Human Subjects Research

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. College students - b. Prisoners - c. The elderly - d. Adults with decisional impairments

b. Prisoners

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

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

Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because: - a. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated - b. The need for the signatures of both parents outweighs the two subparts - c. Subpart C still applies, as the potential subjects are juveniles - d. Only subpart C applies because of the need for assent forms, as a result of in loco parentis status for juveniles

a. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated

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

b. All research funded by HHS

Additional safeguards that may be included in a social and behavioral study may include: - a. Requiring a legally authorized representative to provide signed consent for an incapacitated subject - b. Remove all direct identifiers from the data as soon as possible - c. Requiring pregnancy tests before administration of the study drug - d. Frequent monitoring of the subject's heart through ECG after administration of the study drug

b. Remove all direct identifiers from the data as soon as possible

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: - a. The employer may encourage or deny participation of workers - b. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results - c. The research study's finding could affect an employee's pay, benefits, or promotion potential - d. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization - e. All of the above

e. All of the above

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

c. Invasion of privacy, breach of confidentiality, and study procedures

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

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. Respect for persons - b. Justice - c. Beneficence

a. Respect for persons

The Belmont principle of beneficence requires that: - a. Risks to subjects are reasonable in relation to anticipated benefits - b. Risks are managed so that they are no more than minimal - c. Subjects derive individual benefit from study participation - d. The study makes a significant contribution to generalizable knowledge

a. Risks to subjects are reasonable in relation to anticipated benefits

An example of an individual financial COI is: - a. A researcher's spouse hold equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study - b. A researcher's spouse works at the same university as the researcher - c. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza - d. A researcher's 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher's ongoing projects

a. A researcher's spouse hold equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study

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 participants sign confidentiality agreements, the researcher can guarantee confidentiality - b. The researcher cannot control what participants repeat about others outside the group - c. If group members know each other confidentiality is not an issue - 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

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include: - a. Keeping the key linking names to responses in a secure location - b. Requiring all members of the research team to sign confidentiality agreements - c. Reporting data in aggregate form in publications resulting from the research - d. Destroying all identifiers connected to the data - e. All of the above

e. All of the above

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

b. Confidentiality of the prisoners' health status is maintained

According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: - a. Beneficence - b. Respect for persons - c. Justice

c. Justice

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

a. 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 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 behavior - b. Private Information - c. Public Information - d. Private Behavior

a. Public behavior

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, 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 U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups - b. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression - 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 researcher conducts a linguistic study of comments posted on a local public blog

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

. During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - a. Leave the meeting immediately - b. Disclose their potential COI and may answer questions, but recuse themselves from voting - c. Disclose their potential COI, but not answer any questions about the study - d. Disclose their potential COI and not participate in any action

b. Disclose their potential COI and may answer questions, but recuse themselves from voting

The federal regulations at 45 CFR 46 provide additional protections for subjects who are workers/employees to protect them from potential risks of harm - a. True - b. False

b. False

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. 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 - b. Acceptable only when the researcher's IRB grants a special waiver - c. Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners - d. A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher

c. Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners

Identify the example of when situation and time are key to assessing risk of harm in a research study: - a. Research on the prevalence of retired individuals who have been harassed in different academic disciplines - b. A survey with educators on their experience about implementation of a novel preschool program - c. A study asking women if they have completed an advanced degree and what city they were born in - d. A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States

d. A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States

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. Social vulnerability - c. Communicative vulnerability - d. Economic vulnerability

d. Economic vulnerability

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

a. Officials of the institution may overrule an IRB approval

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

c. Must occur within 12 months of the approval date

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: - a. Approve this project since the risk appears to be no more than minimal - b. Approve this project because the superintendent is the ultimate authority on what happens in his facility - c. Approve this project but submit it for federal review - d. Not approve this project because the prisoners are merely a population of convenience for the student

d. Not approve this project because the prisoners are merely a population of convenience for the student

A medical record is an example of: - a. Public behavior - b. Private behavior - c. Public information - d. Private information

d. Private information

According to the federal regulations, which of the following studies meets the definition of research with human subjects? - a. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests - b. 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 - c. 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 - d. 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

a. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests

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

a. Determined by the institution in its written policies and procedures

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. Experience emotional or psychological distress - b. Lose their legal status - c. Feel that their privacy has been invaded - d. Lose their employment

a. Experience emotional or psychological distress

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: - a. Obtains, uses, studies, analyzes, or generates identifiable private information - b. Obtains, uses, studies, analyzes, or generates identifiable public information - c. Observes public behavior - d. Obtains, uses, studies, analyzes, or generates de-identified private information

a. Obtains, uses, studies, analyzes, or generates identifiable private information

