Prelim
Prelim
Prelim
Privacy Protections - Interviewing participants about sensitive topics individually instead of in front of a
group.
Privacy Protections - Interviewing the in their home or a private office instead of a public place.
Confidentiality Protections - Using only encrypted systems for storing research data on laptops.
Confidentiality Protections - Limiting access to study data to only a few members of the study team.
Confidentiality Protections - Using a code number instead of the participant's real name on study data
and blood/tissue samples.
Confidentiality Protections - Destroying photos, audio tapes, or video tapes at the end of the study
12. Which statement most accurately describes the process leading to the development of the
Nuremberg Code:
b. It was created by the federal government in response to poor research practices in U.S. hospitals.
c. It was created in response to the harms caused by Nazi researchers around the time of the Second
World War.
d. It was created to resolve the issue of whether testing the reactions of pilots constitutes human
subjects research.
13. Which of following protocols is the one that is most likely to require IRB review?
14. Which of the following statements most clearly illustrates the principle of beneficence?
b. Making sure that the selection of subjects includes people from all segments of the population.
15.Which statement best describes information that must be included in a consent form?
C. A literature review
16. 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?
a. Report the adverse drug experience to the IRB only if there are several other occurrences
b. 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
c. Do not report the adverse drug experience to the IRB since it is a common adverse experience
d. Report the adverse drug experience as part of the continuing review report.
17. According to the federal regulations, which of the following studies meets the definition of research
with human subjects?
a. A cognitive psychologist enrolls undergraduate students for a computer-based study about the
effect of mood on problem-solving behaviors.
b. Undergraduate students in a field methods class are a research question and asked to interview
another classmate, to be followed by class discussion on interview techniques.
c. A researcher sets up a meeting with the superintendent of a large and diverse public school system to
get data about the ethnic composition of the school system and the number of students receiving free
lunches.
d. A researcher conducts a comparison of the comments made in a publicly available blog and the
blogger's comments on a similar topic in a weekly magazine.
a. Private information
b. Public behavior
c. Private behavior
d. Public information
19. A census is a regularly-occurring and official count of a particular population. Census data available
at the Philippine Statistics Office website are an example of
a. Public information
b. Public behavior
c. Private behavior
d. Private information
20. According to the federal regulations, which of the following studies meets the definition of research
with human subjects?
a. A researcher asks the director of a local free clinic about the number of patients in the last two years
with newly diagnosed HIV/AIDS.
21. 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:
b. Have the subject sign the consent form under an assumed name.
22. A researcher wants to do a web based survey of college students to collect information about their
sexual behavior and drug use Direct identifiers will not be collected, however, IP present in the data set.
Risk of harm should be evaluated by:
a. Both the magnitude (or severity) and the probability (or likelihood) of harm.
23. What statement about risks in social and behavioral sciences research is most accurate.
24. A researcher wishes to study generational differences in coping mechanisms among adults who
experienced abuse as children. Adequate measures will be instituted to obtain informed consent and
ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects
may
25. A federally funded research study involving children 8 to 12 years old involves collecting a single
voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in
the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of
children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the
study described above. Which of the following procedures best describes the action to be taken by the
investigator?
26. A federally funded research study involving children 8 to 12 years old involves collecting a single
voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in
the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk
assessment would likely conclude that this study involves:
b. More than minimal risk with no prospect of direct benefit to the child.
d. More than minimal risk with prospect of direct benefit to the child.
27. An investigator proposes a study to determine the clinical relevance of a new assay technique to
measure minimal residual disease (MRD) in adolescent (18 to 20 yrs. old) cancer patients undergoing
chemotherapy. The study requires that two additional bone marrow aspirates be performed during the
course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the
assay technique measures. However, future patients with cancer would benefit from improved
interventions based on study findings. The IRB determined that the activity was a minor increase over
minimal risk. Which of the following statements best describes the IRB approval requirements for
involving adolescent cancer patients in the research study?
a. Consent is not required, however, both parents must give permission for the inclusion of the
adolescent child.
d. Assent is not required, however, one parent must give permission for the inclusion of the adolescent
in this study.
28. An investigator is confronted with a life threatening situation that necessitates using a test article in
human subject who is unable to provide informed consent and there is no time to obtain consent fro the
indeedual's LAR and no alternative method or recognized therapy is available. Under the FDA
regulations for investigator using test articles, which of the following describes the best course of action
for the investigator.
A. Use the test article without obtaining consent from the subject or the LAR then notify the IRB
b. Do not use the test article until either the subject or the subject's LAR can give consent.
