Institutional Review Board

Certain categories of research projects that involve human and/or animal subjects are classified as exempt. While a protocol application must still be submitted to the embers of the Institutional Review Board (IRB) for examination prior to initiating the research, the intent of the review is to insure that the Exempt status applies. Unlike expedited and full review levels, exempt status research will not require written reports or records, and there will be no monitoring of the research project by the IRB. Consequently, the purpose of the IRB will be to review the research project submitted to determine if the exempt status applies.

Categories of research projects eligible for exempt status are listed below:

• Research in educational settings that involves routine educational practices such as:

Regular and special education strategies.

Comparison and contrast among techniques of instruction, curricula or classroom management methods or the effectiveness thereof.

• Research that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) when the data are recorded in such a way as to prevent subjects from being identified directly or indirectly.

• Research that involves survey, interview procedures, or the observation of public behavior(including the observation by participants), except where any of the following conditions exist:

Responses or observations are recorded in such a way as to directly identify the subject or any facsimile thereof.

Responses or observations not held in confidence so as to place the subject at risk of criminal or civil liability and/or damage the subject's financial standing or employability.

The research deals with sensitive aspects of a subject's behavior, such as illegal conduct, use of drugs, sexual behavior, or use of alcohol.

• Research that involves existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the Investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. If applicable, attach a specimens release form.

• Research projects that are conducted by or subject to approval of school, department or division heads, and that are designed to study, evaluate, or otherwise examine one or more of the following:

Public benefit or service programs.
Procedures for obtaining benefits or services under those programs.
Possible changes in or alternatives to those programs or procedures.
Possible changes in methods or levels of payment for benefits or services to under those programs.

• Taste and food quality evaluation and consumer acceptance studies that adhere to the following:

If wholesome foods without additives are consumed.

If a food is consumed that contains a food ingredient at or below the level and for use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

1. Exempted review cannot be applied to research proposals involving children as subjects. Children are defined as persons under 14 years of age. In such cases, Expedited or a Full Review will be necessary.

2. If the instrument to be used is a questionnaire or survey that has been generated or modified by the researchers, then an informal consent must also be included. In this case, the appropriate form of review is at least an Expedited Review.

TO APPLY FOR EXEMPT REVIEW STATUS

The Principal Investigator must submit to Charleston Southern University Institutional Review Board (IRB) the following:

Three (3) copies of the completed Exempt Review Application - indicate the categories that qualify this study for exempt status and complete the remainder of the application.

Three (3) copies of any surveys, specimen release forms, impact statements, or other supporting documentation to assure the members of the IRB that appropriate coordination has been completed with outside organizations or institutions (clearances to perform research or distribute surveys, etc., at any facility or institution where the research will be conducted).

Completed copies of the application and copies of the supporting materials should be sent to the Chairperson of the IRB, Dr. Christina Sinisi.

Charleston Southern University
Institutional Review Board

EXEMPTED REVIEW APPLICATION for Research Involving Human and/or Animal Subjects
(Entire application should be typed – provide highest degree with each investigator's name)

Title of Project: Evaluation of attitudes and beliefs among three different Southern Colleges

• General Information:

Investigator(s)
• Principal Investigator: Virginia DeRoma, The Citadel

Signature of Principal Investigator: _____________________________________

Date:

Phone:

e-mail:

Address:

Qualifications to perform research:

• Associate Investigator(s) – list all involved:

Lisa Ross, Ph.D., College of Charleston
Christina Sinisi, Ph.D., Charleston Southern University
Chad Weaver, Candidate for Master's Thesis
Steve Nida, Ph.D., The Citadel

If more Associate Investigators are involved with this project, insert their names on an attached sheet.

• Faculty Sponsor(s) – required for all student research projects

Name: Not Applicable

Signature of Faculty Sponsor ______________________________________

 

2. Coordination for use of facilities – if coordination is required for a laboratory, clinical space, or supervision, provide the name and signature of the individual who has the authority to provide the needed assistance or clearance. An impact statement must be attached to the application in all cases where outside coordination is required.

Coordination Required (describe): Not Applicable

Name of responsible individual: ________________________________________

 

3. Type of Proposal or Activity: o New o Renewal

Date of last IRB approval:___________________________

• Name of grant:

b. Principal Investigator listed on grant:

 

4. Expected cost of the research and method of funding (state specific name of funding source):

Government Agency or Agencies:

Foundation(s):

Corporation(s):

Organization(s):

Individual(s):

• Location of the research (where it will physically be conducted): Charleston Southern University, The Citadel, and College of Charleston

B. Provide the category or categories which qualifies this research for an Exempted Review:

• Abstract of the research proposal: See attached

• Provide an overview of the proposed research in lay language. (This abstract should be limited to no more than one page, yet it should clearly identify what will be done with the subjects, number of subjects, variables, hypothesis, methods, instrumentation or questionnaires, expected duration, and research design).

2. Risks and precautions: List any possible risks – psychological or social. Describe any special precautions to be taken to avoid these risks.

3. Confidentiality – describe procedures:

These surveys will be completely anonymous.

CHARLESTON SOUTHERN UNIVERSITY
Institutional Review Board – Review's Comments
(This space is for IRB use only)
CHARLESTON SOUTHERN UNIVERSITY
Institutional Review Board

 

EXEMPTED REVIEW CHECKLIST

• Does the abstract clearly convey the purpose of the research?

• Are risks and precautions identified in commonly understood language?

• Has the pertinent category (or categories) for an exempted review been indicated on the application?

• Have anticipated costs associated with the research been identified and addressed?

• Has the location of the research been identified, and if research is to be done with an outside investigator or clinical space off the Charleston Southern University campus, have appropriate approvals and signatures been obtained?

• Has the duration of the study and the number of subjects expected been identified?

• Are measures to insure confidentiality described?

• Are page numbers provided for the entire manuscript and has the cover page clearly indicated that this is an exempted review?

• Have all the investigators (principal, associate, and research sponsor) signed the protocol?

• Are three (3) copies of the Exempted Application attached?

• Are three (3) copies of any additional materials, such as impact statements or surveys attached?

• Has this proposal been submitted in accordance with due dates prescribed?