Chapter 4 - Ethical Considerations in Research
A nurse is conducting a study of the effectiveness of a pain medication following surgery. The treatment group is given the pain medication and the comparison group is given a placebo pill. This is an example of which of the following? a. Anonymity b. Complete and/or incomplete disclosure c. Confidentiality d. Privacy
Answer: B In some studies, the nature of the study requires incomplete disclosure of information about the study when obtaining informed consent. Not informing subjects whether they are in the treatment or the comparison group in a study is an example of incomplete disclosure. After the study is completed, the subjects must be debriefed and provided complete disclosure of information about the study that was omitted during the consent process. This is also an unethical study under the principle of beneficence. Subjects must receive the basic standard of care. Patients would need some type of pain medication postoperatively and not a placebo as a comparison.
A study that involved a chart review to obtain information about a patient's smoking history, age, gender, and incidence of cardiovascular disease would usually require which of the following types of review by an institutional review board (IRB)? a. Complete review b. Exempt from review c. Expedited review d. Review by the researcher only
Answer: B Studies that involve the collection or examination of existing data, documents, records, or pathological specimens are usually determined to be exempt from review by the chair or a member of the IRB. In addition, studies that have no apparent risks for the subjects are usually designated as exempt from IRB review by the chair or a member.
Based on the Belmont Report ethical principles, which principle encourages the researcher to "do good and above all do no harm"? a. Autonomy b. Beneficence c. Justice d. Respect of persons
Answer: B The principle of beneficence encourages the researcher to do good and, above all, do no harm. Autonomy means having the freedom to conduct their lives as they choose, without external controls. The principle of justice states that human subjects have a right to fair treatment. The principle of respect for persons indicates that people should be treated as autonomous agents, with the right to choose whether or not to participate in research and to withdraw from a study.
A researcher was collecting data on the sexual activities of a group of college students living in a dormitory on campus. The students were not aware that they were being studied. This is an example of which of the following? a. Breach of confidentiality b. Covert data collection c. Diminished autonomy d. Risk of permanent damage
Answer: B With covert data collection, subjects are unaware that research data are being collected. A breach of confidentiality can occur when a researcher, by accident or direct action, allows an unauthorized person to gain access to the raw data of a study. Persons have diminished autonomy when they have impaired decision-making due to medications, mental illness, or mental capacity. The responsible researcher designs the study to minimize discomfort and the risk of harm for potential subjects, as well as protect their rights to self-determination, privacy, confidentiality, and fair selection and treatment.
A researcher desires to study the lived experience of recently incarcerated pregnant prisoners. This study would most likely require which level of review? a. Exempt b. Expedited c. Complete d. Minimal
Answer: C A complete review is required when a study contains greater than minimal risks to its participants. Vulnerable populations require safety mechanisms to minimize risks, ensure informed consent is sought appropriately, and a plan is in place to promote safety and privacy. Studies that are exempt from review pose no apparent risks to the research subjects. Studies may meet the criteria to receive an expedited review if they carry some risks, but the risks are minimal.
What type of scientific misconduct involves the intentional representation of the work or ideas of others as one's own? a. Fabrication or falsification of study steps b. Irresponsible collaboration c. Plagiarism d. Selective retaining or manipulation of data
Answer: C Research misconduct is a serious ethical problem that includes plagiarism, falsification and fabrication of data, and duplicate publication. Plagiarism is the intentional representation of the work or ideas of others as one's own. Fabrication or falsification of study steps means the deliberate invention of nonexistent information or the misrepresentation of information for a study.
Which of the following unethical studies involved the U.S. Public Health Service studying syphilis in African American men over a 40-year period? a. Jewish Chronic Disease Hospital study b. Nazi medical experiments c. Tuskegee study d. Willowbrook study
Answer: C The Tuskegee syphilis study was conducted to determine the natural course of syphilis in adult black men. The study continued into the 1970s, well after an effective treatment for syphilis had been developed. The Jewish Chronic Disease Hospital study was conducted on older adults who had dementia. In this study, consenting participants were injected with liver cancer cells and examined for response to the cells. Nazi human experimentations were medical experiments on prisoners without their consent, mainly Jews (including Jewish children) from across Europe. The Willowbrook study was conducted from the mid1950s to the early 1970s at Willowbrook Institution for the Mentally Retarded in New York and involved deliberately infecting children with the hepatitis virus.
A study that requires a diabetic patient to do one more blood glucose level per day has what level of discomfort for the subject? a. No anticipated effects b. Risk of permanent damage c. Temporary discomfort d. Unusual levels of temporary discomfort
Answer: C The diabetic patient experiences temporary discomfort when asked to do one more blood glucose level per day during a study. Temporary discomfort is similar to the discomfort the subject would experience in his or her daily life, and ceases with the termination of the experiment.
