CITI Training |2023 Questions & Answers with Rationale
Question 1
Question The PHS regulations about financial conflict of interests require which party
... [Show More] to disclose significant financial conflicts of interest?
Your Answer Researcher
Result Correct
Comment The PHS regulations about financial conflict of interests require the researcher to disclose significant financial conflicts of interest to the organization. The FDA’s regulation governing disclosure of individual COI requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or disclose financial interests of researchers who conducted clinical studies covered by the regulation.
Question 2
Question The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
Your Answer There may be bias by the peer reviewer as to the area of research
Result Correct
Comment Conflicts of interest may arise in the peer review process (for example, bias causes a reviewer to respond positively to a manuscript because it involves research or methodology in which the reviewer has a personal interest).
Question 3
Question An example of an individual financial COI is:
Your Answer A researcher’s spouse holds equity in a publicly traded
pharmaceutical company that is also the sponsor of the researcher’s study.
Result Correct
Comment An individual COI may arise when an individual has a personal or financial interest, which may affect or appear to affect the design, conduct, or reporting of the research.
Question 4
Question The FDA regulations governing disclosure of individual COIs require:
Your Answer Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
Result Correct
Comment The FDA’s regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or to disclose financial interests of researchers who conducted clinical studies covered by the regulation. The regulation specifies that the FDA may refuse to file any marketing application that does not contain a disclosure of researchers’ financial interests or a certification that the applicant acted with due diligence to obtain researchers’ disclosures, but was unable to do so.
Question 5
Question A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
Your Answer No later than the time of proposal submission
Result Correct
Comment The NIH is a PHS agency. Therefore, this proposed research is subject to the PHS regulation regarding objectivity in research, which requires researchers to submit COI disclosures no later than the time a proposal is submitted to a PHS funding agency.
Question 1
Question A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?
Your Answer Significant risk device
Result Correct
Comment A significant risk device presents a potential for serious risk to the health, safety, or welfare of the subject and it: (1) Is intended to be implanted into a human; (2) Is used in supporting or sustaining human life; (3) Is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise prevents impairment of human health; or (4) Otherwise presents serious risk to health, safety, and welfare of a subject.
Question 2
Question An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?
Your Answer Treat the patient with the drug based on physician's best medical judgment
Result Correct
Comment Based on physician's best medical judgment the patient may be
treated with the drug since it is a marketed drug with an approved labeled dosage. An IND is not required. There is no research being conducted for the purpose of changing the labeling of the drug or marketing a new indication.
Question 3
Question An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?
Your Answer Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
Result Correct
Comment An IND is required. The investigator and the sponsor are proposing research that may change the formulation of the drug, the dosage, and the population (children) from the currently approved labeling for this drug. An IDE is not required as there is no device involved. Because this research is on drugs, it is under the primary purview of, and regulated by, the FDA, not OHRP.
Question 4
Question The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:
Your Answer Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
Result Correct
Comment 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule, often referred to as Part 11, was published May 20, 1997 and was intended to enable, but not require, the use of electronic documents in the regulatory process for drugs and devices. Part 11 specifies processes that must be in place assuring that electronic documents and signatures are equivalent to paper documents and handwritten signatures.
Question 5
Question An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow:
Your Answer The medical center to replace the use of paper records with electronic records for its research.
Result Correct
Comment Part 11 specifies processes that must be in place assuring that electronic documents and signatures are equivalent to paper documents and handwritten signature. Therefore, if an institution wants to eliminate all paper records for research, the electronic system must be "Part 11 compliant."
Question 1
Question Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?
Your Answer Original signed consent documents include provisions for recontacting subjects
Result Correct
Comment It is necessary to determine and document at the time of initial consent whether subjects wish to be re-contacted. It is critical to discuss with prospective subjects whether they may be re-contacted and whether they wish to receive further information, if available.
Question 2
Question As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:
Your Answer De-Identified
Result Correct
Comment The new NIH policy expects informed (valid) consent even when the source individuals for genetic data are not identifiable (de-identified) to investigators accessing and using the data.
Question 3
Question Identify which types of discrimination the Genetic Information NonDiscrimination Act (GINA) protects individuals from:
Your Answer Health insurance and employment discrimination
Result Correct
Comment GINA protects individuals against discrimination in health insurance and employment. Other forms of discrimination are not addressed by GINA.
Question 4
Question When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?
Your Answer Effects of findings on other family members
Result Correct
Comment All of these issues are important in genetics research. However, potential effects of research findings on family members is the most important consideration.
Question 5 [Show Less]