SOCRA Updated CCRP Exam Questions and Answers by shay

TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principlesguiding human subject research:

Respect for Persons(informed consent, autonomy, protection of vulnerable populations).

Beneficence(maximize benefits, minimize harms).

Justice(fairness in subject selection and treatment).

TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.

TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.

TheICH Guidelines (1996)outline harmonized regulatory requirements for good clinical practice.

Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.

Thus, the correct answer isD (The Belmont Report).

TheNuremberg Code (1947)established voluntary consent as essential following Nazi war crimes.

Helsinki (1964) built upon it; Belmont Report (1979) refined U.S. ethics.

Thus, the correct foundational WWII document isthe Nuremberg Code.

FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is how the device will be used in the specific study.

21 CFR 812.3(m): Defines a “significant risk device study” as one that “is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.”

Risk is judged within the context of the protocol — i.e., use of the device in that particular study (D).

Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA’s risk classification. For example, a stent used in an approved indication may be NSR, but if used in a new anatomical location, it may be SR.

Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the intended clinical context rather than device attributes alone.

ICH E6(R2) 4.5.1:“The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC.”

Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.

Thus, enrollment requires protocol amendment and IRB approval.