of interest, and ethical issues in specific types of research
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.
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).
Principles of research ethics

Learning outcomes:

  • Describe 4 ethical principles for clinical trials
  • List 3 ethical principles that were violated during the Tuskegee Study.
  • Describe issues of beneficence in the TGN 1412 Study.
Ethics in Big data research

Learning outcomes:

  • List the four core values that are at stake in Big Data Research
  • List 7 fields of study included in Big Data Research
  • Discuss researchers’ ethical obligations regarding the return of results to participants
  • Describe the Ten Simple Rules regarding responsible conduct of research in your country.
Research in resource-poor environments

Learning outcomes:

  • Explain why use of placebos in clinical trials may be unethical in developing countries
  • Discuss issues related to provision of background and ancillary care, informed consent, access to the study intervention after the trial, and collaboration with host-country stakeholders.