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

a. 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

According to Subpart D, research with children may be eligible for exemption under Category 2 when: - a. The research involves the use of educational tests - b. The children will be interviewed by the researcher - c. The children will be asked to complete a survey - d. The research with children will involve participant observation with researcher interaction

a. The research involves the use of educational tests

The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research - a. True - b. False

a. True

When a research project includes the collection of biological samples, all planned future uses the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject - a. True - b. False

a. True

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

b. Examining age at first arrest as a predictor of adult criminal history

Which is true of inducements in research? - a. Offering $10 for an hour long research study constitutes undue inducement - b. 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 - c. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons - d. Like coercion undue inducement is easy for IRBs to determine

b. 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

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. Beneficence - b. Justice - c. Respect for persons

b. Justice

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 hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB? - a. No, this does not need to be reported because the subject had the heart attack when they were home, not at the focus group - b. No, this does not need to be reported because it is unrelated to participation in the study - c. No, this does not need to be reported because the subject recovered - d. No, this does not need to be reported because two weeks have passed

b. No, this does not need to be reported because it is unrelated to participation in the study

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identify of the subjects can be readily ascertained. Which of the following statements is true? - a. This research would be eligible for expedited IRB review because the researcher is not interacting with the children and the playground is public - b. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting - c. This research would be eligible for expedited IRB review because the researcher is participating in the activities observed - d. This research would require full committee review because it involves children

b. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting

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 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 - b. 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 - 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 in which subjects were told that they performed in the third quartile on an anagram task when in reality the 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

The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: - a. Physical vulnerability - b. Institutional vulnerability - c. Cognitive or communicative vulnerability - d. Economic or social vulnerability

c. Cognitive or communicative vulnerability

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? - a. Yes, this must be reported because it involved a subject in a research study and it is up to the IRB to determine if it was related to participation - b. 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 - c. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study - d. No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study

c. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections - a. Children, prisoners, and terminally ill - b. Pregnant women, prisoners, and mentally disabled - c. Pregnant women, prisoners, children - d. Prisoners, children, and elderly

c. Pregnant women, prisoners, children

A waiver of the requirement for documentation of informed consent may be granted when: - a. The investigator has no convenient place to store signed consent forms separate from the research data - b. Potential subjects might find some of the research questions embarrassing, personal, or intrusive - 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

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

c. 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

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

c. Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk

An example of an institutional COI is: - a. The organization's president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization - b. The organization gives scholarships to some post-doctoral researchers - c. One of the organization's deans is the vice-chair of the organization's IRB - d. An industry sponsor pays for the construction of a new research laboratory at the organization

d. An industry sponsor pays for the construction of a new research laboratory at the organization

What is the term for management controls that are built into a research study (for example, independent data analysis)? - a. Required controls - b. Mandated controls - c. Objective controls - d. Inherent controls

d. Inherent controls

Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of: - a. Economic vulnerability - b. Therapeutic misconception - c. Deferential vulnerability - d. Medical vulnerability

d. Medical vulnerability

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

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

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: - a. Have the subject sign the consent form under an assumed name - b. Obtain a Certificate of Confidentiality - c. Code the subjects' responses - d. Obtain a waiver of documentation of informed consent

d. Obtain a waiver of documentation of informed consent

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 to home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, 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? - a. Within 24 hours - b. Within two weeks - c. Within 48 hours - d. Promptly

d. Promptly

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

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

The COI management plan aims to: - a. Reduce IRB review burden when a COI is disclosed - b. Eliminate all COIs in research when a COI is disclosed - c. Address disclosure of COIs in multi-center research when a COI is disclosed - d. Provide procedures or extra steps to be taken to minimize the risk of bias when a COI is disclosed

d. Provide procedures or extra steps to be taken to minimize the risk of bias when a COI is disclosed

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

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

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? - a. 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 - b. The new research would need full review by a convened IRB because children are a protected population - c. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors - d. 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

d. 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

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define: - a. If personal identifiers will be retained and used in the data analysis - b. If the study results, if any, will be included in the employee's personnel records - c. Who will have access to the data - d. How the data will be collected and secured - e. All of the above

e. All of the above