Ch 4 Examining Ethics in Nursing Research

33. A descriptive comparative study of blood vessel structures of placentas obtained at delivery from women who had pregnancy-induced hypertension to those of women who were normotensive through pregnancy would be an example of what level of IRB review? a. Expedited review b. Exempt from review c. Full review d. Final review

ANS: A Studies may meet the criteria to receive an expedited review if they carry some risks. Studies that are exempt from IRB review pose no apparent risks to the research subjects. A study that carries greater than minimal risks must receive a full review by an IRB during a convened meeting. Final review is not one of the three levels of IRB review.

16. When obtaining informed consent from study subjects, the researcher will ensure that subjects freely choose whether or not to participate and will provide subjects a. general knowledge and overview of the study. b. information about the study methods and design. c. reports about the study results and conclusions. d. the right to choose whether to be in the control versus the study group.

ANS: A Informed consent includes disclosure to the subject of essential study information, comprehension of this information by the subject, competence of the subject to give consent, and voluntary consent of the subject to participate in the study. Information on the study design is given only as it applies to what will happen to the subject. It is not necessary to provide reports about the study results and conclusions as part of gaining informed consent. Subjects are generally randomly assigned to control versus study groups and choice of placement is not a part of informed consent.

11. The greatest risk to a person confined to an institution who is a research subject is a. diminished autonomy. b. discomfort. c. lack of information. d. lack of privacy.

ANS: A Persons who are vulnerable because of legal or mental incompetence, terminal illness, or confinement to an institution have diminished autonomy. They are not necessarily at higher risk for discomfort, lack of information, or lack of privacy than are other subjects. They are not necessarily at higher risk for discomfort, lack of information, or lack of privacy than are other subjects. They are not necessarily at higher risk for discomfort, lack of information, or lack of privacy than are other subjects.

2. An important initial focus of the Declaration of Helsinki, developed in 1964, was to a. differentiate therapeutic from nontherapeutic research. b. define the concept of informed consent of research subjects. c. prevent the use of placebos during clinical drug trials. d. prohibit nontherapeutic research to protect subjects from harm.

ANS: A The Declaration of Helsinki was adopted in 1964 and its major focus was to differentiate between therapeutic research and nontherapeutic research. The Nuremberg code helped to define the concept of informed consent of subjects. The Declaration of Helsinki did not prevent the use of placebos, but declared that researchers must provide subjects in the placebo group with access to proven diagnostic and therapeutic procedures after the study. The Declaration of Helsinki did not prohibit nontherapeutic research, but developed guidelines to address issues with this type of research.

7. Which ethical principle protects human subjects from harm? a. Beneficence b. Ethics c. Justice d. Respect for persons

ANS: A The ethical principle of beneficence encourages the researcher to do good and to "do no harm." Ethics is not a specific ethical principle. The principle of justice addresses the fair treatment of human subjects. The principle of respect for persons indicates that human subjects should be treated as autonomous agents with rights to self-determination.

2. According to the HIPAA privacy rules, which are covered entities that may use and disclose a limited data set to researchers for study? Select all that apply. a. Health plans b. Healthcare providers c. Institutional Review Boards d. Researchers

ANS: A, B Healthcare providers, health plans, and healthcare clearinghouses are covered entities. Institutional Review Boards and researchers are not correct statements.

6. A researcher has submitted a proposal to an Institutional Review Board (IRB) to evaluate the effects of a new drug on newborn infants. In this case, members of the IRB should include: Select all that apply. a. an ethicist. b. a hospital pharmacist. c. a neonatologist. d. a pharmaceutical representative.

ANS: A, B, C When selecting an IRB, there must be at least five members of varying backgrounds to promote a complete, scholarly, and fair review of research. When vulnerable subjects such as newborns are part of a study, at least one member must have knowledge and experience in working with these subjects. A neonatologist and a hospital pharmacist would both be included in this case. All IRBs must have an ethicist, lawyer, or minister whose primary concern is nonscientific. A pharmaceutical representative would have a conflict of interest in promoting the drug

MULTIPLE RESPONSE 1. Which patient information requires de-identifying to maintain privacy? Select all that apply. a. E-mail addresses b. Full-face photographs c. State of residence d. Medical record numbers

ANS: A, B, D E-mail addresses, full-face photographs, and medical record numbers may all be used to identify patients and must be de-identified in study reports to prevent linking study results to individuals. The state of residence is not necessarily an identifier, but any geographic division smaller than a state is.

