Chapter 13: Legal and Ethical Issues
Obtaining consent illustrates which ethical principle? A. Respect B. Beneficence C. Justice D. Fidelity
A Obtaining consent is a legal principle that implies that potential subjects understand the implications of participating in research and they agree to participate. It promotes the ethical principles of respect.
Which ethical principle would be violated if a person was not provided the freedom to participate or not participate in research? A. Respect for persons B. Beneficence C. Justice D. HIPAA disclosure
A Respect for persons is the ethical principle that would be violated if a person were not given the freedom to participate or not participate in research.
Vulnerable population in terms of performing research include: (Select all that apply.) A. elderly B. middle-aged men. C. pregnant women. D. prisoners. E. childbearing women.
A, C, D The elderly, pregnant women, and prisoners are all populations that are considered to be vulnerable in terms of performing research.
Which basic ethical principle is relevant to the conduct of research that is an obligation to do no harm and maximize possible benefits? (p. 13-33) A. Justice B. Beneficence C. Respect for persons D. Informed consent
B Beneficence is an obligation to do no harm and maximize possible benefits.
Which ethical principle is an obligation to do no harm and maximize possible benefits? A. Respect for persons B. Beneficence C. Justice D. Health Insurance Portability and Accountability Act (HIPAA) disclosure
B Beneficence may be defined as an obligation to do no harm and maximize possible benefits.
Which ethical principle requires researchers to treat human subjects fairly? A. Respect for persons B. Beneficence C. Justice D. HIPAA disclosure
C Justice is the ethical principle that requires researchers to treat human subjects fairly.
The 1969 Milledgeville, Georgia case violated which ethical principle? A. Right to freedom from coercion or constraint B. Right to fair treatment and protection C. Right to be informed about purpose of the research D. Right to institutional approval of program before implementation
D Use of investigational drugs on disabled children without a psychiatrist's review violated the principle of the right to institutional approval of the program prior to implementation.
Which ANA Human Rights guideline would pertain to nurses being informed in writing about research participation as a condition of employment? A. Right to self-determination B. Scope of application C. Responsibilities to support knowledge development D. Informed consent
A Nurses have the right to know that participation in research is a requirement of employment. Scope of application refers to the fact that the ANA guidelines apply to all individuals involved in research. Nurses have an obligation to support the development of knowledge that expands the depth and breadth of the scientific knowledge or base of nursing practice, but this is not an ANA guideline. Informed consent is the protection of the right to self-determination of potential subjects.
Which ethical principle states that people have the right to self-determination and to treatment as autonomous agents? A. Respect for persons B. Beneficence C. Justice D. HIPAA disclosure
A Respect for persons is an ethical principle that states people have the right to self-determination and to treatment as autonomous agents.
What should be included as part of an informed consent? (Select all that apply.) A. Study procedures B. Benefits of the study C. Any alternative procedures or treatments D. A waiver of rights in case of injury E. Outcomes of the study
A, B, C All study procedures related to data collection must be included in the informed consent. The benefits and importance of the study must be explained in the informed consent. If there are any alternative procedures or treatments available to the participants, they must be informed of them before obtaining informed consent. Outcomes of the study cannot be determined prior to doing the study and are not included in the informed consent.
The 1994 Ivory Coast, Africa research study violated which ethical principle? A. Right to freedom from coercion or constraint B. Right to fair treatment and protection C. Right to be informed about purpose of the research D. Right to institutional approval of program before implementation
B Because subjects were denied access to medication with a known benefit, the right to fair treatment and protection was violated.
Which basic human right is the freedom of a person to determine the time, extent, and circumstances under which private information is shared or withheld from others? A. Right to self-determination B. Right to privacy and dignity C. Right to anonymity and confidentiality D. Right to fair treatment
B Right to privacy and dignity is the freedom of a person to determine the time, extent, and circumstances under which private information is shared or withheld from others.
Responsibilities of the IRB include what? A. Ensuring that the research design is appropriate B. Protecting subjects from undue risk C. Monitoring implementation of the study D. Overseeing sample selection
B The purpose of an IRB is to oversee the protection of human subjects. The IRB has no authority to prevent conduction of research on the basis of quality of the research design. The IRB has no authority to monitor implementation of a study. The IRB has no authority to oversee sample selection.
What is true regarding anonymity or confidentiality? A. Anonymity means that the researcher agrees not to link the information collected with the subject when reporting study findings. B. Anonymity means that the subject's identity cannot be linked, even by the researcher, to data obtained. C. Confidentiality means that the subject has the right to determine the time and circumstances under which private information is shared. D. Confidentiality means that data obtained are known only to the researcher.
B To maintain anonymity, no one must be able to trace the data to the participant. To maintain anonymity, even the researcher does not know the identity of the participants. The subject's right to determine the time and circumstances under which private information is shared is called the right to privacy and dignity. Confidentiality means that the identity of the participants is known only to the researcher.
The 1932 to 1973 Tuskegee Alabama syphilis research study violated which ethical principle? (Select all that apply.) A. Right to freedom from coercion or constraint B. Right to fair treatment and protection C. Right to be informed about purpose of the research D. Right to institutional approval of program before implementation E. Right to anonymity and confidentiality
B, C Denying the patient access to a treatment for a serious medical condition violated the principle of right to fair treatment and protection. Right to be informed about purpose of the research violated informed consent.
