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
 Editors of journals have a major role in monitoring and preventing research misconduct in the
published literature. Friedman identified criteria for classifying a publication as fraudulent,
questionable, or valid. According to these criteria, research articles were classified as
“fraudulent if there was documentation or testimony from coauthors that the publication did
not reflect what had actually been done.” Articles were questionable if no coauthor could
produce the original data or if no coauthor had personally observed or performed each phase
of the research or participation. A research article was considered valid “if some coauthor had
personally performed or participated in each aspect of the research and publication.”

DIF: Cognitive Level: Evaluation REF:

MULTIPLE CHOICE

1. A research study offers elderly men who have, in the past, been prison inmates $1,500 for
participation in an all-day workshop at which they agree to be hypnotized and tell stories of
incarceration, which are later published. The research participants are allowed to listen to the
tapes of what they say under hypnosis and to withdraw permission to use any part of the
information. Why is this scenario a violation of self-determination?
a. Allowing participants to withdraw permission to use part of the research
information violates the study integrity and represents deception.
b. It is an example of coercion.
c. Prisoners are a vulnerable population and should not be used as research subjects.
d. What is said under hypnosis may not be true.
ANS: B
The right to self-determination is based on the ethical principle of respect for persons. This
principle holds that because humans are capable of self-determination, or controlling their
own destiny, they should be treated as autonomous agents who have the freedom to conduct
their lives as they choose without external controls. A subject’s right to self-determination can
be violated through the use of (1) coercion, (2) covert data collection, and (3) deception.
Coercion occurs when an overt threat of harm or excessive reward is intentionally presented
by one person to another to obtain his or her compliance. In the example, offering elderly men
$1,500 for one day could be considered offering an excessive reward: therefore, it is an act of
coercion violating the human right to self-determination.

DIF: Cognitive Level: Analysis REF: Page 164

2. A researcher working for Google collects data on fair treatment in the workplace. He attempts
to attach one of the raw data forms to a message to himself, so that he can finish the data
analysis at home that evening, but accidentally sends it to another employee who had provided
data for the study. The two employees, coincidentally, have an identical opinion about fair
treatment in the workplace. This best describes an example of a violation of which of the
following human rights?
a. Confidentiality
b. Fair treatment
c. Protection from harm
d. None of these—no ethical violation occurred, because the two subjects share a
point of view.
ANS: A
 Confidentiality is the researcher’s management of private information shared by a subject that
must not be shared with others without the authorization of the subject. In the example,
sending one research subject the raw data of a different subject is a direct breach of
confidentiality. A breach in confidentiality can occur when a researcher, by accident or direct
action, allows an unauthorized person to gain access to raw study data. The right to fair
treatment is based on the ethical principle of justice. This principle holds that each person
should be treated fairly and should receive what he or she is due or owed. The right to
protection from discomfort and harm is based on the ethical principle of beneficence, which
holds that one should do good and, above all, do no harm.

DIF: Cognitive Level: Application REF: Page 172

3. In a study of outpatients experiencing panic attacks, a researcher was working in a busy clinic
waiting room and left his computer to consent a new study participant. A transcription of a
patient interview was displayed, and at the end of the transcription was the patient’s medical
record number and a list of medications currently taken. The researcher had not closed down
the screen, and when he returned to his computer, he found an adult patient playing a video
game on the computer. This best describes an example of a violation of which of the
following human rights?
a. Protection from the harm of exposure
b. Security
c. Confidentiality
d. Privacy
ANS: D
Privacy is an individual’s right to determine the time, extent, and general circumstances under
which personal information will be shared with or withheld from others. This information
consists of one’s attitudes, beliefs, behaviors, opinions, and records. The Privacy Act of 1974
provided the initial protection of an individual’s privacy. Because of this act, data collection
methods were to be scrutinized to protect subjects’ privacy, and data cannot be gathered from
subjects without their knowledge. Individuals also have the right to access their records and to
prevent access by others. The intent of this act was to prevent the invasion of privacy that
occurs when private information is shared without an individual’s knowledge or against his or
her will. Invading an individual’s privacy might cause loss of dignity, friendships, or
employment or create feelings of anxiety, guilt, embarrassment, or shame. The HIPAA
Privacy Rule expanded the protection of an individual’s privacy, specifically his or her
protected individually identifiable health information, and described the ways in which
covered entities can use or disclose this information. De-identifying health data involves
removing 18 elements that could be used to identify an individual. An important one on this
list is the individual’s medical record number. In the example, the researcher’s use of an
actual patient identification number on a transcription risks the human right to privacy; a code
number should have been used instead.

DIF: Cognitive Level: Application REF: Page 169

4. Ellen is a participant in a research study. She will receive either the customary medication to
treat her metastatic colon cancer or a new medication that has shown better results in animal
studies and one small human study. This is _____ research.
a. Coercive
b. Correlational