5. A researcher wants to study whether showing a video about car safety increases the likelihood of car seat use among a group of first-time parents. When obtaining informed consent, the researcher must include: Select all that apply. a. an assurance of anonymity. b. a statement of the research purpose. c. consent to incomplete disclosure. d. voluntary participation.

ANS: A, C, D Anonymity and voluntary participation must be assured in all research involving human subjects. In this study, parents who know ahead of time that the purpose is to see whether car seat use is increased may increase their use of car seats whether or not they view the video. In some cases, a statement of the research purpose can influence the results and a consent to incomplete disclosure may be obtained instead.

4. Which of the following represent some degree of risk of causing discomfort or harm to subjects in a study? Select all that apply. a. Asking parents of children in a clinic waiting room to complete a patient satisfaction questionnaire b. Assessing the number of males and females enrolled in nursing schools using enrollment data c. Interviewing nursing home residents about their memories of the Great Depression d. Using pathology reports from a hospital lab to gain data about the percentage of new patients who have anemia

ANS: A, C, D Asking parents to complete a questionnaire increases the risk of temporary discomfort associated with filling out the form. Interviewing nursing home residents increases the risk of discomfort because it may invoke bad memories. Using pathology reports does not confer benefits to the subjects and may run the risk of invasion of privacy. Assessing the numbers of males and females does not increase risk or cause discomfort.

8. A nurse researcher who wishes to use animals in a research study must include which elements in an animal use protocol? Select all that apply. a. Animal living conditions and veterinary care b. Assurances that animals will be kept alive c. Justification for the use of animals over humans d. Procedures to minimize pain and distress

ANS: A, C, D Elements of animal use protocols should include descriptions of animal living conditions and veterinary care, justifications for the use of animals, and procedures that will minimize pain and distress. Researches need to identify methods of euthanasia and do not need assurances that animals will be kept alive

3. Which of the following are true statements about genomic research? Select all that apply. a. Genomic research is a promising area of science related to human disease and healing. b. Genomic research involves unethical challenges dues to the potential that the subject can be identified by the data. c. The Human Genome Project funded by NIH recognized from the onset the ethical and legal dilemmas of genomic research. d. Broad consent in the revised Common Rule was developed to address some of the unresolved issues in genomics research. e. De-identification of data and ownership of specimens are two of the unresolved issues in genomics research.

ANS: A, C, D, E Genomic research is a promising area of science. The Human Genome Project recognized from the onset the ethical and legal dilemmas of genomic research. Broad consent was developed to address unresolved issues in genomics research. Unresolved issues in genomics research include de-identification of data, subjects withdrawing from a study, additional studies being conducted with specimens already collected, return of information to the research subject if beneficial to the subject, and ownership of specimens. Genomic research involves unique ethical challenges due to the potential that the subject can be identified by the data, the ability to store bio specimens for future studies, and notifi

7. Which of the following are true statements about informed consent? Select all that apply. a. Informed consent is the process of providing information to a potential subject and the opportunity to participate in the study. b. The process ends with the subject's signature on a document agreeing to be in a study. c. A potential subject's decision about whether to participate is the informing part of the process. d. Informed consent is incomplete or unethical unless all three elements are incorporated. e. The documentation of informed consent depends on the study's level of risk and the requirement of the IRB who approves the study

ANS: A, E Informed consent requires researchers to obtain a potential subject's voluntary participation in a study, after informing them of possible risks and benefits. The documentation of informed consent does depend on the study's level of risk and the requirements of the IRB. The process of informed consent does not end with the subject's signature on a document agreeing to be in a study. A potential subject's decision about whether to participate is the consenting part of the process. Informed consent is incomplete or unethical unless four elements (disclose, comprehends, competence, and voluntary agreement) are incorporated.

