- Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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- The Belmont Report’s principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:
Persons with diminished autonomy are entitled to protection. - Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and a minimization of risks. - 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.
False
Which member of a study team is ultimately responsible for the conduct of the study at a site?
The Investigator
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
At 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.
True
Which of the following is included in the Nuremberg Code:
A. Voluntary consent
B. Confidentiality of data
C. Equitable selection of subjects
D. Additional protection for vulnerable subjects
Voluntary consent
Which of the following brought increased public attention to the problems with the IRB system?
A. Death of Research Subject (Jesse Gelsinger)
B. “Shut Downs” by OHRP
C. HHS Inspector General Report of 1998
D. 1983 Presidential Commission Report
Death of Research Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of Justice because:
A. Prisoners are not a representative sample of the general population
B. Prisoners are not free to say no
C. Prisoners may not be used to conduct research that only benefits the larger society
D. Prisoners are less educated that the general population and have difficulty understanding research
Prisoners may not be used to conduct research that only benefits the larger society
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
C. Non-maleficence
D. Respect for Persons
Respect for persons
Which of the following was the result of the Beecher article?
A. Additional FDA regulations
B. Realization that ethical abuses are not limited to the Nazi regime
C. An identification of basic ethical principles
D. Multiple Congressional hearings
Realization that ethical abuses are not limited to the Nazi regime
Which of the following statements is accurate in determining subject risk involved in a genetic study:
Understanding the purpose and context of a specific study is critical in determining the risk involved
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:
De-Identified
Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?
Original signed consent documents include provisions for recontacting subjects
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:
Health insurance and employment discrimination
Which choice is the best definition of “genetic determinism?”
Genes are primarily responsible for human traits, including health, behavior, and disease
Under which circumstance does the FDA allow verbal consent prior to participation in a research study?
A. The subject has a legally authorized representative (LAR).
B. The study is minimal risk.
C. The subject is illiterate.
D. The study is greater than minimal risk.
The study is minimal risk.
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 for the individual’s legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:
A. Do not use the test article until either the subject or the subject’s legally authorized representative can give consent.
B. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately.
C. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.
D. Sign the consent form on behalf of the subject and use the test article.
The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.
Which of the following statements in a consent form is an example of exculpatory language?
A. In the event of any injury related to this research, you will be given medical treatment.
B. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for.
C. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill during the research, you may have to drop out.
D. 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.
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
A. 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.
B. Tell the subject about the new drug but discourage him from switching treatments until the study is completed
C. Withhold this new information to avoid confusing the subject with other treatment options or alternatives
D. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients
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 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.
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find ?
The research could not practicably be carried out without the waiver of consent.
An investigator obtains consent and HIPAA authorization 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 subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A breach of confidentiality
To minimize potential risks of harm, a researcher conducting an on-line survey can:
A. Suggest that subjects print a copy of the informed consent form for their records.
B. Comply with the survey software’s Terms of Service agreement.
C. Design the survey so that no direct or indirect identifiers are collected.
D. Specify that all respondents must be legal adults.
C
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?
A. An investigator designs a computer program to extract work experience information from LinkedIn profiles.
B. An investigator analyzes user comments on articles posted on her university’s website.
C. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
D. An investigator registers an account on SecondLife to observe the way people interact with each other.
C.
Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
A. The investigator uses the informed consent process to explain her institution’s method for guaranteeing absolute confidentiality of research data.
B. The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.
C. Respondents are informed that investigators will try to keep their participation confidential; however, confidentiality cannot be assured.
D. Respondents are informed that a research assistant will transfer all the research data to a password-protected computer that is not connected to the internet, via a USB flashdrive. The computer is located in a research team member’s office.
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.
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. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her.
B. 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.
C. A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings.
D. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time.
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?
A. Downloading a publicly available dataset that includes high school students’ academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states.
B. Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual’s social network.
C. Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted.
D. 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.
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.
