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.