CITI Program – Biomedical Research Practice Exam

These questions are part of the practice quiz. Start practicing

• Which of the following traits may hinder an individual's ability to provide voluntary informed consent?
• The most important factor in determining whether a research collaboration will be successful is:
• What critical aspect is necessary when enrolling child participants into a research study?
• What is the primary requirement for a database system to be selected for clinical research at an academic medical center?
• Which of the following statements is true regarding the regulations that govern research?
• What should a trainee do if they have a problem with a mentor?
• According to FDA regulations, who is responsible for disclosing individual conflicts of interest in clinical studies?
• The HIPAA "minimum necessary" standard is applicable under which condition?
• What potential issue may arise due to the peer review process in research?
• When reviewing a research study, what should an IRB consider regarding a potential subject population's vulnerability?
• What is the primary ethical concern addressed by the principle of Beneficence?
• What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to?
• Under what conditions is it appropriate to re-contact individuals who provided biological specimens?
• Which of the following best describes the ethical considerations in using biological specimens?
• What is the main responsibility of an Institutional Review Board (IRB)?
• What is true regarding IRB approval for the clinical use of a HUD in healthcare?
• Which of the following statements is true regarding the responsibilities of a reviewer?
• In research that involves PHI, which standard is crucial for compliance?
• Is research concerning the effectiveness of prenatal care programs on reducing HIV risk in young women permitted under Subpart B?
• What distinguishes biomedical research from non-biomedical research?
• When planning focus groups to discuss perceptions of adolescent girls, what is a significant concern for the researcher?
• Which event brought increased public attention to issues with the IRB system?
• For a study involving eclampsia treatment in pregnant women, from whom must consent be obtained?
• Falsification in research typically involves which of the following?
• For an IRB to grant a waiver for informed consent, which condition must be met?
• What should participants be informed about regarding their biological samples?
• What should an investigator do after discovering a serious, unanticipated adverse drug experience in a clinical research trial?
• What are the two steps involved in securing FDA marketing approval for a HUD?
• Which aspect is most important for an IRB to consider in genetic research?
• Which of the following most accurately describes a conflict of commitment?
• Which element is crucial in preserving confidentiality in workplace studies?
• What type of vulnerability applies to prospective research subjects who cannot comprehend information to make decisions?
• What is a critical ethical consideration for researchers storing sensitive data such as HIV status?
• Which statement about mentoring is true?
• According to ICMJE guidelines, who should be recognized in the acknowledgments section?
• How does a membership on an advisory board introduce a conflict of interest for a researcher?
• Which type of research typically requires more stringent ethical reviews?
• For research involving minimal risk to children, what is a likely conclusion of the IRB's assessment?
• Can research including pregnant women be exempt from regulations under 45 CFR 46 if conditions for exemption are met?
• What constitutes a significant factor in determining whether an event is classified as an unanticipated problem?
• Which statement best defines "genetic determinism"?
• Which of the following is a responsibility of each author?
• How can data lifecycle management (DLM) be accurately described?
• What constitutes a breach of confidentiality in research?
• In a study of fetoscopic laser surgery to benefit the fetus, who must give consent according to Subpart B?
• In research reporting, what is essential regarding methods and procedures?
• What constitutes an individual financial conflict of interest for a researcher?
• Why might the FDA allow use of a HUD for a condition that it is not expressly approved for?
• If an investigator proposes research involving adolescents and minimal risks are considered, what is required for IRB approval?
• What could be a potential risk for subjects lacking cognitive capacity in a research study?
• Which type of discrimination does the Genetic Information Non-Discrimination Act (GINA) protect individuals from?
• Which of the following practices helps ensure justice in the selection of research subjects?
• How should a new pacemaker that is designed to pose fewer risks be classified?
• Why is the use of prisoners in research a concern under the Belmont principle of Justice?
• What are the three ethical principles discussed in the Belmont Report?
• What pressure might workers experience when asked to participate in research studies?
• What is the primary role of oversight bodies like IRB or IACUC?
• Which research approach minimizes risk to human subjects when using biological specimens?
