CITI -Social&Behavioral Research

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.

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt

To ensure that researchers are conducting a study according to IRB requirements, IRBs could:

Observe the consent process or research procedures

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.

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

Provide potential subjects with information at the appropriate reading comprehension level

The COI management plan aims to:

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

Research with older adults should include:

Provisions for assessing capacity to consent

Which of the following studies need IRB approval?

Studies collecting data about living individuals.

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

A researcher proposes to conduct a study at a foreign site that 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.

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.

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

Nuremberg Code

Judged human experimentation conducted by Nazis. Voluntary consent by human subject is absolutely essential

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

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.

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.

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

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

What can "gender expression" tell you about a particular subject?

How they interpret their gender identity

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

An aging population has resulted in the need to:

Include more older adults in research to ensure generalizability of research results

The informed consent process with older adults can be improved by:

Including a limited number of alternatives

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

Invasion of privacy, breach of confidentiality, and study procedures

The FDA regulations governing disclosure of individual COIs require:

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

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.

Data are made anonymous by

Destroying all identifiers connected to the data.

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Determined by the institution in its written policies and procedures

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.

Which of the following is something an IRB should do with respect to review of GSD research?

Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities.

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

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.

Researchers should be particularly sensitive of which of the following when potentially working with GSD subjects, regardless of the type of research?

Heteronormative or gendernormative language

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability?

High potential for individual benefit from participating in research

Which is true of inducements in research?

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.

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

Institutional Review Board (IRB)

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

Institutional priorities take precedence over all IRB determinations.

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

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

Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects:

Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons

breach of obligation

describes an actual violation of a moral or legal duty.

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

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

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

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?

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

Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects?

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.

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.

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

Designated institutional officials

Beneficence

Make effort to secure well-being. -Do not harm -Maximize possible benefits and minimize possible harm/risk

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

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.

No later than the time of proposal submission

Human subject

a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

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.

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.

Parental Permission should be waived for research in GSD youth when:

Obtaining permission will disclose GSD status to the parent when the child has not yet disclosed to them AND the disclosure might put the child at risk for violence, bullying or being kicked out of their family home.

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

Legally Authorized Representatives (LARs) should be involved in the consent process when:

Prospective subjects are assessed and determined to lack capacity to make consent decisions

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

Additional safeguards that may be included in a social and behavioral study may include:

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

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.

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.

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.

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.

Clinicians find it difficult to care for older adults because:

They have not been included in studies so prescribing drugs involves a lot of unknown risk

Belmont Report

basic ethical principles for research involving human subjects. -Respect for person's autonomy -Beneficence -Justice

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)

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

Any equity interest in a publicly held company that exceeds $50,000

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

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

Justice

Equals be treated equally. -To each person an equal share. -To each person according to individual need. -To each person according to individual effort. -To each person according to societal contribution. -And to each person according to merit.

The diversity in sexuality includes

Gays, Lesbians, Heterosexuals, Bisexual people, Pansexual people, and Asexual people

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?

Directory information.

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

Researcher

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 Belmont principle of beneficence requires that:

Risks are managed so that they are no more than minimal.

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

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

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.

Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?

The Family Educational Rights and Privacy Act.

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 Study of Untreated Syphilis

Older adults have been excluded from research participation because:

Their conditions are considered to confound research protocols

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

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?

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

Research

a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. To test a hypothesis with conclusions to be drawn

Declaration of Helsinki

basis of good clinical practices. Addresses research protocols, informed consent, risks/benefits, et plus

Respect for Person

individuals treated as autonomous agents, and those with diminished autonomy are entitled protection

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

justice

Conflict of Interest

objective fact situation in which there is increased potential for harm or wrongdoing as a result of compromised independence.

Expedited Review

research presents no more than minimal risk. Does not have to be full convened committee.

Full Board (convened) Review

research that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. Must receive approval by majority of members.

Exempt Review

research with human subjects that generally involves no more than minimal risk. Does not require ongoing review, unless amended st it no longer fulfills the exempt criteria

IRB Review

to protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality.