Ethics NR
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 theseno ethical violation occurred, because the two subjects share a point of view.
ANS: A Confidentiality is the researchers 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.
13. What specific area of ethics does HIPAA address? a. Privacy b. Justice c. Coercion to participate in a research study d. Informed consent
ANS: A The Health Insurance Portability and Accountability Act (HIPAA) was implemented in 2003 to protect an individuals health information. The U.S. DHHS developed regulations titled the Standards for Privacy of Individually Identifiable Health Information, and compliance with these regulations is known as the Privacy Rule.
10. To take positive action to prevent any harm to the research subjects best defines which of the following principles? a. Beneficence b. Justice c. Privacy d. Respect
ANS: A 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. This includes positive actions taken to prevent harm to research subjects. Privacy is the right an individual has to determine the time, extent, and general circumstances under which personal information will be shared or withheld from others. Such information consists of ones attitudes, beliefs, behaviors, opinions, and records. The right to fair treatment is based on the ethical principle of justice. The right to self-determination is based on the ethical principle of respect for persons.
12. 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 IRBs 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
ANS: A Universities and healthcare agencies have IRBs that function in a similar way to review research following federal regulations. If both a university and a hospital, or if more than one hospital, should be involved in a research study, both IRBs must give permission for the study to be conducted. This poses significant expenditure of time for such research.
6. Which of the following represent a breach in confidentiality? (Select all that apply.) a. The teenaged son of a researcher reads some of the raw interview data on the researchers computer. b. The researcher accidentally includes the real names of one participants 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 researchers 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.
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 subjects identity is accidentally revealed, violating the subjects 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.
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.
12. In the Jewish Chronic Disease Hospital Study, 22 patients were injectedunknowinglywith 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.
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.
21. From an ethical point of view, what is the point of determining that a potential research subject is incompetent? a. An incompetent subject 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 subject necessitates a different consenting process. d. The researcher has a responsibility to exclude all incompetent persons from research participation.
ANS: C Some persons have diminished autonomy or are vulnerable and less advantaged because of legal or mental incompetence, terminal illness, or confinement to an institution. 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.
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 researchers 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.
1. Why are research ethics essential? (Select all that apply.) a. Research subjects 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 subjects must be protected from deliberate violation of their rights.
ANS: A, C, E 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.
5. 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? (Select all that apply.) 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 freestanding. d. Nobody will know that a qualitative study was performed. e. No denial of the full scope of data collection is made.
ANS: A, C, E Research misconduct is defined as the fabrication, falsification, or plagiarism in processing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences in opinion. Fabrication in research is the making up of results and recording or reporting them. Falsification of research is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. The data from this study were neither fabricated nor falsified; it is the researchers decision when to disseminate research results.
3. Which one of the following are considered vulnerable populations from an ethical point of view? (Select all that apply.) 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
ANS: A, D Some persons have diminished autonomy or are vulnerable and less advantaged because of legal or mental incompetence, terminal illness, or confinement to an institution. 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. The U.S. DHHS has identified certain vulnerable groups of individuals, including pregnant women, human fetuses, neonates, children, mentally incompetent persons, and prisoners, who require additional protection in the conduct of research. Sometimes students feel forced to participate in research to protect their grades or prevent negative relationships with the faculty conducting the research.
2. Why are vulnerable populations considered vulnerable and to what are they vulnerable? (Select all that apply.) 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
ANS: A, D, E Some persons have diminished autonomy or are vulnerable and less advantaged because of legal or mental incompetence, terminal illness, or confinement to an institution. 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. The U.S. DHHS has identified certain vulnerable groups of individuals, including pregnant women, human fetuses, neonates, children, mentally incompetent persons, and prisoners, who require additional protection in the conduct of research. Neonates are extremely vulnerable and require extra protection to determine their involvement in research. Some hospitalized patients are survivors of trauma (such as auto accidents, gunshot wounds, or physical and sexual abuse) who are very vulnerable and who often have decreased decision-making capacities. Sometimes students feel forced to participate in research to protect their grades or prevent negative relationships with the faculty conducting the research. Other subjects are coerced to participate in studies because they believe that they cannot refuse the excessive rewards offered, such as large sums of money, specialized health care, special privileges, and jobs.
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.
4. A nurse plans to interview prisoners as part of her masters thesis on treatment of health problems in correctional institutions. What special measures must she take before she studies these potential subjects? (Select all that apply.) a. Justify to an institutional review board why she must use prisoners as subjects. b. Devise a consent process that provides for a conservators signature. c. Destroy all of her records. d. Devise interview questions that avoid any mention of prisons or prisoners. e. Bracket her previous beliefs about prisoners. f. Assure that the consent process involves no coercion.
