What is considered exempt research in the context of the IRB? a. Work evaluating educational practices in established educational settings.
b. Research for the immediate good of society.
c. Work evaluating medical practices in hospital settings.
d. Research using non-human subjects, i.e.,
animals.
What is true of expedited research? a. They present minimal risk to participants.
b. They do not involve a clinical population as subjects.
c. They involve studies that urgently need to be conducted.
d. They include fewer than thirty subjects in the study.
Research that involves a minor revision to an
already approved protocol is expected to be _________ by the IRB. a. exempt
b. expedited
c. given a full review
d. excused
What is true about training in the protection of human subjects? a. Federal regulations require it.
b. Training is often difficult to obtain because few professors are trained
in ethics.
c. Federal regulations do not require it but recommend that institutions provide training to researchers.
d. Training is provided by most institutions and must be done on an individual level only.
What is not included in a CITI training module that trains researchers in the protection of human subjects? a. A brief history of research
b.
Key ethical principles
c. Quizzes that test understanding of each section
d. Specific recommendations for how researchers should design their studies
Angelina is in the process of submitting an IRB application. She would like to increase her chances of obtaining IRB approval for her proposal. What measure is not likely to help increase her chances? a. Consulting the IRB to find
out what potential ethical concerns they might have with the proposal before submitting it.
b. Including all the stimuli and materials that will be used in the study in as much detail as possible.
c. Utilizing the consent form wizard, if available, to generate consent forms.
d. Providing vague answers to vague questions on the IRB application.
When researchers are
seeking approval to conduct research with human subjects, the IRB will request from them… a. a broad and general description of the study aims only.
b. a detailed literature review of past relevant work to justify why the study is being done.
c. a brief abstract of the research and more detailed study procedure and materials.
d. a waiver of liability to ensure that the IRB is not
liable should something go wrong.
What information is contained in the abstract of an IRB application? a. A summary of methods, results and implications of the study.
b. A summary of specific aims of the research and why the research is important.
c. A summary of the consent form that will be shown to participants.
d. A summary of the
researcher's proposed outcome of the IRB application.
What is the difference between quantitative and qualitative research? a. Quantitative research involves research in the hard sciences (i.e., physics), while qualitative research involves research in the humanities.
b. Quantitative research tends to use open-ended and exploratory methodology, while qualitative research uses statistical techniques.
c. Quantitative research generally uses statistical techniques while qualitative research may use open-ended questions and more subjective approaches.
d. Quantitative research involves research in the humanities while qualitative research involves research in the hard sciences (i.e., physics).
What is the main aim of the abstract in an IRB application? a. To convince the IRB committee
of the importance of the research.
b. To convince the IRB committee that the researcher has sufficient expertise conducting the research.
c. To inform the IRB committee of the research materials and procedures.
d. To inform the IRB committee of the results of the research.
What is the main function of the protocol section of an IRB application? a. It
should summarize the entire project.
b. It should provide a convincing argument for why the research is important.
c. It should contain the professional qualifications of the researchers.
d. It should detail how researchers intend to obtain informed consent from participants.
Julian is writing the protocol section of an IRB application for his study. He is unsure about
how much information he should provide to the IRB with regards to his experiment materials. What should Julian do to increase the chances of obtaining IRB approval? a. Set up an appointment with the IRB to get a response to his concerns in person.
b. Submit a brief description of his study materials.
c. Submit as detailed a description as possible of his study materials.
d. Talk to
other researchers to find out how they described their research materials to the IRB.
David is conducting research on strategies that college students use to learn a second language. In his IRB proposal, he states that he will be recruiting students who speak only English at home. This is an example of a(n): a. inclusion criteria.
b. equitable criteria.
c. homogenous
criteria.
d. coercive criteria.
What is true of all consent forms in the IRB application? a. Consent forms should be written in language that is appropriate for the age and/or reading level of the participants.
b. Consent forms should be written in formal, technical language that is reflective of the scientific field.
c. Consent forms should include
diagrams that show the research materials and process.
d. Consent forms should contain a waiver for participants to free researchers of legal responsibility should anything go wrong in the study.
Which of the following is not an example of a vulnerable population of research participants? a. Individuals with illnesses
b. Premature infants
c.
