CITI

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Researcher

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study (2006-2009)

What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)

- Protecting the rights and welfare of human subjects. - Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. - Reviewing subject recruitment materials and strategies.

Per federal regulations, which of the following elements must be included in an informed consent document?

All foreseeable risks and discomforts.

If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?

Research about aptitude testing

According to the federal regulations, research is eligible for exemption, if:

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

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

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:

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

What is the period of time an educational institution has to respond to a request by an eligible student or parent to review an educational record?

45 days

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

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

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 faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified

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.

In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:

FERPA, PPRA, and Subpart D of the federal regulations

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?

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

The most concerning issue with using a family member to interpret in the consent process is that the family member may not:

Interpret accurately due to language issues, cultural standards, or embarrassment

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 subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

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?

Securing a Certificate of Confidentiality

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Situational cognitive vulnerability

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 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.

Informed consent can be facilitated in a variety of ways. Which of the below is the best way to enhance the understanding of research?

Asking a staff person who speaks the subject's language fluently to explain the concepts in the consent form.

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

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. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

Justice

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.

Student administrative data refers to:

Student educational records in paper and electronic form

A student is conducting a research project that involves using a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?

Exempt Review

Content from online educational tools that is not protected under FERPA includes:

Any metadata that an online tool produces (for example, data about a student's usage of a tool, or how much time it took them to take an assessment or look at a video) is not protected if it is not tied to any identifying information

Identify the example of when situation and time are key to assessing risk of harm in a research study:

Asking women if they have had an abortion

Which of the following is the least important activity when protecting human subjects in international research?

Assessing transportation conditions

PPRA gives parents some level of control over their child's:

Participation in third-party survey research or exposure to instructional materials developed by researchers

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 will be conducted.

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?

Physical control, coercion, undue influence, and manipulation

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

Prisoners

Data are made anonymous by

Destroying all identifiers connected to the data

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

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

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

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

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:

Economic vulnerability

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

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

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level

The consent process must allow subjects to consider whether or not to participate. Which of the following would be the best way to enhance subject understanding for non-English speakers?

Providing interpreters and time for discussion with advocates during the consent discussion.

Belmont Report- 3 principles

1) Respect for persons 2) Beneficence 3) Justice

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

All of the following: Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. The employer may encourage or deny participation of workers. The research study's finding could affect an employee's pay, benefits, or promotion potential. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results.

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research funded by HHS

A researcher is conducting a study of students with special needs in a local school. The study requires the analysis of identifiable student performance data from the past five years. The study results will be published in a peer-reviewed journal and presented at conferences and could potentially help thousands of young students. Which of the following is true?

FERPA prevents the school from providing the data because the researcher does not have prior consent of the parents

Which federal agency oversees the enforcement of FERPA?

Family Policy Compliance Office (FPCO)

Which of the following is correct?

Individual educational institutions have the liberty to define what they consider directory information within certain guidelines.

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:

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

Researchers must report potential unanticipated problems that involve risks to others directly to the:

Institutional Review Board (IRB)

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?

The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.

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?

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

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

True

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater 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?

Will the researcher have collaborators at the research site abroad?

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:

Workers

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:

first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?

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.

An "eligible student" means:

students when they turn 18 years of age or when they enter a postsecondary institution

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (There may be more than one correct answer. Please be sure to select all correct answers.)

- Faculty Advisor/Research Mentor - IRB Office

A subject who does not speak English in the U.S. may indicate other areas that must be considered and addressed by researchers. Which of the following is most typically an associated concern?

Cultural differences

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:

All of the following: Who will have access to the data. If the study results, if any, will be included in the employee's personnel records How the data will be collected and secured If personal identifiers will be retained and used in the data analysis.

Parental notification, in lieu of active parental permission, is allowed when:

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

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

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:

Cognitive or communicative vulnerability

To minimize potential risks of harm, a researcher conducting an on-line survey can:

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

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Designing the survey so that subjects are not forced to answer one question before going to the next.

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

Ensuring that risks are reasonable in relationship to anticipated benefits.

Which example of research with prisoners would be allowable under the regulations?

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

The age of majority in international research is determined by the

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

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:

Medical Vulnerability

Researchers should engage certified interpreters to ensure the subject's comprehension. Even so, communication and comprehension may be difficult. The best strategy for the researcher is to:

Meet with the interpreter prior to meeting with the subject to ensure the interpreter understands the terms and concepts.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

Must occur within 12 months of the approval date.

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?

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

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB?

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

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:

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

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:

Obtain a waiver of documentation of informed consent.

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:

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

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval.

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 (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?

Promptly

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

A researcher is conducting a study of four graduate students enrolled in a unique university program. The foundation supporting the study wants a report providing summary information about the students' outcomes, including their grades and survey responses. What would be the least risky option?

Provide a summation of survey results, without the grades

Which of the following statements about prison research is true?

Researchers may study the effects of privilege upgrades awarded by the prison

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:

Respect for persons

The following groups were originally opposed to FERPA:

School counselors and university administrators

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

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?

The IRB will not review this study because it is not research as defined by the federal regulations.

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.

A waiver of the requirement for documentation of informed consent may be granted when:

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?

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 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?

The research must pose no more than minimal risk.

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

Which of the following is a risk associated with a small cell size?

The risk of disclosure of students' information reported in that cell

An eligible student's educational record is generally not disclosed in situations where:

The student's professor is collecting data for their own research.

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:

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

An example of an individual financial COI is:

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

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

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

A student working on his dissertation 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, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?

Full Board Review

The specific 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

In the case of Gonzaga v. Doe, the U.S. Supreme Court determined that:

the U.S. Supreme Court ruled that the law does not give right to private cause of action- that is, lawsuits against non-compliant educational institutions