C. Submit a research protocol to the IRB and justify an expedited review approval of the consent
document so test article can be used immediately
d. 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
29. A researcher leaves a research file in her car while she attends a concert and her car is stolen. The
file charts of aggregated 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?
30. Additional protections researchers can include in their practice to protect subject privacy and data
confidentiality include:
31. 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. A researcher asks cocaine users to provide names and contact information of other cocaine users who
might qualify for a study.
c. 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.
d. In order to eliminate the effect of observation on behavior, a researcher attends a support group and
records interactions without informing the attendees.
32. A researcher is examining the quality of life for prisoners who are HIV-positive using surveys
followed by interview. The IRB must ensure that:
a. Age appropriate.
b. Of high quality.
c. Educational.
34. A graduate student wants to examine the effect of print media versus televised media on individuals
position on several social issues. The superintendent of a local work release facility, a family friend will
stlow the graduate student access to the prison population to help her quickly accrue subjects. The
student's IRB should
a. Approve this project since the risk appears to be no more than minimal
b. Approve this project because the superintendent is the ultimate authority on what happens in his
facility
c. Not approve this project because the prisoners are merely a population of convenience for the
student
35. When workers are asked to participate in a research study, vulnerabilities related to the subject's
employment may include:
b. The research study's finding could affect an employee's pay, benefits, or promotion potential
c. Employees may experience pressure from management to participate in the study because the
employer perceives the study to be advantageous to the organization.
d. Unions may encourage employees to participate with the expectation that "entitlements" may follow
from study results
a. True
b. False
b. Written rules
d. Standards of care
38. The personal conviction that something is absolutely right or wrong in all situations is called:
a. Values
b. Morals
c. Ethics
d. standards of practice
39. Nurse's code of ethics is a set of ethical principles generally accepted by members of the profession.
The standard or principles that a nurse must observe in the practice should promote which duty?
a. Uses judgment in relation to individual competence when accepting and delegating responsibilities.
b. Plays a major role in determining and implementation of desirable standards of nursing practice.
d. Acts through professional organization and participates in establishing and maintaining equitable
social and economic working conditions in nursing.
40. Constraints can influence subject's voluntariness in situations related to informed consent. These
constraint least likely include:
a. Coercion
b. Exploitation
C. Undue violence
d. Significant trauma
A. Fidelity
b. Justice
c. Veracity
d. Confidentiality
a. Accountability
b. Responsibility
c. Nonmaleficence
d. Veracity
43. The one that promotes the philosophical and theological study of morality, moral judgments and
moral problems is called:
a. Values
b. Morals
c. Ethics
d. Standards of practice
44. A client is advised by the doctor to undergo chemotherapy. An informed consent is not yet signed.
This client requests information related to chemotherapy and the drugs that will be given to him. The
nurse explained the side effects of the medications, including the length of treatment and the prognosis
of the disease. The nurse answered all the questions of the client honestly even though the client may
choose not to undergo chemotherapy. The nurse in this situation is promoting:
a.Fidelity
b. Justice
c. Veracity or Honesty
d. Confidentiality
45. The nurse in a unit is caring for several clients. To distribute nursing care the nurse utilized the
principle of triage due to the limited availability of resources. The nurse is promoting which ethical
principle?
a. Fidelity
b. Justice
c. Veracity
d. Confidentiality
46. Nurses agree to be advocates for their patients. Practice of advocacy calls for the nurse to:
c. Assess the client's point of view and prepare to articulate this point of view.
a. The order is an error, violates hospital policy, or would be detrimental to the client.
48. Ethical dilemmas often arise over a conflict of opinion. Once the nurse has determined that the
dilemma is ethical, a critical first step in negotiating the difference of opinion would be to:
a. Consult a professional ethicist to ensure that the steps of the process occur in full.
b. List the ethical principles that inform the dilemma so that negotiations agree on the language of the
discussion.
C. Ensure that the attending physician has written an order for an ethics consultation to support the
ethics process.
