FAQs

General

The IRB is a federally mandated university committee established to protect the rights and welfare of human subjects participating in research projects. The IRB reviews research involving human subjects according to policies set forth by the United States Department of Health and Human Services regulations (45 CFR Part 46) and the U.S. Food and Drug Administration (21 CFR Part 56). Compliance with these federal regulations safeguards human subjects, the institution sponsoring the research project, and researchers.

Human participants are defined as: living individual(s) about whom an investigator conducting research obtains a) data through intervention or interaction (including online interaction) with the individual; or b) identifiable private information.

Examples include:

  • Individuals who are asked to complete questionnaires, participate in interviews, or whose behavior is observed in daily activities
  • Oral history interviewees whose subjective perceptions are studied
  • Student and teachers observed in the classroom for the study of various methods or development of curricula

The Department of Health and Human Services (DHHS) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Intervention includes “both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.”

  • Is the project designed to produce generalizable knowledge?
  • Generalizable knowledge builds the knowledge base of the profession is some material way.
  • Will information be collected in a systematic way?
  • Systematic means the project is conducted using step-by-step procedures organized according to a set of interrelated ideas or principles.

Research is defined as "a systematic investigation when human beings or their environment is manipulated; when information is sought from them directly (as through interview, examination, or questionnaire) or indirectly (as through observation), and when information concerning specific, individually identifiable human beings is asked for from third parties whether through access to files, data banks, or other depositories--or through direct inquiry.

Please note: You may not begin your research until the IRB has given your research protocol full unconditional approval.

Review of Exempt or Expedited protocols takes about three to four weeks. If the submitted materials need revision, the process will take longer. The review process for protocols submitted for Full Review can take a month or longer to complete. You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol.

The UWG IRB meets once every month to conduct full-board reviews. Expedited and exempt reviews occur on a rolling basis. Please remember the IRB consists primarily of UWG faculty and follows the University calendar. Review may take longer at the end of semesters and during summer; review is typically suspended over the winter break.

The University of West Georgia has assured the federal regulatory agencies that the institution will review and approve all research involving human subjects before it is initiated.

This includes research which falls into any of the following categories:

  • The research is conducted by University faculty, staff, or students
  • The procedures are performed on the premises of the University
  • The procedures are performed with or involve the use of facilities or equipment belonging to the University
  • The research involves University students, staff, or faculty
  • The research project satisfies a requirement imposed by the University as the condition for the award of a degree or certification in the University
  • The research project satisfies an obligation of the faculty appointment at the University, as consistent with departmental research goals and objectives
  • Research requiring "continuing review"
  • Research conducted by affiliated faculty/staff
  • Research conducted at another institution by UWG affiliated persons
  • Research in foreign countries conducted by UWG affiliated persons
  • Research conducted in courses (courses in research methods and class assignments involving research with human participants require IRB approval if the research project(s) will be contributing to generalizable knowledge (will be published or presented outside the university community.)
  • Faculty-supervised student research (Faculty must take an active role in ensuring that research projects are conducted in accordance with the IRB's requirements)
  • Research at a pilot or feasibility stage (pilot and feasibility studies, even those with only one human participant, require the same review as full-scale research projects. Applications to the IRB for pilot studies should be identified as such, and participants must be told during the consent process that the study is a pilot)
  • Research involving secondary use of data (projects that use data on humans gathered in earlier projects and in which individual identifiers are present require IRB review.

Some research involving oral histories incorporate systematic study leading to generalizable knowledge according to federal definitions, and therefore are subject to IRB oversight. Examples might include interviews with Iraq war veterans that are intended to draw general conclusions and learn about the impact of using National Guard soldiers in a war, or open ended interviews intending to create an archive for future research.

Some oral histories are incorporated into projects that are not defined as research under federal regulation. Examples might include folklore research or artistic creations such as documentaries, which may contain a definable point of view, but do not attempt to draw conclusions and therefore do not contribute to generalizable knowledge. Examples might include a video interview with holocaust survivors created to preserve or describe individual experiences, or interviewing a prisoner for a magazine article on prison life. Neither intends to draw conclusions or inform policy. The information is specific to a person, their experiences, and events.

Whether subject to IRB approval or not, participants in oral history projects should be allowed to review the material prior to public archive and decide if they do not wish any or all of the oral history archived.

The majority of humanities projects do not require review by the IRB. While these projects are clearly scholarly work, they do not always meet the regulatory definitions of research. There are, however, cases where the project would fall under the purview of the IRB. Studies which qualify as “research” and which involve “human subjects,” as defined in the federal regulations, would require IRB review. Examples that do not require IRB review are:

  • Interview activities that are categorized as "journalism"
  • an interview with content experts or consultants about factual issues only, in which no personal information is obtained from the interviewees
  • A Mass Communications student proposed creating a documentary film to tell the stories of street children living in a South American country. The purpose of the film was to establish a sense of urgency to help these children. This is a descriptive case study not intended to be generalizable;
  • An art student proposed producing photographs of the visual images in a poem by a famous poet. The images are of living individuals engaged in specific activities. This would also be a descriptive case study and not generalizable.

