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Internal Review Board FAQs

1. What is the Institutional Review Board (IRB)?
2. How does the IRB function?
3. Does my project involve human subjects?
4. What is research?
5. Can the Board stop me from conducting my research?
6. Does the IRB serve as a scientific review panel?
7. I believe that my study is eligible for exempt status. Do I still need to complete the entire application?
8. Is anyone available to speak to classes and/or groups about the IRB process?
9. What is considered minimal risk?
10. What materials should I submit to the Human Subjects Office?
11. How long does the approval process take?
12. Will the Human Subjects Office personnel help researchers complete the applications?
13. Does the project require full IRB Review?
14. Do projects involving students in the Department of Psychology require any additional information in the consent forms?
15. When do projects require consent?
16. Is it necessary to explain to the subjects ahead of time how data from the study will be used?
17. What do I do with the consent forms once they are signed?
18. How do studies get approved?

1. What is the Institutional Review Board (IRB)?
The IRB is the Green Mountain College's committee that reviews and approves protocols for the use of human subjects in research. Federal regulations require that the IRB membership represent a variety of backgrounds, training and experience. At least one IRB member must have no formal or family connection with the University. At least one member must be a non-scientist.

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2. How does the IRB function?
See manual

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3. Does my project involve human subjects?
Human Subject refers to an individual, living or dead, about whom a researcher obtains:

1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

Intervention includes both physical procedures, by which data are gathered (for example, venipuncture), and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between researchers and subjects.

Private information includes information about behavior that occurs in a context, in which an individual can reasonably expect that no observation or recording is taking place, and information, which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, client or medical records or information obtained in an interview).

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4. What is research?
Research is defined as a systematic investigation that contributes to the larger body of knowledge of any given discipline. This includes collection of scholarly materials for theses and dissertations done by students, and investigations carried out by faculty and staff for publication and/or presentation.

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5. Can the Board stop me from conducting my research?
Yes. The IRB has the authority to disapprove, suspend or terminate research that is not carried out according to its requirements or may be associated with unexpected serious harm to subjects. Any such step shall include a statement of the IRB's reasons for its action and will be reported promptly to the principal investigator, the Vice President for Research, and the funding agency.

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6. Does the IRB serve as a scientific review panel?
No, but if a proposed project appears to lack scientific merit or rigor, or duplicate existing work with more than minimal risk to subjects, the Board is required to consider whether the benefits to individual subjects and society outweigh the potential for harm to them.

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7. I believe that my study is eligible for exempt status. Do I still need to complete the entire application?
Yes. Some research is considered to be exempt from full committee review, however, the UGA IRB requires that such activities be reviewed and approved by the HSO and be issued an approval date so that the status of the research may be annually reviewed. Only the IRB can make a determination of any exempt that may apply.

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8. Is anyone available to speak to classes and/or groups about the IRB process?
Yes, Anyone on the IRB committee.

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9. What is considered minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

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10. What materials should I submit to the Human Subjects Office?
1. An original, fully completed application. Each researcher must sign the application, and for students, the signature of a faculty advisor is also required.
2. All applicable attachments, including consent forms, surveys, interview guides, instruments, recruitment flyers, and letters of authorization from each institution involved other than the GMC.
3. One additional copy of the application and all attachments are also required.

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11. How long does the approval process take?
Up to 3 weeks.

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12. Will the Human Subjects Office personnel help researchers complete the applications?
Yes, please feel free to email the IRB at irb@greenmtn.edu.

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13. Does the project require full IRB Review?
Some projects may have criteria that do not require full IRB review. There are six administrative categories that need only to be reviewed by the Human Subjects Office and there are several categories that may be reviewed by one or more Board members for expedited review. All research that involves more than minimal risk and/or does not clearly fall into one of the administrative or expeditable categories will be reviewed at a convened meeting of the IRB. Please refer to see manual for a detailed explanation of the different levels of review.

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14. Do projects involving students in the Department of Psychology require any additional information in the consent forms?
Yes. If students are required to participate in the subject pool you must make clear the terms under which they will receive credit for full or partial participation, their freedom to not take part in all or any part of the research, and the alternative ways in which they might fulfill their course requirements. In all human-subject activities where sensitive issues of personal behavior, depression, addiction, substance abuse, dietary disorders, suicidal tendencies, sexual disorders might be revealed, you must include on the consent form sources of professional consultation and care. In addition, efforts must be made to insure that all participants are legally adults.

Because many human subject activities, particularly in Psychology, are conducted in the context of both teaching and research, you must provide the subjects with an oral or written explanation (debriefing) of the nature, design, and implications of the project even if deception is not a part of the experiment. A debriefing script or form must be submitted with the application as an attachment.

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15. When do projects require consent?
Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive consent if the project involves no more than minimal risk; the waiver doesn't adversely affect subjects; the research couldn't practicably carried out without the waiver; and, where appropriate, subjects are given information about the project afterwards. Otherwise consent must be obtained. For additional information on consent requirements see manual.

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16. Is it necessary to explain to the subjects ahead of time how data from the study will be used?
Yes. If data obtained will be made available to any person or organization other than the subject, the researcher, and the researcher’s staff, the informed consent must disclose: the person or agencies to whom information will be furnished; the purpose of the disclosure; and the nature of the information to be furnished.

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17. What do I do with the consent forms once they are signed?
You must keep the signed consent forms in a secure location. These consent forms must be retained for a period of three years after the study is complete. For some disciplines the forms and data must be kept longer. For example, the American Psychological Association requires forms and data be kept for six years.

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18. How do studies get approved?
A - Studies are reviewed by a minimum of five individuals (one is not affiliated with GMC). All voting members of the review committee must agree that the use of human subjects is acceptable.

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