Prisoners
d. Individuals without health insurance
Marcus had donated his biological samples as a voluntary participant in a research study on health and fertility in men. He later learns that the researchers had used his sample as part of another study examining health and DNA without his prior knowledge. What is true in terms of the ethical implications of the researchers' actions? a. Informed consent from
Marcus was violated.
b. There were no ethical mistakes because Marcus was not additionally harmed.
c. Confidentiality of Marcus' identity was violated.
d. With the additional analyses, there was no longer minimal risk to Marcus and exposing him to more than minimal risk was unethical on the part of the researchers.
Consider the case where DNA samples from the Havasupai
were misused. What were the consequences that the University involved in the research had to face? a. The Havasupai sued the university, which ultimately paid $700,000 to the tribe's members and returned the blood samples.
b. The university did not face any consequences because they were deemed to have committed no ethical offences.
c. The Havasupai did not sue the university but negotiated for more payment for
the DNA samples to be used in other ways.
d. The university was banned from conducting all forms of DNA research after the incident with the Havasupai.
Ed is writing an IRB application for a new study. In his application, he reused portions of an assignment that he wrote for an advanced level class in psychology. What is a problem with his IRB application that is most likely to arise as a result of his actions?
a. There is conflicting information in different parts of the application.
b. There is insufficient detail about the study's importance.
c. The proposal contains language unsuitable for a general audience such as the IRB committee.
d. There are missing elements in the consent document.
Simon has a study that urgently needs to be conducted. What is not an action he
should take to speed up the process of obtaining IRB approval? a. Submit a proposal that is as detailed as possible when describing the study procedure.
b. Use existing templates for generating consent documents.
c. Call the IRB or set up a meeting to find out what the potential issues of concern they might have with his study.
d. Exclude materials such as recruitment flyers from his
application as these materials cannot be completed in time for IRB application submission.
Jasmine would like to carry out a study examining the effects of exercise on mood in college students. However, she realizes that there are no direct benefits to students who participate in her study. Jasmine… a. will likely not obtain IRB approval because there are no benefits to participants.
b. will likely obtain IRB
approval only if her study offers monetary compensation to participants.
c. will likely obtain IRB approval because the IRB does not consider direct benefits to participants when deciding whether to approve a study.
d. will likely not obtain IRB approval if she fails to cite any benefit of conducting the study.
Surveys are usually seen as non-invasive tools that involve minimum risk to participants.
However, this might not be true of some surveys. Why might the Beck Depression Inventory contain more than minimal risk to respondents? a. The items can trigger depression in non-depressed individuals.
b. An item asking about suicidality could trigger suicide behavior in vulnerable individuals.
c. An item asking about gender identity can cause emotional upset in some individuals.
d.
The items can lead to low mood in most individuals.
Policies on how long research materials should be kept sometimes differ across professional associations and departments. Which of the following options contain the highest-level guideline that you should defer to in terms of how long you should keep research materials? a. What your professor says
b. University policy
c. American
psychological association (APA)
d. Psi chi
In the Milgram study, ________________ deception led participants to falsely believe they were administering shocks. In other studies, ________________ deception involves withholding information about some aspects of the experiment. a. active, passive
b. passive, active
c. active, hoaxing
d. passive, hoaxing
Which of the following is true about research with prisoners as participants? a. Recruiting prisoners as participants is not allowed by the Department of Health and Human Services (DHHS).
b. Recruiting prisoners as participants is allowed, and informed consent is not required regardless of the study design.
c. Recruiting prisoners as participants
is allowed if the risks incurred by prisoners for a study exceeds research risks posed to other populations.
d. Recruiting prisoners as participants is allowed if the compensation given does not exceed their general living conditions.
Which of the following is true about obtaining informed consent with child participants? a. If the participants are children in school, then all that is needed is permission by a
teacher in charge for the children to participate in research.
b. If a parent is present, then all that is needed is verbal consent by the child to participate in research.
c. Both parent and child must provide consent for research participation unless the child is too young to consent or has a disability that makes it difficult to provide assent.
d. Only parental consent is required for a child to
participate in research.
The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence.
which of the following is not part of informed consent? The patient has failed to follow any treatment recommended by the physician.
Risks and Discomforts
A description of any reasonably foreseeable risks or discomforts to the subject. (21 CFR 50.25(a)(2).) The informed consent process must describe the reasonably foreseeable risks or discomforts to the subject.
You have a legal informed consent if you have described to your patient the procedure you are going to do in detail. True:informed consent means a decision made by or for a patient after being informed about the proposed procedures, risks, benefits, and alternatives to the proposed treatment.
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