Download Ethical Principles in Human Subject Research: A Q&A Review of Key Cases and Guidelines and more Exams Medical ethics in PDF only on Docsity!
CCRP EXAM PREP|2025-2026| REAL 300 QUESTIONS
&ANSWERS|VERIFIED|FALL-SRING QTR|A+ GRADE
ASSURED
Who was tried in the Nuremburg Military Tribunals and why? ANSWER: Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? ANSWER : After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948. What historical document was born from the Nuremberg Military Tribunals? ANSWER: The Nuremberg Code (1947) According to the Nuremberg Code (1947), all unnecessary physical and mental suffering and injury... ANSWER : should be avoided According to the Nuremberg Code (1947), voluntary consent of the human subject is... ANSWER : absolutely essential
According to the Nuremberg Code (1947), the experiment must yield Correct Answer: generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature According to the Nuremberg Code (1947), animal experimentation should. ................................................................................................................ Correct Answer: precede human experimentation According to the Nuremberg Code (1947), no experiment should be conducted if there is reason to believe... ANSWER : death of disabling injury will occur According to the Nuremberg Code (1947), the degree of risk to subject should. Answer:ne ver exceed the humanitarian importance of the problem According to the Nuremberg Code (1947), risk to subjects should be minimized through... ANSWER: proper preparations According to the Nuremberg Code (1947), experiments should only be conducted by Answer: scientifically qualified investigators
According to the Declaration of Helsinki (1964), informed consent must be obtained from who? ANSWER : The subject or legal guardian According to the Declaration of Helsinki (1964), design and performance of experimental procedure must be... ANSWER: formulated in a clear protocol According to the Declaration of Helsinki (1964), research protocols should be transmitted to... ANSWER: a specially appointed independent committee for consideration, comment and guidance Who ran the Tuskegee Study of Untreated Syphilis in the Negro Male? ANSWER: The US Public Health Service and the Tuskegee Institute What was the purpose of the Tuskegee Experiments? ANSWER: To justify treatment programs for black Americans When were the Tuskegee Experiments intiated? ANSWER: 1932 What were the the concerns with the Tuskegee experiments? ANSWER: - No informed consent
- Misleading advertisement
- Had to agree to autopsy to have funeral costs covered
- Treatment denied to some patients
- Risky spinal tap diagnostic Who broke the story of the Tuskegee Experiments? Peter Buxton told the story to an Associated Press reporter When did the Tuskegee Study end? ANSWER:1972, 25 years after a cure was known and publicly available How were participants in the Tuskegee experiments impacted? ANSWER: 28 died from syphilis, 100 died from related diseases, and 40 wives and 19 children were infected What historical document was the direct result of the Tuskegee Syphilis Trial? ANSWER:The Belmont Report (1979) When was the Henry K Beecher paper published? ANSWER:Published in 1966 How was the Belmont Report (1979) developed? ANSWER:The report of the National Commission for the Protecting of Human Subjects in Biomedical and
According to the Belmont Report (1979), respect for persons means that those with diminished authority are entitled to... ANSWER: Protection According to the Belmont Report (1979), subjects entering into research voluntarily and with adequate information is an example of what foundation of ethical research? ANSWER:Respect for persons According to the Belmont Report (1979), concerns for privacy and confidentiality are an example of what foundation of ethical research? ANSWER:Respect for persons According to the Belmont Report (1979), respecting decisions, protecting from harm, and securing well-being are examples of what foundation of ethical research? ANSWER:Beneficence According to the Belmont Report (1979), beneficence is defined as... ANSWER:Doing no harm and maximizing benefits while minimizing possible risks What is the opposite of malfeasance as described in the Belmont Report (1979)? ANSWER:Beneficence According to the Belmont Report (1979), justice implies... ANSWER:fairness
and is manifested in equitable selection of subjects for research According to the Belmont Report (1979), justice means that selection of subjects for research should be based on... ANSWER:reasons directly related to the problem being studied, not systematic selection of a class of individuals due to compromised position, manipulability, etc. What does the Belmont Report (1979) say about who should receive benefits of research? ANSWER:Benefits should not be restricted to those who can afford it, and research should not involve persons from groups not likely to benefit from application of the research What did the Henry K Beecher Paper reveal ANSWER:22 published medical studies where patients had been experimented on with no expected benefit to them, showing that unethical studies were widespread and represented a systemic problem in medical research rather than exceptions Human Radiation Experiments (1945-1957) ANSWER:The Atomic Energy Commission conducted secret and classified radiation experiments and releases on unknowning Americans to assess how the human body metabolizes radioactive material.