21. A researcher using a small sample of an easily distinguishable group of subjects wishes to use extensive quotes in the research report. This researcher risks a. a loss of study validity. b. breaching confidentiality. c. losing objectivity. d. reduction of benefits to subjects.

ANS: B Breach of confidentiality is of special concern in qualitative studies that have few study participants and involve the reporting of long quotes. Study validity is related to the proper use of study tools and measurements. Objectivity is the ability of the researcher to avoid interpreting results in a biased manner. Benefits to subjects are not necessarily compromised in small studies using quotations

19. If a healthcare provider discloses information about a patient to a researcher for a study, the provider and the researcher must have a(n) a. agreement about the study's purpose. b. data use agreement. c. limited data set. d. written study proposal.

ANS: B A data use agreement limits how data may be used and how it will be protected and must be in place for a provider to disclose data to a researcher. Agreement about the study's purpose is not necessary for sharing information. A limited data set describes the type of data that may be disclosed without an individual subject's authorization or an IRB waiver; to disclose this limited data set, a data use agreement must be in place. The written study proposal does not confer the right to disclose patient data to a researcher.

13. When a researcher indicates that assent for participation was gained in a study involving 10-year-old children, this indicates which has occurred? a. The children gave informed consent to participate in the study. b. The children have agreed to be subjects in the study. c. The parents granted approval for their children to participate. d. The parents do not need to give consent because the children gave consent.

ANS: B Assent is gained from children who are subjects and represents their agreement to participate. Assent is not informed consent, which must be given by a child's parent or legal guardian. Assent does not represent approval by the parents. Assent is given in conjunction with informed consent by the parent or legal guardian and is not sufficient by itself to allow a minor to participate in a study.

3. The Tuskegee Syphilis Study violated several ethical principles in which way? a. Coercion of subjects to participate in the study in exchange for treatment b. Failing to inform subjects about the purpose and procedures in the study c. Failing to inform the Centers for Disease Control about the results of the study d. Not informing the subjects' physicians that they were in the study

ANS: B In the Tuskegee Syphilis Study, subjects were not informed about the purpose and procedures of the study; some were not even informed that they were subjects. Subjects were not coerced by the promise of treatment, which was not offered, even when the benefits were known. The Centers for Disease Control was informed about the results and decided the study could continue. In the Jewish Chronic Disease Study, subjects' physicians were not informed.

17. A special concern when conducting research using terminally ill cancer patients as subjects is a. an inability to randomly assign subjects to study groups. b. an increased risk of harm with decreased benefits. c. difficulty enlisting subjects for participation in the study. d. poor control of extraneous variables.

ANS: B Participating in research may carry increased risks with minimal or no benefits for terminally ill subjects. Subjects may still be randomly assigned to control versus study groups. Terminally ill patients may be more likely to be willing to participate in research. There is no difference when controlling extraneous variables in studies involving terminally ill patients.

18. Which subject groups may feel especially coerced to participate in research studies? a. Children b. Institutionalized patients c. Pregnant women d. Terminally ill patients

ANS: B Persons confined to institutions may feel coerced to participate in research because they fear harm or because they feel that they may receive special benefits for participation. Children, pregnant women, and terminally ill patients are allowed to give assent or consent freely for participation in research.

14. A researcher wishes to study the effects of anti-seizure medications on adult subjects who have severe cognitive impairments. Which statement is true about using these subjects in research? a. Assent must be gained from the subjects and is sufficient for participation. b. A legally authorized guardian must give informed consent. c. These adults cannot be used as subjects for this study. d. The subjects' physicians must give consent for participation in the study.

ANS: B Persons with mental illness or a cognitive impairment are incapable of giving informed consent. A researcher must gain approval from a legally authorized representative or guardian along with gaining assent from the participant. Assent must be gained if possible, but is not sufficient for participation in a study. Adults with mental impairments may be used in studies if their rights are protected and proper consent is obtained. Physicians are not legally authorized representatives.

32. An institutional review board consists of a committee of peers who examine studies for ethical concerns with three levels of review. A descriptive study with anonymous online data collection using a social support scale and demographic questionnaire is an example of what level of IRB review? a. Expedited review b. Exempt from review c. Partial review d. Full review

ANS: B Studies that are exempt from IRB review pose no apparent risks to the research subjects. Studies may meet the criteria to receive an expedited review if they carry some risks. Partial review is not one of the three levels of IRB review. A study that carries greater than minimal risks must receive a full review by an IRB during a convened meeting.

