CERTIFICATION FOR IRB
PROFESSIONALS
CIP® EXAM PREP
Complete Q&A Study Guide — 2025 Edition
Premium Edition · Exam-Focused · Fully Expanded
Covering All Domains: Federal Regulations · Ethical Principles · IRB Operations
Informed Consent · Special Populations · Research Risk · HIPAA · International
Research
200+ Q&A Pairs Memory Tricks Exam Traps Practice Sets
, TABLE OF CONTENTS
Section 1 — Foundations of Research Ethics & Historical Background
Section 2 — Federal Regulations: 45 CFR 46 (The Common Rule)
Section 3 — FDA Regulations: 21 CFR Parts 50 & 56
Section 4 — The Belmont Report: Principles & Applications
Section 5 — IRB Membership, Structure & Operations
Section 6 — Types of IRB Review: Full Board, Expedited & Exempt
Section 7 — Informed Consent: Requirements, Waivers & Exceptions
Section 8 — Special Populations: Children, Prisoners & Pregnant Women
Section 9 — Research Risk, Benefit Analysis & Vulnerable Subjects
Section 10 — HIPAA, Privacy & Confidentiality in Research
Section 11 — Continuing Review, Reportable Events & Noncompliance
Section 12 — International & Multi-Site Research
Section 13 — Research Involving Biological Specimens & Genetic Data
Section 14 — Conflicts of Interest in Research
Section 15 — Practice Examination: 40 Mixed Questions
, SECTION 1: Foundations of Research Ethics & Historical
Background
Understanding the historical events that shaped modern human subjects protections is essential for the
CIP exam. Questions about research history appear regularly and require you to link events to the
specific regulations or principles they generated.
Q1. What was the Nuremberg Code, and why was it significant in research ethics?
A: The Nuremberg Code (1947) was a set of 10 ethical principles developed following the
Nuremberg Doctors' Trial, which prosecuted Nazi physicians for conducting brutal experiments on
concentration camp prisoners without consent. The Code established that voluntary consent is
'absolutely essential' and that research must benefit society, be based on animal studies, avoid
unnecessary harm, and allow subjects to withdraw. It is considered the foundational international
document for research ethics.
■ Exam Note: The Nuremberg Code directly preceded and influenced the Declaration of Helsinki.
■ Common Trap: Do not confuse the Nuremberg Code with the Belmont Report — they are separate
documents from different eras. The Code is international; the Belmont Report is U.S.-specific.
■ Mnemonic: 'N for Nazi trials → N for Nuremberg → 10 principles, consent is #1'
Q2. What was the Tuskegee Syphilis Study and what regulations did it directly trigger?
A: The Tuskegee Syphilis Study (1932–1972) was a U.S. Public Health Service study in which 399
Black men with syphilis in Alabama were deliberately left untreated — even after penicillin became
the standard of care — to study the natural progression of the disease. Participants were deceived
and denied treatment. When exposed in 1972, public outrage led directly to: (1) the National
Research Act of 1974, which created the National Commission for the Protection of Human
Subjects; and (2) the Belmont Report (1979); and ultimately (3) the Federal Policy for the Protection
of Human Subjects (45 CFR 46).
■ Exam Note: This is one of the most frequently tested historical events on the CIP exam.
■ Common Trap: The study was NOT halted because participants died — it ran for 40 years. It ended because
a whistleblower (Peter Buxtun) leaked it to the press.
Q3. What is the Declaration of Helsinki?
A: The Declaration of Helsinki is an ethical framework developed by the World Medical Association
(WMA) in 1964 and revised multiple times (most recently in 2013). It extends the Nuremberg Code's
principles specifically to medical research involving human subjects, including research on
identifiable data and materials. Key additions over the Nuremberg Code include: research must be
preceded by adequate laboratory and animal testing; research protocols must be reviewed by an
independent ethics committee; special protections for vulnerable populations; and requirements for
post-study access to beneficial interventions.
■ Exam Note: Unlike U.S. regulations, the Declaration of Helsinki is not legally binding in the U.S. but is widely
adopted and influences FDA regulations for international studies.
, Q4. What was the Willowbrook Hepatitis Study?
A: Willowbrook was a New York state institution for children with intellectual disabilities. From the
1950s–70s, researchers deliberately infected newly admitted children with hepatitis virus to study
the disease. Parents were sometimes coerced into consenting by linking participation to admission
to the overcrowded institution. This study illustrates exploitation of vulnerable populations and
coercive consent — two key themes in the Belmont Report's principles of respect for persons and
justice.
■ Exam Note: Willowbrook is frequently cited in questions about vulnerable populations and coercive consent.
Q5. What was the Jewish Chronic Disease Hospital Case?
A: In 1963, researchers at the Jewish Chronic Disease Hospital in Brooklyn injected live cancer
cells into elderly debilitated patients without their knowledge or consent, to study immune response.
The case highlighted the need for full disclosure in informed consent and the importance of IRB
oversight.
Q6. What is the National Research Act of 1974?
A: The National Research Act (Public Law 93-348) was passed in response to public outrage over
Tuskegee. It established the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, which was charged with identifying basic ethical principles for
human subjects research. The Commission produced the Belmont Report (1979), which laid the
philosophical foundation for all subsequent U.S. human subjects regulations.
