Policies and Procedures
November 2011 newsletter
March 2012 newsletter
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 new protocol submission xform in IRBManager. 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 new protocol submission xform in IRBManager. 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 new protocol submission xform in IRBManager. 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, an email announcing the continuation review at least six weeks ahead of the continuing review due date. Submit an xform 107 to request continuing review or close a study. 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 a modification request xform.
Last updated on March 26,2014
ETSU Office for the Protection of Human Research Subjects
Ross Hall fourth floor P.O. Box 70565 Johnson City, TN 37614
(423)439-6053 phone (423)439-6060 fax
© ETSU 2005