The Institutional Review Board (IRB) shall be an advisory body to the President on the protection of human and animal subjects participating in University of West Georgia approved research projects.  It shall review all research proposals involving human and animal subjects for the purpose of protecting the physical and mental well being of participants in research projects conducted by and though the University.  The Institutional Review Board shall consist of at least seven (7) members.  Members of the Institutional Review Board shall minimally consist of the Director of Sponsored Operations (ex-officio), the Dean of the Graduate School, four faculty members, and one member of the community.  Members are appointed by Vice President for Academic Affairs to serve terms of three years each and are replaced in rotation.  Additional ad hoc members may be appointed to the IRB when necessary to comply with federal guidelines.

The University of West Georgia encourages and supports faculty’s, academic staff members' and students' efforts to engage in instruction, research and public service.  When research is conducted using University facilities or otherwise under its sponsorship, the individuals conducting the inquiry act as University representatives.  University policy requires that all research studies, including those involving human or animal subjects, shall be under the supervision of a qualified faculty/academic staff member and shall be so designated and executed as to safeguard the rights and welfare of the subjects in compliance with the U.S. Department of Health and Human Services regulations on the Protection of Human Subjects [stated in the Code of Federal Regulations (45 CFR 46 as amended and interpreted)] and on the Animal Welfare Act, Health Research Extension Act as per requirement of Section 495(b)(2) of the PHS Act.  The committee assists investigators in insuring that the rights and welfare of subjects are adequately protected.  Such research activity would include master's theses, Ed.S. research projects, doctoral dissertations, faculty research, or class-related activities, including undergraduate and graduate independent study courses.

403.01 Statement of Principles

A balance between freedom of inquiry for scholars and recognition of the ethical concerns of animal rights, peers, subjects, sponsors, government agencies, and the public at large shall be maintained by the IRB.  The members of the IRB maintain that numerous issues tied to human and animal research merit much further attention by the academic community.  The IRB strongly encourages faculty, academic staff members, student groups, departments, schools, and colleges to discuss the ethical responsibilities of scholars as they apply to research to ensure awareness and sensitivity of subjects' needs.

403.02   Protection of Human Subjects

1. Approve a proposed project.
2. Disapprove a proposed project (with justification).
3. Allow rejected project researchers ample opportunity for due process.
4. Modify a project, require alternative investigative procedures, and impose precautions.
5. Design, collect, and retain informed consent forms.
6. Require continuing project reviews throughout the research period, review complaints concerning the research, and require periodic research progress reports.
7. Terminate research found to be at extreme variance with federal compliance regulations.

403.0202 The Responsibilities of the Research Principal Investigator

It is the professional responsibility of each Principal Investigator (PI) who proposes to conduct research involving human subjects to outline in detail:  

1. The risks to which the human subjects will be exposed during the administration of the research procedures.
2. The significance of the proposed research to warrant exposure of subjects to the defined risk(s).
3. A description of safeguards and procedures employed to minimize the level of the subjects' exposure to risk.
4. A description of methodology involved in informing subjects of the exposure to research risk and an explanation of methodology to be employed in obtaining the subjects' informed consent to participation.

The PI must submit the required information and a full copy of the research proposal to the IRB requesting research project approval.  Upon receipt of IRB approval, the researcher may initiate the project.  A sample consent form is found in Section 403.0209. A consent form for use with minors is found in Section 403.0210.

403.0203 Definition of Terms

The University of West Georgia IRB adheres to the Code of Federal Regulations’ definitions for the following terms used to describe research:

Research:  A systematic investigation designed to develop or contribute to generalizable knowledge.  Activities which meet this definition constitute "research" for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes.  For example, some "demonstration" and "service" programs may include research activities [45 CFR 46.102(e)].
 
Risk:  The risks of harm anticipated in the proposed research must not be greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(g)].

