CITI Social & Behavioral Research - BasicRefresher Social & Behavioral Research - Basic-Refresher

docx

School

University of Phoenix *

*We aren’t endorsed by this school

Course

SSGS500

Subject

Psychology

Date

Dec 6, 2023

Type

docx

Pages

Uploaded by ChancellorPowerPuppy26

CITI Social & Behavioral Research - Basic/Refresher Belmont Report and Its Principles Question 1 Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Your Answer Determining that the study has a maximization of benefits and a minimization of risks. Comment The principle of beneficence includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being" (The National Commission 1979). The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. Ensuring the selection of subjects is equitable is an example of applying the principle of justice. Question 2 Which of the following are the three principles discussed in the Belmont Report? Your Answer Respect for Persons, Beneficence, Justice Comment The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice. Question 3 The Belmont Report’s principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Your Answer Persons with diminished autonomy are entitled to protection. Comment The Belmont Report’s principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. Persons with diminished autonomy should not be excluded from participating in research, because then they would be excluded from receiving the benefits of research. The Belmont Report does not limit persons with diminished autonomy with participating in greater than minimal risk research. The Belmont Report also does not limit persons involved in research from benefitting financially. Defining Research with Human Subjects – SBE Question 1 According to the federal regulations, which of the following studies meets the definition of research with human subjects? Your Answer A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

Comment A cognitive scientist studying the effect of moods on problem-solving behaviors is asking a research question and is interacting with living individuals. Questioning a superintendent of schools to acquire data about the ethnic composition of a school system is asking "about what" questions rather than "about whom" questions (if a study proposed interviewing the superintendent of public schools about his or her experience in the field of education or about his or her perceptions about the current problems within the school system and possible solutions, the questions would become "about whom"). Analyses of public behavior such as writing for a blog or a newspaper do not meet the definition because there is no interaction or intervention with a human subject and no collection of private information. Finally, in the class exercise described, the intention is pedagogical (to learn how to conduct and interview) rather than to answer a research question. Question 2 According to the federal regulations, which of the following studies meets the definition of research with human subjects? Your Answer An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. Comment In the study of the effects of evoking stereotypes on subsequent performance, the researcher has a research question and will be manipulating the behavior of individuals. An in-house study conducted with the intention of improving a department's mentoring programs is not research with human subjects, but rather program improvement. Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects. Question 3 A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of: Your Answer Public behavior Comment Public behavior occurs in a place where one does not reasonably expect privacy. The riders here are observed on public streets. These observations are public behavior. If the observation and recording of similar information occurred in a private training facility it could be considered private behavior and private information. Examples of public information would be donor lists in a concert program or names and addresses in telephone directories. Private information includes information that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Question 4 According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Your Answer A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. Comment The study of passenger lists is a study of individuals who are no longer living. A human subject is a living individual. Questioning individuals to acquire data about the number of newly diagnosed HIV cases is asking "about what" questions rather than "about whom" questions. Conducting a linguistic analysis of comments posted on a public blog involves neither interaction with individuals nor collecting private identified information and thus does not meet the definition of research with human subjects. The study proposed by the developmental psychologist does meet the definition of research with human subjects. It involves interactions with living individuals and is designed to contribute to a field of knowledge. Question 5 A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of: Your Answer Public information Result Correct Comment Census data is a public source of data. The summarized data presented are available to individuals via the web without requiring a password.. When an individual completes the census form, there is no expectation that the data will remain private. Census data do not describe behaviors, but provide information about members of a given population. Students in Research Question 1 In the U.S., the first federal regulations for human subjects research began in 1991 with the codification of the ________. Your Answer Common Rule Comment The first federal regulations for human subjects protections was the Common Rule. The Nuremberg Code resulted from the 1940s Nuremberg Military Tribunal, during which Nazi physicians were convicted of unlawful experimentation on concentration camp prisoner. The Declaration of Helsinki (developed by the World Medical Association in 1964 and last revised in 2013) sets forth morally binding ethical principles for medical doctors engaged in biomedical research involving human subjects, as well as identifiable human biospecimens and data. The Belmont Report (The National Commission 1979) underscores similar ethical considerations for protecting human research subjects. In the United States, the Common Rule, which is the informal name of the U.S. Department of Health and Human Services (HHS) Policy for the Protection of Human Subjects (45 CFR 46, Subpart A) was codified in 1991 and revised in 2018. Question 2 Identify one way faculty researchers can possibly avoid undue influence of student subjects? Your Answer Avoid recruiting their own students in the research