Match the description with the essential information considered when researchers obtain informed consent from potential participants. Sharing descriptions of appropriate alternative procedures of courses of treatment with potential benefit to the subjects: a. Competency to give consent b. Consent to incomplete disclosure c. Disclosure of alternatives d. Description of benefits e. Offer to answer questions f. Option to withdraw g. Description of risks and discomforts h. Explanation of procedures i. Voluntary participation
Answer: C The investigator discloses the appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subjects.
Which of the following are essential element(s) of informed consent? a. Competency to give consent b. Comprehension of essential study information c. Disclosure of essential information regarding the study d. All the above
Answer: D All the above are correct because the essential elements of informed consent are disclosure of essential information regarding the study, comprehension of this information, competency to give consent, and consent given voluntarily.
In qualitative research, what is the primary reason for not identifying the subjects by name in the transcripts? a. To ensure fair treatment of the subjects during data analysis b. To prevent diminished autonomy of the subjects c. To promote fair selection of the subjects during the data collection process d. To protect the subjects from a breach of confidentiality
Answer: D Qualitative studies often have very limited numbers of subjects by design, and researchers take additional precautions to prevent a breach of confidentiality. A breach of confidentiality can occur when a researcher, by accident or direct action, allows a subject to be recognized by an unauthorized person during data collection or analysis or in the published study.
Mary Jane Smith is mentally retarded and has been asked to participate in a study. Her diminished autonomy must be managed if she is to participate in a study. This characteristic is directly linked to which of the following human rights? a. Confidentiality b. Fair treatment c. Privacy d. Self-determination
Answer: D Right to self-determination is based on the principle of respect for persons and indicates that humans are autonomous agents who are capable of controlling their own destiny. However, some persons have diminished autonomy because of legal or mental incompetence, terminal illness, or confinement to an institution and must have special protection of their right to self-determination when participating in a study. In the example, Ms. Smith can assent to participate in the study, but her legal guardian must give consent for her participation. Confidentiality is the researcher's safe management of information or data shared by a subject to ensure that the data are kept private from others. The right to fair selection and treatment is based on the ethical principle of justice. Privacy is the freedom people have to determine the time, extent, and general circumstances under which their private information will be shared with or withheld from others.
Which of the following unethical studies involved deliberately infecting children with the hepatitis virus? a. Jewish Chronic Disease Hospital study b. Nazi medical experiments c. Tuskegee study d. Willowbrook study
Answer: D The Willowbrook study was conducted from the mid-1950s to the early 1970s at Willowbrook Institution for the Mentally Retarded in New York and involved deliberately infecting children with the hepatitis virus. The Jewish Chronic Disease Hospital study was conducted on older adults who had dementia. In this study, consenting participants were injected with liver cancer cells and examined for response to the cells. Nazi human experimentations were medical experiments on prisoners without their consent, mainly Jews (including Jewish children) from across Europe. The Tuskegee syphilis study was conducted to determine the natural course of syphilis in adult black men. The study continued into the 1970s, well after an effective treatment for syphilis had been developed.
Match the description with the essential information considered when researchers obtain informed consent from potential participants. Description of any benefits to the subjects or to other people or future patients that may reasonably be expected from the research: a. Competency to give consent b. Consent to incomplete disclosure c. Disclosure of alternatives d. Description of benefits e. Offer to answer questions f. Option to withdraw g. Description of risks and discomforts h. Explanation of procedures i. Voluntary participation
Answer: D The investigator describes any benefits to the subjects or to other people or future patients that may reasonably be expected from the research, including any financial advantages or other rewards for participating in the study.
Match the description with the essential information considered when researchers obtain informed consent from potential participants. The researcher offers to answer any questions the prospective subjects may have. a. Competency to give consent b. Consent to incomplete disclosure c. Disclosure of alternatives d. Description of benefits e. Offer to answer questions f. Option to withdraw g. Description of risks and discomforts h. Explanation of procedures i. Voluntary participation
Answer: E The researcher offers to answer any questions the prospective subjects may have.
Match the description with the essential information considered when researchers obtain informed consent from potential participants. Prospective subjects receive a complete description of the procedures to be followed and identification of any procedures that are experimental in the study. a. Competency to give consent b. Consent to incomplete disclosure c. Disclosure of alternatives d. Description of benefits e. Offer to answer questions f. Option to withdraw g. Description of risks and discomforts h. Explanation of procedures i. Voluntary participation
Answer: H Prospective subjects receive a complete explanation of the procedures to be followed and identification of any procedures that are experimental in the study.
