Training and Education Resources

New Video!

Writing Good Stipulations (10:35)

IRBs can approve research with stipulations. Unclear stipulations from the board can be confusing and waste investigators’ time. This video shows what makes a “good” stipulation and provides examples of how to fix unclear or poorly written stipulations. PDF Script. Published 3/28/2025.

Training Videos by Topic

General

Closed-Loop Brain Stimulation for the Treatment of Psychiatric Disorders
How to Fill Out the New OHRE Reliance Intake Form
How to Use the Updated Messaging System in IRBIS
IND and IDE Exemptions: Regulations, Guidance & Case Studies
IRB 101: Foundations of Human Subjects Protections at UNC
OHRE Town Hall: Communicating with Research Participants through Email or Text
An Overview of IRB Compliance and SWAG
Protection of Pupil Rights Amendment
Research Security Review of IRB Applications Involving International Research
State of the IRB 2024
Writing Good Stipulations

The Revised Common Rule (45 Code of Federal Regulations 46)

102: Definitions for Purposes of this Policy
107: IRB Membership
108: IRB Functions & Operations
109: IRB Review of Research
111 Criteria Part 1: Risks are Minimized
111 Criteria Part 2: Risks to Subjects are Reasonable
111 Criteria Part 3: Selection of Subjects is Equitable
111 Criteria Parts 4 & 5: Informed Consent
111 Criteria Part 6: Safety Plan Monitoring
111 Criteria Part 7: Privacy and Confidentiality Protections
111-114: Criteria for IRB Approval of Research and More
115: IRB Records
116-117: General Requirements and Documentation of Consent
118-120: Indefinite or No Plans for Involving Human Subjects
122-124: Use of Federal Funds, Early Termination of Funds, and Conditions
205: Additional Criteria for Research Involving Neonates of Uncertain Viability
Subpart D: Vulnerable Populations – Children

Our library of education resources is constantly growing and by no means complete. Please complete our education request form to suggest a topic you’d like us to add. You can also meet with an IRB Analyst to discuss your IRB questions/issues during our regularly scheduled office hours.

All Videos (A-Z)

111 Criteria Part 1: Risks are Minimized (4:12)

This video reviews part one of the 111 Criteria in the Revised Common rule and provides a refresher for the minimum standards that IRBs should apply to all human subjects’ research. PDF script. Published 3/3/2024. Back to top

111 Criteria Part 2: Risks to Subjects are Reasonable (4:37)

This video reviews part two of the 111 Criteria in the Revised Common rule and provides a refresher for the minimum standards that IRBs should apply to all human subjects’ research. PDF script. Published 4/1/2024. Back to top

111 Criteria Part 3: Selection of Subjects is Equitable (5:25)

This video reviews part three of the 111 Criteria in the Revised Common rule and provides a refresher for the minimum standards that IRBs should apply to all human subjects’ research. PDF script. Published 5/1/2024. Back to top

111 Criteria Parts 4 & 5: Informed Consent (8:08)

This video reviews parts 4 and 5 of the 111 Criteria in the Revised Common rule, which describe how to properly seek and document consent. PDF script. Published 06/03/2024. Back to top

111 Criteria Part 6: Safety Plan Monitoring (9:38)

This video reviews part 6 of the 111 Criteria in the Revised Common rule, which says a research plan must make “adequate provision(s) for monitoring the data collected to ensure the safety of subjects.” But what are “adequate provisions?” and how do IRB members evaluate safety monitoring plans? PDF script. Published 7/2/2024. Back to top

111 Criteria Part 7: Privacy and Confidentiality Protections (8:37)

This video explains the difference between privacy and confidentiality, outlines the privacy and confidentiality standards a research application must meet for approval, and identifies the most common red flags to look for when reviewing a study. PDF script. Published 8/05/24. Back to top

Additional Criteria for Research Involving Neonates of Uncertain Viability (8:21)

This video walks through OHRE’s checklist for the additional criteria for research involving neonates of uncertain viability described in 45 CFR 46.205. PDF script and IRB review checklist. Published 5/31/2023. Back to top

Closed-Loop Brain Stimulation for the Treatment of Psychiatric Disorders (1:00:35)

Flavio Frohlich explains his research in brain stimulation and how neurotherapeutics may open the door for individualized, highly effective brain stimulation in psychiatry. Dr. Frohlich is a tenured associate professor in the Departments of Psychiatry and Cell Biology and Physiology, and is the director of the Carolina Center for Neurostimulation. Presented to OHRE staff and IRB members on 3/13/2025.

