ANS: A, B, D

A breach of confidentiality can occur when a researcher, by accident or direct action, allows
an unauthorized person to gain access to the study raw data. Confidentiality can also be
breached in the reporting or publication of a study when a subject’s identity is accidentally
revealed, violating the subject’s right to anonymity. Breaches of confidentiality can harm
subjects psychologically and socially, as well as destroy the trust they had in the researchers.
Breaches of confidentiality can be especially harmful to a research participant if they involve
(1) religious preferences; (2) sexual practices; (3) employment; (4) racial prejudices; (5) drug
use; (6) child abuse; and (7) personal attributes, such as intelligence, honesty, and courage.

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7. An improvement in research ethics could prevent some or all of which of the following?
(Select all that apply.)
a. Breaches of anonymity
b. Researchers’ failures to report their funding sources in publications
c. Minimal risk to research participants
d. Unauthorized data collection
e. Patients’ inability to understand complex research designs
ANS: A, B, D
Ethical research is essential to generate sound knowledge for practice. The ethical conduct of
research has been a focus since the 1940s because of the mistreatment of human subjects in
selected studies. Human rights are claims and demands that have been justified in the eyes of
an individual or by the consensus of a group of individuals. Having rights is necessary for the
self-respect, dignity, and health of an individual. The human rights that require protection in
research are (1) self-determination, (2) privacy, (3) anonymity and confidentiality, (4) fair
treatment, and (5) protection from discomfort and harm. Although Institutional Review
Boards exist to protect patient rights, this is not a reason that research ethics are essential.
Results published in professional journals do not represent a violation of privacy, if the
researcher has attended to ethical mandates.

DIF: Cognitive Level: Synthesis REF: Page 159

8. In order for consent to be voluntary, which must occur? (Select all that apply.)
a. The subject must sign a consent form.
b. The subject cannot be mentally incompetent.
c. The subject cannot be shamed, forced, or cajoled into participation.
d. The subject cannot be paid (remunerated), because this would be coercive.
e. The researcher must confirm that the person signing the consent form truly
understands what the research will involve.
ANS: C, E
 Voluntary consent means that the prospective subject has decided to take part in a study of his
or her own volition without coercion or any unique influence. Voluntary consent is obtained
after the prospective subject has been given essential information about the study and has
shown comprehension of this information. In some studies, the consent form may be replaced
by oral consent or the consent form may be used but the subject’s signature is waived. A
person who is mentally incompetent or incapacitated may be a research subject, but his or her
legal representative must consent for participation. If an individual is judged incompetent and
incapable of consent, the researcher must seek approval from the prospective subject and his
or her legally authorized representative. It is the researcher’s responsibility to confirm that the
person signing the consent form truly understands what the research entails. Sometimes
nursing studies have included a small financial reward of $10 to $30 or support for
transportation to increase participation, but this would not be considered coercive.

DIF: Cognitive Level: Analysis REF: Page 180

9. Which of these statements concerning guidelines for consenting children for research
participation are true? (Select all that apply.)
a. No infant or child may be used in research if he or she refuses treatment.
b. Emancipated minors may consent for themselves.
c. Coercion is wrong, but begging a child to participate is acceptable.
d. An 11-year-old should be asked to assent for research participation.
e. If infants and children participate in research, they should sign a consent form.
f. Infants cannot refuse to participate in research if their parents consent.
ANS: B, D, F
The unique vulnerability of children makes the decision to include them as research subjects
particularly important. To safeguard their interests and protect them from harm, special ethical
and regulatory considerations have been put in place for research involving children.
However, the laws defining the minor status of a child are statutory and vary from state to
state. Often a child’s competency to consent is governed by age, with incompetence being
nonrefutable up to age 7 years. Thus, a child younger than 7 years is not believed to be mature
enough to assent or consent to research. A child 7 years or older with normal cognitive
development can provide assent or dissent to participation in a study, and the process for
obtaining the assent should be included in the research proposal. To obtain informed consent,
federal regulations require both the assent of the children (when capable) and the permission
of their parents or guardians. An infant is not capable of speech or of understanding the
purpose of a research study.