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Comment By recruiting students from other classes, faculty researchers can minimize the potential of undue influence. Students from the faculty's own classroom may feel coerced to participate. Question 3 Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. Correct Answer - Protecting the rights and welfare of human subjects. - Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. - Reviewing subject recruitment materials and strategies. Comment Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, the IRB is charged with protecting the rights and welfare of human subjects and reviewing and overseeing human subjects research. IRBs do not investigate scientific misconduct nor do they review manuscripts prior to submission for publication. Question 4 Your informed consent form must describe _______. Your Answer All foreseeable risks and discomforts. Comment Per the federal regulations, the informed consent form must describe all foreseeable risks and discomforts. Question 5 A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review? Your Answer Determination for Exemption Comment This study would qualify for a determination for exemption (under Category 2). This exemption category states that any research study involving educational tests, surveys, interviews, or observations of public behavior can be deemed exempt, unless the data is recorded in a way that identifies human subjects, directly or through identifiers linked to the subjects, and disclosure of any human subjects' responses outside the research could reasonably place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation. Question 1 Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. Your Answers - Faculty Advisor/Research Mentor - IRB Office Comment

Student researchers can find resources on various websites dedicated to human subjects research, including their institution's human subject protections website (if applicable). They may also contact their faculty advisor and IRB office for immediate assistance. Some institutions have a staff member or student mentor specifically charged with assisting student researchers during the IRB process. Question 2 Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)? Your Answer Exempt Comment Exempt research is human subjects research that is "exempt" from the Common Rule provisions. Per federal guidance, the recommendation is that researchers should not be able to self-determine whether a study qualifies for exemption. Institutional policy should clearly designate who is responsible for making exemption determinations – and it could be an IRB member or experienced staff person with knowledge of the exemption categories and the research activity. Expedited and convened reviews both require IRB approval. Question 3 Your informed consent form must describe _______. Your Answer All foreseeable risks and discomforts. Comment Per the federal regulations, the informed consent form must describe all foreseeable risks and discomforts. Question 4 Which of the following studies would need IRB approval? Your Answer Studies collecting identifiable information about living individuals. Comment If a study intends to collect identifiable or information about a living individual, you would need IRB review and approval. History and Ethical Principles - SBE (ID 490) Question 1 A study was submitted to the IRB designed to evaluate the effect of background noise on an individual’s ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of: Your Answer Respect for persons Result Correct Comment The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of justice requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience.

Question 2 According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: Your Answer Justice Comment According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of justice. The principle of beneficence requires minimizing the risk of harms and maximizing the potential benefits. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent). Question 3 The researcher’s failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies? Your Answer "Tastes, Ties, and Time (T3)" study Comment Although no students were identified by name in the T3 study, some data were specific enough to allow for re- identification of students by an outside researcher. This is an example of the failure to protect subjects from deductive disclosure of their identities. The primary ethical problems of the other studies include physical harms and unanticipated psychological harm. Question 4 A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report? Your Answer Justice Comment This proposal would violate the principle of justice which requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience. Choosing a single school that her children attend might be viewed as providing a subject population of convenience. Evaluating the program in multiple schools across a school district could avoid this problem. If the schools in the district have wide variations in household income, this study might eliminate students from less affluent families without access to internet service and electronic tools, failing to ensure that benefits and burdens of research are equitably distributed. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. Question 5 Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Your Answer PHS Tuskegee Study Comment In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from syphilis in the PHS Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects and created the Belmont Report that ultimately informed federal regulations for the protection of human subjects. The Stanford Prison Experiment occurred prior to the codification of federal regulations, and is not directly linked to the establishment of the National Research Act of 1974. Defining Research with Human Subjects - SBE (ID 491) Question 1 According to the federal regulations, which of the following studies meets the definition of research with human subjects? Your Answer A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three- month period. Comment The study in the 4th grade classrooms about the relationship between the time of day reading is taught and reading comprehension does meet the definition of research with human subjects. The study is designed to contribute to generalizable knowledge about student performance and the research question can only be answered using a systematic investigation. Information collected by the playground designer does not involve any information about human subjects even though it does involve interaction between the designer and school staff. An analysis of aggregate data doesn't involve interactions with living individuals nor the collection of private identifiable data. An economic feasibility study will gather information from people with relevant information and expertise but does not meet the definition of research with human subjects, because the intention of the study is to answer "about what" questions rather than "about whom" questions. Question 2 A medical record is an example of: Your Answer Private information Comment A medical record is considered private because it includes identifiable information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. A medical record is not considered public information, nor is it considered a behavior. Private information includes information that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects per federal regulations (45 CFR 46.102(e)). Question 3 According to the federal regulations, which of the following studies meets the definition of research with human subjects? Your Answer A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. Comment The study of passenger lists is a study of individuals who are no longer living. A human subject is a living individual. Questioning individuals to acquire data about the number of newly diagnosed HIV cases is asking "about what" questions rather than "about whom" questions. Conducting a linguistic analysis of comments posted on a public blog involves neither interaction with individuals nor collecting private identified information and thus does not meet the definition of research with human subjects. The study proposed by the developmental psychologist does meet the definition of research with human subjects. It involves interactions with living individuals and is designed to contribute to a field of knowledge. Question 4 According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Your Answer Obtains, uses, studies, analyzes, or generates identifiable private information. Comment In order to meet the definition of research with human subjects a researcher must obtain data about a living individual through interaction or intervention or, alternatively, obtain individually identifiable private information. If a researcher obtains public information or de-identified information about individuals, and has not interacted or intervened with the individuals, those individuals are not considered human subjects for the purposes of the research. Question 5 A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members, and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB? Your Answer The IRB will not review this study because it is not research as defined by the federal regulations. Comment This proposal is obtaining data from human subjects, but this project is not research, because it is not "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." This project will not be reviewed by the IRB. The Federal Regulations – SBE Question 1