When a subject's identity cannot be linked, even by the researcher, with his or her individual response, this subject is said to have which of the following? a. Anonymity b. Complete and/or incomplete disclosure c. Confidentiality d. Privacy
Answer: A A subject has anonymity when his or her identity cannot be linked, even by the researcher, with his or her individual responses. When the researcher does know the identities of the subjects and can link them to their individual responses they must maintain confidentiality. Confidentiality is the researcher's management of private data in a study so subjects' identities are not linked with their responses by others.
Subjects with diminished autonomy require what type of documentation of informed consent? a. Formal written consent form b. Short-form written consent form c. Tape recording of consent process d. Videotaping of the consent process
Answer: A A written, formal consent document with the essential elements of informed consent is required by the U.S. Department of Health and Human Services for subjects with diminished autonomy.
A homeless person was offered $100 to participate as a subject in a study. Offering this large amount of money might be interpreted as which of the following? a. Coercion b. Covert subject selection c. Deception d. Invasion of privacy
Answer: A Coercion occurs when one person intentionally presents an overt threat of harm or an excessive reward to another person to get him or her to participate in a study. With covert data collection, subjects are unaware that research data are being collected. The use of deception, the actual misinforming of subjects for research purposes, can also violate a subject's right to self-determination. An invasion of privacy occurs when private information is shared without a person's knowledge or against his or her will.
Researchers exaggerated the number of subjects in their study and indicated that their sample size was 100 when it was only 50. This is an example of what type of scientific misconduct? a. Fabrication or falsification of study steps b. Irresponsible collaboration c. Plagiarism d. Selective retaining or manipulation of data
Answer: A Fabrication or falsification of study steps means the deliberate invention of nonexistent information or the misrepresentation of information for a study. In this example, the sample size is misrepresented, and the data for the extra subjects would be fabricated. Research misconduct is a serious ethical problem that includes plagiarism, falsification and fabrication of data, and duplicate publication. Plagiarism is the intentional representation of the work or ideas of others as one's own.
A nurse was conducting a study of the lipid levels in a group of Hispanic women. All subjects were given the values of their lipids (high-density lipoprotein [HDL], low-density lipoprotein [LDL], and total cholesterol) and their cardiovascular (CV) risk level. This is an example of which of the following? a. Benefits of the study b. Elimination of risks from the study c. Fair treatment in selection of subjects d. Risks of the study
Answer: A Having knowledge of the lipid values and the CV risk level would be considered benefits of this study. Subjects would be provided this information about their health and could use this information in managing their CV health.
Match the description with the essential information considered when researchers obtain informed consent from potential participants. Prospective subjects should know the extent to which their responses and records will be kept confidential. a. Competency to give consent b. Consent to incomplete disclosure c. Disclosure of alternatives d. Description of benefits e. Offer to answer questions f. Option to withdraw g. Description of risks and discomforts h. Explanation of procedures i. Voluntary participation
Answer: A Prospective subjects should know the extent to which their responses and records will be kept confidential. Subjects are promised that their identity will remain anonymous in reports and publications of the study.
Which ethical code or regulation had a major focus on differentiating therapeutic research from nontherapeutic research? a. Declaration of Helsinki b. Department of Health, Education, and Welfare 1973 Regulations of the Protection of Human Research Subjects c. National Commission for the Protection of Human Subjects of d. Biomedical and Behavioral Research d. Nuremberg Code
Answer: A The Declaration of Helsinki defined therapeutic research as research that provides patients with an opportunity to receive a treatment that might have beneficial results. Nontherapeutic research is conducted to generate knowledge for a discipline; the results of the study might benefit future patients, but will probably not benefit those acting as research subjects. The Nuremberg Code includes guidelines that should help you evaluate the consent process, protection of subjects from harm, and balance of benefits and risks in a study. The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Following the Belmont Report, federal regulations to protect human research subjects were developed and continue to be updated as needed, most recently in 2017.
Which of the following are parts of balancing benefits and risks for a study? Select all that apply. a. Assessing the benefits of the study b. Assessing the risks of the study c. Eliminating all risks of the study d. Maximizing the benefits of the study
Answer: A, B, D Assessing benefits, maximizing benefits, and assessing risks of the study are all part of the benefit-risk ratio. Eliminating all risks is not part of the process, because most risks can only be minimized and often cannot be eliminated.
Which of the following potential research subjects have diminished autonomy and are incompetent to give informed consent? a. Adult patients in a clinic b. Children c. College students over 18 d. Older in a nursing home
Answer: B Children are people with diminished autonomy who are incompetent to give informed consent and need a legal guardian to give consent for their participation in a study. A child older than 7 years of age needs to be given the opportunity to assent to participate in a study.