ANS: A, F The U.S. DHHS has identified certain vulnerable groups of individuals, including pregnant women, human fetuses, neonates, children, mentally incompetent persons, and prisoners, who require additional protection in the conduct of research. Researchers need to justify their use of subjects with diminished autonomy in a study, and the need for justification increases as the subjects risk and vulnerability. Subjects with diminished autonomy may be subject to coercion.
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 subjects 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.
18. A researcher receives permission to use the information in a hospital data set, without patient identifiers. What level of subject consent is required? a. Partial: the subjects must all be notified that their data is being re-used. b. None. c. Partial: the subjects must all be notified if the results are published. d. Full: all subjects must be contacted and must agree to have their data used.
ANS: B Covered entities (healthcare provider, health plan, and healthcare clearinghouse) may use and disclose a limited data set to a researcher for a study without an individual subjects authorization or an IRB waiver.
15. A researcher is applying for a grant renewal on the subject of a promising new treatment for liver cancer. His research group has used the treatment for 13 subjects. The results9 responded and 4 did notare 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 he chose to do this, what would it represent? a. Beneficence b. Fabrication c. Falsification d. Plagiarism
ANS: B Fabrication in research is the making up of results and recording or reporting them. Falsification of research is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another persons ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others research proposals and manuscripts. The principle of beneficence requires the researcher to do good and above all, do no harm.
19. 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 RN research subjects 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 RN subjects are then asked to describe their feelings 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
ANS: B Studies that cause temporary discomfort are described as minimal-risk studies, in which the discomfort encountered is similar to what the subject would experience in his or her daily life and ceases with the termination of the study. Many nursing studies require the subjects to complete questionnaires or participate in interviews, which usually involve minimal risk. The physical discomforts might be fatigue, headache, or muscle tension. The emotional and social risks might entail the anxiety or embarrassment associated with responding to certain questions. The economic risks might consist of the time spent participating in the study or travel costs to the study site. Participation in many nursing studies is considered a mere inconvenience for the subject, with no foreseeable risks of harm. Most clinical nursing studies examining the impact of a treatment involve minimal risk.
5. A graduate student receives a mailed survey asking her to participate in research about unpleasant experiences in graduate school. She is asked to return the survey, and the instructions say, 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 subjects 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.
ANS: B The requirements for written consent may be waived in research that presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. For example, if questionnaires are used to collect relatively harmless data, a signed consent form from the subjects would not be required. The subjects completion of the questionnaire may serve as consent. The top of the questionnaire might contain a statement such as Your completion of this questionnaire indicates your consent to participate in this study.
9. The right an individual has to receive treatment even if he decides not to participate in the research best defines which of the following human rights? a. Beneficence b. Justice c. Privacy d. Respect
ANS: B The right to fair treatment is based on the ethical principle of justice. Privacy is the right an individual has to determine the time, extent, and general circumstances under which personal information will be shared or withheld from others. Such information consists of ones attitudes, beliefs, behaviors, opinions, and records. 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. The right to self-determination is based on the ethical principle of respect for persons.
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? 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 subjects 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.
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 individuals 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 subjects identity cannot be linked, even by the researcher, with his or her individual responses.
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 childs 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.
14. 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 subjects 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 subjects he excluded. This is an instance of which of the following? a. Beneficence b. Fabrication c. Falsification d. Plagiarism
ANS: C Fabrication in research is the making up of results and recording or reporting them. Falsification of research is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another persons ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others research proposals and manuscripts. The principle of beneficence requires the researcher to do good and above all, do no harm.
6. Both a subject in an experimental group who receives an experimental treatment and a subject in a control group who receives a control treatment are considered to be subjects 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 subject 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 subject is blind to treatment.
ANS: C Therapeutic research gives the patient an opportunity to receive an experimental treatment that might have beneficial results. In experimental research this means only that the subject is recruited into the study and randomly assigned to either a treatment or control group, not that the subject receives the experimental treatment.
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 c. Therapeutic d. Dangerous
ANS: C Therapeutic research gives the patient an opportunity to receive an experimental treatment that might have beneficial results. Nontherapeutic research is conducted to generate knowledge for a discipline, and the results from the study might benefit future patients but will probably not benefit those acting as research subjects. The Declaration of Helsinki differentiated therapeutic research from nontherapeutic research. Neither descriptive nor correlational research involves treatment or manipulation of a variable. There is no evidence of coercion.
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 subjects 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 researchers 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.
20. Dr. Adamson is conducting research on a new and promising chemotherapy treatment for breast cancer that improves survival and decreases adverse symptoms. Sixty subjects 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. His wife, newly diagnosed with breast cancer, is randomly assigned to the treatment group; he removes her from the treatment group and places her in the experimental group. What ethical violation has occurred? a. Mrs. Adamson has a right to self-determination: her husband has decided her group assignment for her. b. Mrs. Adamsons husband has no right to know about her breast cancer: this is a violation of confidentiality. c. Mrs. Adamson shouldnt be a member of the study: its a conflict of interest. d. Mrs. Adamson has no right to be included in the experimental group: it unfairly excludes someone else from this special benefit.
