Ethical Dilemmas in Human Subject Research: Protecting Identity and Confidentiality, Exams of Marketing Business-to-business (B2B)

Download Ethical Dilemmas in Human Subject Research: Protecting Identity and Confidentiality and more Exams Marketing Business-to-business (B2B) in PDF only on Docsity! lOMoAR cPSD|38783425 l | MAN542S BUSINESS RESEARCH METHODS TEST EXAM Questions and Answers Already graded A+ 2024 You correctly answered 5 out of 5 questions from the questionnaire. Question 1 The failure of the researcher to protect research subjects from deductive disclosure of identity (i.e., re-identification of subjects by other researchers) is the main ethical violation in which of the following studies? Your Answer Study "Tastes, Ties and Time (T3)" Result Correct Comment Although no students were identified by name in the T3 study, some data were specific enough to allow re-identification of students by an outside researcher. This is an example of the lack of protection of subjects from the deductive disclosure of their identities. The main ethical problems of the other studies include physical damage and unforeseen psychological damage. Question 2 Which of the following studies is most directly related to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for the protection of human beings? Your Answer HHS Tuskegee Study Result Correct Comment In the United States, the news that researchers deceived and withheld the treatment of subjects suffering from syphilis in the PHS Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects from Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission took it upon itself to establish a U.S. research code of ethics for U.S. research involving human beings and created the Belmont Report which ultimately informed federal regulations for the protection of human beings. The Tearoom Trade Study and the Stanford Prison Experiment occurred before the codification of federal regulations but are not directly related to the establishment of the National Research Act of 1974. lOMoAR cPSD|38783425 The T3 study occurred after the codification of federal regulations. Question 3 Humphreys' data collection for the Tearoom Trade studio under the pretext that it was a lookout is an example of a violation of the principle of: Your Answer Respect to people Result Correct Comment Humphreys' data collection for the Tearoom Trade studio while posing as a checkpoint is an example of a violation of the principle of respect for people. Respect for people requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent). The principle of beneficence requires balancing the risk of harm with potential benefits. The principle of justice requires that benefits and burdens be equitably distributed and that subject populations are not chosen for convenience. Question 4 A researcher submits a study to the IRB that proposes to evaluate a new after-school online tutoring program for middle school students in a local school district that examines the effect on students' grades. She proposes to do this evaluation at the school her children attend, because she is familiar with the school district. Students can use their personal smartphone or computer to participate in the program. Could this study be determined to be violating which principle of the Belmont Report? Your Response Justice Result Correct Comment This proposal would violate the principle of fairness that requires that the benefits and burdens of research be equitably distributed and that subject populations not be chosen for convenience. Choosing a single school your children attend could be seen as a population of convenience. Evaluating the program at multiple schools in a school district could avoid this problem. If schools in the district have wide variations in household incomes, this study could eliminate students from less affluent families without access to internet service and electronic tools, by failing to ensure that the benefits and burdens of research are equitably distributed. The principle of charity requires that the risks be reasonable in relation to the expected benefits. The principle of respect for individuals requires subjects to understand that participation is voluntary and to be provided with detailed information about the study before giving consent to participate. lOMoAR cPSD|38783425 Question 2 Your informed consent form must describe . Your Answer All foreseeable risks and discomforts. Result Correct Comment Under federal regulations, the informed consent form must describe all foreseeable risks and discomforts. Question 3 Where could student researchers and/or subject students find additional resources regarding the IRB approval process? Select all that apply. Your Answers- Faculty Advisor/Research Mentor Result Correction Correct Answer- Advisor of the Faculty/Research Mentor - IRB Office Comment Student researchers can find resources on various websites dedicated to human subject research, including their institution's human subject protection website (if applicable). They can also contact their faculty advisor and IRB office for immediate assistance. Some institutions have a staff member or student mentor specifically tasked with assisting student researchers during the IRB process. Question 4 One student plan to interview 15 principals at neighboring high schools. The student plans to collect data on personal experiences principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have made personally) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on directors' careers. The student will collect identifiers. Would this study be subject to what kind of review? lOMoAR cPSD|38783425 Your Response Review Called Result Correct Comment This study would qualify for the review called because the IRB must carry out a careful analysis. The study consists of an interview in which the data collected could have an impact on directors' careers and contains subject identifiers. Question 5 Under the regulations of the U.S. Department of Health and Human Services (HHS, for its freedoms, for its human beings, and the U.S. Food and Drug Administration (FDA), what is the Institutional Review Board (IRB) responsible for? Select all that apply. Their Answers- Protect the rights and well-being of human beings. - Ensure that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. - Review of materials and strategies for recruiting subjects. Result Correct Comment Under the regulations of the U.S. Department of Health and Human Services (HHS, for its thanks to the U.S. Food and Drug Administration, for its part, the IRB) is responsible for protecting the rights and well-being of human subjects and for reviewing and supervising the research of human subjects. IRBs do not investigate scientific misconduct or review manuscripts prior to submission for publication. You correctly answered 5 out of 5 questions from the questionnaire. Question 1 According to federal regulations, the accelerated review process can be used when study procedures raise: Your Answer There is nothing more than minimal risk and research activities fall