CUHSR Application Materials, 2004 Revision

Preface
Bradley University's Institutional Review Board (IRB), the Committee on the Use of Human Subjects In Research (CUHSR), is an official committee of the University. Its status and mandate are listed in the Faculty Handbook, [The regulations are under IV Guidelines for Faculty Activities: F. Principles, Rules, and Regulations Governing the use of Human Subjects in Research at Bradley University. Forms are available through: http://cuhsr.bradley.edu.   CUHSR was designed to meet all appropriate laws and regulations of the Federal Government for research using human subjects, and investigators are encouraged to obtain a copy of the most recent Federal publications.

Review Categories. Federal regulations categorize planned human subjects research into three categories: research requiring full IRB evaluation, research exempt from full Committee review and research that is expeditable. All protocols must be reviewed by the Chair of CUHSR who establishes the appropriate category of review.

Exemption/Expedited Requests
If you believe that your planned research meets the Federal criteria for exemption from full IRB review or is expeditable, you still need to submit a summary of your proposed research to the Chair of CUHSR and request a determination that the proposed research does indeed qualify as exempt from full IRB review. This request for verification of exemption may be submitted at any time, and a written response will be sent back as soon as possible (no more than two weeks during the main academic terms). Such a request should include a summary of the planned research and an explicit statement of why you believe that research is exempt, including explicit acknowledgement that certain critical risk elements will not be involved (e.g., children, drugged patients, coercion, manipulation of variables, obtrusive or invasive measurements, sensitive materials, or potential identification of participants). You cannot begin your project until you have RECEIVED notification that the Chair of the CUHSR concurs that your investigation is exempt or expedited [see also Faculty Handbook Chapter 6F, Section 10.]

Organization of Application Materials
There are three parts to these materials:
(1) Faculty Handbook's Human Subjects Section
(2) General Application Information
(3) Model Forms for Application, Statements of Consent, and

     Status Reports

General Procedures for Proposal Submission
The CUHSR meets once a month during the academic year. For a proposal to be considered, an application form must be RECEIVED one week before the scheduled meeting. Check the website or with the current chair to determine the current meeting weekday.

Anyone who has submitted a proposal is encouraged to attend the actual review of their proposal. Attendance is not required, and absence should not negatively affect the evaluation of a good, clear proposal. However, if their are omissions, ambiguities or other perceived problems in the proposal, the presence of the applicant(s) may greatly facilitate the evaluation process and speed up the process of revising the proposal to meet the requirements of the Committee. Especially if attendance is inconvenient, you may want to contact the Chair of the CUHSR and request an opinion concerning the usefulness of meeting attendance.

Send all materials to:

Jackie Ruthman, Chair, CUHSR
Department of Nursing
Bradley University, BUR 213
Peoria, IL 61625
jlr@bradley.edu