22. A subject's right to fair selection and treatment in a study is related to which ethical principle? a. Beneficence b. Justice c. Privacy d. Respect for persons

ANS: B The right to fair selection and treatment of subjects is based on the ethical principle of justice, requiring people to be treated fairly and to receive what they are owed. The principle of beneficence requires that subjects are protected from harm. The principle of privacy requires that anonymity and confidentiality are protected. The principle of respect for persons requires that human subjects should be treated as autonomous agents with rights to self-determination.

30. Which is an example of falsification in research? a. Citing work by another researcher and claiming it as one's own b. Making up statistics about the incidence of reactions to an intervention c. Omitting data about a subject that disproves the researcher's hypothesis d. Using data gained without the consent of the research subjects

ANS: C Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented. Plagiarism is citing another's research and claiming it as one's own. Fabrication involves making up results and reporting them. Lack of informed consent occurs when the researcher fails to gain consent from study subjects.

12. A researcher will have greater success gaining approval for a research study involving pregnant women if which provision is put into place? a. Care is taken to maintain strict confidentiality of subjects. b. Consent is given by the pregnant women's significant others. c. Subjects may experience therapeutic effects from the intervention. d. Subjects receive financial rewards for participation in the study

ANS: C Pregnant women are considered to have legal and/or mental diminishment of autonomy. Research involving such subjects is generally more acceptable if the research is therapeutic. Confidentiality and consent must be maintained in all research involving human subjects and do not influence approval for subjects with diminished capacity. Confidentiality and consent must be maintained in all research involving human subjects and do not influence approval for subjects with diminished capacity. Financial rewards may be a form of coercion.

9. When conducting research to study medical devices for human use, the nurse researcher must comply with the Department of Health and Human Services human subjects' regulations as well as regulations put forth by the a. American Nurses Association (ANA). b. Code of Federal Regulations (CFR). c. Food and Drug Administration (FDA). d. Presidential Commission for the Study of Bioethics.

ANS: C The FDA and the DHHS regulations govern most of the biomedical and behavioral research conducted in the United States. Drugs, medical devices, biological products, human dietary supplements, and electronic devices are all regulated by these two entities. The ANA, CFR, and the Presidential Commission do not have specific regulations governing research of medical devices. The ANA, CFR, and the Presidential Commission do not have specific regulations governing research of medical devices. The ANA, CFR, and the Presidential Commission do not have specific regulations governing research of medical devices.

6. The ethical principles of respect for persons, beneficence, and justice are considered essential elements in research involving human subjects. In which document are these principles identified? a. Declaration of Helsinki b. Department of Health, Education, and Welfare regulations (DHEW) c. National Commission for the Protection of Human Subjects in the Belmont Report d. Nuremberg Code

ANS: C The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed in the United States in 1978. This commission developed ethical research guidelines based on the ethical principles of respect for persons, beneficence, and justice and made recommendations to the U.S. Department of Health and Human Services (DHHS) in the Belmont Report. A major focus of the Declaration of Helsinki was the differentiation of therapeutic research from nontherapeutic research. The Department of Health, Education, and Welfare (DHEW) regulations were published in 1973 providing for the protection of human research subjects. The development of the Nuremberg Code in 1949 addressed the mistreatment of human subjects.

20. In a study about pregnant women's use of tobacco, the researcher can link individual subjects' identities to their responses on a questionnaire, but does not share this information with others. This is an example of a. anonymity. b. breach of confidentiality. c. confidentiality. d. privacy.