• Regarding studies aimed at improving cancer treatments for adolescents, what is required for parental permissions?
• Is Investigator B's research using the biospecimens considered human subjects research if the identifiers are retained by Investigator A?
• What is the required action if an investigational biologic is not properly screened for viral contaminants?
• Which of the following statements is true regarding the responsibilities of reviewers?
• What action was taken by the IRB after the loss of subject records in the study involving housekeeping employees?
• What should an investigator do to study a marketed high blood pressure product for use in children under age 12?
• Which of the following is true regarding the traditional peer review process?
• Which defines the federal government's stance on reporting research results?
• Which of the following most accurately describes the practice of ghost authorship?
• In which circumstance can a clinician use a HUD without obtaining IRB approval?
• Which of the following are the three principles discussed in the Belmont Report?
• How frequently must IRB continuing review occur for protocols that involve greater than minimal risk?
• What must be included in consent documents to allow for re-contacting subjects?
• How should authorship order typically be arranged in scientific papers?
• What is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?
• Which of the following is a requirement for ethical research involving human participants?
• When a subject receives the wrong study drug leading to severe nausea, what classification does this event fall under?
• When taking part in a clinical trial, what is an important factor a participant should consider about their consent?
• In a study examining new therapies for pregnant women, which party must provide consent?
• What does the term validity refer to in a research context?
• Which vulnerable population is not specifically outlined in the Common Rule’s requirements?
• When research involves a 10-year-old child who declines to participate, what best describes the investigator's duty?
• Which groups are specifically protected under federal regulations (45 CFR 46), regarding additional protections?
• A research collaboration can be enhanced by:
• When may expedited review for a new proposed study be used according to federal regulations?
• When conducting research that includes biological samples, what is true regarding consent?
• When is it necessary for researchers to report significant financial conflicts of interest, as per PHS regulations?
• Which regulatory requirement does NOT apply to an investigation of a Humanitarian Use Device (HUD)?
• Which of the following statements most accurately describes the review process for grant proposals?
• When is a "disclosure accounting" required under HIPAA?
• Which document can a clinician refer to for proper guidelines on using a HUD in clinical practices?
• What is an example of exculpatory language in an informed consent form?
• In a life-threatening situation requiring the use of a test article without informed consent, what should the investigator do?
• What is an important consideration for clinicians involved in using or studying HUDs?
• What does the HIPAA standard aim to ensure in terms of research involving health information?
• When is IRB approval required for an investigation involving a significant risk HUD?
• In the context of DLM, what does managing data primarily refer to?
• If a Data Safety Monitoring Board indicates a higher than expected adverse event rate, what must be revised?
• What element is included in the Nuremberg Code?
• Which three goals are central to data lifecycle management (DLM)?
• What does the FDA recommend for clinical use of a HUD outside its approved indications?
• Which statement most accurately describes the mentoring relationship?
• What is considered good mentoring practice?
• How are the risks associated with social behavioral research (SBR) best characterized?
• What must be done if a clinical study experiences a higher incidence of an adverse event than expected?
• In terms of research ethics, why is informed consent critically important?
• What is required by HIPAA for the use and disclosure of protected health information (PHI), unless waived by the IRB or privacy board?
• What is a characteristic of a HIPAA authorization?
• Which statement is true about authorship practices?
• What should a researcher do if a child who is required to assent to a study declines to participate?
• If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:
• How are potential volunteers informed about the benefits and risks in clinical trials?
• Which of the following most accurately describes an institutional conflict of interest?
• Which concept is NOT one of the ethical principles outlined in the Belmont Report?
• Can Investigator B use biological specimens for cancer research without re-consent if they are de-identified?
• What aspect was relevant to an IRB determining that the secondary analysis of a CDC database does not involve human subjects?
• The Belmont Report's principle of respect for persons emphasizes two ethical convictions. What is the second conviction?
• Which characteristic defines a mentor?
• In the context of HIPAA, what best defines the term "research"?
• Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?
• What is the most appropriate course of action for a physician treating an adult patient with ADHD using an approved drug for another indication?