Tearoom Trade Study (1970) ANSWER:Analysis of male-male sexual behavior in public toilets by Laud Humphreys. He observed acts masquerading as a voyeur rather than a researcher, tracked participants without their consent by using their license plate numbers, and interviewed them in disguise without disclosing his true intent (research) Stanford Prison Experiment (1970) ANSWER:Volunteers in a mock prison took on the roles of guards and inmates. The experiment was discontinued due to ongoing physical and psychological abuse inflicted on many prisoners. San Antonio Contraceptive Study (1971) ANSWER:Poor Mexican-American women given placebos instead of contraceptives without knowing they were subject to such research. There were high numbers of unplanned pregnancy in the placebo group University of Rochester Death of Healthy Subject (1996) ANSWER:Student dies of heart attack after undergoing lung procedure (bronchoscopy) in study on smoking and air pollution Death in a Gene Transfer Trial (1999) ANSWER:18 year old volunteer was injected with adenoviral vector carrying a corrected gene to test the safety of the procedure and died four days later despite not being ill prior. PI on the study had
a conflict of interest and animal data regarding risks given patient's underlying liver issues was not considered. IRB approved consent form was not used. Johns Hopkins Death of Healthy Subject in an Asthma Study (2001) ANSWER:Inhaled hexamethonium, used to treat high BP in the 50s and 60s and designed to promote a mild asthma attack. Federal investigation found that IRB did not take proper precautions or follow federal regulations, leading to suspension of research. Also issues with pressure on employees to participate in research. What is ICH? ANSWER:The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use What is the purpose of the International Conference on Harmonization (ICH)? ANSWER:An attempt to streamline the process for developing and marketing new drugs internationally What is Good Clinical Practice (GCP)? ANSWER:An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects What does compliance with Good Clinical Practice (GCP) provide assurance of?
The guideline for Good Clinical Practice (GCP) was developed with consideration of the current good clinical practices of what countries? ANSWER:The EU, Japan, US, as well as Australia, Canada, the Nordic countries, and the World Health Organization When generating clinical trial data that are intended to be submitted to regulatory authorities, what guideline should be followed? ANSWER:The guideline for good clinical practice The principles established in GCP may also be applied to what? ANSWER:Other clinical investigations that may have an impact on the safety and well-being of human subjects What are the categories of International Committee on Harmonization (ICH)? ANSWER:Quality guidelines Efficacy guidelines Safety guidelines Multidisciplinary guidelines ICH Quality Guidelines ANSWER:Conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical
quality based on Good Manufacturing Practice (GMP) risk management ICH Safety Guidelines ANSWER:Uncover potential risks like carcinogenicity, genotoxicity, and reprotoxicity What have ICH safety guidelines accomplished recently? ANSWER:A non-clinical testing strategy for assessing the QT interval prolongation liability, the single most important cause of drug withdrawals in recent years ICH Efficacy Guidelines ANSWER:Concerned with the design, conduct, safety, and reporting of clinical trials, covering novel trypes of medicines derived from biotechnological processes and the use of pharmacogentics/genomics techniques to produce better targeted medicines ICH Multidisciplinary Guidelines ANSWER:Including medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI) Clinical Safety constitutes what ICH efficacy guidelines? ANSWER:E1-E2F Good Clinical Practice constitutes what ICH efficacy guidelines? ANSWER:E6 (ICH E6 GCP 1.21)
thinking on good clinical practices. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of applicable statutes, regulations, or both Where are FDA regulations published and when? ANSWER:The Code of Federal Regulations is issued annually in the Federal Register Decipher the following regulation title: 21 CFR 312.28 (b) ANSWER:Title 21 Part 312 Section 28 Paragraph b In a regulation title, 21 corresponds to what regulatory authority? ANSWER:Food and Drug Administration (FDA) In a regulation title, 45 corresponds to what regulatory authority? ANSWER:Health & Human Services (HHS) The 300 series of parts apply to... ANSWER:Drug regulations The 600 series of parts apply to... ANSWER:Biologics regulations The 800 series of parts apply to.... ANSWER:Device regulations 45 CFR 46 refers to what? ANSWER:Protection of Human Subjects
What does 45 CFR 46 outline? ANSWER:Regulations set forth by the U.S. Department of Health and Human Services. HHS regulations apply to research involving human subjects conduced or funded in whole or in part by HHS 21 CFR 50 refers to what ANSWER:Protection of Human Subjects, as set forth by the FDA 21 CFR 56 refers to what ANSWER:Institutional Review Boards, as set forth by the FDA FDA regulations apply to all clinical investigations regulated by the FDA under sections... ANSWER:505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including floods, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products 45 CFR 46 Subpart A ANSWER:Basic HHS Policy for Protection of Human Research Subjects, also called the Common Rule. Describes the required protections for all human subjects
21 CFR 56 Subpart B ANSWER:IRB organization and personnel 21 CFR 56 Subpart C ANSWER:IRB functions and operations 21 CFR 56 Subpart D ANSWER:Records and Reports 21 CFR 56 Subpart E ANSWER:Administrative Actions for Noncompliance Are there exemptions to 45 CFR 46.101? ANSWER:Exemptions do not apply to research involving prisoners, subpart C. Exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigators do not participate in the activities being observed What are the exemptions from IRB requirement (21 CFR 56.104)? ANSWER:Any investigation that commenced before July 27, 1981 Emergency use of a test article Taste and food quality evaluations and consumer acceptance studies Emergency use of a test article is exempt from 21 CFR 56.104 (IRB requirement) provided that.... ANSWER:Such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject
to IRB review What is a legally authorized representative? ANSWER:An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure involved in the research What does minimal risk mean? ANSWER:The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests According to 45 CFR 46.102, research means... ANSWER:a systemic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge According to 21 CFR 50.3c, clinical investigation means... ANSWER:Any experiment that involves a test article and one or more human subjects and that their is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing
