Ensuring and reporting research ethics
Ethical considerations in research
History of research ethics
- 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
Institutional review board (IRB) and informed consent
- 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.
Ethics aspects of study methods
- 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
- 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.
Principles of research ethics
- 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 in Big data research
- 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.
Research in resource-poor environments
- 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.
- 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.