Research Ethics & Human Subjects Protection
Which ethical principle emphasizes respect for individual autonomy in research participation?
Respect for Persons
What is the primary purpose of a control group?
To provide a comparison for evaluating the intervention
What body is responsible for protecting the rights and welfare of research participants at an institution?
Institutional Review Board (IRB)
What principle ensures that research data can be traced to the individual who recorded it?
Attributable
What is an adverse event (AE)?
Any unfavorable medical occurrence during a study, regardless of causality
What is the primary purpose of informed consent?
To enable voluntary, informed participation
What term describes a variable that influences both the exposure and the outcome?
Confounder
What does Good Clinical Practice (GCP) provide?
International standards for ethical and scientific quality in clinical research
Why are source documents critical in clinical research?
They provide the original evidence of study data
What is the primary purpose of safety reporting?
To identify and manage risks to participants
When must consent be an ongoing process rather than a single event?
Throughout the participant’s involvement in the study
What does blinding aim to minimize in a clinical study?
Bias in treatment administration or outcome assessment
What type of review is typically required for ongoing studies after initial approval?
Continuing review
What is the primary purpose of monitoring in clinical research?
To verify data accuracy and protocol compliance
What distinguishes research from clinical care?
Research aims to generate generalizable knowledge
What core document outlines ethical principles for research involving human subjects?
The Belmont Report
What is the main advantage of randomization in clinical research?
Reducing bias and confounding
What is a protocol deviation?
A departure from the approved study protocol
What does “data integrity” mean in the context of research?
Data is accurate, complete, consistent, and reliable
What role does quality assurance play in clinical research?
Ensuring processes meet regulatory and ethical standards
What ethical principle focuses on fair and equitable selection of research participants?
Justice
What type of study follows participants forward in time from exposure to outcome?
Prospective study
What is the primary goal of regulatory oversight in clinical research?
Participant safety and data integrity
What practice helps prevent transcription errors in research documentation?
Contemporaneous recording of data
Why is risk assessment ongoing throughout a study?
New information may change the risk–benefit balance