Voluntary consent
  • Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
  • Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
  • Which of the following is included in the Nuremberg Code:
  • Which member of a study team is ultimately responsible for the conduct of the study at a site?
to understand primary and secondary endpoints
  • The Data Manager should review the study protocol:
  • IRB continuing review of an approved protocol must:
  • The HIPAA "minimum necessary" standard applies...Your answer : To all human subjects research that uses PHI.
  • The primary purpose of a Certificate of Confidentiality is to:
An organizational IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy Official"), depending on the issue.
  • If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
  • A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The potential for bias.
  • A conflict of interest implies:
  • A financial conflict of interest could involve:
  • The National Research Act of 1974
  • The 1974 National Research Act
To all human subjects research that uses PHI without an authorization from the data subject.
  • The HIPAA "minimum necessary" standard applies...Your answer : To all human subjects research that uses PHI.
  • The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
  • Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
Protect identifiable research information from compelled disclosure.
  • The primary purpose of a Certificate of Confidentiality is to:
  • The use of prisoners in research is a concern under the Belmont principle of Justice because:
  • The Data Manager should review the study protocol:
  • Which of the following was the result of the Beecher article?
Remove all direct identifiers from the data as soon as possible.
  • Additional safeguards that may be included in a social and behavioral study may include:
  • Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
  • What statement about risks in social and behavioral sciences research is most accurate:
  • To minimize potential risks of harm, a researcher conducting an on-line survey can:
Receiving stock in a company funding your research.
  • Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
  • A financial conflict of interest could involve:
  • Which of the following brought increased public attention to the problems with the IRB system?
A breach of confidentiality.
  • Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
  • Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
  • An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
  • In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
Use standards to reduce the time required to set up the database and to increase the consistency of the data
  • When designing a database and data collection instruments for a study, the Data Manager should:
  • What statement about risks in social and behavioral sciences research is most accurate:
  • The use of prisoners in research is a concern under the Belmont principle of Justice because:
  • Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
Prisoners may be used to conduct research that only benefits the larger society
  • The use of prisoners in research is a concern under the Belmont principle of Justice because:
  • The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
  • The HIPAA "minimum necessary" standard applies...Your answer : To all human subjects research that uses PHI.
  • The primary purpose of a Certificate of Confidentiality is to:
There was neither a violation of privacy nor a breach of confidentiality.
  • A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?
  • According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
  • A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
  • As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?
At study startup
  • Which of the following is included in the Nuremberg Code:
  • IRB continuing review of an approved protocol must:
  • t what point should a Data Manager get involved with the database development?
  • Informed consent is considered an application of which Belmont principle?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
  • Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation?
  • According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
The Investigator
  • t what point should a Data Manager get involved with the database development?
  • Which member of a study team is ultimately responsible for the conduct of the study at a site?
  • Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation?
  • Every member of a study team must define quality the same way in order to produce a high quality database.
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
  • The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?
  • Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
  • Which of the following brought increased public attention to the problems with the IRB system?
Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
  • Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:
  • A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
  • If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
US Public Health Service Policy
  • The 1974 National Research Act
  • A financial conflict of interest could involve:
  • The National Research Act of 1974
  • The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?
Any equity interest in a publicly held company that exceeds $50,000
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
  • The HIPAA "minimum necessary" standard applies...Your answer : To all human subjects research that uses PHI.
  • Identify the example of when situation and time are key to assessing risk of harm in a research study:
Invasion of privacy, breach of confidentiality, and study procedures
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
  • Identify the example of when situation and time are key to assessing risk of harm in a research study:
  • Risk of harm in social and behavioral sciences generally fall in three categories, which are:
  • The use of prisoners in research is a concern under the Belmont principle of Justice because:
Occur at least annually.
  • t what point should a Data Manager get involved with the database development?
  • Which of the following is included in the Nuremberg Code:
  • Destroying all identifiers connected to the data.
  • IRB continuing review of an approved protocol must:
Designated institutional officials
  • What statement about risks in social and behavioral sciences research is most accurate:
  • Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
  • Identify the example of when situation and time are key to assessing risk of harm in a research study:
  • Which member of a study team is ultimately responsible for the conduct of the study at a site?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
  • Which of the following is included in the Nuremberg Code:
  • Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
  • Which of the following was the result of the Beecher article?
  • Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
  • Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
  • A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:
Design the survey so that no direct or indirect identifiers are collected.
  • Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
  • Additional safeguards that may be included in a social and behavioral study may include:
  • To minimize potential risks of harm, a researcher conducting an on-line survey can:
  • The primary purpose of a Certificate of Confidentiality is to:
The changes must be immediately implemented for the health and well being of the subject.
  • Additional safeguards that may be included in a social and behavioral study may include:
  • To minimize potential risks of harm, a researcher conducting an on-line survey can:
  • Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
  • When designing a database and data collection instruments for a study, the Data Manager should:
Realization that ethical abuses are not limited to the Nazi regime
  • Which of the following is included in the Nuremberg Code:
  • A HIPAA authorization has which of the following characteristics:
  • Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
  • Which of the following was the result of the Beecher article?
For a minimum of three years after completion of the study
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
  • The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • Additional safeguards that may be included in a social and behavioral study may include:
Death of Jesse Gelsinger
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
  • HIPAA protects a category of information known as protected health information (PHI). PHI includes:
  • Which of the following brought increased public attention to the problems with the IRB system?
  • The National Research Act of 1974
Greater than $5,000 of ownership in any single public entity/public company.
  • According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
  • The HIPAA "minimum necessary" standard applies...Your answer : To all human subjects research that uses PHI.
  • Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
  • To minimize potential risks of harm, a researcher conducting an on-line survey can:
Destroying all identifiers connected to the data.
  • The primary purpose of a Certificate of Confidentiality is to:
  • IRB continuing review of an approved protocol must:
  • Destroying all identifiers connected to the data.
  • The Data Manager should review the study protocol:
Respect for Persons
  • Which of the following is included in the Nuremberg Code:
  • Informed consent is considered an application of which Belmont principle?
  • IRB continuing review of an approved protocol must:
  • t what point should a Data Manager get involved with the database development?
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
  • A financial conflict of interest could involve:
  • Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?
  • The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
Identifiable health information that is created or held by covered entities and their business associates.
  • Which of the following brought increased public attention to the problems with the IRB system?
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
  • A conflict of interest implies:
  • HIPAA protects a category of information known as protected health information (PHI). PHI includes:
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