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10. The Tuskegee study was ethically objectionable because informed consent was flawed, an
available treatment was not provided, and deception was practiced. If informed consent had
been properly administered and research subjects informed of the availability of penicillin
when it became available, why would this still represent an ethically objectionable study?
(Select all that apply.)
a. The researcher has an obligation to actively do good for the research subjects;
merely informing them of the availability of penicillin would not have been
sufficient to meet this obligation.
b. It took place in one state of the Union and so had limited generalizability.
c. Some of the research subjects were illiterate and could not provide consent.
 d. There was no need for the study to be performed in the first place, since enough
was known about syphilis at the time.
e. Since African American men in Alabama were in an inferior social position, they
constituted an underrepresented and potentially vulnerable population; every effort
should have been made to include participants from other ethnic groups.
ANS: A, E
In 1932, the U.S. Public Health Service (U.S. PHS) initiated a study of syphilis in black men
in the small rural town of Tuskegee, Alabama. The study, which continued for 40 years, was
conducted to determine the natural course of syphilis in the adult black male. The research
subjects were organized into two groups: one group consisted of 400 men who had untreated
syphilis and the other consisted of a control group of 200 men without syphilis. Many of the
subjects who consented to participate in the study were not informed about the purpose and
procedures of the research. Some individuals were unaware that they were subjects in a study.
The subjects were examined periodically but were not treated for syphilis, even after penicillin
was determined to be an effective treatment for the disease in the 1940s. There was
insufficient knowledge about the natural course of syphilis at the time the study was begun.
Consent of illiterate subjects does not prohibit consent. Single-site research is not considered
ethically objectionable per se.

DIF: Cognitive Level: Analysis REF: Page 180

11. A researcher obtains consent from a person with a recent traumatic brain injury (TBI) to
observe the person and test her at intervals, using cognitive survey instruments. The person
has not yet regained the ability to speak, and can understand and obey only simple commands.
She nods yes, and shakes her head for no. The subject’s husband, who has the authority to
consent for his wife because he has legal power of attorney for health care, is consented for
the study, and the patient is asked to assent.. Does this fulfill the requirements for consenting
someone with diminished capabilities? Why or why not? (Select all that apply.)
a. Yes, it does.
b. No, it does not.
c. The subject should have been told the purpose of the study over and over again,
and the tests the researcher planned to administer, until the subject nodded that she
understood. Her husband should not make this decision for her.
d. The researcher must obtain consent from both the legal representative and the
subject.
e. The researcher need not obtain assent for research involving persons with
decreased ability or total inability to give informed consent. The subject will
probably not remember any of this later, anyhow.
f. The subject should have been asked to consent, and the husband to assent. That is
the proper procedure.
g. The prospective subject can understand only simple commands but, because of her
TBI, she is not competent to consent.
h. The subject is asked to assent in case she has an opinion about this and might
understand the purpose of the study. Eliciting her cooperation is wise in either
case.
ANS: A, G, H
 Some persons have diminished autonomy or are vulnerable and less advantaged because of
legal or mental incompetence, terminal illness, or confinement to an institution (Fry et al.,
2011). These persons require additional protection of their right to self-determination, because
they have a decreased ability, or an inability, to give informed consent. In addition, these
persons are vulnerable to coercion and deception. Neonates and children (minors), the
mentally impaired, and unconscious patients are legally or mentally incompetent to give
informed consent. They should, however, be asked to assent, since their cooperation is
essential for high-quality data collection. If an individual is judged incompetent and incapable
of consent, the researcher must seek approval from the prospective subject and his or her
legally authorized representative.

