Ethics, Integrity, and Regulatory Compliance
The ethical framework
Candidates should be fluent in the governing principles: respect for persons, beneficence, and justice. Know how informed consent operationalizes respect for persons, how risk-benefit assessment operationalizes beneficence, and how fair subject selection operationalizes justice. Understand that consent is a process, not a signature, and that it must be voluntary, informed, and ongoing.
Regulatory architecture
Learn the roles of institutional review boards or research ethics committees, the distinction between review and approval, and the requirement for continuing review and amendment submission. Know the categories of review (exempt, expedited, full board) at a conceptual level, and understand that exemption is a determination made by the reviewing body, not by the investigator. Understand the purpose of trial registration, data monitoring committees, and adverse-event reporting.
Integrity concepts
Distinguish fabrication, falsification, and plagiarism from honest error and from questionable research practices such as selective outcome reporting, inappropriate authorship, and salami slicing. Know authorship criteria conceptually: substantial contribution, drafting or critical revision, final approval, and accountability. Understand conflict-of-interest disclosure and the handling of human biospecimens and identifiable data.
Traps
- Assuming that de-identified data is automatically exempt from review.
- Confusing a waiver of documentation of consent with a waiver of consent itself.
- Treating vulnerable populations as categorically excluded rather than requiring additional safeguards.
- Overlooking that protocol deviations must be documented and, if serious, reported.
Worked rule of thumb
For any scenario, ask three questions in order: Is the study under ethics review and approval? Is consent valid or appropriately waived? Are privacy and data protections proportionate to the risk? A failure at any step is a compliance problem regardless of scientific merit.