Human Subject: A live human subject about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.  "Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.  "Interaction" includes communication or interpersonal contact between investigator and subject.  "Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and includes information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.  Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the information) in order to obtain information which constitutes research involving human subjects [45 CFR 46.102(f)]

403.0204  CPHS Review Procedures

Individuals at the University of West Georgia interested in conducting research involving human subjects must follow the procedures outlined below:  

1. Read Institutional Review Board application procedures at the IRB website www.westga.edu/~vpaa/irb.  Application materials are available at this site.  You may also request application materials from the IRB Chair.  Section 403.0209 contains the application.
2. Faculty and Staff submit three (3) completed applications to the IRB chair.  Students submit four (4) completed applications to the IRB chair.

403.0205 Classification of Research

Under Federal Regulation [45 CFR 46], research involving the use of human subjects is classified into three distinct categories or levels: exempt, expeditable, or nonexempt.

A. Level 1: Exempt Research

Federal Regulations mandate that very narrowly defined types of research are exempt. There are exclusive restrictions related to research involving subject populations that include prisoners, fetuses, pregnant women, children, institutionalized individuals (i.e. mentally disabled), other potentially vulnerable groups and human in vitro fertilization.  An outline of specific regulations relating to restricted research populations can be obtained from the Sponsored Operations Office.
 
Research activities in which the only involvement of human subjects will be one or more of the following categories and which do not involve sensitive or protected populations are exempt from 45 CFR 46. (NOTE:  The IRB will make the final determination as to whether a research project may be classified as "exempt").
 

1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:

1. Research on regular and special education instructional strategies.
2. Research on the effectiveness of/or the comparison among instructional techniques, curricular, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

1. Information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects.
2. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2.b) of this section if:

1. The human subjects are elected or appointed public officials or candidates for public office.
2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, 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.

5. Research and demonstration projects which are conducted by/or subject to the approval of department or agency heads and which are designed to study, evaluate, or otherwise examine:

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

6. Taste and food quality evaluation and consumer acceptance studies:

1. If wholesome foods without additives are consumed.
2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe or an 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 U.S. Department of Agriculture.
   

B. Level 2: Research Activities Which May Be Reviewed Through Expedited Review Procedures 

Federal Regulation identifies ten restricted types of research which may be reviewed by the IRB using an expedited procedure. There are exclusive restrictions related to research involving subject populations that include prisoners, fetuses, pregnant women, children, institutionalized individuals (i.e. mentally disabled), other potentially vulnerable groups and human in vitro fertilization.  An outline of specific regulations relating to restricted research populations can be obtained from the Budget and Research Services Office.
 
Research activities involving minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may be reviewed by the IRB through the expedited review procedure authorized in 46.110 of 45 CFR Part 46.
 

1. Collection of hair and nail clippings in a non-disfiguring manner deciduous teeth and permanent teeth if patient care indicated a need for extraction.
2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
3. Recording of data from subjects eighteen (18) years of age or older using noninvasive procedures routinely employed in clinical practice.  This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy.  It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography.  It does not include exposure to electromagnetic radiation outside the visible range (for example, x- ray, microwaves).
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects eighteen (18) years of age or older and who are in good health and not pregnant.
5. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
6. Voice recordings made for research purposes such as investigations of speech defects.
7. Moderate exercise by healthy volunteers.
8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
9. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
10. Research on drugs or devises for which an investigational new drug exemption is not required.

C. Level 3: Nonexempt Research

All other research must be reviewed in full by the IRB.

403.0206 Ethical Research Guidelines for Research Involving Human Participants

From the American Psychologist, June 1981, pgs. 637-638.

The decision to undertake research rests upon a considered judgment by the individual researcher about how best to contribute to knowledge and human welfare.  Having made the decision to conduct research, the investigator considers alternative directions in which research energies and resources might be invested.  On the basis of this consideration, the researcher carries out the investigation with respect and concern for the dignity and welfare of the people who participate and with cognizance of federal and state regulations and professional standards governing the conduct of research with human participants.
 

