Training and Education Resources
New Video!
This video reviews 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. Published 4/1/2024.
Training Videos by Topic
General
How to Use the Updated Messaging System in IRBIS
IRB 101: Foundations of Human Subjects Protections at UNC
State of the IRB 2024
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 Part 1: Risks are Minimized
111 Part 2: Risks to Subjects are Reasonable
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.
All Videos (A-Z)
102: 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. Published 3/31/2023. Back to top
107: 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. Published 4/26/2023. Back to top
108: IRB Functions & Operations (6:35)
This video highlights the key clauses of Code of Federal Regulations 45 part 46.108: IRB Functions & Operations. Published 5/1/2023. Back to top
109: 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?” Published 6/28/2023. Back to top
111-114: 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. Published 6/23/2023. Back to top
111 Part 1: Risks are Minimized (4:12)
This video reviews 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. Published 3/3/2024. Back to top
111 Part 2: Risks to Subjects are Reasonable (4:37)
This video reviews 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. Published 4/1/2024. Back to top
115: 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. Published 9/29/2023. Back to top
116-117: 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. Published 10/31/2023. Back to top
118-120: 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. Published 12/19/2023. Back to top
122-124: 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. Published 2/5/2024. Back to top
205: 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. Published 5/31/2023. 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. Published 7/23/2023. 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. Published 9/6/203. Back to top
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. Published 5/1/2023. Back to top
Newsletters
National Institute on Minority Health Disparities (NIMHD) Quarterly Newsletter
Office of Human Research Protections (OHRP) Monthly Newsletter
Office of Dietary Supplements (ODS) Newsletter
Additional Resources
Non-Governmental Organizations (NGOs)
Glossary of Clinical Research Terms in Plain Language
The Research Clinic: An Interactive Research Integrity Exercise