Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based, Exams of Cryptography and System Security

Download Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based and more Exams Cryptography and System Security in PDF only on Docsity! Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers What is the term for management controls that are built in to a research study (for example, independent data analysis)? - correct answer Inherent controls An example of an individual financial COI is: - correct answer A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - correct answer There may be bias by the peer reviewer as to the area of research The FDA regulations governing disclosure of individual COIs require: - correct answer Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies The COI management plan aims to: - correct answer Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers An example of an institutional COI is: - correct answer An industry sponsor pays for the construction of a new research laboratory at the organization An example of an individual financial COI is: - correct answer A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. - correct answer No later than the time of proposal submission The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? - correct answer Researcher Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers A medical record is an example of: - correct answer Private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers taught, and collect weekly assessments of reading comprehension for each child over a three-month period. According to federal regulations, the expedited review process may be used when the study procedures pose: - correct answer No more than minimal risk and the research activities fall within regulatory categories identified as eligible. According to the federal regulations, research is eligible for exemption, if - correct answer The research falls into one of six categories of research activity described in the regulations. Continuing review of an approved and ongoing protocol - correct answer Must occur within 12 months of the approval date. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? - correct answer Officials of the institution may overrule an IRB approval. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - correct answer Prisoners. The primary purpose of a Certificate of Confidentiality is to: - correct answer Protect identifiable research information from compelled disclosure. Additional safeguards that may be included in a social and behavioral study may include: - correct answer Remove all direct identifiers from the data as soon as possible. If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: - correct answer Obtain a waiver of documentation of informed consent. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers As part of the consent process, the federal regulations require researchers to: - correct answer Provide potential subjects with information at the appropriate reading comprehension level. Privacy and Confidentiality - SBE Quiz - correct answer Privacy and Confidentiality - SBE Quiz 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? - correct answer There was neither a violation of privacy nor a breach of confidentiality. When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? - correct answer The researcher cannot control what participants repeat about others outside the group. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct answer Securing a Certificate of Confidentiality. Data are made anonymous by - correct answer Destroying all identifiers connected to the data. Research with Prisoners - SBE Quiz - correct answer Research with Prisoners - SBE Quiz 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)? - correct answer A faculty member makes identifiable data about sexual behavior Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers available to graduate students, although the subjects were assured that the data would be de-identified. One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should NOT be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher? - correct answer The researcher should contact prison authorities of the medical issue , and report the events to the IRB of record. A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that: - correct answer Confidentiality of the prisoners' health status is maintained. Which of the following statements about prison research is true? - correct answer Researchers may study the effects of privilege upgrades awarded by the prison. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers known as: - correct answer Subpart D: Additional Protections for Children Involved as Subjects in Research Research in Public Elementary and Secondary Schools - SBE Quiz - correct answer Research in Public Elementary and Secondary Schools - SBE Quiz According to federal regulations, "children" are defined as: - correct 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. Parental notification, in lieu of active parental permission, is allowed when: - correct answer An IRB has approved a waiver of the requirement for parental permission. According to Subpart D, which of the following research activities with children would qualify for an exemption? - correct answer Research about educational testing Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: - correct answer Provide parents certain rights over their children's educational records. If research in a private school is directly funded by the Department of Education, then: - correct answer PPRA applies. International Research - SBE Quiz - correct answer International Research - SBE Quiz 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? - correct answer Will the researcher have collaborators at the research site abroad? PPRA gives parents some level of control over their child's: - correct answer Participation in third-party Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers survey research or exposure to instructional materials developed by researchers The age of majority in international research is determined by the - correct answer Laws, customs, and norms in the area in which the research will be conducted. What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? - correct answer In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - correct answer Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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: - correct answer Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. 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? - correct 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. Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects? - correct answer Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers subjects' significant others to be a part of the focus group. Research and HIPAA Privacy Protections Quiz - correct answer Research and HIPAA Privacy Protections Quiz A HIPAA authorization has which of the following characteristics: - correct answer Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: - correct answer An organizational IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy Official"), depending on the issue. Vulnerable Subjects - Research Involving Workers/Employees Quiz - correct answer Vulnerable Subjects - Research Involving Workers/Employees Quiz Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers The HIPAA "minimum necessary" standard applies... - correct answer To all human subjects research that uses PHI without an authorization from the data subject. Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... - correct answer Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, except: - correct answer Workers HIPAA's protections for health information used for research purposes... - correct answer Supplement those of the Common Rule and FDA. When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: - correct answer All of the above Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers An example of a COI is: - correct answer An industry sponsor pays for the construction of a new research laboratory at the organization The FDA regulations governing disclosure of individual COIs require: - correct answer Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - correct answer There may be bias by the peer reviewer as to the area of research Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities? - correct answer Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Which of these is not a good practice for physical security? - correct answer To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious. Which of these is not generally a good practice for fax machine use? - correct answer Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine. Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard? - correct answer Measures including device data encryption, anti-malware software, and communications encryption. Which of these is not generally a good practice for telephone use? - correct answer Using voicemail systems and answering machines that do not require a password or PIN for access. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct 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. Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects? - correct 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. 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? - correct answer Designing the survey so that subjects are not forced to answer one question before going to the next. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct answer Designing the survey so that subjects are not forced to answer one question before going to the next. What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - correct answer procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. What are some considerations for a U.S researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? - correct answer In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct answer Will the researcher have collaborators at the research site abroad? A Researcher proposes to conduct a study at a foreign site that 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. The age of majority in international research is determined by the - correct answer Laws, customs, and norms in the area in which the research will be conducted. 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 availably of the research, but will not consent Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations? - correct 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. 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 availably 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? - correct 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. 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Which type of research must be submitted on Form B - no risk beyond everyday life and - correct answer Both recording participant identity and experimental procedures Which type of research must be submitted on Form C - correct answer Both research involving children and risk beyond everyday life To speed up the approval process, an IRB administer can be the sole reviewer of __ proposals. - correct answer Form A Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals? - correct answer Any procedure that causes pain or distress in human beings may cause pain or distress in other animals. Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do? - correct answer Obtain IACUC approval for the change. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations? - correct answer The research team must obtain IACUC approval for the proposed research procedures prior to starting the work. Which entity is responsible for monitoring institutional compliance with PHS Policy? - correct answer The Office of Laboratory Animal Welfare (OLAW) Which of the following is true regarding the use of animals in research? - correct answer The attending veterinarian must be allowed to have access to all research animals at all times. Which of the following is empowered by the U.S. federal government to review and approve research activities involving vertebrate animals? - correct answer The Institutional Animal Care and Use Committee (IACUC) Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Which of the following is the main reason why proper training in euthanasia techniques is important? - correct answer Improper techniques can cause unnecessary pain and distress in animals. What is the primary purpose of the "3Rs" concept from Russell and Burch? - correct answer To decrease the use of animals in research and to minimize pain and distress caused by animal experiments. Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? - correct answer Directory information. 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers data from school records to researchers. The Protection of Pupil 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. - correct answer If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? - correct answer Research about aptitude testing Subpart D, Additional HHS Protections for Children, specifically prohibits the use of exemption for research involving survey procedures, interview procedures, or participant observation when the researcher participates in the activities being observed. - correct answer Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers PPRA gives parents some level of control over their child's: - correct answer Participation in third-party survey research or exposure to instructional materials developed by researchers Parental notification, in lieu of active parental permission, is allowed when: - correct answer An IRB has approved a waiver of the requirement for parental permission. PPRA gives parents some level of control over their child's participation in third-party survey research or exposure to instructional materials developed by researchers. FERPA gives parents certain rights with respect to their children's educational records. The ability to opt out of health education would be an institutional, local or state law, and is not covered in this module about research. The access to medical records would be covered under Health Insurance Portability and Accountability Act (HIPAA) and is not covered in this module as it does not relate to research in public schools. - correct answer Parental permission must be secured or waived in accordance with criteria established by federal regulation. When a waiver has been approved, investigators may Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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. - correct answer The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: - correct answer All research funded by HHS The provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding. - correct answer 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific Department of Health and Human Services (HHS) regulations that apply to research with children. Subpart B specifies Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Subpart C specifies Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects and Subpart A is the Basic HHS Policy for Protection of Human Research Subjects (generally referred to as the Common Rule). - correct answer According to federal regulations, "children" are defined as: - correct 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. 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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. - correct answer According to Subpart D, research with children may be eligible for exemption under Category 2 when: - correct answer The research involves the use of educational tests 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. - correct answer Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? - correct answer Federal regulations do not require the documentation of minors' assent. