Thank you for visiting the website for the Lynchburg IRB. Use the menu to the left of this page to navigate to specific pages of the site. Contact the IRB Director, Dr. Alisha Walker Marciano, with questions about the information on these pages.
The purpose of the 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 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.
Please visit the Resources for a Successful Application page for sample completed protocol proposals, a reviewer checklist, and other helpful resources.
Forms and Templates
Use the links below to access protocol proposal forms and templates. All research involving humans must be approved by the Lynchburg IRB. If you are not sure whether your project is considered human subjects research as defined by the federal government (45 CFR 46.102), please complete the research determination form below. If your project is for a class assignment only (ie benign research topic and no presentation/publication outside of class), please complete the class project waiver of IRB form below. See class projects policy for more details and/or if you are unsure whether your project qualifies for a class assignment waiver of IRB.
*Note: All documents should be submitted electronically using Google documents. Please share all completed documents with the IRB Director, Dr. Alisha Walker Marciano.*
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 in order to receive the research determination proposal template. If the final determination is that your project does qualify as human subjects research, then you will need to submit an application for review (see Minimal Risk and Full Board descriptions 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 in order to receive the minimal risk research protocol proposal template. Note: Please contact the IRB Director 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 in order to receive the full board protocol proposal template. Note: Please contact the IRB Director 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 in order 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 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 (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 in order to receive the class projects waiver of IRB form. Once received, the waiver may be completed by the student but the instructor MUST check a box at the bottom to indicate review prior to sharing it with the IRB Director.
Study Status Check-in: Although ongoing projects no longer require yearly renewal, researchers should complete a study status check-in form once per year to indicate whether the project is ongoing. Please complete the study status check-in request form in order to receive the study status check-in form. The IRB approval date and approval number are needed to submit the request for the form.
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 in order to receive the research closure template. Please submit the closure form within 30 days of the end of data collection.
Site Permission Form: Conducting Research Outside of the Institution: In order to conduct a research study outside of the institution (i.e. educational setting, business, etc.) it is necessary that you obtain permission from the appropriate administrator (i.e. principal, district supervisor, manager, etc.). Please complete the site permission request form in order to receive the administration permission form template. Submit the completed administration permission form with your research proposal when proposing to collect data at an off-campus site.
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 with the developmental level of the participants. Parental consent is also required unless a waiver is being requested. Please contact the IRB Director 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 for a copy of the Parental Informed Consent 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 for an IRB authorization agreement.