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Your Answer Must occur within 12 months of the approval date. Comment Continuing review of an approved protocol must occur within 12 months of the approval date even if no additional risks have been identified. Review by a convened IRB is not always required (for example, if the study was complete and in data analysis only). Any unanticipated problems must be addressed during the continuing review process, but the review must include other information such as the number of subjects accrued, any relevant recent literature, and a copy of the current consent form. Question 2 According to federal regulations, the expedited review process may be used when the study procedures pose: Your Answer No more than minimal risk and the research activities fall within regulatory categories identified as eligible. Comment Research is eligible for expedited review when it poses no more than minimal risk to the participants and when all the activities fall within categories identified as eligible. Studies with more than minimal risk do not qualify for expedited review even if the subjects are adults, the sponsor is in a hurry, or the study replicates previously approved research. Question 3 In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? Your Answer Prisoners Comment Prisoners are provided additional protections in the HHS regulations. The HHS regulations do not have specific additional protections for the elderly, for students, or for persons whose decision-making capabilities are impaired. Researchers may consider and the IRB may require additional safeguards for these populations. Question 4 Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Your Answer Officials of the institution may overrule an IRB approval. Comment If an IRB has disapproved a protocol, that disapproval may not be overturned by an institutional official or anyone at that institution, such as a department chair. However, an IRB-approved protocol may be subject to other reviews at the institution and may be disapproved (overruled). Question 5 According to the federal regulations, research is eligible for exemption, if: Your Answer The research falls into one of eight categories of research activity described in the regulations. Comment

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption. Assessing Risk – SBE Question 1 Identify the example of when situation and time are key to assessing risk of harm in a research study: Your Answer A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers (who are underage to purchase tobacco) in the United States Comment Purchasing tobacco products is illegal for persons under 21 years of age in the U.S., so any assessment of the risk of participating in the study for individuals will have to consider that the research may include an illegal activity and the risk would be dependent on legal situation of the study location. Question 2 A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: Your Answer Experience emotional or psychological distress. 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 would feel that their privacy was being invaded. Because confidentiality procedures have been built into the protocol it is also unlikely that the subjects might lose legal status or employment. Question 3 Additional safeguards that may be included in a social and behavioral study may include: Your Answer Remove all direct identifiers from the data as soon as possible. Comment When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral. Question 4 Risk of harm in social and behavioral sciences generally fall in three categories, which are: Your Answer Invasion of privacy, breach of confidentiality, and study procedures Comment Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally fall in. Invasions of privacy can occur if personal information is accessed or collected without the

subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction. Question 5 The primary purpose of a Certificate of Confidentiality is to: Your Answer Protect identifiable research information from compelled disclosure. Comment Certificates of Confidentiality protect sensitive information provided by research subjects from civil, criminal, or administrative subpoena. Informed Consent – SBE Question 1 A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? Your Answer The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. Comment When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a 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 her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest. Question 2 A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Your Answer Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. Comment A statement in a consent form that says that subjects who agree to take part in the 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 in order to protect their welfare, and statements about providing referrals do not waive subjects' rights. Question 3

