A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.
B. Respect for persons.
A. Milgram’s “Obedience to Authority” study
B. The Tuskegee study
C. Zimbardo’s “Stanford Prison Experiment”
D. Harvard “Tastes, Ties, and Time (T3)” study (2006-2009)” study
C. Respect for persons.
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. Tearoom Trade Study (Humphreys).
D. The Harvard T3 study.
A. The IRB will not review this study because it does not involve an investigational new device.
B. The IRB will not review this study because it is not research as defined by the federal regulations.
C. The IRB will review this study because it includes human subjects and is considered research.
D. The IRB will not review this study because it does not include human subjects as defined by the federal regulations.
A. De-identified private information.
B. Observations of public behavior.
C. Identifiable public information.
D. Identifiable private information.
A. A researcher uses the Customs Office’s passenger lists for ships bringing immigrants to the US between 1820-1845 to track the numbers of immigrants from certain ethnic groups.
B. A researcher conducts a linguistic study of comments posted on a local public blog.
C. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
D. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.
A. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger’s comments on a similar topic in a weekly magazine.
B. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.
C. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
D. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.
A. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
B. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.
C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
D. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.
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.
The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided.
A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.
An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.
All the subjects are adults and the risk is minimal.
The investigator is experienced in the field of inquiry.
Participation in the research will involve 10 minutes or less of the subjects’ time.
The research falls into one of six categories of research activity described in the regulations.
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
More than minimal risk, but the study replicates previously approved research.
Any level of risk, but all the subjects are adults.
Institutional priorities take precedence over all IRB determinations.
Department chairs can overturn an IRB disapproval.
Officials of the institution may overturn an IRB disapproval.
Officials of the institution may overrule an IRB approval.
Must be conducted by a convened IRB.
Is limited to review of unanticipated problems.
Must occur within 12 months of the approval date.
Is not required unless additional risks have been identified.
A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers
Asking women if they have had an abortion
Research on the prevalence of HIV-infected individuals in communities
A survey about sexually transmitted diseases
Breach of confidentiality, loss of autonomy, and study procedures
Study procedures, breach of confidentiality, and loss of employment
Invasion of privacy, adverse reaction to study drug, and discrimination
Invasion of privacy, breach of confidentiality, and study procedures
Anonymizing data effectively manages the risk of creating emotional distress.
Risks are specific to time, situation, and culture.
There are never any risks.
If a study offers potential benefits, it is not necessary to minimize risks.
Allow law enforcement to investigate abuse cases.
Protect researchers from disclosing conflicts of interest.
Prevent subjects from knowing the purpose of a study.
Protect identifiable research information from compelled disclosure.
Solely by the probability of expected harm.
Both the magnitude (or severity) and the probability (or likelihood) of harm.
Solely by the magnitude or severity of expected harm.
Neither the magnitude or probability of harm.
The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn’t have to ask the parents for permission.
The therapist creates her clients’ records; therefore, she does not need parents’ permission to use the information for research purposes.
If it is the best interests of the community that the children participate in the study, parental permission is optional.
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.
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.
Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
In the event of any distress you may have related to this research, you will be given access to appropriate resources.
The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects’ attention on the material.
A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
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 study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
The investigator has no convenient place to store signed consent forms separate from the research data
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
Potential subjects might find some of the research questions embarrassing, personal, or intrusive
The subjects are literate in their own language; however, they do not read, write, or speak English
Provide potential subjects with information at the appropriate reading comprehension level.
Recommend that potential subjects discuss their decision to participate with family members.
Provide a list of the IRB members who reviewed the protocol.
Describe penalties that may be imposed for non-participation.
Reporting data in aggregate form in publications resulting from the research.
Requiring all members of the research team to sign confidentiality agreements.
Keeping the key linking names to responses in a secure location.
Destroying all identifiers connected to the data.
The subjects’ privacy has been violated.
