IRB

History and ethical principles: 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)

Unanticipated Problems and Reporting Requirements: 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

Assessing Risk: 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.

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

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

Research with Children: 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.

Assessing Risk: The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

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.

Assessing Risk: 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.

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

Risks are specific to time, situation, and culture.

Research with Prisoners: A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.

History and ethical principles: 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

Research with Prisoners: A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

Not an excessive incentive.

Research with Prisoners: 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

Assessing Risk: 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.

Defining Research with Human Subjects: 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.

The Federal Regulations: 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.

Research with Children: 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.

History and ethical principles: The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

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

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

Research with Prisoners: Which of the following statements about prison research is true?

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

Privacy and 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?

Securing a Certificate of Confidentiality

Research with Children: 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 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

Which of the following studies need IRB approval?

studies collecting data about living individuals.

Privacy and Confidentiality: Data are made anonymous by

Destroying all identifiers connected to the data.

History and ethical principles: 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

Defining Research with Human Subjects: According to the federal regulations, which of the following studies meets the definition of research with human subjects?

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

Defining Research with Human Subjects: 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 care givers to determine which intervention methods most effectively manage aggression.

Privacy and 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.

Informed Consent: 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.

Defining Research with Human Subjects: 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.

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

All foreseeable risks and discomforts.

Research with Children: Protections for Children Involved as Subjects in Research apply to:

All research funded by HHS

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

Unanticipated Problems and Reporting Requirements: Researchers must report potential unanticipated problems that involve risks to others directly to the:

Institutional Review Board (IRB)

The Federal Regulations: 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.

Unanticipated Problems and Reporting Requirements: 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 because it is unrelated to participation in the study.

Unanticipated Problems and Reporting Requirements: 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.

Informed Consent: 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.

Defining Research with Human Subjects: 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.

Informed Consent: 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.

Informed Consent: 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.

The Federal Regulations: 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.

Research with 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.

Privacy and 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.

Privacy and 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?

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

Unanticipated Problems and Reporting Requirements: 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

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

justice

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

must occur 12 months within approval date

The Federal Regulations: 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