within the regulatory categories identified as eligible. Result Correct lOMoAR cPSD|38783425 Comment Research is eligible for accelerated review when it poses no more than minimal risk to participants and when all activities fall within the categories identified as eligible. Studies with more than minimal risk do not qualify for accelerated review, even if the subjects are adults, the sponsor is in a hurry, or the study replicates previously approved research. Question 2 Continuous review of an approved and ongoing study that poses more than minimal risk that was initially approved by a convened IRB: Your Response Must occur within 12 months of the date of approval. Result Correct Comment The continuous review of an approved protocol must take place within 12 months of the date of approval, even if no additional risks have been identified. Review by a convened IRB is not always required (e.g., if the study was complete and only in data analysis). Any unforeseen issues should be addressed during the ongoing review process, but the review should include other information, such as the number of topics accumulated, any relevant recent literature, and a copy of the current consent form. Question 3 According to federal regulations, research is eligible for exemption, if: Your Answer Investigation falls into one of the eight categories of research activities described in the regulation. Result Correct Comment Research is only eligible for exemption if all activities associated with the research fall into one of the eight categories of activities outlined in federal regulations. Regulations allow some research with children to be exempt (although institutional policy may not be). The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption. lOMoAR cPSD|38783425 Where a possible disclosure of subjects' responses is the main source of potential harm, the collection of data anonymously can provide the best protection and the removal of direct identifiers is an additional safeguard. The other responses are additional safeguards but refer to studies that may involve investigational drugs or that are biomedical and not social behavioral. Question 4 A researcher wants to study generational differences in coping mechanisms among adults who experienced abuse as children. Appropriate measures shall be instituted to obtain informed consent and ensure that confidentiality is not violated. The most likely additional risk is that some subjects may: Your Response Experiment emotional or psychological distress. Result Correct Comment Some subjects may experience emotional or psychological distress. The fact that the subjects have consented to participate in the study makes it unlikely that they will feel that their privacy is being invaded. Because confidentiality procedures have been incorporated into the protocol, it is also unlikely that subjects will be able to lose legal status or employment. Question 5 Which statement about risks in social and behavioral science research is more accurate: Your Answer Risks are specific to time, situation, and culture. Result Correct Comment Research in the social and behavioral sciences sometimes poses risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive topic or topic at a given time and/or place may not be at another time and/or place. The risk of emotional distress cannot be managed by anonymizing the data, but by developing a plan to respond to distress should it occur. Risks should always be minimized as much as possible, regardless of the potential for benefit. You correctly answered 5 out of 5 questions from the questionnaire. Question 1 lOMoAR cPSD|38783425 AskA therapist at a free college clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes the use of the data she has and will collect about children for a case-based research project. Which of the following statements about parental permission is correct? Parents of children may feel pressure to give the therapist permission to use their children's data so that she continues to provide services to their children. Result Correct CommentWhen a caregiver becomes a researcher, both child clients and their parents may not feel free to choose not to participate in the provider's study. An investigator who is also a care provider should be very clear that the decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to his clients' records as a physician does not entitle him to use the information in the records for research purposes without parental permission and the child's consent. Permission from a school authority to conduct research does not replace the need for permission or consent. Finally, the right of children to choose cannot be overridden in the pursuit of an indeterminate Community interest. Question 2 QuestionA general requirement for informed consent is that no informed consent can include any exculpatory language. Exculpatory language is one that waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the investigation from negligence liability. Which of the following statements in the form of consent is an example of exculpatory language? Your Response Participating in the investigation is voluntary, but if you choose to participate, you waive the right to legal redress for any injury related to the investigation. Result Correct CommentA statement on a consent form that subjects who agree to participate in research waive their legal rights constitutes exculpatory language. Statements about the voluntary nature of consent, about the possible need to remove subjects from a study to protect their well-being, and statements about the provision of references do not waive the rights of subjects. Question 3 QuestionOne criterion for waiving informed consent is that, where appropriate, subjects receive additional pertinent information after the study. In which of the following studies it would NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic evaluated by members of the research team. Result Correct lOMoAR cPSD|38783425 If subjects learned that the research team assigned them to study conditions based on undesirable or unflattering physical characteristics, the knowledge that their appearance was judged negatively by the research team could be very distressing and therefore it would not be appropriate to inform subjects after the study about how they were assigned. Informing subjects about the actual research procedures in the other studies would be unlikely to cause them harm. Question 4 Question an exemption from the informed consent documentation requirement may be granted when: The only record linking the topic and research is the consent document and the main risk is a breach of confidentiality. Result Correct CommentThe requirement to document informed consent may be waived if the only record linking the topic and research is the consent document and the main risk is a breach of confidentiality. The requirement may also be waived if the study poses no more than minimal risk to the subjects and does not involve procedures for which written consent is normally required outside the context of the