49. In most ethical dilemmas, the solution to the dilemma requires negotiation among members of the
health care team. The nurse's point of view is valuable because
a. The nurse's code of ethics recommends that a nurse be present at any ethical discussion about client
care
b. The principle of autonomy guides all participates to respect their own self-worth
c. Nurses have a legal license that encourages their presence during ethical discussions
d. Nurses develop a relationship to the client that is unique among all professional health care
providers
50. Privacy and confidentiality of all client information is legally protected. In which of the following
situations would the nurse make an exception to this practice?
a. When the nurse decides that the family has a right to know the client's diagnosis
c. When a visitor insists that he has been given permission by the client
51. Which of the following is the best example of an ethical dilemma faced by the nurse?
a. Deciding the order in which staff members should take their breaks
b. Deciding whether or not to tell a client about the client's diagnosis
c. Deciding whether or not to ask another nurse to care for a very complex patient
52. An HIV+ gay, who is part of the ongoing research study in the nurse that the physician avoids
touching him. The nurse recognizes the physician's behavior suggests?
a. Prejudice
b. Stereotyping
C. Discrimination
d. Ethnocentrism
53. All but one is the principle as stipulated in the in the Belmont Report?
c. Exculpable language
d. Do no harm
a. A 17 yr. old student who is studying in a prestigious school and with good scholastic record
b. A pregnant woman who is in the labor room; upon LE-3 cms. c. A prisoner who is 25 yrs of age and
convicted with theft.
a. Parent/LAR must provide a signed informed consent b. Provide a signed assent from the subject
57. These are the methods as privacy from human subjects, except?
A. Interviewing the participant in their home or a private office instead of a public place
d. De-identifying photos, audio tapes, or videos tapes of the participant that will be made during the
study
a. A family member's consent for another individual may be sufficient, as long as community consent is
given
c. A prior permission and consent from the council within the locality is a must.
d. Community consent to participate in the research study is sufficient and no IRB approval is required
59. IRBS reviewing research in a different geographical location and/or cultural context have a
responsibility to
a. Defer to an IRB that is in the situated within the local research context
b. Ask specialists with direct knowledge of the local research context to participate in IRB
C. Obtain knowledge of the local context by talking to those who have traveled to the region
d. discussions
E. B or c
F. A or b
True
False
61. A 46-year-old woman is currently enrolled in a Phase 2 study of a drug for severe diabetic
neuropathy. While the study is on-going, a new drug becomes commercially available that may have
equal or greater benefit to the subject. The investigator should do which of the following, except?
a. Disclose this new information to the subject with other treatment options or alternatives
b. Discuss the pros and cons of both the investigational drug and the commercially available drug and
then withdraw the subject from the ongoing clinical trial.
c. Give the subject comprehensive information about the new drug, including its side effects.
d. Tell the subject about the new drug and allow him to decide whether to withdraw or to continue with
the ongoing 2 study.
62. A general requirement for the informed consent form is that it may not 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 statements in a consent form is an example of exculpatory language?
a. I waive any possibility of compensation for injuries that I may receive as a result of participation in
this research.
b. In the event of any injury you may have related to this research, you will be given medical treatment.
c. 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.
d. The investigator may stop you from participating in this research without your consent if you side
effects that make your condition worse. If you become ill during the research, you may have to drop out.
EXCULPATORY LANGUAGE/ ACCEPTABLE LANGUAGE
EL - 63. In the event that you suffer a research-related injury, your medical expenses will be your
responsibility or that of your third-party payer
EL - 64. By agreeing to this use, you are giving up all claims to any money obtained by the researchers
from commercial or other use of these specimens
AL - 65. I voluntarily and freely donate any and all blood, urine, and tissue samples to the name of
research institution) and hereby relinquish all property rights, title, and interest I may have in those
samples
EL - 66. By consenting to participate in this research, I give up any property rights I may have in bodily
fluids or tissue samples collected during this research.
EL - 67. Although the results of research, including your donated materials, may be patentable or have
commercial value, you will have no legal or financial interest in any commercial development resulting
from the research
EL - 68. I waive any possibility of compensation, including any right to sue, for injuries that I may receive
as a result of participation in this research
EL - 69. If you suffer a research-related injury, neither the institution nor the investigator can assume
financial responsibility or liability for the expenses of treatment for such injury.
EL – 70. Tissue obtained from you in this research may be used to establish a cell line that could be
patented and licensed. No financial compensation will be provided to you should this occur
AL - 71. By consenting to participate, you authorize the use of your bodily fluids and tissue samples for
the research described above
72. Katrina who is a research nurse is conducting a research on vulnerable subjects, she understands the
definition of vulnerable subjects if she states which of the following?
b. People who are at high risk of unintended side effects because of their circumstances
People who have no risk of unintended side effects because of their healthy bodies
d. People who are capable of giving consent for the participation of others.
73. A nurse can obtain an assent of child who is capable of understanding the basic concepts of an
informed consent for
a. Respect of the child's right to self determination
74. Nurse Myka is conducting a research involving institutionalized people. She feels that the people are
forced to participate in the study even though there's a slight resistance. Which of the following can she
do?
a. Emphasize that the study has been tested in mice first and has been proven safe.
b. Emphasize that the study is voluntary and they may opt not to participate.