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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
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
A. Invasion of privacy, adverse reaction to study drug, and discrimination
B. Breach of confidentiality, loss of autonomy, and study procedures
C. Invasion of privacy, breach of confidentiality, and study procedures
D. Study procedures, breach of confidentiality, and loss of employment
Invasion of privacy, breach of confidentiality, and study procedures
The primary purpose of a Certificate of Confidentiality is to:
A. Allow law enforcement to investigate abuse cases.
B. Protect researchers from disclosing conflicts of interest.
C. Prevent subjects from knowing the purpose of a study.
D. Protect identifiable research information from compelled disclosure.
Protect identifiable research information from compelled disclosure.
If disclosure of a subject’s involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:
A. Obtain a waiver of documentation of informed consent.
B. Have the subject sign the consent form under an assumed name.
C. Code the subjects’ responses.
D. Obtain a Certificate of Confidentiality.
A. Obtain a waiver of documentation of informed consent.
What statement about risks in social and behavioral sciences research is most accurate:
A. Anonymizing data effectively manages the risk of creating emotional distress.
B. There are never any risks.
C. Risks are specific to time, situation, and culture.
D. If a study offers potential benefits, it is not necessary to minimize risks.
C. Risks are specific to time, situation, and culture.
According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?
A. Gift authorship
B. Plagiarism
C. Conflict of interest
D. Harassing a co-worker
B. Plagiarism
The typical first main phase in response to a research misconduct allegation is called:
A. The audit
B. Remediation
C. The inquiry
D. The adjudication
C. The inquiry
Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
A. Misconduct must be proven beyond a reasonable doubt.
B. The standard of innocent until proven guilty does not apply in misconduct cases.
C. To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
D. The Policy covers conflicts of interest and the misuse of grant funding.
C. To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
Which of the following is true regarding research misconduct?
A. A central federal agency handles all cases of research misconduct.
B. Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
C. Funding agencies normally perform their own misconduct inquiry before the institution becomes involved.
D. The U.S. government is required to reveal publicly the identity of any person who commits misconduct.
B. Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy?
A. Yes because it involves a form of falsification.
B. No; instead it is a type of authorship dispute.
C. No; instead it is a type of financial conflict of interest.
D. Yes because it involves a form of fabrication.
B. No; instead it is a type of authorship dispute.
Identify one way faculty researchers can possibly avoid undue influence of student subjects?
Avoid recruiting their own students in the research
By recruiting students from other classes, faculty researchers can minimize the potential of undue influence. Students from the faculty’s own classroom may feel coerced to participate.
Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)?
Exempt
Exempt research is human subjects research that is “exempt” from the Common Rule provisions. Per federal guidance, the recommendation is that researchers should not be able to self-determine whether a study qualifies for exemption. Institutional policy should clearly designate who is responsible for making exemption determinations – and it could be an IRB member or experienced staff person with knowledge of the exemption categories and the research activity. Expedited and convened reviews both require IRB approval.
A graduate student needs to conduct a research project for her master’s thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?
Not Human Subjects
This study would qualify as not human subjects because the data that the student is collecting does not meet the definition of human subjects research. She is not collecting any information about the store owners and her study seeks to find information about the items in the store.
A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals’ careers. The student will collect identifiers. This study would be subject to which type of review?
Convened Review
This study would qualify for convened review because the IRB must conduct a careful analysis. The study involves an interview where the data collected could have an impact on the principals’ careers and it contains subject identifiers.
In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the __.
The Common Rule
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 relationship to anticipated benefits
The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. The principle of justice requires that the selection of subjects is fair.
A study was submitted to the IRB designed to evaluate the effect of background noise on an individual’s ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:
Respect for persons
The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of justice requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience.
The researcher’s failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?
“Tastes, Ties, and Time (T3)” study
Although no students were identified by name in the T3 study, some data were specific enough to allow for re-identification of students by an outside researcher. This is an example of the failure to protect subjects from deductive disclosure of their identities. The primary ethical problems of the other studies include physical harms and unanticipated psychological harm.
A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?
justice
The Belmont principle of beneficence requires that:
Risks to subjects are reasonable in relation to anticipated benefits.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?f
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