citi quizes
Justice.
-Researchers recruit participants for their study in a fair and equitable manner -Consider the fair and equitable distribution of benefits
The risks of harm typically associated with social and behavioral research.
social, psychological, economic, dignitary, and legal.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A developmental psychologist videotapes interaction between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
Census data is an example of:
Public information.
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 elderly gentleman, whose wife is his legally authorized representative since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
Belmont Report and Its Principles The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
"Tastes, Ties, and Time (T3)" study (2006-2009).
Data are made anonymous by
Destroying all identifiers connected to the data.
Belmont Report and Its Principles Beneficence.
-Do not harm -Maximize possible benefits and minimize possible harms (Cost-benefit analysis).
Belmont Report and Its Principles Respect for Persons.
-Individuals should be treated as autonomous agents -Persons with diminished autonomy are entitled with protection.
study procedures.
simply taking part in research can put subjects at risk.
The Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
assessing risk.
Probability and Magnitude of Harm, Situation/Time, Subject Population and Assessing Risk Objectively.
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.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
Belmont Report and Its Principles Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relation to anticipated benefits.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have an equal or greater benefit to the subject. The investigator should do which of the following?
Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of an exculpatory language?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
Identifiable private information.
ASSESSING RISK Risks Associated with Participation in Social and Behavioral Sciences Research.
Invasion of privacy, breach of confidentiality and study procedures.
According to federal regulations, the expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
Belmont Report and Its Principles According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Prisoners.
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
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?
The IRB will not review this study because it is not research as defined by the federal regulations.
Belmont Report and Its Principles Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?
The Public Health Service Study of Untreated Syphilis.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
The Federal Regulations According to the federal regulations, research is eligible for exemption, if:
The research falls into one of eight categories of research activity described in the regulations.
When does a focus group deal 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.
Privacy and Confidentiality 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.
informed consent The purpose of informed consent is:
To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.
Breach of Confidentiality.
an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status.
Belmont Report and Its Principles Deception-Respect for Persons.
occurs when the researcher omits information about the study or gives false information.
Invasion of Privacy.
personal information is accessed or collected without the subjects' knowledge or consent, or if a subject's participation in a study is revealed despite assurances that this would not happen.
Belmont Report and Its Principles Informed Consent.
the participants can voluntarily withdraw from the study any time, without penalty or negative repercussions.
respect for persons
treating persons as autonomous agents and protecting those with diminished autonomy
