SOCRA CCRP Ethics and GCP 2 — Questions and Answers
Question 1: What are the five criteria an IRB must consider when approving research involving human subjects?
- Budget, timeline, sponsor reputation, site capacity, staff qualifications
- Risks minimized, risks reasonable to benefits, equitable subject selection, informed consent obtained, data safety monitored (Correct answer)
- FDA approval, institutional approval, staff training, equipment validation, protocol review
- Regulatory compliance, financial viability, scientific merit, ethical oversight, publication plan
Correct answer: Risks minimized, risks reasonable to benefits, equitable subject selection, informed consent obtained, data safety monitored
IRBs must find that risks are minimized, risks are reasonable relative to benefits, subject selection is equitable, informed consent is obtained, and safety monitoring is adequate.
Question 2: Under GCP, what is required for a research site to conduct a clinical trial?
- Only a signed protocol
- Adequate facilities, qualified staff, IRB approval, and signed agreements with the sponsor (Correct answer)
- FDA direct approval of the site only
- A budget agreement with the sponsor
Correct answer: Adequate facilities, qualified staff, IRB approval, and signed agreements with the sponsor
Sites must have adequate facilities and staff, current IRB approval, signed clinical trial agreements, and relevant essential documents in place before initiating a trial.
Question 3: What is 'research misconduct' in the context of clinical trials?
- Any protocol deviation regardless of intent
- Fabrication, falsification, or plagiarism in conducting or reporting research (Correct answer)
- Failure to meet enrollment targets
- Any GCP violation noted on an FDA inspection
Correct answer: Fabrication, falsification, or plagiarism in conducting or reporting research
Research misconduct is defined as fabrication (making up data), falsification (manipulating data), or plagiarism (using others' work without credit) in conducting or reporting research.
Question 4: What does 'equipoise' mean in clinical research ethics?
- Equal randomization between treatment arms
- Genuine uncertainty within the expert community about the comparative merits of study treatments (Correct answer)
- Equal distribution of study benefits across sites
- Balancing subject burden with research value
Correct answer: Genuine uncertainty within the expert community about the comparative merits of study treatments
Clinical equipoise is the state of genuine uncertainty in the clinical community about which treatment in a trial is superior, ethically justifying randomization.
Question 5: What is a 'conflict of interest' in clinical research, and why is it significant?
- When a site investigator is also the IRB chair — it is not significant
- A situation where personal or financial interests could unduly influence research decisions, potentially compromising integrity (Correct answer)
- A disagreement between sponsor and investigator about protocol design
- When two sponsors fund the same study
Correct answer: A situation where personal or financial interests could unduly influence research decisions, potentially compromising integrity
A conflict of interest occurs when personal, financial, or other interests could compromise research objectivity, potentially biasing outcomes or violating participant protections.
Question 6: What is the GCP requirement for investigator training and qualifications?
- Investigators must hold an MD degree only
- Investigators must be qualified by education, training, and experience to conduct the specific trial (Correct answer)
- Only the PI requires training; subinvestigators do not
- A single GCP course completed at any point in the investigator's career is sufficient
Correct answer: Investigators must be qualified by education, training, and experience to conduct the specific trial
GCP requires that investigators be qualified by education, training, and experience, and have access to the resources needed to properly conduct the specific trial.
SOCRA CCRP Ethics and GCP 2
What are the five criteria an IRB must consider when approving research involving human subjects?