CRP Ethical Considerations & Compliance 2 — Questions and Answers
Question 1: A researcher discovers mid-study that a participant is experiencing unexpected adverse effects. What is the FIRST ethical obligation?
- Consult the IRB before taking any action
- Immediately report to the sponsor and pause enrollment
- Protect participant safety and report the finding promptly (Correct answer)
- Complete data collection to avoid compromising study validity
Correct answer: Protect participant safety and report the finding promptly
Participant safety always takes precedence; the researcher must act immediately and report the adverse event through proper channels.
Question 2: Which principle from the Belmont Report addresses the fair distribution of research burdens and benefits across population groups?
- Beneficence
- Justice (Correct answer)
- Respect for Persons
- Non-maleficence
Correct answer: Justice
Justice requires that vulnerable populations not be exploited and that research benefits and burdens be distributed equitably.
Question 3: A researcher has a financial stake in the company whose product is being tested. This situation most directly creates a:
- Protocol deviation
- Conflict of interest (Correct answer)
- Privacy breach
- Regulatory violation
Correct answer: Conflict of interest
A personal financial interest in the outcome of research constitutes a conflict of interest that must be disclosed and managed.
Question 4: Under 45 CFR 46 (the Common Rule), which of the following studies is EXEMPT from full IRB review?
- Research involving deception of participants
- Anonymous surveys about educational practices in standard settings (Correct answer)
- Clinical trials of investigational drugs
- Studies involving prisoners as subjects
Correct answer: Anonymous surveys about educational practices in standard settings
Anonymous surveys on educational practices in standard settings qualify for an exemption under 45 CFR 46.104(d)(2).
Question 5: What does the term 'therapeutic misconception' refer to in research ethics?
- Believing all research involves some therapeutic benefit
- A participant believing research treatment is individualized clinical care (Correct answer)
- Researchers overstating therapeutic value in consent forms
- Sponsors misrepresenting study risks to regulators
Correct answer: A participant believing research treatment is individualized clinical care
Therapeutic misconception occurs when participants fail to understand that research goals differ from individualized clinical treatment.
Question 6: A sponsor requests that a researcher not publish negative results. Complying with this request would most directly violate which ethical obligation?
- Confidentiality
- Scientific integrity and transparency (Correct answer)
- Participant autonomy
- Regulatory reporting requirements
Correct answer: Scientific integrity and transparency
Suppressing negative findings undermines scientific integrity and can distort the evidence base, harming future patients and researchers.
Question 7: Which federal regulation specifically governs the protection of human subjects in research conducted or supported by the U.S. Department of Health and Human Services?
- 21 CFR Part 312
- 45 CFR Part 46 (Correct answer)
- ICH E6 Good Clinical Practice
- FDA Guidance for Industry 2018
Correct answer: 45 CFR Part 46
45 CFR Part 46, known as the Common Rule, is the primary federal regulation protecting human research subjects under HHS.
CRP Ethical Considerations & Compliance 2
A researcher discovers mid-study that a participant is experiencing unexpected adverse effects.
What is the FIRST ethical obligation?