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IRB Tutorial

IRB Exam

1) Which types of changes to an IRB-approved research protocol require IRB approval?

All changes

Only major change of the study method

Questions of the surveys/interviews

Changes to the Informed Consent

2) According to the manual, competing researcher priorities can overlap with which one of the following threats to ethical decision making?

Inadequate knowledge of research ethics while using human participants

Forgetting important information over time

Inadequate reflection

Inadequate moral reasoning

None of the above

3) Cultivating an attitude of constant questioning of the research process and “placing oneself on the shoes of one’s respondents” defines good ____________ of a researcher.

Preparation

Compliance

Reflectivity

Autonomy

4) Researchers are permitted to continue to collect study data if AUCA IRB approval expires.

True

False

5) According to the module, when using students as research subjects, there is the risk that students may feel coerced. When trying to get students GPA scores for your study, which of the following should be done to address the concern for Respect for Persons?

Make a request for information to the appropriate department.

Obtain a signed consent/permission form from the student subject

Ask the student's teacher for permission to use information about their grades.

Obtain an oral consent/permission from the student.

6) Which of the following statements about threats to ethical decision making is FALSE?

Threats can influence one another.

Threats can operate simultaneously in any given research situation

Threats deal only with researcher-participant interactions

There are eight major threats

7) The following are the three elements to the informed consent process:?

Voluntariness, Benefits, Signature

Information, Comprehension, Voluntariness

Compensation, Information, Signature

Information, Recruitment, Voluntariness

8) Match the following fundamental ethical principles with their key statements:

a) Beneficence

Maximize benefits and minimize potential harm

Acknowledge autonomy

Fair distribution of risks and benefits

b) Respect for Persons

Maximize benefits and minimize potential harm

Acknowledge autonomy

Fair distribution of risks and benefits

c) Justice

Maximize benefits and minimize potential harm

Acknowledge autonomy

Fair distribution of risks and benefits

9) Threats to ethical decision making that can arise in team-based research can take all of the following forms EXCEPT:

Different academic backgrounds

Miscommunication or lack of communication between team members

Differing priorities related to research

Differing levels of understanding of ethical principles

10) It is permissible to contact prospective participants before obtaining AUCA IRB approval if you know the individuals just to make sure you will have an adequate number of participants.

True

False

11) AUCA researcher has completed collecting data for a particular study; however, still needs to analyze the data. The data analysis will be performed at AUCA. Can this study be closed?

True

False

12) Which of the following threats to ethical decision making is the MOST likely to contribute to researcher coercion of participants?

Forgetting information over time

Competing priorities

Lack of time, high workload, and stress

Inadequate reflection

13) The Researcher asks: "How would I want to be treated if I was a participant in this study?" Failure to ask this question may result in which issue?

Inadequate Reflection

Inadequate Moral Reasoning

Competing Priorities

Lack of Time, High Workload, Stress

14) My research is planned for 18 months. If my IRB Approval Note expires in 12 months, I must submit continuing review or re-approval request form to IRB.

True

False

15) A Human Subject is a living individual about whom a researcher obtains data through intervention with the individual and non-identifiable public information.

True

False

16) I want to conduct research involving my students and am planning to give them extra credit for participation. They will be asked to fill out a survey about their experience during their application process in our University. Does this qualify as coercion?

Yes because students were not offered alternative ways to get an equal number of extra credit points.

No, because they survey content does not pose more than Minimal Risk to students

Yes, because students are offered an easy way to get additional credits if they are failing the course

No, because I'm not offering pay

17) According to the Belmont Report, what principle should be applied during the selection of research subjects?

The Principle of justice

The Principle of Beneficence

The Principle of Respect for Persons

The Principles of random selection

18) According to Belmont Report, how may researcher apply the principle of "Respect for Persons" in practice? Select one:

Ensure that no harm is done to participants

Implement the consent process

Minimize possible risks

Maximize possible benefits

19) The nature and scope of risks and benefits include the following EXCEPT:

psychological

physical

social

economic

recreational

20) “A study is considered to pose no more than ___ _ to the subjects when the probability of harm or discomfort that the subjects might experience in the research is not greater in and of themselves than those ordinarily encountered in daily life and in routine interaction with others“

Usual Risk

Expected Risk

Minimal Risk

Standard Risk

21) Which two basic requirements ensure the Respect for Persons principle in research?

Acknowledging autonomy and protecting those with diminished autonomy

Selecting minimal number of participants possible and introducting informed concent process

Minimizing your sample and random selection

Minimizing the risk and maximizing the benefit

22) Paying high amount of money to participants for participation in research is not recommended because it might increase the possibility of ___________:

Coercion

Overspending the budget

Undue reward

Hard