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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. An IRB will determine whether and how documentation is required for a particular study. The document does not require parental input or parental review. - correct answer A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like- minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is: - correct answer Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners. Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems since Wardens of Juvenile prisoners - unlike those for adult Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher? - correct answer The researcher should contact prison authorities of the medical issue , and report the events to the IRB of record. The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? - correct answer "Tastes, Ties, and Time (T3)" study (2006-2009) According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - correct answer Justice Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - correct answer Respect for persons Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers The Belmont principle of beneficence requires that: - correct answer Potential benefits justify the risks of harm. 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? - correct answer The Public Health Service Study of Untreated Syphilis Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: - correct answer Must occur within 12 months of the approval date. According to federal regulations, the expedited review process may be used when the study procedures pose: - correct answer No more than minimal risk and the research activities fall within regulatory categories identified as eligible. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - correct answer Prisoners According to the federal regulations, research is eligible for exemption, if: - correct answer The research falls into one of eight categories of research activity described in the regulations. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? - correct answer Officials of the institution may overrule an IRB approval. Risk of harm in social and behavioral sciences generally fall in three categories, which are: - correct answer Invasion of privacy, breach of confidentiality, and study procedures A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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: - correct 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. A waiver of the requirement for documentation of informed consent may be granted when: - correct answer The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. As part of the consent process, the federal regulations require researchers to: - correct answer Provide potential subjects with information at the appropriate reading comprehension level. 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct answer There was neither a violation of privacy nor a breach of confidentiality. 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)? - correct 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. 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers information? - correct answer Securing a Certificate of Confidentiality Data are made anonymous by - correct answer Destroying all identifiers connected to the data. When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? - correct answer The researcher cannot control what participants repeat about others outside the group. A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB? - correct answer No, this does not need to be reported because it is unrelated to participation in the study. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability? - correct answer High potential for individual benefit from participating in research Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: - correct answer Pregnant women, prisoners, children Which is an example of a situation where deferential vulnerability might be a factor? - correct answer A physician recruiting his patients In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: - correct answer Situational cognitive vulnerability NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers situation. Which of the following was not included as possibly leading to vulnerability? - correct answer High potential for individual benefit from participating in research A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: - correct answer Economic vulnerability If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: - correct answer Obtain a waiver of documentation of informed consent. The primary purpose of a Certificate of Confidentiality is to: - correct answer Protect identifiable research information from compelled disclosure. Additional safeguards that may be included in a social and behavioral study may include: - correct answer Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Remove all direct identifiers from the data as soon as possible. A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: - correct answer Both the magnitude (or severity) and the probability (or likelihood) of harm. Identify the example of when situation and time are key to assessing risk of harm in a research study: - correct answer Asking women if they have had an abortion Which of the following studies would need IRB approval? - correct answer Studies collecting identifiable information about living individuals. Identify one way faculty researchers can possibly avoid undue influence of student subjects? - correct answer Avoid recruiting their own students in the research Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review? - correct answer Convened Review The Belmont principle of beneficence requires that: - correct answer Risks to subjects are reasonable in relation to anticipated benefits. An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle? - correct answer Justice According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: - correct answer Justice Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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: - correct answer Respect for persons Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - correct answer Respect for persons A medical record is an example of: - correct answer Private information 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: - correct answer Public behavior Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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: - correct answer Obtains, uses, studies, analyzes, or generates identifiable private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct 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. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers The primary purpose of a Certificate of Confidentiality is to: - correct answer Protect identifiable research information from compelled disclosure Identify the example of when situation and time are key to assessing risk of harm in a research study: - correct answer Asking women if they have had an abortion 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? - correct 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. 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 Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? - correct 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. 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: - correct 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. A waiver of the requirement for documentation of informed consent may be granted when: - correct answer The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. As part of the consent process, the federal regulations require researchers to: - correct answer Provide Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers potential subjects with information at the appropriate reading comprehension level. 