Confidentiality of the data has been breached.
There was neither a violation of privacy nor a breach of confidentiality.
There was both a violation of privacy and a breach of confidentiality.
A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
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.
A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.
Using pseudonyms in research reports.
Securing a Certificate of Confidentiality.
Using data encryption for stored files.
Waiving documentation of consent.
The researcher cannot control what participants repeat about others outside the group.
Using pseudonyms in reports removes the concern about any confidences shared in the group.
If group members know each other confidentiality is not an issue.
If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
Not an excessive incentive.
Of high quality.
A valid use of a statistical technique referred to “snowball sampling” wherein the inclusion of the first subject leads to the recruitment of another one subject.
A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher.
Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
Acceptable only when the researcher’s IRB grants a special waiver.
Approve this project since the risk appears to be no more than minimal.
Not approve this project because the prisoners are merely a population of convenience for the student.
Approve this project since the superintendent is the ultimate authority on what happens in his facility.
Approve this project but submit it for federal review.
Examining age at first arrest as a predictor of adult criminal history.
Examining the use of financial incentives to improve compliance with dentist appointments.
Investigating genetic biomarkers as predictors of intelligence.
Determining safety of a new formulation of deodorant.
Do nothing in regards the Subpart C since 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.
Have made initial contact with potential subjects while they were in prison.
Obtain the permission of the Parole Board to ensure that no negative consequences will happen to those who decline to take part, and who return to prison.
Stop since this type of study is not permitted under CRS 42.44.101.
All prisoners receive HIV testing.
A medical doctor serves as co-investigator.
The survey instrument is standardized.
Confidentiality of the prisoners’ health status is maintained.
Is wrong since the chair is the only person who can determine that a study is exempt from further review. It is not the researcher’s call.
Is correct if the IRB chair is also the prisoner representative for the Board.
Is correct since the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners.
Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.
This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.
This research would require full committee review since it involves children.
This research would be eligible for expedited IRB review since the researcher is participating in the activities observed.
This research would be eligible for expedited IRB review since the researcher is not interacting with the children and the playground is public.
Parents must approve written documentation.
Documentation is required unless waived by an IRB.
To protect minors documentation is always required.
Federal regulations do not require the documentation of minors’ assent.
Parents must be notified that the study is taking place.
An independent consultant must approve the waiver.
The students must be offered an optional classroom activity.
The research must pose no more than minimal risk.
Subpart B: Additional Protections for Children Involved as Subjects in Research
Subpart A: The Common Rule
Subpart D: Additional Protections for Children Involved as Subjects in Research
Subpart C: Protections for Children in Research
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.
Persons who are under 18 years of age.
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.
Persons who are under 21 years of age.
The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.
The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.
The new research would need full review by a convened IRB because children are a protected population.
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
The children will be asked to complete a survey
The research involves the use of educational tests
The children will be interviewed by the researcher.
The research with children will involve participant observation with researcher interaction.
All research involving children
All research that is more than minimal risk
All research funded by any federal agency
All research funded by HHS
Stated in the human subject protection regulations, but not in the drug or device regulations
Included in the consent process
Determined by research staff
Determined by the institution in its written policies and procedures
No, this does not need to be reported since the subject had the heart attack when they were home, not at the focus group.
No, this does not need to be reported since it is unrelated to participation in the study.
No, this does not need to be reported because two weeks have passed.
No, this does not need to be reported since the subject recovered.
Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm.
Yes, this must be reported because it involved a subject in a research study and it’s up to the IRB to determine if it was related to participation.
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study.
Institutional Risk Manager
American Psychological Association
HIPAA Compliance Officer
Institutional Review Board (IRB)
Within 48 hours
Within 24 hours
Within two weeks
Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk
Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk
Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk
Expected, related or possible related to the research, suggests the research puts others at greater risk
Institutional Risk Manager
American Psychological Association
HIPAA Compliance Officer
Institutional Review Board (IRB)