Thank you for visiting the University of Lynchburg IRB website. Use the menu to the left of this page to navigate to specific site pages. Contact the IRB Director at [email protected] with questions about the information on these pages.

The purpose of the University of Lynchburg IRB is to perform ethical review of proposals for human subject research and to provide leadership in the development of and education on policies and procedures for the responsible and ethical conduct of human subject research. The primary concern of the University of Lynchburg IRB is the protection of the rights and welfare of human subjects involved in research conducted at or by researchers affiliated with the University of Lynchburg.

Forms and Templates

The University of Lynchburg IRB must approve all research involving humans. Use the links below to access protocol proposal forms and templates. Forms to select from include:

Research Determinations – Use this if you are unsure as to whether your project is considered human subjects research as defined by the federal government (45 CFR 46.102)

Minimal Risk Research – Use this for exempt or expedited non-federally funded research proposals

Full Board Review – Use this for non-federally funded research that involves minors or is more than minimal risk

Modifications – Use this to make changes to approved protocols

Class Projects Waiver – Use this for class assignments (i.e., a benign research topic and no presentation/publication outside of class) that involve research

Closure – Use this to close out your study after data collection is complete

*Note: All documents should be submitted electronically using Google Docs. Please share all completed documents with the IRB Director at [email protected].*

Research Determinations (assessment, evaluation, class projects, and other special activities): If you are not sure if your study qualifies as “human subjects research,” please complete the research determination request form to receive the research determination proposal template. Suppose the final determination is that your project qualifies as human subjects research. In that case, you will need to apply for review (see the descriptions of Minimal Risk Research and Full Board Review below).

Minimal Risk Research (inherently minimal risk or risk that has been sufficiently minimized): If you are conducting non-federally funded research with minimal risk to participants (formerly categorized as either exempt or expedited), please complete the minimal risk research proposal request form to receive the minimal risk research protocol proposal template. Note: Please contact the IRB Director at [email protected] to request the protocol proposal form for federally funded research.

Full Board Review (research with more than minimum risk): If you are conducting non-federally funded research with vulnerable populations (all research with minors must be reviewed at the level of full board review) and/or research with more than minimal risk, please complete the full board review research proposal request form to receive the full board protocol proposal template. Note: Please contact the IRB Director at [email protected] to request the protocol proposal form for federally funded research.

Modifications to Approved Research: If you need to update or change an approved research protocol, please complete the research modification request form to receive the research modification proposal template. Modifications to research projects may not be initiated until IRB approval has been obtained. The original approval number and the date of approval will remain as the approval of the record and will be needed to submit the request form.

Class Projects Waiver of IRB form (for projects conducted as a class assignment only): If your project is solely a classroom-directed assignment (the project cannot be on a sensitive topic such as sexual activity, abuse, rape, or drug/alcohol use and cannot be presented or published outside of the classroom), please complete the class projects waiver request form to receive the class projects waiver of IRB form. Once received, the student may complete the waiver; however, the instructor must check a box at the bottom to indicate that it has been reviewed before sharing it with the IRB Director.

Closure of Study: After a study has been completed (i.e., no further contact with human subjects), please complete the research study closure request form to receive the research closure template. Please submit the closure form within 30 days of the end of the data collection period.

Informed Assent (participants under the age of 18): Use the standard assent form for participants who are minors. Revise the assent form and language of the assent form to fit the developmental level of the participants. Parental consent is also required unless a waiver is being requested. Please contact the IRB Director at [email protected] for a copy of the standard assent form template.

Parental Informed Consent (parent/guardian of participants under the age of 18): Use the standard parental consent form for the parent/guardian of participants who are minors. Please contact the IRB Director at [email protected] for a copy of the standard assent form template.

Institutional Authorization Agreement: If you are collaborating with researchers at another institution and either a) are using the University of Lynchburg IRB as the IRB of record or b) are using another institution as the IRB of record, please contact the IRB Director at [email protected] for an IRB authorization agreement.