Deck 9: Ethics in Research

Question 1

A researcher is applying for Institutional Review Board (IRB) approval, and the form specifies that the researcher indicate the probable level of risk. The research creates situations in which the participants, registered nurses, are placed in unusual code-like situations in which they do not know what action to take, and actors play the parts of other healthcare providers. The participants are then asked to describe their feelings in the scenarios, and their levels of confidence as they go through 15 scenarios. What level of risk does this study pose?

A)No anticipated effects
B)Temporary discomfort
C)Unusual discomfort
D)Risk of permanent harm

Answer 1

Temporary discomfort

Question 2

A researcher is applying for a grant renewal, on the topic of a promising new treatment for liver cancer. The researcher's group has used the treatment for 13 participants. The results, 9 responded and 4 did not, are not statistically significant. However, if the researcher entered each patient as three different people and reported the results as 27 responded and 12 did not, the results would be statistically significant. If the researcher chose to do this, what would it represent?

A)Beneficence
B)Fabrication
C)Falsification
D)Plagiarism

Answer 2

Fabrication

Question 3

An Institutional Review Board (IRB) assures that (1) the rights and welfare of the individuals involved are protected, (2) appropriate methods are used to secure informed consent, and (3) potential benefits of the investigation are greater than the risks. Which is an example of how the IRB determines the level of potential risk?

A)It requires the researcher to provide a list of potential benefits to the clients and the results of a pilot study verifying this.
B)It compels the researcher to disclose the researcher's consenting process.
C)It provides for a supervisor from IRB to be present for all data collection.
D)It reviews the researcher's description of the study's potential risks and compares them with everyday risk.

Answer 3

It reviews the researcher's description of the study's potential risks and compares them with everyday risk.

Question 4

A researcher receives permission to use the information in a hospital data set, without patient identifiers. What level of participant consent is required?

A)Partial: the participants must all be notified that their data are being reused.
B)None.
C)Partial: the participants must all be notified if the results are published.
D)Full: all participants must be contacted and must agree to have their data used.

Question 5

A researcher is applying for renewal of a large federal grant, without which his very promising research on panic disorder cannot continue. He is completing renewal forms, which include a synopsis of his results, to date. If he excludes two of the participants with very severe panic disorder and three with mental health disorders of another kind, the results are statistically significant. He writes the report and does not mention the five participants he excluded. What word best describes this researcher's actions?

A)Beneficence
B)Fabrication
C)Falsification
D)Plagiarism

Question 6

A researcher who is also a university professor is performing a multi-site study, in which on-site interviews are conducted with nurses in five hospitals in a major city. Each hospital has an Institutional Review Board (IRB). From how many institutional review boards or committees must the researcher obtain permission to conduct the study?

A)Six-each of the five hospitals, and the university
B)One-only the university
C)Five-only the hospitals
D)None-educational research is exempt from review

Question 7

A graduate student receives a mailed survey packet asking the student to participate in research about unpleasant experiences in graduate school. The student is asked to return the survey, with the statement, "Return of this instrument implies consent." Why does this constitute consent?

A)Studies like this are exempt from institutional review board oversight, so consent is not required.
B)Not returning the survey constitutes refusal, and participants may indeed refuse by not completing the survey. The opposite is equally true.
C)The study is anonymous, so there is no risk of disclosure.
D)Only interventional research requires consent.

Question 8

The right an individual has to receive treatment even if that individual decides not to participate in the research best defines which human right?

A)Beneficence
B)Justice
C)Privacy
D)Respect

Question 9

In what way could the researchers in the Willowbrook study have designed their research on the hepatitis virus so that it was ethically acceptable?

A)The researchers could have given each participant a chance to assent.
B)The researchers could have performed their study on persons who were capable of full assent.
C)The researchers could have made the study available at many institutions for the mentally retarded.
D)The researchers could have performed descriptive research on persons already infected with hepatitis.

Question 10

Both the participant in the experimental group who receives an experimental treatment and the participant in the control group who receives the control treatment are considered to be participants in therapeutic research. Why is this?

A)A patient in an experimental research study who elects to be a member of the experimental group knows he or she will be receiving the experimental treatment.
B)Each patient who is consented to be a research participant in an experimental study, in which the treatment has potentially beneficial results, has the potential to receive a therapeutic intervention.
C)The research is designed to measure the effect of the therapeutic treatment, as compared with the usual therapeutic treatment; hence, this is therapeutic research.d.Each participant is blind to treatment.

