Institutional Review Board (IRB)

Purpose of the Institutional Review Board 

Per the University’s Rules and Regulations, the Lincoln University Institutional Review Board (IRB) is designated as a “Special” committee (2.06). The functions of the IRB are to:

 Review all research proposals and educational experiences that involve human subjects;

  • Make recommendations to the appropriate university officials regarding the implementation of the above-mentioned proposals upon approval and/or funding;
  • Review experimental methods to be used in research involving human subjects;
  • Maintain updated assurance statements with the appropriate agencies; and
  • Maintain university compliance with appropriate government regulations.

All research involving a) university faculty or affiliated parties and b) human subjects must undergo review by the IRB. Regardless of how researchers categorize their own research, completion and approval of the IRB Research Committee is required before any data is collected.

Research proposals generally fall into one of the following categories: 

  • Full Review: Requires a full IRB Committee review.
  • Expedited: Require an expedited IRB Committee review.
  • Exempt: Exempt from review. 

Upon initial review by the chair, each initial submission will be categorized as either Exempt, Expedited Review, or Full Review. This determination will be made by adhering to the IRB Code of Regulations, as outlined by the U.S. Department of Health and Human Services. Exempt project submissions require no further exploration by the committee and are hence the quickest to be approved. Depending on both the nature of the proposed study (i.e. participant demographics, methodologies, etc.) and any related concerns identified by the IRB chair or committee, Expedited and Full reviews will take longer to obtain approval.

IRB Proposal Form

 

IRB Process

The Primary Investigator (PI) must submit an IRB application form, which can be found on this webpage. Please download and complete the application form and email it to the IRB chair. Please be thorough in your responses, especially:

  • If the proposed project involves vulnerable populations and;
  • During sections on project description, methodologies, risks, and assurances of anonymity.

The PI must also submit an “Informed Consent” form, which is also located on this webpage.

The IRB chair and/or committee will review the application to determine if the proposed project adheres to national guidelines.

The application will either be approved or returned to the PI with the request for changes or additions.

IRB Project Status Designations

  • Studies that require a Full IRB Committee review potentially pose risks to a participant that is considered more harmful than most activities of daily life. Minimal risk is defined by the Office for Human Risk Protections as “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.” Studies that require a full committee review usually require one month for completion of the review.
  • Studies that are eligible for an Expedited review do not exceed the standards for minimal risk as described above. These studies usually require a period of two to three weeks for completion of the review. For more information on expedited review, please go to this website
  • Studies that are Exempt from full or expedited committee reviews do not exceed the standards for minimal risk and require no identifying information or other data that could potentially jeopardize a participant’s social or career standing. Completion and submission of the IRB Research Proposal Form is required for studies falling into this category.

Please keep in mind that the IRB Chair and the IRB Committee are responsible for determining which designation a proposal receives. Completion of an approved informed consent document is also required for all submitted studies.

IRB Deadlines

  • During the Academic Year: As designated a “Special Committee” by the University, the IRB committee meets on the 2nd Tuesday of each month on a need-be basis to examine, review, and discuss relevant submissions.To ensure that the it be reviewed as soon as possible, please submit the application no later than the first Tuesday of the month, otherwise it will not be reviewed until the following month.
  • For Summer: Please note that the university IRB does not meet during summer months. Accordingly, please ensure that an IRB application is submitted to the board no later than the second Tuesday of April for any research projects involving human subjects anticipated during summer months.

IRB: Additional Information

Click here to learn more about the IRB Code of Regulations, as outlined by the U.S. Department of Health and Human Services.

Click here to learn more about Informed Consent. 

Lincoln University IRB Chair

Dr. Mick B. Brewer

Please submit all applications to: brewerm@lincolnu.edu