HTH 408 IRB app – Flashcards

The Belmont principle of beneficence requires that: A. Subjects derive individual benefit from study participation. B. Potential benefits justify the risks of harm. C. The study makes a significant contribution to generalizable knowledge. D. Risks are managed so that they are no more than minimal.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: A. Beneficence. B. Respect for persons. C. Justice.

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? A. Milgram's "Obedience to Authority" study B. The Tuskegee study C. Zimbardo's "Stanford Prison Experiment" D. Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study

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: A. Justice. B. Beneficence. C. Respect for persons.

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? A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. B. Stanford Prison Experiment (Zimbardo). C. Tearoom Trade Study (Humphreys). D. The Harvard T3 study.

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? A. The IRB will not review this study because it does not involve an investigational new device. B. The IRB will not review this study because it is not research as defined by the federal regulations. C. The IRB will review this study because it includes human subjects and is considered research. D. The IRB will not review this study because it does not include human subjects as defined by the federal regulations.

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: A. De-identified private information. B. Observations of public behavior. C. Identifiable public information. D. Identifiable private information.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the US between 1820-1845 to track the numbers of immigrants from certain ethnic groups. B. A researcher conducts a linguistic study of comments posted on a local public blog. C. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. D. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine. B. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches. C. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. D. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university. B. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department. C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. D. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.

Census data is an example of: Public information. Private behavior. Private information. Public behavior.

A medical record is an example of:

According to the federal regulations, which of the following studies meets the definition of research with human subjects? 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. The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

According to the federal regulations, research is eligible for exemption, if: All the subjects are adults and the risk is minimal. The investigator is experienced in the field of inquiry. Participation in the research will involve 10 minutes or less of the subjects' time. The research falls into one of six categories of research activity described in the regulations.

According to federal regulations, the expedited review process may be used when the study procedures pose: No more than minimal risk and the research activities fall within regulatory categories identified as eligible. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting. More than minimal risk, but the study replicates previously approved research. Any level of risk, but all the subjects are adults.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Institutional priorities take precedence over all IRB determinations. Department chairs can overturn an IRB disapproval. Officials of the institution may overturn an IRB disapproval. Officials of the institution may overrule an IRB approval.

Continuing review of an approved and ongoing protocol Must be conducted by a convened IRB. Is limited to review of unanticipated problems. Must occur within 12 months of the approval date. Is not required unless additional risks have been identified.

Identify the example of when situation and time are key to assessing risk of harm in a research study: A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers Asking women if they have had an abortion Research on the prevalence of HIV-infected individuals in communities A survey about sexually transmitted diseases

Risk of harm in social and behavioral sciences generally fall in three categories, which are: Breach of confidentiality, loss of autonomy, and study procedures Study procedures, breach of confidentiality, and loss of employment Invasion of privacy, adverse reaction to study drug, and discrimination Invasion of privacy, breach of confidentiality, and study procedures

What statement about risks in social and behavioral sciences research is most accurate: Anonymizing data effectively manages the risk of creating emotional distress. Risks are specific to time, situation, and culture. There are never any risks. If a study offers potential benefits, it is not necessary to minimize risks.

The primary purpose of a Certificate of Confidentiality is to: Allow law enforcement to investigate abuse cases. Protect researchers from disclosing conflicts of interest. Prevent subjects from knowing the purpose of a study. Protect identifiable research information from compelled disclosure.

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: Solely by the probability of expected harm. Both the magnitude (or severity) and the probability (or likelihood) of harm. Solely by the magnitude or severity of expected harm. Neither the magnitude or probability of harm.

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? The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. If it is the best interests of the community that the children participate in the study, parental permission is optional. 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 liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? 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. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. In the event of any distress you may have related to this research, you will be given access to appropriate resources. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.

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: A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance. 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 study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.

A waiver of the requirement for documentation of informed consent may be granted when: The investigator has no convenient place to store signed consent forms separate from the research data The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. Potential subjects might find some of the research questions embarrassing, personal, or intrusive The subjects are literate in their own language; however, they do not read, write, or speak English

As part of the consent process, the federal regulations require researchers to: Provide potential subjects with information at the appropriate reading comprehension level. Recommend that potential subjects discuss their decision to participate with family members. Provide a list of the IRB members who reviewed the protocol. Describe penalties that may be imposed for non-participation.