Question 11

In a study of outpatients experiencing panic attacks, a researcher was working in a busy clinic waiting room and left his computer unattended while consenting a new study participant. A transcription of a patient interview was displayed, and at the end of the transcription were 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 the room, he found an adult patient playing a video game on the computer. This best describes an example of a violation of which human right?

A)Protection from the harm of exposure
B)Security
C)Confidentiality
D)Privacy

Question 12

A physician is conducting research on a new and promising chemotherapy treatment for breast cancer that improves survival and decreases adverse symptoms. Sixty participants will be recruited; of these, thirty will be assigned to the experimental group, receiving the new treatment, and thirty to the control group, receiving the usual chemotherapy. The physician's wife, newly diagnosed with breast cancer, is randomly assigned to the control group; he removes her from the control group and places her in the experimental group. What ethical violation has occurred?

A)The physician's wife has a right to self-determination: her husband has decided her group assignment for her.
B)The physician has no right to know anything about his wife's breast cancer: this is a violation of confidentiality.
C)The physician's wife shouldn't be a member of the study: it's a conflict of interest.
D)The physician's wife has no right to be included in the experimental group: it unfairly excludes someone else from this special benefit.

Question 13

A master's student knows next to nothing about Maslow's theory related to hierarchy of needs but, on an advisor's recommendation, decides to use it as a theoretical framework for the student's thesis. The student goes online and finds a Wikipedia page, copying the description of Maslow's theory verbatim, putting a citation at the end of the paragraph, but not using quotation marks. What word best describes this master's student's actions?

A)Beneficence
B)Fabrication
C)Falsification
D)Plagiarism

Question 14

A researcher working for Google collects data on fair treatment in the workplace. She attempts to attach one of the raw data forms to an e-mail message to herself, so that she 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 study participants, coincidentally, have an identical opinion about fair treatment in the workplace. This best describes an example of a violation of which human right?

A)Confidentiality
B)Fair treatment
C)Protection from harm
D)None of these-no ethical violation occurred because the two participants share a point of view.

Question 15

What specific area of ethics does the Health Insurance Portability and Accountability Act (HIPAA) address?

A)Privacy
B)Justice
C)Coercion to participate in a research study
D)Informed consent

Question 16

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 later are published. The research participants are allowed to listen to the tapes of what the men said 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 participants.
D)What is said under hypnosis may not be true.

Question 17

To take positive action to prevent any harm to the research participants best defines which ethical principle?

A)Beneficence
B)Justice
C)Privacy
D)Respect

Question 18

A master's student knows next to nothing about Maslow's theory related to hierarchy of needs but, on an advisor's recommendation, decides to use it as a theoretical framework for the student's thesis. The student goes to the library and accesses an old master's thesis that also uses the theory and copies three pages, word for word. This student uses the other student's reference to Maslow's work. What word best describes this master's student's actions?

A)Beneficence
B)Fabrication
C)Falsification
D)Plagiarism

Question 19

The right an individual has to be told that he is a potential participant in a research study and may decide not to be so best defines which human right?

A)Beneficence
B)Justice
C)Privacy
D)Self-determination

Question 20

A patient in a research study will receive either the customary medication to treat the patient's metastatic colon cancer or a new medication that has shown better results in animal studies and in one small study with humans. This is what kind of research?

A)Coercive research
B)Correlational research
C)Therapeutic research
D)Dangerous research

Question 21

In order for consent to be voluntary, which must occur?

A)The participant must sign a consent form.
B)The participant cannot be mentally incompetent.
C)The participant cannot be shamed, forced, or cajoled into participation.
D)The participant will not 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.

Question 22

Why are vulnerable populations considered vulnerable? To what are they vulnerable?

A)Physical harm because of a preexistent mental or physical condition
B)The possibility of being assigned to the experimental group
C)Unethical researchers
D)Coercion
E)Diminished autonomy because of an impaired ability to consent

Question 23

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?

A)Beneficence
B)Self-determination
C)Anonymity
D)Confidentiality
E)Fair treatment

Question 24

A breach in confidentiality occurs. Which of the following represent a breach in confidentiality?