If the intended use of the data collected is solely for reporting back to the funding agency as a basis for evaluating the project, then the associated data collection activities typically do not require IRB review and approval (keep in mind that there are some federal agencies, such as the Centers for Disease Control (CDC), that may require evaluative data collection activities to receive IRB review and approval).

However, the IRB recognizes that there may be situations where you want to use the evaluation data for research purposes or to collect additional data from your project participants strictly for research purposes. In these situations, IRB review and approval of the research-related aspects are required. In either case (use of evaluation data for research or collection of additional data strictly for research) your consent document(s) should clearly differentiate the evaluation components (for which participation is generally mandatory) from the research related components (for which participation in or use of collected evaluation data is voluntary).

IRB review of classroom-related activities is not required at UWG when the collection of information from participants is exclusively for the purpose of class discussion or for the purpose of training in research or research methods*. Instructors who believe that their students’ classroom-related activity does not require IRB review may choose to submit the Classroom Research Form. Instructors who are uncertain about whether their classroom activities require IRB review should contact the Office of Research & Sponsored Projects.

Even when IRB review is not required, activities designed to collect information from human participants should protect the rights of these participants. In such cases, the instructor remains responsible for educating students about the protection of human subjects and providing ethical guidance for all student projects.

*Note: Data collected for a class project may not be used for publication or presentation outside the UWG community, unless the project was reviewed and approved by the IRB prior to recruitment and data collection. Should there be any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future (e.g., for a Senior Paper, a Master’s Thesis, by the instructor), an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection.

Generally speaking it takes three to six weeks for an IRB project to be approved. Though this may seem like a long time, the materials must be processed by the Office of Research & Sponsored Projects staff, distributed to the IRB members (a week before the meeting for Full Board Review). Most projects require revisions. Sometimes they are minor. An application that is complete, with all attachments, and proofread with no typos can be reviewed more quickly than a project submission that is incomplete or poorly prepared.

You may submit your application at any time, but you must receive IRB approval before you begin recruiting participants or collecting data. For a full board review, complete application materials must be received by the first day of the month in which the review will take place.

You should submit the appropriate application form, an informed consent form or survey cover letter, training certifications for all researchers involved, and any tests, surveys, interview questions you will be using in your study, and any recruitment materials.

Before starting an application, investigators must identify the appropriate Review Type. This determines which application is completed

  • Exempt status is for minimal risk* studies meeting specific criteria. Research is “exempt from full board review”, but an “Exempt” application must still be completed and submitted for review. Only the IRB Chair, committee members, or IRB Administrator may determine if an application meets exempt status. 
  • Expedited review is for minimal risk* studies meeting specific criteria. Protocols are generally reviewed by one primary IRB reviewer. Protocols approved under Expedited review are subject to IRB continuing review.
  • Full Board review is for protocols that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a convened IRB meeting. Examples of protocols requiring Full Board review include randomized double-blind placebo-controlled studies; Phase I, II, III and IV clinical trials. Studies asking questions about drug use, immigration status, or involving “at-risk” populations, etc. may require Full Board review.

*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

  • An observational study of the public behavior of persons at a tennis club, as long as you are not video taping or photographing the people you are observing.
  • An anonymous survey or interview (e.g., no names are collected or can be linked to the participants), as long as the survey does not cover sensitive or psychologically distressing topics
  • A study analyzing secondary data sets (e.g., Census Data or Medicare Data) where identifiers have been removed
  • Any study using archival documents that are publicly available, such as library archives or legal cases.
  • Use of personal/individual identifiers;
  • Use of minors where interaction with researchers is involved (school settings that go beyond observations or where the researcher has contact with the children, e.g. surveys or interviews);
  • The subject of research relates to sensitive information where the identities of the subjects may be capable of being recognized;
  • Audio taping or videotaping the subjects because then the subjects are not anonymous;
  • Use of vulnerable populations including minors, pregnant women, prisoners, and cognitively impaired persons. Other groups may be considered vulnerable populations based on the study design.

Examples of studies that would not be Exempt under Normal Educational Practices are:

  • Collecting privileged information such as socio-economic status, sexual information, abuse, etc.
  • Educational activities involving procedures that are rarely used and are not considered “best practice” in the field.
  • Studies that may involve normal educational practice, but are greater than minimal risk to the students.
  • A teacher surveys students in the classroom about their after-school activities. The setting is typical, but the activity is not normal education practice.
  • A teacher randomly divides the classroom into two groups and conducts an experimental educational program with one group and conducts the normal educational program with the second group for research purposes. This activity is not normal educational practice for most classrooms.

The IRB consists of faculty, researchers and members of the community at large. Individual experiences and interests cross diverse areas. Protocols should be written in layman terms to be clearly understood by members of all disciplines.

The IRB will seek assistance from qualified persons outside its membership when it receives protocols that require expertise beyond that available on the Committee. While outside experts may inform the IRB's decisions, they do not vote on research protocols presented for review.