Institutional Review Board (IRB)

  • Federal Wide Assurance Number: FWA00012546
  • IRB-IORG Registration Number: IORG0005181

 

Committee Members

  • Jeremy Lopuch, Chair, College of Education, Sport, and Human Sciences
  • Valerie Jepson, College of Arts and Sciences
  • Sandra Neels, College of Visual and Performing Arts
  • Jane Thomas, College of Business and Technology
  • Jason Allen, Non-Affiliated Representative
  • Sebastian van Delden, Provost and Vice President for Academic Affairs, Authorized University Representative, Ex-Officio Member
  • Kristin Smith, Director, Grants and Sponsored Research Development, Ex-Officio Member


Meeting Schedule and Submission Deadlines

Protocol due dates apply only to applications requiring Full Board review.  Expedited and Exempt reviews are conducted on an on-going basis.

Fall 2024
November 1, 2024 (Protocols due by October 25)

Spring 2025
February 20, 2025 (Protocols due by February 13)

May 14, 2025 (Protocols due by May 7)

 

What is the IRB?

The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects. The IRB is responsible for reviewing all research involving human subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision about whether or not to participate.

 

What Research Must Be Reviewed by the IRB?

The IRB reviews and monitors human subjects research that fits the definitions of research and human subject as defined by the Code of Federal Regulations. Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102 (l)). The IRB considers data gathering activities not to be within its scope of review if the data is used for non-research purposes, such as institutional evaluation, and/or if it will not result in presentation or publication. Such activities, including but not limited to course evaluations or alumni surveys, are not typically within the scope of the IRB review. A human subject is defined by Federal Regulations as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” (45 CFR 46.102(e)(1)).

Engaging in human subject research without IRB approval has serious ethical implications and violates federal policies. Students, faculty, and staff are required to submit IRB applications before embarking on any data collection. Even pilot studies should be approved by the IRB.

Ramifications for Faculty and Staff

  • Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission.
  • Many sponsors will not release funds to the University for the investigator's use without IRB approval.  Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
  • Liability issues arising from unapproved research may become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the University.
  • Suspension of Research: The University may suspend all research activities for a specified time frame as a disciplinary measure.

Ramifications for Students

  • Credit may be withheld: Winthrop may refuse to grant students course credit for research conducted without IRB approval.
  • Thesis work may not be accepted.
  • Degrees may not be awarded for work based on non-IRB reviewed projects.
  • Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
  • Funding may be withheld: IRB approval is required if you are a participant in a grant program. These programs will not release funds without IRB approval.

 

Types of IRB Review

There are three levels of IRB Review (full board, expedited, and determining if exempt from IRB oversight), determined by the nature of the protocol, level of potential risk to human subjects, and the subject population. The determination of level of review applicable to a particular study is made by the IRB. Regardless of the kind of review, all applications use the same submission form.

Convened IRB Review (Full Board)

  • Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk.
  • Studies with the possibility of physical risk, such as studies involving exercise, should include a medical history and review in order to determine whether or not a person should participate in the study. In some populations, such as the elderly, it is suggested that consent of a primary family doctor be obtained. In all situations where exercise is performed, researchers should be trained in handling emergency situations.
  • Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study.

Expedited IRB Review

Only research involving no more than minimal risk to subjects may be considered for expedited review. An expedited review is conducted by an individual reviewer or a few reviewers, rather than going to the full board.

Federal guidelines provide categories for expedited review. Examples of categories include:

  • Collection of data through noninvasive procedures (physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.)
  • Prospective collection of biological specimens for research purposes by noninvasive means (non-disfiguring hair/nail clippings; uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.)
  • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.

Exempt Review

Research with very minimal risk to human subjects and that meets one of the categories of exemption as defined by 45 CFR 46 may be exempted from full board review. Although the project does not require full board approval, the IRB chair or designee must certify the exemption before the research study begins. If the risks to human subjects appear questionable or the project does not fit into the federally defined categories for exemption, then the study must undergo either full or expedited review. Some research may qualify for an exemption if a limited IRB review is conducted. Limited review is conducted by an IRB member to ensure that appropriate privacy and confidentiality protections are in place. An exemption is granted by the IRB upon initial review of the application. Since this constitutes a review, protocols that are deemed exempt are effectively “exempt from continuing review.”


How to Request IRB Review

To request review of your proposed research project by the IRB, complete the Request for Review of Research Involving Human Subjects form, Informed Consent form, and other documents as related to your research. The signed and approved PDF of the protocol, including all attachments, must be submitted to Michele Smith, Grants and Sponsored Research Development, by the submission deadlines published above in order to be considered at that meeting if Full Board review is required. Protocols received after the submission deadline will be reviewed at the next scheduled meeting. Protocols that may qualify for an exemption or that qualify for review under the expedited process are reviewed on an on-going basis.

 

Protocol FAQs

 

Informed Consent FAQs

 

CITI Training

All members of the research team, including the primary investigator, co-researchers, research assistants, and/or faculty advisors must complete CITI Human Subject training before submitting a protocol for IRB review.

  • Required Training Course for Faculty/Staff:  Basic or Refresher
  • Required Training Course for Undergraduate Students:  Undergraduate
  • Required Training Course for Graduate Students: Basic or Refresher

Instructions to create a CITI account and additional information about CITI can be found here. Users with an account can log into the CITI Training Site.


Policies and Guidelines


Helpful Links

45CFR46: Protection of Human Subjects
Belmont Report
Human Subject Regulations- Decision Charts