CITI

In assessing this consideration, an IRB's determination may hinge on whether the information obtained by a big data researcher is individually identifiable and private

Does the big data project involve "human subjects?"

When IRBs are applying the federal regulatory criteria for approval to protocols involving socially or economically disadvantaged persons:

Each criterion should be analyzed in relation to the special characteristics of the populations

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

Concerning big data research with traditional research, federal regulations:

Do not specifically address big data research or differentiate it from traditional research

An example of an institutional COI is:

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

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue

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

A recognized retention strategy for research involving marginalized populations is:

"Collateral contacts" such as family and friends

The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?

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

According to the federal regulations, which of the following studies meets the definition of research with human subjects? (3)

A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors

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 is an example of big data use in research?

A study examines social interactions by combing different datasets (social media data from Facebook and geolocation data from an app)

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

According to the federal regulations, which of the following studies meets the definition of research with human subjects? (2)

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

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 above

The following groups may be vulnerable in the context of "socially and economically disadvantaged" including: (Choose all that apply)

All of the above

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

All of the above

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

Recruiting into research ...

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

Data that does not cross state lines when disclosed by the covered entity

Data are made anonymous by

Destroying all identifiers connected to the data

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge

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 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:

Experience emotional or psychological distress

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 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

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.

The Belmont Report cautions that:

Inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

What is the main risk of harm in big data research characterized as?

Informational

What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Inherent controls

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

Invasion of privacy, breach of confidentiality, and study procedures

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?

Justice

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

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 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

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

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

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

Officials of the institution may overrule an IRB approval

Informed consent in research with homeless youth is:

Often carried out with waiver of documentation when risk is no greater than minimal

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

Big data can be:

Predictive, Prescriptive, descriptive

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:

Pregnant women, prisoners, children

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

A medical record is an example of:

Private information

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

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

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

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:

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:

Respect for persons

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

Risks are specific to time, situation, and culture

The Belmont principle of beneficence requires that:

Risks to subjects are reasonable in relation to anticipated benefits.

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

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. Which 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

A waiver consent may be appropriate to use in big data studies when:

The cost of seeking and documenting consent from all of the subjects involved in the research may be prohibitive and would prevent the researcher from being able to conduct the research

Which of the following is a general consideration for IRBs reviewing big data research?

The likelihood of re-identification

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

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 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

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 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

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

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

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

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

When required, the information provided to the data subject in a HIPAA disclosure accounting ...

must be more detailed for disclosures that involve fewer than 50 subject records

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