1. In planning a study, the investigator has the responsibility to make a careful evaluation of its ethical acceptability.  To the extent that the weighing of scientific and human values suggests a compromise of any principle, the investigator incurs a correspondingly serious obligation to seek ethical advice and to observe stringent safeguards to protect the rights of human participants.
2. Considering whether a participant in a planned study will be a "subject at risk," according to recognized standards, is of primary ethical concern to the investigator.
3. The investigator always retains the responsibility for ensuring ethical practice in research.  The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom, however, incur similar obligations.
4. Except in minimal-risk research, the investigator establishes a clear and fair agreement with research participants prior to their participation that clarifies the obligations and responsibilities of each.  The investigator has the obligation to honor all promises and commitments included in that agreement.  The investigator informs the participants of all aspects of the research that might reasonably be expected to influence willingness to participate and explains all other aspects of the research about which the participants inquire.  Failure to make full disclosure prior to obtaining informed consent requires additional safeguards to protect the welfare and dignity of the research participants.  Research with children or with participants who have impairments that would limit understanding and/or communications requires special safeguarding procedures.
5. Methodological requirements of a study may make the use of concealment or deception necessary.  Before conducting such a study, the investigator has a special responsibility to

1. Determine whether the use of such techniques is justified by the study's prospective scientific, educational, or applied value.
2. Determine whether alternative procedures are available that do not use concealment or deception.
3. Ensure that the participants are provided with sufficient explanation as soon as possible.

6. The investigator respects the individual's freedom to decline to participate in or to withdraw from the research at any time.  The obligations to protect this freedom require careful thought and consideration when the investigator is in a position of authority or influence over the participant.  Such positions of authority include, but are not limited to, situations in which research participation is required as part of employment or in which the participant is a student, client, or employee of the investigator.

7. The investigator protects the participant from physical and mental discomfort, harm, and danger that arise from research procedures.  If risks of such consequences exist, the investigator informs the participant of that fact.  Research procedures likely to cause serious or lasting harm to a participant are not used unless the failure to use these procedures might expose the participant to risk of greater harm, or unless the research has great potential benefit and fully informed and voluntary consent is obtained from each participant.  The participant should be informed of procedures for contacting the investigator within a reasonable time period following participation should stress, potential harm, or related questions arise.

8. After the data are collected, the investigator provides the participant with information about the nature of the study and attempts to remove any misconceptions that may have arisen.  Where scientific and human values justify delaying or withholding this information, the investigator incurs a special responsibility to monitor the research and to ensure that there are no damaging consequences for the participant.

9. Where research procedures result in undesirable consequences for the individual participant, the investigator has the responsibility to detect and remove or correct these consequences, including long-term effects.

10. Information obtained about a research participant during the course of an investigation is confidential unless otherwise agreed upon in advance.  When the possibility exists that others may obtain access to such information, this possibility, together with the plans for protecting confidentiality, is explained to the participant as part of this procedure for obtaining informed consent.

403.0207 Application Procedures                                                                             

Faculty, staff, or students who wish to conduct research must first submit application materials to the Institutional Review Board for review.  The application is available in PDF format near the end of this page.

All research will be classified as either exempt, expedited, on nonexempt.  If your participants are minors (under the age of 18), your research study will be classified as either expedited or nonexempt.  Examples of exempt research include: case studies of individuals eighteen (18) or older, analysis of existing records, and survey research conducted on adults.  Examples of expedited research include:  research comparing instructional methods used by teachers or researchers in the K12 classroom, survey research conducted on minors, and experimental studies with children where there is no greater than a minimal risk to the participants.

Expedited and exempt research can be reviewed by two members of the IRB.  If your research falls under one of these two categories, turnaround time for your application will typically be no greater than two weeks, provided that you have submitted all required paperwork.

Few research studies at UWG will be classified as nonexempt.  Any research study that puts participants at risk (defined as greater than minimal risk) will be classified as nonexempt.  An example of nonexempt research would be an exercise study in which participants were asked to run to exhaustion.  Participation could result in physical harm, which places the study under the classification of nonexempt research.  If your research is classified as nonexempt, all members of the IRB must meet for a full board review of your application.  It may take as long as 4 weeks to convene a meeting of the full board, so please plan accordingly if you think your research may be classified as nonexempt.

