We hope that the information on this page will be helpful to you, your research team, and your study participants. Links on this page will take you to a file or website. These resources include sample protocol proposals that were previously approved by the Lynchburg IRB, a reviewer checklist, and quick guides to help you get started on proposal submissions. Credit and citations for author organizations/agencies should be given accordingly. If you encounter broken links, please contact the IRB Director at [email protected].

IRB Quick Reference Guide
This is a summary of the steps necessary to submit a research protocol proposal to the IRB. It may be useful to hand out to students in classes and/or to print and hang on a wall or bulletin board in your class or office.

Class Projects Waiver of IRB Form
The class projects waiver of the IRB form must be requested using the Google form provided under Forms and Templates on the IRB website. This document is provided to allow students and instructors to view the questions that need to be answered for a class project waiver form.

Blank Protocol Proposal Form
Protocol proposals must be requested using the Google form provided under Forms and Templates on the IRB website. This document is provided to allow researchers to view the questions that need to be answered in the Minimal Risk Research Protocol Proposal Form.

Reviewer Checklist
IRB reviewers use this checklist to determine whether researchers have thoroughly responded to all questions in the Minimal Risk Research Proposal Form. This is a Word document and may be printed and used as a checklist to help researchers before submitting a proposal to the IRB Director.

Sample Completed Protocol Proposal (Faculty)
This is an example of a completed minimal-risk research protocol proposal that was submitted for faculty research and was approved by the IRB. You may use this as a guide to determine the level of detail and type of information expected in response to each question. Personally identifying information of the researchers has been removed. The principal investigator has approved the posting of this sample for review but has NOT approved the use of the content by others. Using content from this sample without permission is considered plagiarism.

Sample Completed Protocol Proposal (Graduate Student)
This is an example of a completed minimal-risk research protocol proposal that was submitted for faculty research and was approved by the IRB. You may use this as a guide to determine the level of detail and type of information expected in response to each question. Personally identifying information of the researchers has been removed. The principal investigator has approved the posting of this sample for review but has NOT approved the use of the content by others. Using content from this sample without permission is considered plagiarism.

Sample Completed Protocol Proposal (Undergraduate Student)
This is an example of a completed minimal-risk research protocol proposal that was submitted for faculty research and was approved by the IRB. You may use this as a guide to determine the level of detail and type of information expected in response to each question. Personally identifying information of the researchers has been removed. The principal investigator has approved the posting of this sample for review but has NOT approved the use of the content by others. Using content from this sample without permission is considered plagiarism.

• Community-Based Research at the University of Lynchburg
• Student Scholar Showcase at the University of Lynchburg

• OHRP Information on the Belmont Report
• OHRP Information on the Common Rule
• 45 CFR 46
• Federal Drug Administration Human Subjects Information
• National Institutes of Health Bioethics Brochure

• Emergency Medical Care and Research: OPRR Letter (1991)
• Financial Conflict of Interest: HHS Guidance (2004) (PDF – 85 KB)
• Investigator Responsibility FAQs (PDF – 44 KB)
• Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007) (PDF – 180 KB)
• Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (Video)
• Withdrawal of Subjects from Research: Data Retention and Other Related Issues: OHRP Guidance (2010) (PDF – 45 KB

• Certificates of Confidentiality – Privacy Protection for Research Subjects: OHRP Guidance (2003) (PDF – 18.9 KB)
• Children: Information on Special Protections for Children as Research Subjects
• Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (“407”) Review Process (2005) (PDF – 113 KB)
• Children: Research with Children FAQ (PDF – 69 KB)
• HIV Serostatus, Informing Those Tested, PHS Policy (1988)
• HIV Serostatus, Sex-Partner Notification, PHS Policy (1990)
• Prisoner Research Certification
• Prisoner Research: OHRP Guidance (2003) (PDF – 67 KB)
• Prisoner Research FAQ (PDF – 69 KB)
• Research Involving Vulnerable Populations (Video)

• Becoming a Research Volunteer brochure – in English (PDF)*
• Becoming a Research Volunteer brochure – in Spanish (PDF)*

*These brochures have a place for the IRB contact information. Please place our email address in that space: [email protected].