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: Your Answer A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. Comment If subjects were to learn 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 A waiver of the requirement for documentation of informed consent may be granted when: Your Answer The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. Comment The requirement to document informed consent can be waived if the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The requirement may also be waived if the study poses no more than minimal risk to subjects and involves no procedures for which written consent is normally required outside of the research context. With regard to non-English speakers, if documentation is required, investigators must provide informed consent materials in the subjects' language. If a researcher anticipates that subjects might be embarrassed by questions, this concern should be addressed in the consent process. Finally, identifying secure storage space for consent forms is an investigator's responsibility. Question 5 As part of the consent process, the federal regulations require researchers to: Your Answer Provide potential subjects with information at the appropriate reading comprehension level. Comment Researchers must provide information to subjects in a manner that facilitates comprehension. Therefore, the material must be written at the appropriate reading comprehension level. Researchers may not impose penalties for non- participation because to do so would violate the ethical principle of respect for persons. In some circumstances it may be appropriate to ask subjects to discuss the research with their families before making a decision about whether to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of the IRB members who reviewed the research. Privacy and Confidentiality – SBE Question 1 In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? Your Answer Securing a Certificate of Confidentiality Comment

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection. Question 2 Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include: Your Answer All of the above Comment Reporting data in aggregate form can help protect the identity of subjects(but does not make the data anonymous). Keeping keys in secure locations and requiring members of the research team to sign confidentiality agreements are methods for protecting identifiable information. Researchers can also remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects. Question 3 Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects’ privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? Your Answer A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. Comment No agreements were made regarding confidentiality with the subjects who were unknowingly audio-taped; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement about confidentiality, but the subjects’ right to decide who can access their personal information was violated. If a researcher told 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 subjects’ right to control who has access to personal information. Question 4 A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? Your Answer There was neither a violation of privacy nor a breach of confidentiality. Comment The subjects’ privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality. Question 5

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? Your Answer The researcher cannot control what participants repeat about others outside the group. Comment It is not possible for a researcher to promise confidentiality in a focus group setting. Participants may choose to repeat sensitive information outside the group setting even if they have signed confidentiality agreements. This is true even if the participants know each other. Using pseudonyms in the report does not remove concerns about what group members might say outside the group. Research with Children – SBE Question 1 A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? Your Answer Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review. Comment Research involving children may be expedited if the level of risk is no more than minimal and if the research falls into a category of research identified as eligible for expedited review. Therefore, unless the nature of the topic would raise the level to more than minimal risk to the adolescent subjects, the study previously approved for adults through expedited review procedures would also be eligible for expedited review. It is not necessary for adolescents to have obtained some adult rights through emancipation procedures, nor must the reading level of the subjects be predetermined in order for a study involving minors to be eligible for expedited review. Consent forms, including the readability of the information, must always be tailored to the particular subject population of a study. Question 2 A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true? Your Answer This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting. Comment The exemption categories that may be used with children include observations of children in public settings, as long as the researcher does not participate in the activities being observed or record information in such a manner that the identity of the subjects can be readily ascertained. Research does not require full committee review when it involves children, unless it does not fall into an exempt or expedited category. Question 3 According to federal regulations, “children” are defined as: Your Answer Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Comment