A)The teenaged son of a researcher reads some of the raw interview data on the researcher's computer.
B)The researcher accidentally includes the real names of one participant's husband and two daughters in the finished article, instead of changing these to pseudonyms.
C)A researcher presents her findings at a research conference.
D)A tape of a research interview is misplaced in the researcher's home, and is never found.
E)The researcher mentions to a colleague that all of the participants in a recent research project on anger were divorced women.

Question 25

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 participant's husband 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?

A)Yes, it does.
B)No, it does not.
C)The participant should have been told the purpose of the study over and over again, and the tests the researcher planned to administer, until the participant 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 participant.
E)The researcher need not obtain assent for research involving persons with decreased ability or total inability to give informed consent. The participant will probably not remember any of this later, anyhow.
F)The participant should have been asked to consent, and the husband to assent. That is the proper procedure.
G)The prospective participant can understand simple commands but, because of her TBI, she is not competent to consent.
H)The participant 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.

Question 26

How would a professor who wants to have his students provide data for a research study go about doing that, without involving coercion?

A)Mention that participation provides extra points.
B)Have a research assistant consent all participants and collect all data.
C)Offer extra points to the whole class if 50% of them act as participants.
D)Open the study to all students on campus and provide nonacademic incentives.

Question 27

A researcher conducts a mixed methods study on exercise as a modality of controlling hyperglycemia. The study has both quantitative results, describing the amount that glucose falls with various amounts of exercise, and qualitative results, describing participants' mood and sense of well-being with different kinds of exercise. The researcher decides to publish an article based on the quantitative findings immediately but wait to publish the qualitative results later. What are the reasons that this would not be an instance of researcher misconduct?

A)The data from the quantitative part of the study are reported completely and honestly.
B)The journal does not accept qualitative research.
C)Both "arms" of the study are free-standing: reporting only the quantitative results does not misrepresent the findings.
D)Nobody will know that a qualitative study was performed.
E)No denial of the full scope of data collection is made.

Question 28

Thuy is a nurse researcher. She completes her paperwork for the 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?

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
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.”

Question 29

From an ethical point of view, what is the point of determining that a potential research participant is incompetent?

A)An incompetent participant must receive more extensive explanation before consenting to participate in research.b.According to HIPAA, a different level of records security must ensue.
C)Inclusion of the participant necessitates a different consenting process.
D)The researcher has a responsibility to exclude all incompetent persons from research participation.

Question 30

A nurse plans to interview prisoners as part of the nurse's master's thesis on treatment of health problems in correctional institutions. What special measures must the nurse take before studying these potential participants?

A)Justify to an Institutional Review Board why the nurse must use prisoners as participants.
B)Devise a consent process that provides for a conservator's signature.
C)Destroy all of the nurse's records.
D)Devise interview questions that avoid any mention of prisons or prisoners.
E)Bracket the nurse's previous beliefs about prisoners.
F)Assure that the consent process involves no coercion.

Question 31

Why are research ethics essential?

A)Research participants must be protected from accidental disclosure of information.
B)Institutional Review Boards exist to protect patient rights.
C)Researcher misconduct may result in dissemination of potentially harmful results.
D)Results published in professional journals represent a clear violation of privacy.
E)Research participants must be protected from deliberate violation of their rights.

Question 32

Which of these statements concerning guidelines for consenting children for research participation are true?

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.

Question 33

Research articles may be considered fraudulent in which of the following instances?

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.

Question 34

An improvement in research ethics could prevent some or all of which of the following?

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

Question 35

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 participants informed of the availability of penicillin when it became available, why would this still represent an ethically objectionable study?

A)The researcher has an obligation to actively do good for the research participants; merely informing them of the availability of penicillin would not have been sufficient to meet this obligation.
B)The research took place in one state of the Union and so had limited generalizability.
C)Some of the research participants 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 black 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.

Question 36

Which one of the following are considered vulnerable populations, from an ethical point of view?

A)Students
B)Persons with osteoporosis who are subject to hip fracture
C)Persons who are depressed
D)Prisoners
E)Persons who have recently suffered loss of a spouse

Question 37

Which of the following statements are true?

A)HIPAA regulations were formulated to address ethical treatment of research participants.
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.