research. With respect to non-English speakers, if documentation is required, researchers must provide informed consent materials in the subjects' language. If a researcher anticipates that subjects might be embarrassed by the questions, this concern should be addressed in the consent process. Finally, the identification of a secure storage space for consent forms is the responsibility of the researcher. Question 5 QuestionAs part of the consent process, federal regulations require researchers to: Your Response provides potential subjects with information at the appropriate reading comprehension level. Result Correct CommentResearchers should provide information to subjects in a way that facilitates understanding. Therefore, the material should be written at the appropriate level of reading comprehension. Investigators cannot impose penalties for non-participation because doing so would violate the ethical principle of respect for people. In some circumstances, it may be appropriate to ask subjects to discuss the research with their families before deciding on whether or not to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of IRB members who reviewed the research. You correctly answered 3 of 5 questions from the questionnaire. Question 1 The data is made anonymous by lOMoAR cPSD|38783425 Comment No agreement on confidentiality was reached with the subjects who were unknowingly recorded in audio; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement on confidentiality, but the right of the subjects to decide who can access their personal information was violated. If an investigator tells subjects that only he or she would have access to identifiable data and then gives identifiable data to others, that action constitutes a breach of confidentiality and a violation of privacy, the right of subjects to control who has access to personal information. You correctly answered 4 out of 5 questions from the questionnaire. Question 1 Which of the following online research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A researcher proposes to join a moderate support group for cancer survivors posing as survivors. She plans to insert comments to see how members respond. Result Correct Comment The study in which the researcher impersonates a cancer survivor involves deception and research without any informed consent process. Therefore, the study raises concerns about the ethical principle of respect for people. Any compromise of principle must be justified by any scientific benefit derived from the study. When a support group or blog is open to each and every reader, it can be argued that published communications are not intended to be private and can therefore be observed and recorded without informed consent. The researcher studying interracial adoptees used the Internet in a manner comparable to posting a brochure on a bulletin board. Question 2 Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey on a sensitive personal topic remains voluntary throughout a study? lOMoAR cPSD|38783425 Your Answer Dar examples in the consent process of the types of questions to be asked. Result Correction Correct AnswerDesign the survey so that subjects are not forced to answer one question before moving on to the next. Comment Voluntary participation in research includes the right to withdraw from a study at any time and the right to opt out of answering questions. Online surveys that force subjects to answer one question before moving on to the next one violate the requirement that all participation in research be voluntary. Providing contact information for the researcher, privacy policies, and survey description are important, but do not address the requirement. Question 3 To minimize the potential risks of harm, a researcher conducting an online survey can: Your Answer Did the survey so that no direct or indirect identifiers are collected. Result Correct Comment In most Internet-based research, the main risk of harm is a breach of confidentiality. A simple way to help maintain the confidentiality of a subject's identity is not to collect direct or indirect identifiers. Suggesting that subjects should print a copy of the informed consent form does not protect them from an inadvertent violation of identifiable responses. Similarly, compliance with the Terms of Service does not protect against a breach. It must be specified that all subjects are of legal age does not guarantee compliance. Question 4 Researchers striving to conduct an online study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is: Individuals may post privately identifiable information about themselves online without the intention of making it public and available to researchers. Result Correct Comment Information posted online could possibly be accessible to anyone with an Internet connection. However, individuals may post their privately identifiable information online without the intent lOMoAR cPSD|38783425 of making this information public. Privately identifiable information that can be accessible to anyone can create the potential for several different risks of harm to subjects who may not be aware that their information is public. Assuming a pseudonymous online identity poses no risk of harm to subjects. While it is true that researchers can recruit, consent and inform subjects online with little or no interaction, this, would also not pose any risk of harm to subjects. Similarly, waiving consent documentation does not pose any potential risk of harm to subjects and is not unique to Internet-based research. Question 5 Which of the following methods could be considered a "best practice" in terms of informing respondents how their responses to an online survey about personal information will be protected? The researcher uses the informed consent process to explain how respondents' data will be transmitted from the website to its encrypted database without ever recording respondents' IP addresses but explains that confidentiality cannot be absolutely guaranteed on the Internet. Result Correct Comment Although there are no guaranteed methods to ensure absolute confidentiality of research data collected online, some Internet-based research experts have identified "best practices" to describe commonly accepted confidentiality protections, such as including explanations about how data is transmitted from the subject to the researcher, how the researcher will maintain and secure the data. Consent processes should also include a discussion to emphasize that there is no way to guarantee absolute confidentiality if the data is personal or sensitive in nature. You correctly answered 5 out of 5 questions from the questionnaire. Question 1 A researcher is interested in evaluating risk-taking by individuals. The investigator is sitting on a bench near a busy four-way intersection. She plans to record the number of cyclists wearing a safety helmet and whether they stop at the intersection before proceeding to correlate wearing safety clothing with risk-taking. This collection of information is an example of: Your Response Public behavior Result Correct