• In any collaboration, data ownership is typically determined by?
• What important issue is addressed by a researcher conducting an anonymous survey on attitudes toward walking?
• Is a study comparing new treatments for seasonal affected disorder (SAD) allowed to include pregnant women under Subpart B?
• If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:
• Are pregnant women, fetuses, and neonates considered vulnerable subjects in research?
• Which of the following actions is NOT appropriate when an unanticipated problem arises in a clinical trial?
• What constitutes adequate justification for the exclusion of women from NIH-funded research?
• What phase follows an inquiry after a research misconduct allegation?
• What is the responsibility of clinicians using a HUD in their practice?
• Informed consent is primarily an application of which Belmont principle?
• What is the purpose of FDA regulations concerning electronic records and signatures?
• What is the primary purpose of informed consent in research?
• What is the main function of a Technology Transfer Office with respect to collaborative research?
• What must be proven to establish a misconduct finding according to U.S. Federal Research Misconduct Policy?
• If someone intentionally removes data points from the data set to generate a deceptive conclusion, what type of research misconduct is this?
• Can research concerning mushroom extract supplementation on pregnant women be permitted under Subpart B?
• How can the principle of beneficence be applied in a study using human subjects?
• In research involving biological samples, what must be fully explained to participants?
• Which situation is an example where deferential vulnerability might be present?
• What should a researcher do if they discover a conflict of interest during a study?
• A Humanitarian Use Device (HUD) is designed for a condition affecting how many individuals in the U.S. annually?
• What is the primary concern when a subject misses the administration of the second study drug due to external circumstances?
• What is the main purpose of Institutional Review Boards (IRBs)?
• Which type of research aimed at prisoners is allowed under federal guidelines?
• What is the expected outcome of pharmacogenomic research?
• Which statement accurately reflects HIPAA's protections for health information used in research?
• Which of the following is true about the management of conflicts of interest?
• What is a key component in determining if research poses minimal risk to subjects?
• When federally supported research involves prisoners, what unique member must the IRB include?
• What type of research misconduct involves data manipulation?
• Which group requires additional HHS regulations due to past research abuses?
• Which statement best exemplifies the importance of mentoring?
• In the context of genetic research, what is the significance of a subject's demographic background?
• What must be included in the study design for research involving workplace studies?
• When is informed consent necessary in the context of a HUD?
• Which of the following is true regarding an acknowledgments section?
• What should an investigator do if a new, potentially beneficial drug becomes available during a subject's participation in a clinical trial?
• Amendments to IRB-approved protocols do not need prior approval if they:
• Can a researcher collect data about fetuses exposed to high lead levels during pregnancy under Subpart B?
• What did the National Research Act of 1974 achieve?
• Which principle holds that individuals participating in research should be respected as autonomous agents?
• Which of the following represents the greatest ethical challenge in informed consent for clinical trials?
• What is the main purpose of pharmacogenomic research?
• What suffices to warrant authorship in scientific research?
• Which of the following is true regarding academic-industry collaborations?
• What should an investigator do if an elderly gentleman's legally authorized representative is unavailable, but he has shown interest and assent for clinical trial participation?
• According to NBAC's analytic approach, what type of vulnerability might an acutely ill person face?
• What is most likely to create a poor relationship between a mentor and a trainee?
• Which statement most accurately describes the process leading to the development of the Nuremberg Code?
• The FDA evaluates a Humanitarian Device Exemption (HDE) based on which of the following criteria?
• What might be a condition for using a HUD outside of its approved indication?
• Which of the following is true regarding industry-sponsored research?
• What is most likely to be considered plagiarism?
• What information must be included in a consent form for research?
• What does an IRB's risk assessment typically conclude for studies involving children with minimal risks?
• What is the primary duty of an IRB when reviewing research involving prisoners?
• What is the goal of understanding the risks involved in genetic studies?
• Which incident most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report?
• Which method is recognized as a form of data collection in social behavioral research?
• For how long are investigators typically required to keep consent documents and research records?