Ethics in IRB Research
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Questions and Answers

What is the Institutional Review Board (IRB) charged with? (Select all that apply)

  • Conducting research
  • Ensuring ethical research practices (correct)
  • Reviewing research proposals (correct)
  • Monitoring compliance with regulations (correct)
  • What type of review does a study using a survey with no identifiable information fall under?

    Exempt Review

    This study would qualify for an Exempt review (under category 2). This category states that any research study involving the use of educational tests, surveys, interviews, or observations of public behavior can be qualified as Exempt unless ______.

    information obtained is recorded in such a manner that human subjects can be identified

    What category does a master's degree candidate's study of junk food in convenience stores fall under?

    <p>Not Human Subjects</p> Signup and view all the answers

    Why does this study qualify as not involving human subjects?

    <p>The data collected does not meet the definition of human subjects research</p> Signup and view all the answers

    Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (Select all that apply)

    <p>Faculty Advisor/Research Monitor</p> Signup and view all the answers

    The history of ethical regulations in human subjects research began with the?

    <p>Nuremberg Code</p> Signup and view all the answers

    How can faculty researchers avoid undue influence of student subjects?

    <p>Avoid using their own students in their research</p> Signup and view all the answers

    What is one way faculty researchers can minimize the potential of undue influence?

    <p>By recruiting students from other classes</p> Signup and view all the answers

    Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

    <p>Exempt</p> Signup and view all the answers

    What does exempt research mean with respect to human subjects?

    <p>Exempt from provisions of Title 45, Part 46, Subpart A (the Common Rule)</p> Signup and view all the answers

    Which of the following studies need IRB approval?

    <p>Studies collecting data about living individuals</p> Signup and view all the answers

    What must be obtained if a study intends to collect data about living individuals?

    <p>IRB review and approval</p> Signup and view all the answers

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

    <p>All foreseeable risks and discomforts</p> Signup and view all the answers

    What must all foreseeable risks and discomforts be included in?

    <p>Informed consent</p> Signup and view all the answers

    What type of review does a dissertation study involving interviews of principals with identifiable information fall under?

    <p>Full Board Review</p> Signup and view all the answers

    A careful analysis by the IRB must be conducted if the study involves an interview where the data collected could have an impact on the principals' careers and includes ______.

    <p>identifiers of the subjects</p> Signup and view all the answers

    Study Notes

    Institutional Review Board (IRB) Responsibilities

    • Ensures ethical standards are maintained in research involving human subjects.
    • Reviews proposed research studies for ethical considerations.

    Exempt Review Category

    • Research with surveys collecting non-identifiable data about individuals' education levels, political views, and social perceptions qualifies for exempt review.

    Exempt Studies Under Category 2

    • Includes educational tests, surveys, and public behavior observations.
    • Exempt status is valid unless identifiers linking subjects to responses present risks to their privacy or well-being.

    Definition of Not Human Subjects Research

    • Studies collecting data on items instead of direct human subjects, such as analyzing junk food availability in stores, do not require human subjects review.

    Identifiers in Research

    • Any research focusing solely on non-identifiable items rather than human subjects is exempt from IRB review.
    • Federal regulations stipulate no identifiers should be collected to avoid categorization as human subjects research.

    Resources for IRB Approval Process

    • Faculty advisors or research monitors can assist with IRB inquiries.
    • The IRB office provides additional guidance and procedures for research approval.

    Ethical Regulations in Research

    • The history of ethical regulations began with significant events that highlighted the need for oversight in human subjects research.

    Avoiding Undue Influence in Research

    • Faculty researchers should not involve their own students to prevent any feelings of coercion in participation.

    Minimizing Coercion Through Recruitment

    • Recruiting students from different classes reduces risks of undue influence, enhancing participants' voluntary involvement.

    Exempt Review Characteristics

    • Exempt reviews do not require prior IRB approval but need a determination from the IRB or its designee.

    Exempt Research Definition

    • Exempt research still involves human subjects but bypasses certain federal provisions; IRB reviews ensure correct classification.

    IRB Approval Necessity

    • Mandatory IRB approval is required for studies collecting data about living individuals.
    • Informed consent documents must detail all foreseeable risks and discomforts to participants.

    Importance of Foreseeable Risks

    • Inclusion of all potential risks in consent documents promotes transparency and informed decision-making for participants.

    Full Board Review Necessity

    • Studies collecting identifiers from principals regarding potentially sensitive information require full board review due to inherent risks.

    Expedited Review Limitations

    • Some research studies cannot be expedited due to potential risks linked to identifiers; careful IRB analysis is crucial in sensitive contexts.

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    Description

    This quiz covers the responsibilities of Institutional Review Boards (IRBs), including their role in ensuring ethical standards in research involving human subjects. Learn about exempt review categories and the definition of not human subjects research, as well as the implications of identifiers in research studies.

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