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?

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.

The Belmont principle of beneficence requires that:

A. The study makes a significant contribution to generalizable knowledge.

B. Subjects derive individual benefit from study participation.

C. Risks are managed so that they are no more than minimal.

D. Potential benefits justify the risks of harm.

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:

A. Justice.

B. Beneficence.

C. Respect for persons.

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

A. Beneficence.

B. Justice.

C. Respect for persons.

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

a. Providing detailed information about the study to potential subjects.

b. Ensuring that risks are reasonable in relationship to anticipated benefits.

c. Ensuring that the selection of subjects is fair.

d. Ensuring that subjects understand that participation is voluntary

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

a. 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.

b. A researcher conducts a linguistic study of comments posted on a local public blog.

c. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the US between1820-1845 to track the numbers of immigrants from certain ethnic groups.

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

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

a. 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.

b. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

c. 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.

d. 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.

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

a. 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.

b. 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.

c. 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.

d. 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. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.

b. 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.

c. 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.

d. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:

a. Identifiable public information.

b. De-identified private information.

c. Identifiable private information.

d. Observations of public behavior.

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

a. All the subjects are adults and the risk is minimal.

b. The investigator is experienced in the field of inquiry.

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

d. Participation in the research will involve 10 minutes or less of the subjects' time.

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

a. College students.

b. Adults with decisional impairments.

c. The elderly.

d. Prisoners.

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

a. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.

b. More than minimal risk, but the study replicates previously approved research.

c. Any level of risk, but all the subjects are adults.

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

Continuing review of an approved and ongoing protocol

a. Is limited to review of unanticipated problems.

b. Must be conducted by a convened IRB.

c. Is not required unless additional risks have been identified.

d. Must occur within 12 months of the approval date.

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

a. Institutional priorities take precedence over all IRB determinations.

b. Department chairs can overturn an IRB disapproval.

c. Officials of the institution may overrule an IRB approval.

d. Officials of the institution may overturn an IRB disapproval.

An investigator 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:

a. Experience emotional or psychological distress.

b. Lose their legal status.

c. Lose their employment.

d. Feel that their privacy has been invaded.

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:

a. Have the subject sign the consent form under an assumed name.

b. Obtain a Certificate of Confidentiality.

c. Code the subjects' responses.

d. Obtain a waiver of documentation of informed consent.

The primary purpose of a Certificate of Confidentiality is to:

a. Prevent subjects from knowing the purpose of a study.

b. Allow law enforcement to investigate abuse cases.

c. Protect researchers from disclosing conflicts of interest.

d. Protect identifiable research information from compelled disclosure.

Risk should be evaluated solely by the magnitude or severity of expected harm, not probability.

True

False

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

a. If a study offers potential benefits, it is not necessary to minimize risks.

b. Anonymizing data effectively manages the risk of creating emotional distress.

c. There are never any risks.

d. Risks are specific to time, situation, and culture.

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?

a. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.

b. If it is the best interests of the community that the children participate in the study, parental permission is optional.

c. 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.

d. 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?

a. 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.

b. 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.

c. 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.

d. In the event of any distress you may have related to this research, you will be given access to appropriate resources.

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. 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.

b. 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.

c. 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.

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

a. The subjects are literate in their own language; however, they do not read, write, or speak English

b. Potential subjects might find some of the research questions embarrassing, personal, or intrusive

c. The investigator has no convenient place to store signed consent forms separate from the research data

d. 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:

a. Describe penalties that may be imposed for non-participation.

b. Recommend that potential subjects discuss their decision to participate with family members.

c. Provide a list of the IRB members who reviewed the protocol.

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

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