CITI Human Subjects Research Training

A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?

Justice

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

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

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

The Belmont principle of beneficence requires that:

Risks to subjects are reasonable in relation to anticipated benefits.

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:

Public information

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

1. 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.

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

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 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.

A medical record is an example of:

Private information

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:

Public behavior

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

Officials of the institution may overrule an IRB approval.

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.

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.

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

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure

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

Risks are specific to time, situation, and culture.

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.

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

A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers (who are underage to purchase tobacco) in the United States

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 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 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 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.

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

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

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 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.

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

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.

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:

All of the above

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.

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 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.

What consideration should researchers take into account when designing an online study that presents participants with misleading information?

Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.

Which scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study?

The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin."

A waiver of 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

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

Informational

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)

The Common Rule applies to research that:

Meets the definition of “research” and involves “human subjects”

Which of these U.S. federal agencies oversees the use of medical mobile apps (MMA) in research?

U.S. Food and Drug Administration (FDA)

A mobile fitness tracking device collects a broad range of data, although the researcher is only interested in analyzing the data collected about subjects’ number of steps per day. What is a concern the IRB may have about this research study?

The incidental data collected from the device

In which of the following scenarios would an app be subject to the Health Insurance Portability and Accountability Act (HIPAA)?

The app stores or transmits protected health information (PHI) in a HIPAA-covered entity

Regulation of mobile health technology varies by product type and ______.

Degree of risk posed by use

Before a significant risk medical mobile app (MMA) study can commence, what does the sponsor need to do?

Obtain an investigational device exemption (IDE) from the FDA and IRB approval

What is a common limitation of administrative data reuse?

Access

Which of the following is an example of administrative data?

all of the above

Which type of administrative data use is the lowest risk?

Policy analysis using aggregate data

A researcher is conducting an evaluation of a cross-site summer learning program, using end of grade test scores as a proxy for learning outcomes. The researcher planned to conduct a longitudinal analysis across five school years, prior to being told that the state changed their end of grade test requirements during year three and the data are no longer collected for all students. This is an example of what administrative data limitation?

Availability

Privacy risks include:

all of the above

A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

Not Human Subjects

Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)?

Exempt

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.

- Faculty Advisor/Research Mentor

- IRB Office

In the U.S., the first federal regulations for human subjects research began in 1991 with the codification of the ________.

Common Rule

Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply.

- Protecting the rights and welfare of human subjects.

- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.

- Reviewing subject recruitment materials and strategies.

Content from online educational tools that FERPA does not protect 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) if they are not tied to any identifying information

What does de-identifying data with a code mean?

Presenting data with a code that researchers can match to other data

Which of the following statements is true?

The Higher Education Act of 2008 requires Title IV postsecondary institutions to report aggregate information on graduates

What are the three different ways to reduce the possibility of an unauthorized PII disclosure?

Suppressing, blurring, and masking

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

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

The HIPAA "minimum necessary" standard applies…

To all human subjects research that uses PHI without an authorization from the data subject.

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.

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

Identifiable health information that is created or held by covered entities and their business associates.

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.

HIPAA’s protections for health information used for research purposes…

Supplement those of the Common Rule and FDA.