According to the federal regulations, children are persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the United States, state law dictates the age of majority. In most states, the age of majority is 18. This means that a 17-year-old may be considered a child when applying the federal regulations for protecting research subjects. Question 4 Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Your Answer Federal regulations do not require the documentation of minors' assent. Comment The federal regulations do not require that child assent be documented. Therefore it is not necessary to request a waiver of a requirement to document assent. When an IRB determines that assent is required for a study, the IRB will also determine whether and how assent will be documented. The assent document does not require parental input or parental review. Question 5 According to Subpart D, research with children may be eligible for exemption under Category 2 when: Your Answer The research involves the use of educational tests Comment Subpart D restricts the use of exemptions when children are research subjects. Research that involves interviews, surveys, or participant observation when the researcher interacts with the children is not eligible for exemption under Category 2. Research in Public Elementary and Secondary Schools – SBE Question 1 Parental notification, in lieu of active parental permission, is allowed when: Your Answer An IRB has approved a waiver of the requirement for parental permission. Comment Parental permission must be secured or waived in accordance with criteria established by federal regulation. When a waiver has been approved, investigators may wish to, and IRBs may require, that parents be notified that the study will take place, giving them the opportunity to withdraw their children from the study. Parental notification can never be substituted for active parental permission if the criteria for a waiver have not been met. Question 2 Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? Your Answer The Family Educational Rights and Privacy Act. Comment A student's disciplinary status is part of his or her school record. In accordance with FERPA, schools must usually have written parental permission before they can release data from school records to researchers. The Protection of Pupil

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Rights amendment is concerned with the kinds of questions that may be included in surveys and interviews with minor school children. The No Child Left Behind Act is a specific amendment to PPRA that gives parents additional rights over the content of research materials. Subpart D of 45 CFR 46 is concerned with the rights of children as research subjects and does not regulate school systems. Question 3 In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools: Your Answer FERPA, PPRA, and Subpart D of the federal regulations Comment FERPA, PPRA, and Subpart D of the federal regulations also govern research in the public schools. Question 4 If research in a private school is directly funded by the Department of Education, then: Your Answer PPRA applies. Comment If research in a private school is directly funded by the Department of Education, PPRA applies, regardless of the risk level of the research (more than minimal or no more than minimal). A private school that does not receive any federal funding is not subject to the provisions of FERPA or PPRA. Question 5 Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? Your Answer Directory information. Comment Schools may disclose, without consent, directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that directory information is not protected, and they must allow parents and eligible students a reasonable amount of time to request that the school not disclose directory information about them. FERPA allows schools to disclose identifiable records without permission to certain parties, including organizations conducting research initiated by a school district or a state department of public instruction. International Research – SBE Question 1 A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations? Your Answer No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. Comment

No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. An institution is not engaged if its only involvement is to provide space for the U.S. researchers to conduct their own research. Question 2 A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? Correct Answer If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Comment A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution’s IRB or an institutional official – those decisions are left to institutional policy. Question 3 Which of the following is the least important activity when protecting human subjects in international research? Your Answer Assessing transportation conditions Comment It is essential that researchers have sufficient knowledge of the local research context to be able to design and carry out research in a way that protects the rights and welfare of the subjects. This includes knowledge about unique risks subjects might face given the local socio-economic conditions. Community consultation is particularly important when research has the potential to affect the community as a whole and when there are gatekeepers for the community (for example, a tribal council). Question 4 Which of the following activities constitutes engagement in research? Your Answer Obtaining informed consent and conducting research interviews. Comment If an institution obtains informed consent and conducts research interviews it is engaged in research. Question 5 A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB? Your Answer Will the researchers have collaborators at the research site abroad? Comment There are several factors that determine what kinds of review are needed for international research, including if the researchers have collaborators at the research site abroad. If international research is carried out without the involvement of foreign collaborators the research may be reviewed by the researcher’s home institution. The need for local review will be determined by policies and regulations rather than by U.S. law. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the

collaborating institution is engaged in the research. The other responses are incorrect because they do not help the IRB determine where the research should be reviewed. Question The age of majority in international research is determined by the Your Answer Laws, customs, and norms in the area in which the research will be conducted. Comment The age of majority should be the recognized age of majority in the country or region where the research takes place. Question What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? Your Answer In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Comment The points to consider when obtaining informed consent in non-U.S. settings include in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject may be asked to participate. These individuals may include a spouse, a head of household, or a group leader. However, another individual's permission should not substitute for a subject's voluntary informed consent unless an IRB or equivalent local review committee has waived that consent process. The witness signature line is an issue in documentation of informed consent; ensuring that the consent process does not slow down recruitment is an issue in study design and not a non-U.S. setting specific issue; and maintaining confidentiality is a privacy/confidentiality issue. Internet-Bases Research – SBE Question 1 Which scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study? Correct Answer The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, “If you agree to be in this study click below to begin.” Comment Informed consent is a two-step process—1) providing prospective subjects with information about a research study and 2) documenting that the information was provided. While individuals who enroll in a panel may have agreed to the panel’s registration agreement or terms of service, researchers should not assume these individuals have given permission to be subjects in all research projects. Similarly, the prevalence of bots in online studies does not excuse researchers from having to provide prospective participants with an informed consent process. Researchers would not be expected to secure consent from NPCs or avatar controlled by artificial intelligence, as they would not be considered “living humans.” Including a live button in on a consent process that requires subjects to actively demonstrate their consent to participate is one way of obtaining consent for online studies. While the “live button” method does not create a record that documents informed consent took place, there are other methods that day, such as using electronic informed consent (eConsent) platforms, electronic signature software, like DocuSign, and authentication systems that can track sign-on via usernames and passwords. Question 2