ANS: D A concern with subject selection that is related to justice is that some researchers select certain people as subjects because they like them and want them to receive the specific benefits of a study. Other researchers have been swayed by power or money to make certain individuals subjects so that they can receive potentially beneficial treatments. It is especially important in research not to show preference in assigning subjects. That is the benefit of random assignment: it is fair.
22. How would a professor who wants to have his students provide data for a research study go about achieving this without involving coercion? a. Mention that participation provides extra points. b. Have a research assistant consent all subjects and collect all data. c. Offer extra points to the whole class if 50% of them act as subjects. d. Open the study to all students on campus and provide a nonacademic incentive.
ANS: D A subjects right to self-determination can be violated through the use of (1) coercion, (2) covert data collection, and (3) deception. Coercion occurs when one person intentionally presents another with an overt threat of harm or the lure of excessive reward to obtain compliance. Sometimes students feel forced to participate in research to protect their grades or prevent negative relationships with the faculty conducting the research. They are being coerced.
7. 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.
ANS: D From the mid-1950s to the early 1970s, research on hepatitis was conducted by Dr. Krugman at Willowbrook, an institution for the mentally retarded. The subjects, all children, were deliberately infected with the hepatitis virus. During the 20-year study, Willowbrook closed its doors to new inmates because of overcrowded conditions. However, the research ward continued to admit new inmates. To gain their childs admission to the institution, the parents were forced to give permission for the child to be a subject in the study. Because, the principal of beneficence requires the researcher to do good and above all, do no harm, the only way to study a virus that clearly harms people is non-interventionally: through descriptive or correlational research.
16. A masters student knows next to nothing about Maslows theory related to hierarchy of needs but, on her advisors recommendation, decides to use it as a theoretical framework for her thesis. The student goes to the library and accesses an old masters thesis that also uses the theory and copies three pages, word for word. She uses the other students reference to Maslows work. This is an example of which of the following? a. Nonmaleficence b. Fabrication c. Falsification d. Plagiarism
ANS: D Plagiarism is the appropriation of another persons ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others research proposals and manuscripts. Fabrication in research is the making up of results and recording or reporting them. Falsification of research is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. The principle of beneficence requires the researcher to do good and above all, do no harm.
17. A masters student knows next to nothing about Maslows theory related to hierarchy of needs but, on her advisors recommendation, decides to use it as a theoretical framework for her thesis. The student goes online and finds a Wikipedia page and copies the description of Maslows theory verbatim, putting a citation at the end of the paragraph but not using quotation marks. This is an example of which of the following? a. Nonmaleficence b. Fabrication c. Falsification d. Plagiarism
ANS: D Plagiarism is the appropriation of another persons ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others research proposals and manuscripts. Fabrication in research is the making up of results and recording or reporting them. Falsification of research is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. The principle of beneficence requires the researcher to do good and above all, do no harm.
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 patients 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 individuals 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 ones attitudes, beliefs, behaviors, opinions, and records. The Privacy Act of 1974 provided the initial protection of an individuals 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 individuals knowledge or against his or her will. Invading an individuals 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 individuals 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 individuals medical record number. In the example, the researchers use of an actual patient identification number on a transcription risks the human right to privacy; a code number should have been used instead.
11. An institutional review board (IRB) ensures that (1) the rights and welfare of the individuals involved were protected, (2) the appropriate methods were used to secure informed consent, and (3) the potential benefits of the investigation were greater than the risks. Which of the following is an example of how an IRB determines the level of potential risk? a. It requires the researcher to provide a list of potential benefits to the clients, as well as the results of a pilot study verifying this. b. It compels the researcher to disclose his consenting process. c. It provides for a supervisor from the IRB to be present for all data collection. d. It reviews the researchers description of the studys potential risks and compares them with everyday risk.
ANS: D The functions and operations of an IRB involve the review of research at three different levels: (1) exempt from review, (2) expedited review, and (3) complete review. The level of the review required for each study is decided by the IRB chairperson and/or committee, not by the researcher, based on information provided by the researcher. Studies are usually exempt from review if they pose no apparent risks for the research subjects. Studies that have some risks, which are viewed as minimal, are expedited in the review process.
8. 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 of the following human rights? a. Beneficence b. Justice c. Privacy d. Self-determination
ANS: D The right to self-determination 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. Privacy is an individuals right to determine the time, extent, and general circumstances under which personal information will be shared with or withheld from others. Justice 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.