Please follow these procedures when submitting an application to the IRB for review:

1. Download or request the application for IRB review.
2. Complete the application, providing ALL requested information.
3. If you are a faculty member, submit 3 copies of the completed application. If you are a student, submit 4 copies of the completed application.  If you submit fewer than the required number of copies, your application will be returned to you.
4. You must collate or staple each copy of your application before sending it in. Uncollated copies will be returned to you.
5. Submit copies of your application to:

          IRB Chair
          Vice President for Academic Affairs
          University of West Georgia
          Carrollton, GA 30118

403.0208 IRB Application (PDF) http://www.westga.edu/~vpaa/irb/HumanSubjectsApplication.PDF

403.0209 Informed Consent Template (Word) http://www.westga.edu/~vpaa/irb/ConsentTemplate.doc

403.0210 Authorization for a School and Students to Participate in a Research Study Template (Word) http://www.westga.edu/~vpaa/irb/authorization.doc

403.0211 IRB Information for School Systems in West Georgia and Areas Surrounding Atlanta
  http://www.westga.edu/~vpaa/irb/IRBSchoolSystemDatabase.doc 

403.03 Animal Care and Use

403.0301 Authorization
 
The IRB of the University of West Georgia has authorized the IRB and its IACUC
to:

1. Approve a proposed project's plan for use of animal subjects.
2. Disapprove (with justification) a proposed project's use of animal subjects.
3. Establish procedures to protect the researchers' right to due process.
4. Require alternative investigative procedures and impose precautions to insure compliance with the University of West Georgia "Assurance of Compliance with Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals".
5. Conduct project reviews throughout the research period, review complaints concerning the research, and require periodic research progress reports.
6. Terminate research found to be at variance with federal compliance regulations.

403.0302 The Responsibilities of the Research Principal Investigator

It is the professional responsibility of each Principal Investigator (PI) who proposes to
conduct research involving animal subjects to outline in detail:

1. The risks to which the animal subjects will be exposed during the administration of the research procedures.
2. The significance of the proposed research to warrant the use of animal subjects.
3. A description of the space, care and food to be provided for the animal subjects.
4. A description of methodology involved for the disposal of subjects at conclusion of research and, if it involves euthanasia, the method to be used and why that method was selected.

The PI must submit the required information and a full copy of the research proposal to the IRB requesting research project approval.  Upon receipt of IRP approval, the researcher may initiate the project.

403.0303 Definition of Terms

The University of West Georgia IRB adheres to the Code of Federal Regulations definitions for the following terms used to describe research:

Research.  A systematic investigation designed to develop or contribute to generalizable knowledge.  Activities which meet this definition constitute "research" for purposes of these regulations whether or not they are supported or funded under a program which is considered research for other purposes.  For example, some "demonstration" and "service" programs may include research activities [45 CFR 46.102(e)].

403.0304   U.S. Government Principles for the Utilization and Care of Vertebrate Animals  Used in Testing, Research, and Training

The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animal requires in vivo experimentation with a wide variety of animals species.  Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible institution official shall ensure that these principles are adhered to:

1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et.seq.) and other applicable Federal laws, guidelines, and policies.
2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results.  Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedures.
7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort.  Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species maintained or studied.  In any case, veterinary care shall be provided as indicated.
8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals.  Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
9. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle B, by an appropriate review group such as the IRB.  Such exceptions should not be made solely for the purposes of teaching or demonstration.

For Guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences.

403.0305 Review Procedures

Individuals at University of West Georgia interested in conducting research involving animal subjects must follow the procedures outlined below:
 

1.  Obtain an Institutional Animal Care and Use Procedures Packet from your academic department office, the Graduate School Office, or the Office of Budget and Research Services, which contains:

1. a research procedures manual.
2. a document addressing ethical practices when conducting research with animal subjects.
3. a research proposal form.

2. Submit the original and four copies of the research proposal form to the Office of the Vice President for Academic Affairs for review by the IRB.