The 1974 National Research Act
US Public Health Service Policy
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
Which of the following is included in the Nuremberg Code:
The National Research Act of 1974
Established the National Commission.
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may be used to conduct research that only benefits the larger society
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?
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.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
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 study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well being of the subject.
IRB continuing review of an approved protocol must:
Occur at least annually.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
Identify the example of when situation and time are key to assessing risk of harm in a research study:
Asking women if they have had an abortion
Additional safeguards that may be included in a social and behavioral study may include:
Remove all direct identifiers from the data as soon as possible.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
Destroying all identifiers connected to the data.
Destroying all identifiers connected to the data.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
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?
There was neither a violation of privacy nor a breach of confidentiality.
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)?
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.
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?
Securing a Certificate of Confidentiality.
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:
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?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
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?
The study is human subject research which is eligible for expedited review.
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected.
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?
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
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?
A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?
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.
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:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
The HIPAA “minimum necessary” standard applies…
Your answer : To all human subjects research that uses PHI.
To all human subjects research that uses PHI without an authorization from the data subject.
If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy officer (“Privacy Officer”), or privacy official (“Privacy Official”), depending on the issue.
A HIPAA authorization has which of the following characteristics:
Uses “plain language” that the data subject can understand, similar to the requirement for an informed consent document.
HIPAA protects a category of information known as protected health information (PHI). PHI includes:
Identifiable health information that is created or held by covered entities and their business associates.
When required, the information provided to the data subject in a HIPAA disclosure accounting …
must be more detailed for disclosures that involve fewer than 50 subject records.
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:
Greater than $5,000 of ownership in any single public entity/public company.
A financial conflict of interest could involve:
Receiving stock in a company funding your research.
A conflict of interest implies:
The potential for bias.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
Designated institutional officials
The Data Manager should review the study protocol:
to understand primary and secondary endpoints
When designing a database and data collection instruments for a study, the Data Manager should:
Use standards to reduce the time required to set up the database and to increase the consistency of the data
Every member of a study team must define quality the same way in order to produce a high quality database.
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?
The Clinical Research Associate
In order for a quality process to work, study team members must understand all of the following EXCEPT:
how to perform the other team members’ jobs
Typical study conduct activities performed by the data manager include all of the following EXCEPT:
defining edit checks
t what point should a Data Manager get involved with the database development?
At study startup
Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved.