CIP Ethical & Regulatory Compliance 5 — Questions and Answers
Question 1: The Federal Wide Assurance (FWA) is an agreement between an institution and which federal agency?
- The Food and Drug Administration (FDA)
- The Office for Human Research Protections (OHRP) (Correct answer)
- The National Institutes of Health (NIH)
- The Centers for Disease Control and Prevention (CDC)
Correct answer: The Office for Human Research Protections (OHRP)
An FWA is a formal agreement filed with OHRP in which an institution commits to comply with federal regulations for the protection of human research subjects under 45 CFR 46.
Question 2: Which of the following IRB composition requirements is mandated by federal regulations?
- At least 10 members with doctorates
- At least one member whose primary concerns are non-scientific and at least one member not affiliated with the institution (Correct answer)
- A majority of members must be physicians
- At least two members from the legal profession
Correct answer: At least one member whose primary concerns are non-scientific and at least one member not affiliated with the institution
45 CFR 46.107 requires IRBs to include at least one member whose primary concerns are in nonscientific areas and at least one member who is not affiliated with the institution and is not part of the immediate family of an affiliated person.
Question 3: A study is classified as 'exempt' from IRB review. This means:
- The research requires no ethical oversight whatsoever
- The research meets specific categories defined in regulations where full IRB review is not required, though institutional review may still be needed (Correct answer)
- The PI may proceed without any documentation
- The study has been approved by the IRB without conditions
Correct answer: The research meets specific categories defined in regulations where full IRB review is not required, though institutional review may still be needed
Exempt research falls into specific categories defined in 45 CFR 46.104 where the risk to subjects is low; however, someone authorized by the institution must still determine that the research qualifies for exemption.
Question 4: Under the revised Common Rule (2018), broad consent is a new mechanism that allows subjects to consent to future research use of:
- All future clinical treatments at the enrolling institution
- Stored identifiable biospecimens and identifiable private information for unspecified future research (Correct answer)
- Publication of their de-identified data in peer-reviewed journals
- Participation in any future research conducted by the same PI
Correct answer: Stored identifiable biospecimens and identifiable private information for unspecified future research
The 2018 revised Common Rule introduced broad consent as an option allowing prospective subjects to consent to storage and use of their identifiable biospecimens and data for future unspecified research studies.
Question 5: When an IRB reviews a protocol and determines it meets criteria for approval, which of the following is NOT among the required findings under 45 CFR 46.111?
- Risks to subjects are minimized
- Informed consent will be sought from each prospective subject
- The research has potential to generate revenue for the institution (Correct answer)
- Selection of subjects is equitable
Correct answer: The research has potential to generate revenue for the institution
45 CFR 46.111 lists required criteria for IRB approval including risk minimization, equitable subject selection, and informed consent, but does not include institutional financial benefit as a consideration.
Question 6: Which ethical framework most directly supports the requirement that researchers must fully disclose the nature of a study to potential participants?
- Utilitarianism
- Kantian deontology (respect for autonomy) (Correct answer)
- Virtue ethics
- Social contract theory
Correct answer: Kantian deontology (respect for autonomy)
Kantian ethics emphasizes that persons must be treated as ends in themselves, never merely as means, which requires full disclosure to respect individual autonomy and enable rational decision-making about participation.
Question 7: A researcher proposes to conduct a survey study with adults about their dietary habits. There are no identifiers collected and the topic is not sensitive. Which level of IRB review is most likely appropriate?
- Full board review
- Expedited review
- Exempt review under 45 CFR 46.104(d)(2) (Correct answer)
- No review required since surveys never involve human subjects
Correct answer: Exempt review under 45 CFR 46.104(d)(2)
Research involving survey procedures with adult subjects that do not collect identifiers and do not involve sensitive topics typically qualifies for exemption under 45 CFR 46.104(d)(2).
CIP Ethical & Regulatory Compliance 5
The Federal Wide Assurance (FWA) is an agreement between an institution and which federal agency?