C. Emphasize that the researchers will ensure that their healthcare will be continued.
d. Emphasize that the study is completely under her control and no one will be harmed.
75. A patient is severely ill, before obtaining the consent of the patient, which of the following must a
nurse do?
76. A pregnant patient went to nurse Justine and forces him to put her on the list of the participants of a
research. Upon knowing that the study has not been proven safe for pregnant women, which of the
following must nurse Mike do?
d. Tell her that she cannot be involved unless the risks to the woman and her child are minimal.
77. A nurse is caning for a 12-year-old child, she was tasked to ask for the patient's assent. She needs
further teaching if she states which of the following?
C. Even though a parent's or guardian's consent is already obtained, an assent is necessary for a child
to be allowed in a study
d. A parent's consent has the final say even with the presence of an assent.
a. Pregnant women
B.Prisoners
C.Cancer patients
d. Healthy Adults
79. The following can give a consent to a child's participation in a study except:
80. For mentally disabled people to legally participate in a research, which of the following should be
obtained?
a. Providing equal access to health care for all patients regardless of their social status
b. Providing individualized care for each patient according to their needs and preferences
c. Providing compassionate care for all patients regardless of their diagnosis or prognosis
b. A situation where nurses have doubts or uncertainties about the ethical course of action
c. A situation where nurses have to choose between two or more conflicting ethical principles or
values
d. A situation where nurses are unable to make ethical decisions due to lack of knowledge or experience
83.Which of the following is a potential benefit of using virtue ethics in nursing practice?
a. Qualitative research
b. Genetics research
85. "Above all, do no harm". This principle encompassed in the ethical dimension of;
a. Human dignity
B.Justice
C.Beneficence
d. Anonymity
86. All are the approval criteria in determining for the IRB/EC that research to human subjects is
conducted, except;
87. Ethics Committee that assesses that ethical standards are met, which of the following is an excluded
criterion
b. One non-scientific member and one member from outside the institution
d. Responsible for protecting subjects from undue risk and loss of personal rights and dignity
88. It refers the use of the best scientific evidence, integrated with clinical experience and incorporating
patient values and preferences in the practice of professional nursing care.
a. External Validity
b. Evidence-based practice
c. Research Process
a. Clinical Experience
b. Patient Preferences
c. Due Diligence
90. Which of the following statement that the nurse understands when an assent form is to be
administered to the potential subject:
a. "I have read all of this Information Sheet and Assent Form or, if I cannot read, the study team has read
it and explained it to me."
c. "All of my questions have been answered and I am satisfied with the answers I received. I know that I
can ask questions later if I have any."
91. According to Declaration of Helsinki, physicians are deprived to use an unproven intervention.
a. True
b. False
92. If a researcher determines that his/her study poses no more than minimal risk as there is a need for
the protocol to have IRB review and approval.
A. True
B. False
93. The Belmont Report says that the distinction between research and practice should be harmonized
and ethical consideration must be respected at all times.
a. True
b. False
94. It refers to an individual or judicial or other body authorized under applicable law to consent on
behalf a prospective subject to the subject's participation in the procedure(s) involved in the researchers
A. Impartial Witness
C.Advance Directive
d. An IRB Chairman
95. He established the use of the scientific method in medicine, dismissed several previous
misconceptions, questioned common presumptions, and relied on experimentation. Unlike most of his
contemporaries, he insisted that all living creatures were bound by the sane laws as inanimate matter
a. Walter Reed
b. Edward Jenner
c .Claude Bernard
d. Louis Pasteur
96. An experiment without oxygen at a [simulated] height of 12 kilometers [39,283 feet] conducted on a
37- year-old Jew in good general condition
a. High-altitude experiment
b. Stenlization Experiment
d. Hypothermia Experiment
97. Is a principle outlined in the Belmont Report that requires researchers that subjects, to the degree
that they are capable, be given the opportunity to choose what shall or shall not happen to them.
a. Beneficence
c. Justice
d. Lack of deception
a. Has reached the legal age to provide informed consent in the State.
b. Is willing to accept certain risks if the research will benefit others in the future.
c. Understands the risks and benefits of his or her participation and is able to make a voluntary
decision adequate information is provided.
d. Meets all eligibility criteria for a study and asks the investigator if she or he may participate.
b. Consideration of risks and potential benefits for the fetus and the pregnant woman.
b. They indicate what the researcher ought to do and how they should treat people