Question: When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Answer Options: Is there a power differential between researchers and subjects? Are there adequate resources to conduct the study? Has the researcher completed required training? Are the research procedures greater than minimal risk of harm?

Answer: Is there a power differential between researchers and subjects?

Question: Which is an example of a situation where deferential vulnerability might be a factor?

Answer Options: A physician recruiting patients to be subjects An army medical officer recruiting subjects among lower ranks An employer recruiting among persons who directly report to them A college professor recruiting among their students

Answer: A physician recruiting patients to be subjects

Question: The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:

Answer Options: Institutional vulnerability Economic or social vulnerability Physical vulnerability Cognitive or communicative vulnerability

Answer: Cognitive or communicative vulnerability

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?

Answer Options: Non-significant risk device Significant risk device

Answer: Significant risk device

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?

Answer Options: Treat the patient with the drug based on physician’s best medical judgment Submit an Investigational New Drug, IND, application before treating the subject Inform the patient that the drug cannot be prescribed Submit a research protocol for IRB review and approval before treating the patient

Answer: Treat the patient with the drug based on physician’s best medical judgment

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?

Answer Options: Submit the research protocol to the IRB for review, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research Submit the research protocol to the Office for Human Research Protections, OHRP, for their review Submit an Investigational Device Exemption, IDE, application to the FDA

Answer: Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

Question: The FDA’s regulations related to electronic records and electronic signatures, 21 CFR Part 11, are intended to:

Answer Options: Allow the use of electronic documents and signatures in the regulatory process for drugs and devices. Prohibit the use of paper printouts of electronic records. Require use of electronic records for all drug research. Provide specific standards for the informed consent process.

Answer: Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

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:

Answer Options: The medical center to replace the use of paper records with electronic records for its research. The database system to assign passwords. The investigator to email subjects about the research. The use of paper records meeting FDA requirements.

Answer: The medical center to replace the use of paper records with electronic records for its research.

Question: If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

Answer Options: An organizational IRB or Privacy Board. An organizational IRB or Privacy Board, privacy official, “Privacy Officer”, or security official, “Security Officer”, depending on the issue. A designated privacy official, a.k.a., “Privacy Officer”. A designated security official, a.k.a., “Security Officer”.

Answer: An organizational IRB or Privacy Board, privacy official, “Privacy Officer”, or security official, “Security Officer”, depending on the issue.

Question: When required, the information provided to the data subject in a HIPAA disclosure accounting …

Answer Options: is always the same, regardless of the number of records involved. is limited to the information elements the data subject specifically requests. must be more detailed for disclosures that involve fewer than 50 subject records. is at the discretion of the organization, given its accounting policies.

Answer: must be more detailed for disclosures that involve fewer than 50 subject records.

Question: HIPAA protects a category of information known as protected health information, PHI. PHI covered under HIPAA includes:

Answer Options: Any identifiable health information. Identifiable health information that is created or held by covered entities and their business associates, provided the data subject is a US citizen. Identifiable health information that is created or held by covered entities and their business associates. Identifiable health information that is created or held by covered entities and their business associates that operate across state lines.

Answer: Identifiable health information that is created or held by covered entities and their business associates.

Question: Under HIPAA, “retrospective research”, a.k.a., data mining, on collections of PHI generally …

Answer Options: Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. Does not meet the definition of research, and so requires no HIPAA authorization or meeting one of the criteria for waiving authorization. Must meet HIPAA requirements only if the data collection is in a different jurisdiction, state, than the researcher accessing it. Is covered by Common Rule/FDA requirements, but not HIPAA’s.

Answer: Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

Question: A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

Answer Options: Activities preparatory to research, with certain representations by the researcher. Limited data set with an approved data use agreement. Use of decedents’ information, with certain representations by the researcher. Data that does not cross state lines when disclosed by the covered entity.

Answer: Data that does not cross state lines when disclosed by the covered entity.