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

To minimize potential risks of harm, a researcher conducting an on-line survey can: Your Answer Design the survey so that no direct or indirect identifiers are collected. Comment In most internet-based research, the primary risk of harm is a breach of confidentiality. A simple way to help maintain the confidentiality of a subjects’ identity is not to collect direct or indirect identifiers. Suggesting to subjects that they should print a copy of the informed consent form does not protect them from an inadvertent breach of identifiable responses. Similarly, complying with the Terms of Service does not protect against a breach. Specifying that all subjects be of legal adult age does not ensure compliance. Question 3 Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is: Your Answer Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. Comment Information posted on-line could, conceivably, be accessible to anyone with an internet connection. However, people may post their private identifiable information on-line without the intention of this information being public. Private 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 on-line identity does not pose any risks of harm to subjects. Though it is true that researchers can recruit, consent and debrief subjects on-line with little to no-interaction, this in of itself, would also not pose any risks of harm to subjects. Similarly, waiving the documentation of consent does not pose any potential risks of harm to subjects, and is not unique to internet-based research. Question 4 Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects? Your Answer Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects’ significant others to be a part of the focus group. Comment The federal regulations define both a human subject and research separately, but both definitions must be met to quality as human subjects research. Thus, research with human subjects is defined as a systematic investigation (intent to contribute to generalizable knowledge) involving living individuals about whom a researcher conducting research obtains information through intervention or interaction with the individual, and uses, studies, or analyzes the information or obtains, uses, studies, analyzes, or generates identifiable private information (Protection of Human Subjects 2018). Conducting an on-line focus group with live human beings to research familial support systems would therefore meet the definition of research with human subjects. Analyzing the number of visits to a website provides information about the website itself not about the people who visit it and does not meet the federal definition of research with human subjects. Neither does gathering information about deceased individuals. Using data that are publicly available and de- identified are no longer private or personally identifiable, and would also not meet the federal definition of research with human subjects. Question 5

Revelations about the Facebook Emotional Contagion study highlights what key ethical consideration to conducting research using social media? Your Answer Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites’ terms of use. Comment The researchers who carried out the emotional contagion study did not secure individual consent from the 700,000 Facebook used whose news feed they manipulated. Instead, they relied on language in the terms of use Facebook users agreed to (“analysis, testing, [and] research”) as a means to argue they did not need to consent each individual. Participants did not realize by agreeing to be a Facebook user, they had agreed to let Facebook use them and their information for research purposes without their consent. Question 6 Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an on-line survey about personal information will be protected? Your Answer The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed. Comment Although there are no guaranteed methods to assure absolute confidentiality of research data collected on-line, some internet-based research experts have identified “best practices” for describing commonly accepted confidentiality protections, such as including explanations about how data are transmitted from the subject to the investigator, how the investigator 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 data are of a personal or sensitive nature. Question 7 Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? Your Answer Designing the survey so that subjects are not forced to answer one question before going to the next. Comment Voluntary participation in research includes the right to withdraw from a study at any time and the right to choose not to answer questions. On-line surveys that force subjects to answer one question before going to the next violate the requirement that all participation in research be voluntary. Providing contact information for the researcher, privacy policies, and description of the survey are important, but they do not address the requirement. Question 8 The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool? Your Answer An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. Comment Investigators use the internet as a research tool when they actively engage, or interact, with their participants on-line. This can include distributing an instrument via email or hosting a web-based survey on an on-line survey provider,