The five human rights as outlined by the American Nurses Association (ANA) include what? (Select all that apply.) A. Fair wages B. Self-determination C. Anonymity and confidentiality D. Pursuit of happiness E. Right to fair treatment
B, C , E People should be treated as autonomous agents who have the freedom to choose without external controls. Anonymity exists when the subject's identity cannot be linked, even by the researcher, with his or her individual responses. Confidentiality means that individual identities of subjects will not be linked to the information they provide and will not be publicly divulged. The pursuit of happiness is not a human right outlined by the ANA guidelines. Receiving a fair wage is not a human right outlined by the ANA guidelines. Based on the principle of justice, people should be treated fairly and receive what they are due or owed. (The 5 human rights are the right to: 1. Self-determination 2. Privacy and dignity 3. Anonymity & confidentiality 4. Fair treatment 5. Protection from harm and discomfort)
What is the basic ethical principle to the conduct of research that indicates that people have the right to self-determination and to treatment as autonomous agents? A. Justice B. Beneficence C. Respect for persons D. Informed consent
C Respect for persons is the ethical principle that indicates that people have the right to self-determination and to treatment as autonomous agents.
Which ethical principle is identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research? A. Equality B. Equity C. Justice D. Freedom
C The three ethical principles are respect for person, beneficence, and justice. Equality is not one of the three ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Equity is not one of the three ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Freedom is not one of the three ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
What is the basic ethical principle relevant to the conduct of research that requires human subjects to be treated fairly? A. Justice B. Beneficence C. Respect for persons D. Informed consent
A Justice is an ethical principle that requires human subjects to be treated fairly.
To study the effects of a new antiviral drug on people with AIDS, a researcher conducts a study on a prison population. Which ethical issue is of immediate concern? A. Vulnerable populations may not be selected for the sake of convenience. B. The study must be approved by an IRB panel. C. The language of the consent form must be understandable. D. The confidentiality of data collected must be protected.
A Prison populations are considered vulnerable populations and may not be selected unless this population is clearly appropriate for the study. Vulnerable populations may not be chosen simply for the sake of convenience. Although the study must be approved by an IRB panel, there is an ethical concern that must be addressed before the proposal is submitted to the IRB. Although the language of the consent form must be understandable, there is an ethical concern that must be addressed before potential subjects are recruited. Although the confidentiality of the data collected must be protected, there is an ethical concern that must be addressed before data are collected.
Which basic human right states that justification for use of vulnerable subjects must be provided? A. Right to self-determination B. Right to privacy and dignity C. Right to anonymity and confidentiality D. Right to fair treatment
A Right to self-determination is the basic human right that states that justification for use of vulnerable subjects must be provided.
Which are elements of assent? (Select all that apply.) A. Comprehension of the basic purpose of the research B. An ability to express a preference regarding participation C. Overall purpose of the study D. Letter from pediatrician
A, B Comprehension of the basic purpose of the research, an ability to express a preference regarding participation, and basic understanding of what the child will be expected to do are all elements of assent. A letter from the pediatrician is not required for assent.
Which ethical principle specifies that persons must be respected and protected from harm? A. Respect for persons B. Beneficence C. Justice D. HIPAA disclosure
B Beneficence specifies that persons must be respected and protected from harm.
What occurs when a research study involves subjects who are age 16 years? A. Subjects can render their own consent. B. Parental permission is necessary. C. Only legally declared emancipated minors may participate. D. Consent is necessary only if the study poses a substantial risk to subjects.
B Parental permission is necessary for subjects younger than 18 years. Subjects younger than 18 years cannot render their own consent. Subjects younger than 18 years can participate, but they cannot render their own consent unless they are legally declared emancipated minors. Consent is always necessary.
Which ethical principle is violated when a benefit to which a person is entitled is denied without good reason or when a burden is imposed unduly? A. Respect for persons B. Beneficence C. Justice D. HIPAA disclosure
C Justice is the ethical principle violated when a benefit to which a person is entitled is denied without good reason or when a burden is imposed unduly.
Which basic human right states that individual identities of subjects will not be linked to the information they provide or be publicly divulged? A. Right to self-determination B. Right to privacy and dignity C. Right to anonymity and confidentiality D. Right to fair treatment
C Right to anonymity and confidentiality is the basic human right that states individual identities of subjects will not be linked to the information they provide and will not be publicly divulged.
Which statement is true about informed consent? A. This requirement is satisfied by giving a research participant a consent form. B. Data from patients' records can be used regardless of the willingness of the patient to participate if the data are kept confidential. C. The consent form must be written at an eighth-grade level. D. The presence of a witness is mandatory.
C The consent form must be written so that it is easily understood by participants, regardless of their educational background. Simply giving a participant a consent form to sign does not constitute informed consent. Steps must be taken to ensure that the participant understands the information included in the consent form. Patients have the right to privacy and must authorize the use of their private medical records. The presence of a witness is not always necessary.
Which situation is an example of coercion? A. People become research subjects and are exposed to research treatments without being aware of it. B. Subjects are misinformed about the purpose of the research. C. Subjects feel that their case will be adversely affected if they refuse to participate in a research study. D. Subject responses can be linked with their identity.
C When subjects fear reprisal or withholding of benefits related to their decision to participate in research, they are feeling coerced.
Which basic human right states that people should be treated fairly and should receive what they are due or owed? A. Right to self-determination B. Right to privacy and dignity C. Right to anonymity and confidentiality D. Right to fair treatment
D Right to fair treatment is the basic human right that states people should be treated fairly and should receive what they are due or owed.
The careless treatment of research subjects, without consideration of physical or psychological harm, is a violation of which basic human right? A. Right of informed consent B. Right of self-determination C. Right to fair treatment D. Right to protection from discomfort and harm
D This is a breach of the right to protection from discomfort and harm. The right of informed consent refers to the right of the participant to know about the study, its importance, the rights of participants, and risks and benefits of participation. The right of self-determination refers to the right to choose whether or not to participate. The right to fair treatment refers to treating participants fairly and giving them what they are owed or due.