■ KEY POINT: Timeline to memorize: Tuskegee exposed (1972) → National Research Act (1974)
→ Belmont Report (1979) → 45 CFR 46 first codified (1991) → Common Rule revised (2018,
effective 2019)
PROFESSIONALS
CIP® EXAM PREP
Complete Q&A Study Guide — 2025 Edition
Premium Edition · Exam-Focused · Fully Expanded
Covering All Domains: Federal Regulations · Ethical Principles · IRB Operations
Informed Consent · Special Populations · Research Risk · HIPAA · International
Research
200+ Q&A Pairs Memory Tricks Exam Traps Practice Sets
, TABLE OF CONTENTS
Section 1 — Foundations of Research Ethics & Historical Background
Section 2 — Federal Regulations: 45 CFR 46 (The Common Rule)
Section 3 — FDA Regulations: 21 CFR Parts 50 & 56
Section 4 — The Belmont Report: Principles & Applications
Section 5 — IRB Membership, Structure & Operations
Section 6 — Types of IRB Review: Full Board, Expedited & Exempt
Section 7 — Informed Consent: Requirements, Waivers & Exceptions
Section 8 — Special Populations: Children, Prisoners & Pregnant Women
Section 9 — Research Risk, Benefit Analysis & Vulnerable Subjects
Section 10 — HIPAA, Privacy & Confidentiality in Research
Section 11 — Continuing Review, Reportable Events & Noncompliance
Section 12 — International & Multi-Site Research
Section 13 — Research Involving Biological Specimens & Genetic Data
Section 14 — Conflicts of Interest in Research
Section 15 — Practice Examination: 40 Mixed Questions
, SECTION 1: Foundations of Research Ethics & Historical
Background
Understanding the historical events that shaped modern human subjects protections is essential for the
CIP exam. Questions about research history appear regularly and require you to link events to the
specific regulations or principles they generated.
Q1. What was the Nuremberg Code, and why was it significant in research ethics?
A: The Nuremberg Code (1947) was a set of 10 ethical principles developed following the
Nuremberg Doctors' Trial, which prosecuted Nazi physicians for conducting brutal experiments on
concentration camp prisoners without consent. The Code established that voluntary consent is
'absolutely essential' and that research must benefit society, be based on animal studies, avoid
unnecessary harm, and allow subjects to withdraw. It is considered the foundational international
document for research ethics.
■ Exam Note: The Nuremberg Code directly preceded and influenced the Declaration of Helsinki.
■ Common Trap: Do not confuse the Nuremberg Code with the Belmont Report — they are separate
documents from different eras. The Code is international; the Belmont Report is U.S.-specific.
■ Mnemonic: 'N for Nazi trials → N for Nuremberg → 10 principles, consent is #1'
Q2. What was the Tuskegee Syphilis Study and what regulations did it directly trigger?
A: The Tuskegee Syphilis Study (1932–1972) was a U.S. Public Health Service study in which 399
Black men with syphilis in Alabama were deliberately left untreated — even after penicillin became
the standard of care — to study the natural progression of the disease. Participants were deceived
and denied treatment. When exposed in 1972, public outrage led directly to: (1) the National
Research Act of 1974, which created the National Commission for the Protection of Human
Subjects; and (2) the Belmont Report (1979); and ultimately (3) the Federal Policy for the Protection
of Human Subjects (45 CFR 46).
■ Exam Note: This is one of the most frequently tested historical events on the CIP exam.
■ Common Trap: The study was NOT halted because participants died — it ran for 40 years. It ended because
a whistleblower (Peter Buxtun) leaked it to the press.
Q3. What is the Declaration of Helsinki?
A: The Declaration of Helsinki is an ethical framework developed by the World Medical Association
(WMA) in 1964 and revised multiple times (most recently in 2013). It extends the Nuremberg Code's
principles specifically to medical research involving human subjects, including research on
identifiable data and materials. Key additions over the Nuremberg Code include: research must be
preceded by adequate laboratory and animal testing; research protocols must be reviewed by an
independent ethics committee; special protections for vulnerable populations; and requirements for
post-study access to beneficial interventions.
■ Exam Note: Unlike U.S. regulations, the Declaration of Helsinki is not legally binding in the U.S. but is widely
adopted and influences FDA regulations for international studies.
, Q4. What was the Willowbrook Hepatitis Study?
A: Willowbrook was a New York state institution for children with intellectual disabilities. From the
1950s–70s, researchers deliberately infected newly admitted children with hepatitis virus to study
the disease. Parents were sometimes coerced into consenting by linking participation to admission
to the overcrowded institution. This study illustrates exploitation of vulnerable populations and
coercive consent — two key themes in the Belmont Report's principles of respect for persons and
justice.
■ Exam Note: Willowbrook is frequently cited in questions about vulnerable populations and coercive consent.
Q5. What was the Jewish Chronic Disease Hospital Case?
A: In 1963, researchers at the Jewish Chronic Disease Hospital in Brooklyn injected live cancer
cells into elderly debilitated patients without their knowledge or consent, to study immune response.
The case highlighted the need for full disclosure in informed consent and the importance of IRB
oversight.
Q6. What is the National Research Act of 1974?
A: The National Research Act (Public Law 93-348) was passed in response to public outrage over
Tuskegee. It established the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, which was charged with identifying basic ethical principles for
human subjects research. The Commission produced the Belmont Report (1979), which laid the
philosophical foundation for all subsequent U.S. human subjects regulations.
■ KEY POINT: Timeline to memorize: Tuskegee exposed (1972) → National Research Act (1974)
→ Belmont Report (1979) → 45 CFR 46 first codified (1991) → Common Rule revised (2018,
effective 2019)