Data are made anonymous by: Reporting data in aggregate form in publications resulting from the research. Requiring all members of the research team to sign confidentiality agreements. Keeping the key linking names to responses in a secure location. Destroying all identifiers connected to the data.

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? The subjects' privacy has been violated. Confidentiality of the data has been breached. There was neither a violation of privacy nor a breach of confidentiality. There was both a violation of privacy and 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)? A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees. 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. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.

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? Using pseudonyms in research reports. Securing a Certificate of Confidentiality. Using data encryption for stored files. Waiving documentation of consent.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? The researcher cannot control what participants repeat about others outside the group. Using pseudonyms in reports removes the concern about any confidences shared in the group. If group members know each other confidentiality is not an issue. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.

A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are: Age appropriate. Not an excessive incentive. Educational. Of high quality.

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: A valid use of a statistical technique referred to "snowball sampling" wherein the inclusion of the first subject leads to the recruitment of another one subject. A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher. Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners. Acceptable only when the researcher's IRB grants a special waiver.

A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should: Approve this project since the risk appears to be no more than minimal. Not approve this project because the prisoners are merely a population of convenience for the student. Approve this project since the superintendent is the ultimate authority on what happens in his facility. Approve this project but submit it for federal review.

Which example of research with prisoners would be allowable under the regulations? Examining age at first arrest as a predictor of adult criminal history. Examining the use of financial incentives to improve compliance with dentist appointments. Investigating genetic biomarkers as predictors of intelligence. Determining safety of a new formulation of deodorant.

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to: Do nothing in regards the Subpart C since the research does not meet the criteria for prison research: individuals on parole are not considered prisoners. The definition applies to both minors and adults. Have made initial contact with potential subjects while they were in prison. Obtain the permission of the Parole Board to ensure that no negative consequences will happen to those who decline to take part, and who return to prison. Stop since this type of study is not permitted under CRS 42.44.101.

A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that: All prisoners receive HIV testing. A medical doctor serves as co-investigator. The survey instrument is standardized. Confidentiality of the prisoners' health status is maintained.

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision: Is wrong since the chair is the only person who can determine that a study is exempt from further review. It is not the researcher's call. Is correct if the IRB chair is also the prisoner representative for the Board. Is correct since the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners. Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review? This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting. This research would require full committee review since it involves children. This research would be eligible for expedited IRB review since the researcher is participating in the activities observed. This research would be eligible for expedited IRB review since the researcher is not interacting with the children and the playground is public.

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Parents must approve written documentation. Documentation is required unless waived by an IRB. To protect minors documentation is always required. Federal regulations do not require the documentation of minors' assent.

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 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? Parents must be notified that the study is taking place. An independent consultant must approve the waiver. The students must be offered an optional classroom activity. The research must pose no more than minimal risk.

The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as: Subpart B: Additional Protections for Children Involved as Subjects in Research Subpart A: The Common Rule Subpart D: Additional Protections for Children Involved as Subjects in Research Subpart C: Protections for Children in Research

According to federal regulations, "children" are defined as: Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved. Persons who are under 18 years of age. 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. Persons who are under 21 years of age.

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? The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors. The new research would need full review by a convened IRB because children are a protected population. 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.

According to Subpart D, research with children may be eligible for exemption when: The children will be asked to complete a survey The research involves the use of educational tests The children will be interviewed by the researcher. The research with children will involve participant observation with researcher interaction.

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: All research involving children All research that is more than minimal risk All research funded by any federal agency All research funded by HHS

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: Stated in the human subject protection regulations, but not in the drug or device regulations Included in the consent process Determined by research staff Determined by the institution in its written policies and procedures

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 DHS regulations, the researcher report this event to the IRB? No, this does not need to be reported since the subject had the heart attack when they were home, not at the focus group. No, this does not need to be reported since it is unrelated to participation in the study. No, this does not need to be reported because two weeks have passed. No, this does not need to be reported since the subject recovered.

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB? Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm. Yes, this must be reported because it involved a subject in a research study and it's up to the IRB to determine if it was related to participation. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study.

Researchers must report potential unanticipated problems that involve risks to others directly to: Institutional Risk Manager American Psychological Association HIPAA Compliance Officer Institutional Review Board (IRB)

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe? Promptly Within 48 hours Within 24 hours Within two weeks

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk Expected, related or possible related to the research, suggests the research puts others at greater risk