University of Dubuque

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Exemption

Exemption

IRB Conditions for Exemption

Research that is minimally intrusive into human participants' personal lives, entails little or no vulnerability or risk on the part of those subjects, maintains their confidentiality, and does not seek to manipulate their behavior (beyond gathering observational, questionnaire, or interview data, and/or engaging in transparent pedagogical activities) is exempt from IRB review (beyond a cursory check by the Chair of the committee). Research proposals that meet these conditions can be approved by submitting the Request for Exemption form and receiving the Chair's signature.

Specifically, the following conditions must be met:

  • The research does not focus on special/vulnerable populations (e.g., minors*, prisoners, HIV-infected persons, addicts, victims of sexual or other forms of assault, pregnant women, fetuses, or those unable to consent for themselves because of language differences, lowered intelligence or mental acuity, etc.). (For more information, see Vulnerable subjects tab above.)

(*Below, under Additional Clarifications, see IRB exception allowing opinion surveys of college student populations that may include minors.)

  • The project does not entail recording any behavior which, if disclosed outside the research, might reasonably place subjects at risk of criminal or civil liability or be damaging to their financial standing, academic standing, employability, or reputation.
  • The researcher(s) do not participate in any of the activities being observed or manipulate the environment to elicit behavior, except the following: administering questionnaires or interviews; engaging in transparent educational activities (teaching or training); transparently participating in another culture's or organization's activities as a learner of publicly accessible information.
  • Subjects will not be deceived in any way.
  • Subjects' anonymity or confidentiality will be protected in the reporting of the research. This condition will be satisfied in one or more of the following way(s):
    • Anonymous surveys will be used.
    • Anonymous interviews or observations will be conducted. Data will be gathered via researcher notes and/or audio recordings, but NOT video recording.
    • Subjects' names and other personal identifiers will be removed from the data in the report. Data will be gathered via surveys, researcher notes, and/or audio recordings, but NOT video recording.
  • Informed consent to participate in the research will be obtained from subjects in one of the following ways:
    • Implied consent: Subjects will voluntarily take an anonymous survey or participate in an anonymous interview, and they will be informed in advance that they may, at any time, withdraw from participation or request that their data not be used by the researcher.
    • Informed consent: Before participation, subjects will be required to read and sign an informed consent slip indicating that they understand the nature of the research and give permission for their data to be used in the report. (For more information, see Informed Consent tab at the top of this page.)

Additional Clarifications Regarding Exempt/Non-Exempt Student Research Topics*:

The IRB recognizes that many student coursework research projects may involve low-level surveying (questionnaires or interviews). The following are examples of topics that do, and do not, qualify for exemption from IRB review.

Examples of Exempt Topics: Direct IRB approval is not required for a student to survey people's opinion about such topics as:

  • Opinions of political candidates or issues
  • Opinions regarding American made vs. foreign made products
  • Opinions concerning environmental issues or policies
  • Opinions about university facilities, activities, etc.
  • Opinions regarding the subject's favorite television show, preferred vacation spot, musical preference, etc.

The key element shared by these examples is that they do not require subjects to reveal anything about their personal experiences, behaviors, and/or identity. Therefore, the subjects are not considered to be placed at risk by their participation. In these cases, direct IRB approval is not required for student projects.Such research is covered under the instructor's Course Certification.

IRB exception allowing inclusion of college-student minors in exempt research: While research that focuses on minors (subjects under 18) usually requires direct IRB review, the IRB recognizes that students often survey fellow college students about their opinion on topics like those listed above, and some of those surveyed may happen to be under the age of 18. As long as the research is exempt in all other respects, the IRB will consider such college student opinion polling to be exempt from direct review (and covered under the instructor's course certification).

Examples of Student Research Topics That Are Not Exempt from Direct IRB Review: Any project that proposes to investigate behaviors and/or experiences regarding sensitive topic areas such as those listed below requires IRB approval.

  • Sexual Behavior
  • Sexual Orientation
  • AIDS or HIV
  • Incest
  • Rape or Date Rape
  • Sexual Molestation
  • Substance Use and/or Abuse
  • Eating Disorders or Behaviors
  • Contraception, Pregnancy, or Abortion
  • Questions dealing with any aspects of the subject's mental health, e.g., suicide, depression, compulsive behaviors
  • Religious Orientation and/or views
  • Veteran and/or Wartime Experiences

Course Certification does not cover research on sensitive topics such as these. The instructor must either disallow the topic or direct the student to apply for IRB approval and obtain that approval before beginning research.

* These research topic lists were adapted with permission from Xavier University's IRB website (http://www.xavier.edu/IRB/) in 2008. The University of Dubuque takes sole responsibility for the content and implementation of procedures employed by the IRB at UD. Last update: 8/5/08