Skip to:

Office of General Counsel Policies & Guidelines

Institutional Review for Research : A-110

Policy/Guideline Area

Academic Guidelines

Applicable Divisions

Community Colleges, Universities

Purpose

The purpose of this guideline is to establish the process and procedures for Institutional Review for Research by institutions governed by the Tennessee Board of Regents.

Policy/Guideline

  1. Institutional Review Boards
    1. An Institutional Review Board (IRB) is a specially constituted review body established or designated by an institution to protect the welfare of all human subjects in all research.
      1. In order to conduct human subject research, an IRB review pursuant to 45 CFR, Part 46 must be undertaken. 
        1. Any research project determined by the IRB to be subject to Federal or other regulation shall be conducted pursuant to those regulations.
        2. The IRB must conduct continuing review of non-exempt research at intervals appropriate to the degree of risk.    
        3. Exempt research studies are exempt from continuing review.
      2. All requested changes in the conduct of a study and/or changes to study documents must be approved by the appropriate IRB(s) prior to implementation of that modification. 
        1. The only exception is a change necessary to eliminate apparent immediate hazards to the research subject (21 CFR 56.108 (a) (4).
      3. Researchers must notify the IRB(s) of any unanticipated problems involving risks to subjects or others, and other events as required by institutional policy.
      4. Continuing reviews and re-approval of research must occur on or before the date when IRB approval expires.
      5. If continuing review and re-approval fails to occur by the continuing date specified by the IRB, all research activities must stop, unless the IRB finds that it is in the best interest of individual participants to continue participating in the research interventions or interaction.
        1. The individual IRB will determine if a new application or continuing review materials must be submitted before a new approval may be issued.
    2. When research involves domains under the regulation of the Food and Drug Administration (FDA), institutions will also establish an IRB and procedures for IRB approval consistent with FDA regulations.
      1. Community colleges may partner with universities or other community colleges for assistance in either developing their own IRBs or engage in a collaborative arrangement with a university to hold joint review.
      2. Within the minimum time practicable, i.e., seven (7) business days as an acceptable standard and up to a maximum time of thirty (30) days, it will be determined if the application is complete.
        1. If it is incomplete, the researcher will be notified what needs to be done to complete the application for review.
      3. Once the application is complete, it will be determined if the study is exempt pursuant to 45 CFR 46.101 (b) and (c), expedited pursuant to 45 CFR 46.101, or requires full review in accordance with the Department of Health and Human Services (DHHS) regulations.
      4. Per 45 CFR 46.114, cooperative research projects are those projects covered by this policy which involve more than one institution.
        1. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with policy.

Sources

New Guideline approved at Presidents Meeting August 11, 2009.

Contact

Mickey Sheen
615-366-4437
mickey.sheen@tbr.edu