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What types of research must be submitted to the IRB for review?
Who is required to obtain advance approval if humans are proposed as subjects of research?
Does all research involving human subjects require a full IRB Review?
If I believe that my project meets the requirements for an "exemption" does that mean I don't have to do anything else?
Can either I, as Principal Investigator or Faculty Advisor, or my Department Head (Chair, etc.) approve an exemption under 45 CFR 46.101 (b)?
How can I obtain an approved exemption?
How often does the IRB meet?
How long does it take to receive approval of a protocol which must be reviewed by the full IRB?
How many copies must I submit to the IRB for a protocol which requires review by the full IRB?
| Q |
What types of research must be submitted to the IRB for review? |
| A | ALL proposed studies involving a human’s direct or indirect contribution to the research process (i.e., survey, interview, comparison of teaching techniques, etc.) or a human’s participation as a research subject (i.e., a dexterity study, physical or mental task, biomedical procedure, audio/video tapes, etc.) must be submitted to the IRB office for determination of the appropriate review procedure in accordance with ESU policy. (These examples are not intended to be inclusive. For additional information or clarification of the review requirements, contact the IRB Office)..
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| Q |
Who is required to obtain advance approval if humans are proposed as subjects of research? |
| A |
Faculty, staff and students (undergraduate or graduate) must obtain IRB approval before involving humans (or data collected about or from humans) as subjects of research. If you are not sure whether this policy applies to your proposed study, please contact the IRB office to get clarification BEFORE YOU BEGIN WORK WHICH MAY NOT BE SANCTIONED BY THE UNIVERSITY. |
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| Q |
Do all research activities involving human subjects require a full IRB review? |
| A |
No. There are certain categories or research which may be granted an exemption from full Board review. See 45 CFR 46.101 (b) for general guidelines for exemption. |
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| Q |
If I believe that my project meets the requirements for an "exemption" does that mean I don’t have to do anything else? |
| A |
No. The protocol must be submitted to the IRB office, where the IRB chair will evaluate the "exempt" research status. "Exempt"e; (or an "exemption") means only that an activity does not have to be approved by the full IRB. |
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| Q |
Can either I, as Principal Investigator of Faculty Advisor, or my Department Head (Chair, etc.) approve an exemption under 45 CFR 46.101 (b)? |
| A |
No. ALL research involving human subjects must be submitted to the IRB Office in the proper format, However, investigator(s) may attach a brief memo requesting approval of their research based on the guidelines that they believe are applicable for an exemption of their proposal. |
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| Q |
How can I obtain an approved exemption? |
| A |
One complete copy of the signed Application for Use of Human Subjects in Research, with all attachments, must be submitted to the IRB office for review. If the IRB Chair approves the protocol for exemption from full-Board review, the researcher will be notified in writing as to the regulatory section under which the protocol was approved as "Exempt." The categories of research which may be considered for "exemption" are listed in 45 CFR 46.101 (b).
There can be NO EXEMPTION to the requirement for advance written approval from the IRB BEFORE any research project involving human subjects is initiated. |
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| Q |
How often does the IRB meet? |
| A |
Presently, the Board meets the third Wednesday of each month. If it is not possible to seat a quorum of members for a regularly scheduled meeting, the IRB Chair will attempt to reschedule the regular meeting for the following Wednesday (the fourth Wednesday of the month). If that is not possible, no meeting will be held during that month. |
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| Q |
How long does it take to receive approval for a protocol which must be reviewed by the full IRB? |
| A |
If the protocol is reviewed by the full IRB, the review cycle could take anywhere from one-eight weeks. The length of the review process depends on many factors, among them: how well the protocol is prepared; the extent of revisions/clarifications requested by the Board; reconciliation of subject numbers, recruitment practices, acceptable consent procedures, etc. On rare occasions, a proposed project may require significant revisions and consideration of a rewritten protocol (and/or attachments) by the Board before a final decision is granted. More often, minor revisions may be requested by the IRB and approval may be granted by the Chair upon receipt of an acceptable response to the IRB’s questions/concerns.
In any case, for any type of research requiring an IRB authorization, it is advisable to begin the IRB review process as soon as possible. |
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| Q |
How many copies must I submit to the IRB office of a protocol which requires full IRB review? |
| A |
Under current operating procedures, one (1) complete original (meaning original signatures must be on one set) PLUS seven (7) additional complete sets must be received by the IRB office seven business days prior to the scheduled meeting. NO EXCEPTIONS. |
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