507 CITI Research with Prisoners - SBE, Research with Children - SBE, Research in Public Elementary and Secondary Schools - SBE, International Research - SBE, Internet-Based Research - SBE, Conflicts of Interest in Human Subjects Research

Which of the following is the least important activity when protecting human subjects in international research? a) Determining if the research might present unique risks to subjects given local socio-economic conditions b) Considering local customs, norms, and laws c) Consulting with members of the community from which subjects will be recruited d) Assessing transportation conditions

d) Assessing transportation conditions

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. True or False

true

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

d) The research involves the use of educational tests

To minimize potential risks of harm, a researcher conducting an on-line survey can: a) Design the survey so that no direct or indirect identifiers are collected. b) Comply with the survey software's Terms of Service agreement. c) Suggest that subjects print a copy of the informed consent form for their records. d) Specify that all respondents must be legal adults.

a) Design the survey so that no direct or indirect identifiers are collected.

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

a) Inherent controls

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? a) If a proposed study qualifies for exemption, federal regulations do require review at the foreign site where it will be conducted. b) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. c) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted but still require review at the U.S. site by the institution's IRB. d) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site.

b) If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

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: a) People assume pseudonymous on-line identities, such as an avatar in an MMORPG. b) Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. c) Online studies do not require the documentation of informed consent. d) Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects.

b) Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.

If research in a private school is directly funded by the Department of Education, then: a) PPRA only applies if the research is no more than minimal risk. b) PPRA applies. c) PPRA does not apply. d) PPRA only applies if the research is more than minimal risk.

b) PPRA applies.

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? a) SAT scores. b) Religious affiliation. c) Citizenship. d) Directory information.

d) Directory information.

The age of majority in international research is determined by the a) Laws, customs, and norms in the area in which the research will be conducted. b) Laws in the state where the researchers' institution resides. c) Legal drinking age where the research will take place. d) The research sponsor.

a) Laws, customs, and norms in the area in which the research will be conducted.

Which of the following statements about prison research is true? a) Participation in research can be considered during parole hearings. b) It is permissible for risks to be higher than those that would be accepted by non-prisoners. c) Researchers may study the effects of privilege upgrades awarded by the prison. d) The regulations prohibit compensating prisoners.

c) Researchers may study the effects of privilege upgrades awarded by the prison.

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? a) An investigator registers an account on SecondLife to observe the way people interact with each other. b) An investigator designs a computer program to extract work experience information from LinkedIn profiles. c) An investigator analyzes user comments on articles posted on her university's website. d) An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

d) An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

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

a) 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.

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency? a) 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. b) Procedures in place to ensure that the research complies with ethical principles (such as, the World Medical Association's Declaration of Helsinki). c) Procedures in place to outline how subjects will be randomized. d) Procedures in place to outline how unanticipated problems will be reported to the local IRB.

a) 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.

Parental notification, in lieu of active parental permission, is allowed when: a) The superintendent of schools and the principals have approved the study. b) An IRB has approved a waiver of the requirement for parental permission. c) The researcher anticipates a low response rate. d) The researcher has conducted a similar study at another institution.

b) An IRB has approved a waiver of the requirement for parental permission.

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

b) Federal regulations do not require the documentation of minors' assent.

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: a) Educational. b) Not an excessive incentive. c) Age appropriate. d) Of high quality.

b) Not an excessive incentive

PPRA gives parents some level of control over their child's: a) Educational records b) Participation in third-party survey research or exposure to instructional materials developed by researchers c) Medical records d) Ability to opt out of health education (specifically, sexual health education)

b) Participation in third-party survey research or exposure to instructional materials developed by researcher

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 involving children c) All research funded by HHS d) All research funded by any federal agency

c) All research funded by HHS

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

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

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

d) Disclose their potential COI and may answer questions, but recuse themselves from voting

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

b) Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

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

b) The research must pose no more than minimal risk

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? a) Does the potential subject population include children? b) Will the researchers have collaborators at the research site abroad? c) Does the professor speak Spanish fluently? d) Is the survey more than minimal risk?

b) Will the researchers have collaborators at the research site abroad?

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? a) A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. b) A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time. c) A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. d) A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her.

c) A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.

An example of an institutional COI is: a) One of the organization's deans is the vice-chair of the organization's IRB b) 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 c) An industry sponsor pays for the construction of a new research laboratory at the organization d) The organization gives scholarships to some post-doctoral researchers

c) An industry sponsor pays for the construction of a new research laboratory at the organization

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

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

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: a) Ensure that surveys do not ask school children to provide sensitive information about their parents. b) Allow school counselors to access students' grades. c) Provide parents certain rights over their children's educational records. d) Give school principals the right to discuss students' behavioral problems with their parents.

c) Provide parents certain rights over their children's educational records.

Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects? a) Downloading a publicly available dataset that includes high school students' academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states. b) Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted. c) Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual's social network. d) 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.

d) 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.

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

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

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. a) Not until a notice of award is received b) Never -- the PHS regulation does not require researchers to submit COI disclosures c) Researchers must only submit COI disclosures if they have a significant financial interest related to the research d) No later than the time of proposal submission

d) No later than the time of proposal submission

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? a) Stop all research activities with the subject immediately. b) Notify OHRP and request an exception. c) Withdraw the subject from the study and delete the collected data. d) Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

d) Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

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.