recruiting subjects from on-line panels, conducting interviews on-line, facilitating focus groups in private chat rooms, and posting on-line experiments or interventions on web-based service providers. Research and HIPAA Privacy Protections Question 1 Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally … Your Answer Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. Comment HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board. However, remember that you generally cannot proceed on your own without some approval from an IRB, Privacy Board, or other designated governing entity. Question 2 Recruiting into research … Your Answer Can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity. Comment It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient’s healthcare provider, permission will be required. Question 3 If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: Your Answer An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. Comment If you are unsure about the particulars, consult with your organization's IRB, Privacy Board, or privacy official. For data security issues, consult with your organization's security official. Consulting with an experienced colleague can always be helpful, but their advice is not authoritative. Do not assume that a representative of the funder will know all the rules, or that the generic advice of a professional association will be applicable to your organization’s particular rules. Question 4 When required, the information provided to the data subject in a HIPAA disclosure accounting … Your Answer must be more detailed for disclosures that involve fewer than 50 subject records. Comment

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Where fewer than 50 subjects’ records are involved, the listing must be more specific and detailed, commensurate with the requirements for other kinds of PHI disclosure accounting, including: specific date(s) of disclosures; names of entities to which PHI was disclosed; description of the PHI involved in the disclosure; and purpose of the disclosure. Question 5 The HIPAA "minimum necessary" standard applies… Your Answer To all human subjects research that uses PHI without an authorization from the data subject. Comment Uses and disclosures of data for research that are allowed to bypass the authorization requirement are still subject to the "minimum necessary" standard - that is, the uses/disclosures must be no more than the minimum required for the described research purpose. A covered entity may rely on a researcher's documentation - or the assessment of an IRB or Privacy Board - that the information requested is the minimum necessary for the research purpose. By contrast, research information obtained using an authorization is not bound by the minimum necessary standard – on the theory that the data subject has given explicit permission in accordance with the signed authorization. However, be aware that while HIPAA may not require a minimum necessary justification at all times, an IRB's evaluation of risks and burdens on human subjects arguably does. Vulnerable Subjects – Research Involving Workers/Employees Question 1 When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: Your Answer All of the above Comment Workers who serve as research subjects at their place of employment are vulnerable to numerous kinds of pressure from their co-workers, unions, and employers. Pressure can be applied to workers in subtle ways (such as, an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs). Question 2 Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define: Your Answer All of the above Comment Researchers must recognize that the primary harm in social and behavioral research is the breach of confidentiality. This risk of harm is especially significant when the data being collected involves an employee's experiences at their place of employment (for example, a situation where the employers have ongoing efforts to reduce healthcare costs by getting rid of employees who they believe will cause their healthcare insurance premiums to rise). Question 3

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject. Your Answer True Comment Genetic information has the potential to cause significant harm to research subjects if inappropriately disclosed, including harm to a subject's privacy, social standing, family obligations, employment/employability, or insurance/insurability. Question 4 The federal regulations at 45 CFR 46 provide additional protections for subjects who are workers/employees to protect them from potential risks of harm. Your Answer False Comment False. The federal regulations do not classify workers as a vulnerable population. Conflicts of Interest in Human Subjects Research Question 1 Question The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: Your Answer There may be bias by the peer reviewer as to the area of research Result Correct Comment Conflicts of interest may arise in the peer review process (for example, bias causes a reviewer to respond positively to a manuscript because it involves research or methodology in which the reviewer has a personal interest). Question 2 Question The FDA regulations governing disclosure of individual COIs require: Your Answer Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies Result Correct Comment The FDA’s regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or to disclose financial interests of

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

researchers who conducted clinical studies covered by the regulation. The regulation specifies that the FDA may refuse to file any marketing application that does not contain a disclosure of researchers’ financial interests or a certification that the applicant acted with due diligence to obtain researchers’ disclosures, but was unable to do so. Question 3 Question What is the term for management controls that are built in to a research study (for example, independent data analysis)? Your Answer Inherent controls Result Correct Comment When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher’s opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial. Question 4 Question An example of an individual financial COI is: Your Answer A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study. Result Correct Comment An individual COI may arise when an individual has a personal or financial interest, which may affect or appear to affect the design, conduct, or reporting of the research. Question 5 Question During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Your Answer Disclose their potential COI and may answer questions, but recuse themselves from voting Result Correct Comment

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

IRB policies and procedures generally specify that members with conflicts of interest related to an agenda item must disclose their conflicts of interest, and may answer questions from the IRB about the item with which they have a conflict, but are prohibited from voting on that item.

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

CITI Social & Behavioral Research - BasicRefresher Social & Behavioral Research - Basic-Refresher

Related Documents