Types of Review

The IRB reserves the right to redirect an application to another approval route depending on the degree of risk determined by the reviewer(s).

 

Full Board Review

Full board review applies to human subjects research deemed to involve more than minimal risk or for which a wider range of expertise is required for review. In addition, full board review is required for all research activities involving vulnerable subject populations including, but not limited to: pregnant women and fetuses, international research, prisoners, and cognitively impaired/psychiatric patients.  Full board review is required for studies involving active deception.

The research proposal is presented and discussed at a meeting at which a quorum of IRB members are present. For the research to be approved, it must receive the approval of a majority of those voting members present. (Note that, in effect, an abstention counts as a negative vote.)  If assigned to full board, you have the opportunity to be available during the meeting to provide additional information or answer questions.
This approval path may require 4 to 6 weeks to complete. The Institutional Review Board meets monthly. Click here for Deadlines

Medical Board Review

Medical board review applies to human subjects research that involves the use of  blood or body fluids, ingestion, injection or inclusion of a food products, supplement, or similar product related to an intervention or evaluation and physical interventions.  If assigned to medical board, you have the opportunity to be available during the meeting to provide additional information or answer questions. These studies may require submission to Clinical Trials.gov.

Studies that involve IND or IDE or meet the FDA definition of Clinical Trail will be reviewed by an external Institutional Review Board.  The cost of external review should be included in sponsor and external budgets.  These studies must be submitted to Clinical Trials.gov prior to enrolling the first subject.

The research proposal is presented and discussed at a meeting at which a quorum of IRB members who have medical expertise are present. For the research to be approved, it must receive the approval of a majority of those voting members present. (Note that, in effect, an abstention counts as a negative vote.)
This approval path may require a minimum of  4 to 8 weeks to complete. The Medical Review Board meets on a called basis.

Expedited Review

For human subjects research involving no more than minimal risk, and for minor changes or amendments to approved research, two designated voting members review the proposed research rather than the entire IRB. It cannot be assumed that research poses minimal risk because it involves only interview or survey data collection. Sensitive questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to participants, their relatives, and others. (The same forms are used to apply for expedited or full board review.)

Expedited review categories are specified in the regulation that governs the Institutional Review Board (45 CFR 46.10).

This approval path may require a minimum of  2 to 4 weeks to complete. The Institutional Review Board designated reviewers to perform this service in addition to teaching responsibility. Review schedules may slow down during University breaks and holidays.

Exempt Review

For specific kinds of low-risk human subjects research that have a specified exemption in 45 CFR 46.10. In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption, it cannot place subjects at greater than minimal risk and cannot use high risk subjects. Exemption status does not excuse the research from meeting the ethical intent of the Belmont Report and Common Rule or from obtaining informed consent for research participation. This approval path may require a minimum of 1 to 2 weeks to complete. The following are the six exempt categories as listed in 45 CFR 46.101(b):

Category B 1

Research conducted in established or commonly accepted educational settings, involving normal educational practices.
Category B1 Exempt Form

Category B 2

Research involving only 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 participants can be identified, directly or trough identifiers linked to them. Please visit our FAQ’s for more information on anonymous survey platforms.
  2. Any disclosure of the human participant’s responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability or reputation.
  3. Survey or interview research involves children.

Category B2 Exempt Form

Category B 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 category two (B 2) of this section, if:

  1. The participants 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 be maintained throughout the research and thereafter.

Category B3 Exempt Form

Category B 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 researcher in such a manner that participants cannot be identified, directly or through identifiers linked to them.
Category B4 Exempt Form

Category B 5

Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads and which are designed to study, evaluate or otherwise examine: (a) public health benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs; (d) possible changes in methods or levels of payment for benefits or services under those programs.  (Contact ORI before selecting this exemption category. This exemption must be granted with concurrence from the funding/sponsor agency.   Click here for OPRR guidance.).

Category B5 Exempt Utilizes the Expedited IRB Format

Category B 6

Taste and food-quality evaluation and consumer acceptance studies.
Category B6 Exempt Form

These exemptions do not apply to research involving prisoners, fetuses, pregnant women, or newborns.

Further, the exemption Category B2 above does not apply to children, except in research involving observations of public behavior when the researcher(s) do not participate in the activities being observed.  Interviews, surveys, and interactive observations are not exempt, while educational tests and non-interactive observations are exempt.

Class Projects Exemption

Research involving human subjects, as part of a class project assignment, can receive exempt status. In this case, the project poses no more than minimal risk to the participants, does not involve minors, does not involve deception or videotaping, and will not be presented or disseminated outside of the institution.

Continuing Review
Research projects are reviewed annually for renewal and can be renewed as long as the project remains ongoing.  Exempt projects do not need to be renewed as long as no changes are made to the original protocol.
International Research
The rules for IRB review and exemption may differ if the bases for the institutional assurances are founded upon documents other than the Belmont Report and the Common Rule and research is conducted in countries outside the United States by foreign Principal Investigators. Research conducted in countries outside the United States by U.S.-based Principal Investigators is still covered by the US regulation. However, cultural context must be included in the evaluation of risk associated with the research. Researchers are responsible for compliance with research licensure and approvals required by: Foreign jurisdictions (compiled listing)
Non-Human Subjects Research
Some projects are not defined as human subjects research and do not require IRB approval. Projects that are not defined as human subjects research, market research for the purpose of refining or improving the quality of a service, archeological studies, and oral history where the story teller is aware that the story is being recorded for publication are examples research that does not fit the definition of human subjects research.

Last updated: 7/5/2017

Office of Research Integrity • PO Box 8005, Statesboro, GA 30460 • (912) 478-5465 • irb@georgiasouthern.edu