ANS: C Confidentiality is the researcher's safe management of information or data shared by a subject to ensure the data are kept private. Anonymity exists when the subject's identity cannot be linked, even by the researcher, with individual responses. A breach of confidentiality occurs when a researcher allows an unauthorized person to gain access to the raw data of a study. Privacy is a larger concept encompassing anonymity and confidentiality

23. Which unethical study in previous history involved withholding a treatment from subjects to study the effects of a disease progression on subjects? a. The Jewish Chronic Disease Hospital Study b. The Nazi Medical Experiments c. The Tuskegee Syphilis Study d. The Willowbrook Study

ANS: C In the Tuskegee Syphilis Study, penicillin was deliberately withheld from the research subjects and their families, to study the effects of the natural progression of syphilis. In the Jewish Chronic Disease Hospital Study, subjects were injected with a suspension containing live cancer cells and did not know they were taking part in a study or that the injections contained these live cancer cells. In the Nazi Medical Experiments, an array of atrocious unethical medical experiments was conducted on prisoners of war. In the Willowbrook Study, mentally retarded children were infected with the hepatitis virus and new patients were not admitted to this institution unless their parents consented for their children to participate in this study.

10. To safeguard the right to self-determination among research subjects, the researcher will ensure that subjects a. are afforded anonymity to the researcher and the reader. b. are allowed to choose whether to be in a control or a study group. c. may choose whether or not to participate in a study. d. receive a large monetary reward for participating in the study

ANS: C Self-determination refers to individuals' rights to knowingly become a subject in the study or not, and to do so of their own free will. The right to anonymity means that subjects cannot be identified. Subjects are generally randomly assigned to groups. Subjects who are given large rewards for participation may be coerced.

27. Which situation may allow waiving the need to obtain written consent for participation in a research study? a. The researcher is conducting an informal study about heart disease. b. The researcher is using questionnaires to collect data about suicide risk. c. The subjects do not want documentation linking them to the study. d. The subjects desire complete anonymity in the study.

ANS: C Subjects who do not want documentation linking them to the research who have received information and demonstrated comprehension of the information may have consent waived if they desire. Informal studies and those using questionnaires about potentially harmful subjects do not meet the requirements for waiving of consent. Informal studies and those using questionnaires about potentially harmful subjects do not meet the requirements for waiving of consent. Anonymity can be maintained even with signed consent.

15. A researcher makes every effort to ensure that subjects may benefit from a research intervention while taking measures to minimize potential harm. This is an example of protecting a research subject's right to a. anonymity and confidentiality. b. fair treatment. c. protection from discomfort and harm. d. self-determination.

ANS: C The right to protection from discomfort and harm from a study is based on the ethical principle of beneficence, which states that one should do good and, above all, do no harm. Complete anonymity exists if the subject's identity cannot be linked, even by the researcher, with his or her individual responses. Confidentiality is the safe management of private information shared by a subject. The researcher must refrain from sharing that information without the authorization of the subject. Research findings need to be reported so that a subject or group of subjects cannot be identified. The right to fair treatment suggests that people should be treated fairly and should receive what they are due or owed. Self-determination refers to individuals' rights to knowingly become a subject in the study or not and to do so of their own free will.

26. A researcher gives healthy adult subjects a handout explaining the nature of a study and then obtains written consent from those who choose to participate. Which statement is true about this process? a. Subjects have given informed consent for participation in the study. b. Subjects have not given voluntary consent for participation in the study. c. The researcher has failed to determine comprehension of the study by participants. d. The researcher has not disclosed information about the study to the participants.

ANS: C These subjects have been given written information, but have not stated their understanding, so informed consent has not been obtained. Informed consent implies not only that the researcher has imparted information to the subjects, but also that the prospective subjects have comprehended the information. The researcher needs to discuss the information with the subjects and ask them to restate the information to assess their understanding. The subjects have voluntarily consented to participate. The researcher disclosed information to the subjects about the study.

29. A researcher makes an honest error when tabulating and analyzing research findings. According to the Office of Research Integrity, this constitutes a. fabrication. b. falsification. c. misrepresentation. d. no misconduct.

ANS: D A researcher making an honest error is not guilty of misconduct. Fabrication refers to making up results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented. Misrepresentation refers to presenting data inaccurately

1. The purpose of an institutional review board (IRB) in a university or clinical agency is to a. approve funding for studies based on ethical standards. b. critically appraise ethical aspects of published studies. c. define ethical standards for the institution. d. protect the human rights of subjects in proposed studies

ANS: D Institutional review boards (IRBs) are organized to examine the ethical aspects of studies before they are conducted. IRBs do not approve funding for studies based on ethical standards. IRBs review ethical aspects of studies prior to the conduction of the study, not after they are published. IRBs do not define ethical standards.

