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IRB Information ETSU Campus IRB Meeting Schedule and Submission Deadline ETSU/VA Medical Campus IRB Meeting Schedule and Submission Deadline Policies and Procedures Investigator's Handbook IRB Members Handbook
Request for Exemption (Back to top) What qualifies as exempt? Click here for the exempt categories of research. The principal investigator may make an initial request for study exemption under federal guidelines. The IRB Chair (or designee) will make the final determination for exemption status. Submit a completed Form 103 (.doc) bearing the original signatures and indicating exempt review in section 9, a narrative, and any applicable attachments from the list on pages 2-3 of the Form 103 (e.g., if conducting a survey, submit a copy of the survey instrument). Submit only the 1 (original) packet. No additional copies are required. Refer also to Additional Attachments. There is no submission deadline. Submit at will. Request for Expedited Review (Back to top) What qualifies for expedited review? Click here for the list of approved expedited review categories. Submit a completed Form 103 (.doc) bearing the original signatures and indicating expedited review in section 9, a narrative, and any applicable attachments from the list on pages 2-3 of the Form 103 (e.g., if conducting a survey, submit a copy of the survey instrument, advertisements to recruit subjects, testing forms, etc.). Submit also an Informed Consent Document (ICD) [unless you are applying for a waiver]. Submit 1 (original) packet plus three copies. Refer also to Additional Attachments. There is no submission deadline. Submit at will. Request for Full Review (Back to top) If the level of risk embodied within the research is above minimal risk, then by default, it must be reviewed at the level of Full Review. Submit a completed Form 103 (.doc) bearing the original signatures and indicating full review in section 9, a narrative, and any applicable attachments from the list on pages 2-3 of the Form 103 (e.g., if conducting a survey, submit a copy of the survey instrument, advertisements to recruit subjects, testing forms, etc.). Submit also an Informed Consent Document (ICD) [unless you are applying for a waiver]. Submit 1 (original) packet plus 36 copies. Submit a Curriculum Vitae or other statements of the investigator's qualification to conduct research at this this level. Clinical Trials: If available from the sponsor, submit one copy each of the research Protocol (with the cover sheet showing the amendment # and version date) and Investigator Brochure. Refer also to Additional Attachments. Submission deadlines apply. Return to IRB Home. Click on the appropriate Board (ETSU IRB for non-medical research or ETSU/VA IRB for medical research) to view the meeting dates and submission deadlines. Request for Waiver Approval (Back to top) The waiver provisions [45 CFR 46.116(c)(1) and (2), §46.116(d)(1)-(4) and §46.117(c)(1)or(2)] allow the IRB to approve a consent procedure which does not include, or which alters, some or all of the elements of the informed consent. The IRB may, under certain conditions, even waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects. To see if the research qualifies for a waiver, go to the WAIVER CHECKLIST. Submitting a Waiver Approval for Expedited Review Submitting a Waiver Approval for Full Review Request for Continuing Review (Back to top) The regulations at 45 CFR 46.109(e) require continuing review of human subjects research by an Institutional Review Board (IRB) at intervals appropriate to the degree of risk, but not less than once per year. The ETSU and VAMC policy is to provide approvals based on risks for periods not to exceed twelve months. The IRB Administration will forward, to the attention of the PI, a letter announcing the continuation review at least six weeks ahead of the continuing review due date. A Form 107, attached to the cover letter, will request the information needed necessary for the IRB to conduct a substantive, annual review of the research. Unless the research has been completed or closed, the completed Form 107, along with 2 clean copies of the most recent ICD (without the stamps affixed by the IRB Administration during the review period) must be returned as indicated by the deadline. Please note that this includes research that is currently closed to subject accrual. If an amendment is being submitted at the time of continuing review, the Form 107 should indicate a status changed to "continuing / revised." All revisions must be clearly indicated (use yellow highlighter or type changes in BOLD print). Submission deadlines will be strictly enforced. Request for Modification (Back to top) Once research has been approved by the IRB, no changes, modifications or revisions can be made prior to IRB approval [§46.103(b)(4)(iii)] except where necessary to eliminate apparent immediate hazards to the subject. Requests that are minor in nature (e.g., title change, telephone number correction) can be reviewed by expedited review procedures (reviewed and approved by the Chair or designee) with the written approval released usually within just a couple of days. Modifications submitted for approval that are determined to be "non-minor" in nature must be presented to the IRB. Non-minor modifications are changes that manipulate the risk (increase or decrease) or would serve to cause a potential subject to reconsider whether or not they would want to remain in the study (e.g., adding on 10 more needle sticks). Submit one original copy of the Request for Modification Approval Form along with any applicable attachments. Please visit the Electronic Forms page for instructions and the Amendment Request Form. |
Last updated on May 18, 2006
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