DIF: Cognitive Level: Analysis REF: Page 165

12. In the Jewish Chronic Disease Hospital Study, 22 patients were injected—unknowingly—with
a suspension containing live cancer cells that had been generated from human cancer tissue.
What ethical principles apply here? (Select all that apply.)
a. Beneficence
b. Self-determination
c. Anonymity
d. Confidentiality
e. Fair treatment
ANS: A, B, E
A highly publicized example of unethical research was a study conducted at the Jewish
Chronic Disease Hospital in the 1960s. Its purpose was to determine the patients’ rejection
responses to live cancer cells. Twenty-two patients were injected with a suspension containing
live cancer cells that had been generated from human cancer tissue. An extensive investigation
of this study revealed the patients were not informed that they were taking part in research or
that the injections they received were live cancer cells. In addition, the Jewish Chronic
Disease Hospital Institutional Review Board never reviewed the study; even the physicians
caring for the patients were unaware that the study was being conducted. In addition, the
principle of beneficence requires the researcher to do good and “above all, do no harm.”

DIF: Cognitive Level: Application REF: Page 162

13. Monica is a nurse researcher. She completes her paperwork for an institutional review board
(IRB). Her application for approval is returned to her, with comments as to how it should be
revised and resubmitted. Which of the following comments are within the scope of the IRB?
(Select all that apply.)
a. “You have failed to provide a copy of your survey. Please do so.”
b. “Your study protocol does not provide information on potential risks to anonymity.
Please indicate this in Section 1g.”
c. “Because of inexperience in this area, the IRB invites you to meet with us as one
of the reviewers of this protocol.”
d. “We can only provide provisional approval of your study.”
e. “You have not included information about the risk-to-benefit ratio of this research.
Please do so.”
ANS: A, B, E
 An institutional review board (IRB) is a committee that reviews research to ensure that the
investigator is conducting the research ethically. Universities, hospital corporations, and many
managed care centers have IRBs to promote the conduct of ethical research and protect the
rights of prospective subjects at these institutions. Each IRB has at least five members of
various backgrounds (cultural, economic, educational, gender, racial) to promote a complete,
scholarly, and fair review of research that is commonly conducted in an institution. If an
institution regularly reviews studies with vulnerable subjects, such as children, neonates,
pregnant women, prisoners, and mentally disabled persons, the IRB should include one or
more members with knowledge about and experience in working with these individuals. The
members must have sufficient experience and expertise to review a variety of studies,
including quantitative, outcomes, intervention, and qualitative research (Munhall, 2012b). The
IRB members must not have a conflicting interest related to a study conducted in an
institution. Any member having a conflict of interest with a research project being reviewed
must excuse himself or herself from the review process, except to provide information
requested by the IRB. In reviewing the research, the reviewers may exercise all of the
authorities of the IRB such as require revision of a study protocol or study documents and
disapproval of the research. The IRB reviews research in progress at least yearly.

DIF: Cognitive Level: Application REF: Page 183

14. Which of the following statements are true? (Select all that apply.)
a. HIPAA regulations were formulated to address ethical treatment of research
subjects.
b. If electronic medical records had not been invented, HIPAA would not have been
necessary.
c. Data held by health insurance companies sparked the emergence of HIPAA.
d. Ethics and HIPAA regulations overlap in the area of justice.
e. Ethics and HIPAA regulations overlap in the area of anonymity.
ANS: B, C, E
One of the more recent regulations, the Health Insurance Portability and Accountability Act
(HIPAA), was enacted in 2003 to protect the privacy of an individual’s health information and
was necessitated by the electronic storage and exchange of health information. The principle
of justice holds that human subjects should be treated fairly. Anonymity exists if the subject’s
identity cannot be linked, even by the researcher, with his or her individual responses.

DIF: Cognitive Level: Synthesis REF: Page 159

15. Research articles may be considered fraudulent in which of the following instances? (Select
all that apply.)
a. The person who designed the study and performed all of the research is not
mentioned as an author.
b. The authors hired someone other than themselves to collect, analyze, and interpret
the data.
c. Graduate students collected the data but did not analyze it.
d. A statistician was hired to perform all of the statistical tests.
e. Both quantitative and qualitative results were reported in the same article.
f. The authors used another researcher’s raw data without permission.
ANS: A, B, F