Ethics in Research Flashcards
7 cards from real STP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Ethics in Research flashcards as text
A researcher discovers mid-study that a placebo control group is being harmed by withholding a newly proven effective treatment. What is the ethically required action?
Answer: Stop the trial and offer the effective treatment to all participants
The principle of beneficence requires stopping a trial when continuing would harm participants by denying them a proven effective treatment.
Which concept refers to the ethical requirement that research risks must be reasonable in relation to anticipated benefits?
Answer: Risk-benefit analysis
Risk-benefit analysis is the formal evaluation ensuring that potential harms to participants are justified by the expected scientific or social benefits.
A graduate student is listed as an author on a paper but only washed glassware during the project. This is an example of:
Answer: Gift authorship
Gift authorship occurs when authorship credit is given without meeting the substantive intellectual contribution criteria established by bodies like ICMJE.
Under the Common Rule (45 CFR 46), which category of research qualifies for exemption from full IRB review?
Answer: Anonymous surveys about sensitive personal behaviors
Anonymous surveys posing no more than minimal risk typically qualify for exemption under the Common Rule categories.
The Tuskegee Syphilis Study is most directly cited as the catalyst for which regulatory development?
Answer: The National Research Act and Belmont Report
Public outrage over Tuskegee directly led to the National Research Act of 1974 and ultimately the Belmont Report outlining ethical principles for human research.
A researcher shares de-identified patient data with a colleague at another institution without a data use agreement. This primarily violates:
Answer: Data governance and HIPAA data sharing requirements
Sharing de-identified data without a data use agreement violates HIPAA's requirements for institutional data governance even when data appear anonymous.
Which of the following best describes 'therapeutic misconception' in clinical research?
Answer: A participant believing the research is primarily designed for their personal benefit
Therapeutic misconception occurs when participants conflate the goals of research (generating generalizable knowledge) with the goals of clinical care (optimizing individual treatment).