Criteria for IRB Approval of Research and More (7:53)

This video describes 45 CFR 46.111: Criteria for IRB Approval of Research and the following three short regulations: 46.112, 46.113, and 46.114. PDF script and slides. Published 6/23/2023. Back to top

Definitions for Purposes of this Policy (10:18)

This video walks through the nuances of 46.102’s most important definitions as they apply to research at UNC. 46.102 provides definitions of foundational research concepts such as “human subject,” “research,” and “legally authorized representative,” just to name a few. PDF script or see the IRB review checklist. Published 3/31/2023. Back to top

General Requirements and Documentation of Consent (7:03)

This video describes the basic elements of consent and how to document that consent as defined in 45 CFR 46.116-117. It also describes the limited situations in which written consent may be altered or waived. PDF script and slides. Published 10/31/2023. Back to top

IND and IDE Exemptions: Regulations, Guidance & Case Studies (44:40)

Kim Brownley, Associate Director for Policy and Initiatives at OHRE, discusses how to review human subjects research involving investigational drugs and devices. Topics include definitions and terms, key regulatory text and Guidance, and examples. Slides. Recorded on Zoom 7/18/24.

Indefinite or No Plans for Involving Human Subjects (3:07)

This video discussed the federal regulations for research that initially has indefinite or no plans to include human subjects, then the plan changes. Section 120, which outlines how research conducted or supported by a federal department is reviewed, is also discussed. PDF script. Published 12/19/2023. Back to top

IRB 101: Foundations of Human Subjects Protection at UNC (18:17)

New to research compliance? Have questions about the institutional review board (IRB)? Have no idea what an IRB is? You’re in the right place. This video introduces the makeup and mission of the IRBs at UNC, the foundational definitions and regulations that guide an IRB’s decision-making, the research and the review process at UNC. It also highlights a few landmark cases where human subject protections failed and recommends some next steps in learning about research compliance. PDF script. Published 9/6/203. Back to top

IRB Functions & Operations (6:35)

This video highlights the key clauses of Code of Federal Regulations 45 part 46.108: IRB Functions & Operations. PDF script and slides. Published 5/1/2023. Back to top

IRB Membership (12:05)

What qualifies you to serve on an IRB? This video goes in-depth into the Code of Federal Regulations Part 46.107: IRB Membership. Topics include IRB membership qualifications, unaffiliated members, defining a scientist and non-scientist, conflicts of interest, and more. PDF script. Published 4/26/2023. Back to top

IRB Records (5:05)

What needs to be recorded at an IRB meeting? Who records it and where? How long do we keep records and where do I access them? This video explains 45 CFR 46.115: IRB Records and OHRE’s SOP 1001: Documentation of Records to answer these questions. PDF script and slides. Published 9/29/2023. Back to top

IRB Review of Research (3:25)

This video explores 45 CFR 46.109: IRB Review of Research, answering the question “What is the authority and scope of the IRBs Review of Research?” PDF script and slides. Published 6/28/2023. Back to top

How to Fill Out the New OHRE Reliance Intake Form (5:59)

The Office of Human Research Ethics has a new intake form for Reliance Agreements. The new form helps Reliance staff decide whether UNC can and will agree to serve as the IRB of record for external sites. This video will show you where to find the intake form in IRBIS, how to complete it correctly, and submit it to OHRE. PDF script. Published 7/5/2024. Back to top

How to Use the Updated Messaging System in IRBIS (9:01)

A step-by-step walkthrough of the new messaging system in IRBIS and explains the benefits of a consolidated messaging platform. PDF script. Published 7/23/2023. Back to top

OHRE Town Hall: Communicating with Research Participants through Email or Text (52:58)

In this video, OHRE Director Carley Emerson walks through OHRE’s new guidance for communicating with research participants through email or text and answers audience questions. OHRE Associate Director of Operations Celeste Cantrell discusses new changes in IRBIS. Recorded on Zoom 07/11/2024. PDF of the slides.

An Overview of IRB Compliance and SWAG (8:43)

This video discusses the compliance review process as a whole, the composition of the Safety and Welfare Analysis Group (SWAG) and their role in the process, and the impact of SWAG on promoting efficiency while ensuring a quality review of an event. PDF Script. Published 1/28/25.

Protection of Pupil Rights Amendment (7:43)

How can a simple student survey turn into a Federal lawsuit? One way is to run afoul of the Protection of Pupil Rights Amendment (PPRA). In this video, Senior IRB Analyst Liz Joyce explains what the PPRA is, who it’s designed to protect, and when the law applies. She discusses what the PPRA means for research studies and describes what compliance looks like. PDF script. Published 10/18/24.

Research Security Review of IRB Applications Involving International Research (6:20)

This video covers what research security entails, which laws and policies govern international travel and research, and what the UNC Research Security Program reviews on IRB protocols in international locations. PDF script. Published 12/02/24.

State of the IRB 2024 (28:01)

OHRE Director Carley Emerson discusses the IRB’s metrics for the year 2023, such as the total number of reviewed studies and average turnaround times, and new initiatives for 2024. Recorded at the IRB Retreat on 02/15/2024 at the Rizzo Center at UNC Chapel Hill. Back to top

Subpart D: Vulnerable Populations – Children (3:56)

This video describes the specific protections minor research participants receive under CFR 46 Subpart D. PDF script and slides. Published 5/1/2023. Back to top

Use of Federal Funds, Early Termination of Funds, and Conditions (1:56)

This video covers the last three sections of the revised common rule. Section 122: Use of federal funds. Section 123: Early termination of research support: Evaluation of applications and proposals, and Section 124: Conditions. PDF script. Published 2/5/2024. Back to top