31. A researcher combines data from another researcher's study along with data from the reported study in graphs without noting the source of the data. This is an example of a. an honest error. b. fabrication. c. falsification. d. plagiarism.

ANS: D Plagiarism is citing another's research and claiming it as one's own. An honest error would occur if the researcher was unaware that the data belonged to someone else. Fabrication involves making up results and reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented.

25. A researcher conducts a study to evaluate the frequency of intimate partner violence among females treated for sexually transmitted diseases (STDs). When collecting data, which action may be problematic when protecting subjects' rights? a. Allowing subjects to decline participation in the study b. Approaching all patients who meet eligibility requirements c. Identifying subjects with numbers instead of names d. Instructing subjects to complete every item on the questionnaire

ANS: D Subjects who are told that they must complete every item on a questionnaire risk losing their right to autonomy. Autonomy is protected when subjects are informed that participation is voluntary. Approaching all subjects who meet eligibility requirements removes the possibility of bias. Using numbers instead of names helps to protect privacy.

4. After the Department of Health, Education, and Welfare (DHEW) regulations were published in 1973, all research using human subjects was required to a. avoid using subjects who were ill, mentally impaired, or dying. b. obtain informed consent from all subjects prior to enrollment in a study. c. review only studies in which risk of harm to subjects is especially high. d. undergo full institutional review to examine risks and benefits to subjects.

ANS: D The Department of Health, Education, and Welfare (DHEW) regulations were published in 1973, providing for the protection of human research subjects and requiring full institutional review of all studies involving human subjects. The DHEW regulations do not prohibit using subjects who are ill, mentally impaired, or dying, but provided protections for such subjects. The US Code of Federal Regulations requires informed consent of human subjects. DHEW regulations require institutional review of all human subjects, not just those with especially high risk.

28. Which federal agency was established to manage investigations of misconduct in research? a. Department of Health, Education, and Welfare (DHEW) b. Department of Health and Human Services (DHHS) c. Food and Drug Administration (FDA) d. Office of Research Integrity (ORI)

ANS: D The Office of Research Integrity was developed by the federal government in 1989 to supervise the implementation of the rules and regulations related to research misconduct and to manage any investigations of misconduct. All other statements are not correct statements.

8. Which ethical principle includes the right to self-determination and the right to full disclosure? a. Beneficence b. Ethics c. Justice d. Respect for persons

ANS: D The principle of respect for persons indicates that human subjects should be treated as autonomous agents with rights to self-determination and full disclosure. The ethical principle of beneficence encourages the researcher to do good and to "do no harm." Ethics is not a specific ethical principle. The principle of justice addresses the fair treatment of human subjects.

24. When a prospective subject has decided to take part in a research study of his or her own volition, without coercion or any undue influence describes which element of Informed Consent? a. Disclosure b. Comprehension c. Competence d. Voluntary agreement

ANS: D Voluntary agreement means that the prospective subject has decided to take part in a study of his or her own volition, without coercion or any undue influence. Researchers obtain voluntary agreement after the prospective subject who is competent to make the decision receives the essential information about the study and has demonstrated comprehension of this information. The researcher must disclose essential information about the study to potential subjects in a way that can be understood. The extent to which the potential subject comprehends the information is the second element. Autonomous persons, who can understand the benefits and risks of a proposed study, are competent to give consent which describes the third element.

5. A clinical research nurse identifies which of the following as a vulnerable population? a. Women hospitalized for a mastectomy b. Clients who speak both English and Spanish c. Men 65 years and older belonging to the Active Seniors Wellness Center d. Pediatric clients hospitalized for cancer

ANS: D Vulnerable populations are defined as persons who are susceptible to undue influence or coercion such as children, prisoners, and persons who are economically or educationally disadvantaged. Persons who have impaired decision-making were also identified as being vulnerable. This might include persons with Alzheimer's disease, traumatic brain injury, or persons born with intellectual limitations.