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? - correct answer There was neither a violation of privacy nor a breach of confidentiality. When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? - correct answer The researcher cannot control what participants repeat about others outside the group. Data are made anonymous by - correct answer Destroying all identifiers connected to the data. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action? - correct answer Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations. According to Subpart D, research with children may be eligible for exemption under Category 2 when: - correct answer The research involves the use of educational tests According to federal regulations, "children" are defined as: - correct 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. A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? - correct answer The research must pose no more than minimal risk. The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: - correct answer All research funded by HHS 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? - correct 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. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: - correct answer Provide parents certain rights over their children's educational records. Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? - correct answer The Family Educational Rights and Privacy Act. Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? - correct answer Directory information. If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? - correct answer Research about aptitude testing Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct answer An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. 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: - correct answer Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects? - correct 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. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers 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? - correct 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. HIPAA's protections for health information used for research purposes... - correct answer Supplement those of the Common Rule and FDA. The HIPAA "minimum necessary" standard applies... - correct answer To all human subjects research that uses PHI without an authorization from the data subject A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: - correct answer Data that does not cross state lines when disclosed by the covered entity. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Under HIPAA, a "disclosure accounting" is required: - correct answer For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets. A HIPAA authorization has which of the following characteristics: - correct answer Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - correct answer There may be bias by the peer reviewer as to the area of research There may be bias by the peer reviewer as to the area of research - correct answer It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB? - correct answer No, this does not need to be reported because it is unrelated to participation in the study. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct 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. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct 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. Census data is an example of: - correct answer Public information. According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: - correct answer Identifiable private information. 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? - correct answer The IRB will not review this study because it is not research as defined by the federal regulations. Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Census data (the final report as published by the Census Bureau) is an example of: - correct answer Public Information According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct 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. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? - correct answer A developmental Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers How long is an investigator required to keep consent documents, IRB correspondence, and research records? - correct answer For a minimum of three years after completion of the study According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? - correct answer The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: - correct answer The changes must be immediately implemented for the health and well being of the subject. IRB continuing review of an approved protocol must: - correct answer Occur at least annually. A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: - correct answer Experience emotional or psychological distress. What statement about risks in social and behavioral sciences research is most accurate: - correct answer Risks are specific to time, situation, and culture. Identify the example of when situation and time are key to assessing risk of harm in a research study: - correct answer Asking women if they have had an abortion A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: - correct answer Both the magnitude (or severity) and the probability (or likelihood) of harm. Risk of harm in social and behavioral sciences generally fall in three categories, which are: - correct answer Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers Invasion of privacy, breach of confidentiality, and study procedures A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of A. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability - correct answer C. Economic vulnerability According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four? A. Coercion, undue influence, neglect and disrespect B. Physical control, coercion, undue influence, and manipulation Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers A. Economic vulnerability B. Communicative vulnerability C. Situational cognitive vulnerability D. Capacity-related cognitive vulnerability - correct answer C. Situational cognitive vulnerability When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: A. Are there adequate resources to conduct the study? B. Is there a power differential between researchers and subjects? C. Are the research procedures greater than minimal risk of harm? D. Has the researcher completed required training? - correct answer B. Is there a power differential between researchers and subjects? Which is true of inducements in research? Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers A. Like coercion, undue inducement is easy for IRBs to determine. B. Offering $10 for an hour long research study constitutes undue inducement. C. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. D. Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. - correct answer D. Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability? A. High risk for exploitation B. High potential for individual benefit from participating in research Citi Training, CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions And 100% Correct Answers C. Difficulty providing voluntary, informed consent arising from limitations in decision-making capacity D. Difficulty providing voluntary, informed consent arising from or situational circumstances - correct answer B. High potential for individual benefit from participating in research Which of the following brought increased public attention to the problems with the IRB system? A. HHS Inspector General Report of 1998 B. 1983 Presidential Commission Report C. "Shut Downs" by OHRP D. Death of Jesse Gelsinger - correct answer D. Death of Jesse Gelsinger Issued in 1974, 45 CFR 46 raised which of the following to regulatory status? A. The 1974 National Research Act B. The Nuremberg Code