507 CITI Belmont Report and Its Principles, History and Ethical Principles - SBE, Defining Research with Human Subjects - SBE, The Federal Regulations - SBE, Assessing Risk - SBE, & Informed Consent - SBE, Privacy and Confidentiality - SBE

Identify the example of when situation and time are key to assessing risk of harm in a research study: a) Asking women if they have had an abortion b) Research on the prevalence of individuals who have been harassed in different academic disciplines c) A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers d) A survey about sexually transmitted diseases

a) Asking women if they have had an abortion

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? a) Ensuring that risks are reasonable in relationship to anticipated benefits b) Ensuring that the selection of subjects is fair c) Providing detailed information about the study to potential subjects d) Ensuring that subjects understand that participation is voluntary

a) Ensuring that risks are reasonable in relationship to anticipated benefits

Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)? a) Exempt b) Expedited c) Convened/Full Board

a) Exempt

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. Select all correct answers. a) Faculty Advisor/Research Mentor b) The Student Union c) IRB Office d) Export Control Office

a) Faculty Advisor/Research Mentor c) IRB Office

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? a) Justice b) Respect for persons c) Beneficence

a) Justice

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: a) Must occur within 12 months of the approval date. b) Is limited to review of unanticipated problems. c) Must be conducted by a convened IRB. d) Is not required unless additional risks have been identified.

a) 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: a) No more than minimal risk and the research activities fall within regulatory categories identified as eligible. b) Any level of risk, but all the subjects are adults. c) A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting. d) More than minimal risk, but the study replicates previously approved research.

a) No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

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: a) Respect for persons b) Beneficence c) Justice

a) Respect for persons

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? a) Securing a Certificate of Confidentiality b) Using data encryption for stored files c) Waiving documentation of consent d) Using pseudonyms in research reports

a) Securing a Certificate of Confidentiality

According to the federal regulations, research is eligible for exemption, if: a) The research falls into one of eight categories of research activity described in the regulations. b) The researcher is experienced in the field of inquiry. c) All the subjects are adults and the risk is minimal. d) Participation in the research will involve ten minutes or less of the subjects' time.

a) The research falls into one of eight categories of research activity described in the regulations.

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? a) There was neither a violation of privacy nor a breach of confidentiality. b) Confidentiality of the data has been breached. c) There was both a violation of privacy and a breach of confidentiality. d) The subjects' privacy has been violated.

a) There was neither a violation of privacy nor a breach of confidentiality.

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

d) Both the magnitude (or severity) and the probability (or likelihood) of harm.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? a) 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. b) A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. c) 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. 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 cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

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) In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees. b) 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. c) A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. d) A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.

b) 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 the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________. a) Nuremberg Code b) Common Rule c) Declaration of Helsinki d) Belmont Report

b) Common Rule

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

b) Destroying all identifiers connected to the data.

A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report? a) Respect for persons b) Justice c) Beneficence

b) Justice

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

b) Officials of the institution may overrule an IRB approval.

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

b) The researcher cannot control what participants repeat about others outside the group.

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) 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. b) 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. c) 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. d) 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.

c) 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.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? a) A feasibility study for implementing a year-round school program, focusing on economic issues such as facilities utilization and transportation costs. b) An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. c) 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. d) 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.

c) 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.

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? a) Ensuring that persons with diminished autonomy are protected. b) Providing detailed information about the study and obtaining the subject's consent to participate. c) Determining that the study has a maximization of benefits and a minimization of risks. d) Ensuring that the selection of subjects includes people from all segments of the population.

c) Determining that the study has a maximization of benefits and a minimization of risks.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? a) Adults with decisional impairments b) The elderly c) Prisoners d) College students

c) Prisoners

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

c) Protect identifiable research information from compelled disclosure

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: a) Public information b) Private information c) Public behavior d) Private behavior

c) Public behavior

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of: a) Private behavior b) Private information c) Public information d) Public behavior

c) Public information

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

c) The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? a) A researcher conducts a linguistic study of comments posted on a local public blog. b) A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups. c) 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. d) A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

d) A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

Identify one way faculty researchers can possibly avoid undue influence of student subjects? a) Provide extra credit to those who participate b) Offer more monetary compensation to those who participate c) Conduct research for less than ten minutes during class d) Avoid recruiting their own students in the research

d) Avoid recruiting their own students in the research

A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or 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? a) Expedited Review b) Determination for Exemption c) Not Human Subjects d) Convened Review

d) Convened Review

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: a) Feel that their privacy has been invaded. b) Lose their legal status. c) Lose their employment. d) Experience emotional or psychological distress.

d) Experience emotional or psychological distress.

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: a) Persons involved in research cannot financially benefit. b) Persons with diminished autonomy should only participate in no more than minimal risk research. c) Persons with diminished autonomy should be excluded from research. d) Persons with diminished autonomy are entitled to protection.

d) Persons with diminished autonomy are entitled to protection.

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

d) Provide potential subjects with information at the appropriate reading comprehension level.

Which of the following are the three principles discussed in the Belmont Report? a) Privacy, Confidentiality, Equitable Selection of Subjects b) IRB Review, Federal Regulations, Declaration of Helsinki c) Informed Consent, Institutional Assurance, Researcher Responsibility d) Respect for Persons, Beneficence, Justice

d) Respect for Persons, Beneficence, Justice

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

d) Risks are specific to time, situation, and culture.

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? a) 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. b) In the event of any distress you may have related to this research, you will be given access to appropriate resources. c) 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. d) 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.

d) 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.

The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies? a) Milgram's "Obedience to Authority" study b) Zimbardo's "Stanford Prison Experiment" c) PHS Tuskegee study" d) Tastes, Ties, and Time (T3)" study

d) Tastes, Ties, and Time (T3)" study

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? a) The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. b) 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. c) If it is the best interests of the community that the children participate in the study, parental permission is optional. d) 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.

d) 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.