CITI Training Human Subjects Protection Basic Course

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:

Asking women if they have had an abortion

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

Obtain a waiver of documentation of informed consent.

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:

Securing a Certificate of Confidentiality

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?

Prisoners

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

Invasion of privacy, breach of confidentiality, and study procedures

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

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

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

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 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:

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 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?

Private information

A medical record is an example of:

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

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?

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

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?

Experience emotional or psychological distress.

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:

Full Board Review

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?

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 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 only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

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

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

According to federal regulations, the expedited review process may be used when the study procedures pose:

Justice

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

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

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:

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

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

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.

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

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

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

Public information

Census data (the final report as published by the Census Bureau) is an example of:

Must occur within 12 months of the approval date.

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

Destroying all identifiers connected to the data.

Data are made anonymous by

All foreseeable risks and discomforts.

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

persons with diminished autonomy are entitled to protection

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:

Potential benefits justify the risks of harm.

The Belmont principle of beneficence requires that:

Nuremberg Code

The history of ethical regulations in human subjects research began with the

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

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

- 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.

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.)

The researcher cannot control what participants repeat about others outside the group.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

Respect for Persons, Beneficence, Justice

Which of the following are the three principles discussed in the Belmont Report?

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 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)?

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

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

Officials of the institution may overrule an IRB approval.

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

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

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?

Studies collecting data about living individuals.

Which of the following studies need IRB approval?

Exempt

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