2023

January

CFR 45 46 Subpart D: Vulnerable Populations – Children

Charlotte Coley describes the specific protections minor research participants receive under CFR 46 Subpart D.

February

45 CFR 46.205: Additional Criteria for Research Involving Neonates of Uncertain Viability

Charlotte Coley walks through OHRE’s checklist for the additional criteria for research involving neonates of uncertain viability described in 45 CFR 46.205.

March

AAHRPP Site Visit 2023

April

Human Research Ethics Training Tips: Code of Federal Regulations Title 45, Part 46.102: Definitions for Purposes of this Policy

OHRE Education/Training Manager, Charlotte Coley, shares her tips for navigating the federal regulations regarding research. Part 46.102 provides definitions of foundational research concepts such as “human subject,” “research,” and “legally authorized representative,” just to name a few. Charlotte talks through the nuances of 46.102 most important definitions as they apply to research at UNC.

May

Human Research Ethics Training Tips: Code of Federal Regulations Title 45, Part 46.107: IRB Membership

What qualifies you to serve on an IRB?  Charlotte Coley has the answer. 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.

June

CFR 45 46.108: IRB Functions & Operations

Charlotte Coley highlights the key clauses of Code of Federal Regulations 45 part 46.108: IRB Functions & Operations.

July

46.109 IRB Review of Research

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?” Content by Charlotte Coley.

August

How to Use the New Messaging System in IRBIS

Celeste Cantrell give a step-by-step walkthrough of the new messaging system in IRBIS and explains the benefits of a consolidated messaging platform.

September

45 CFR 46.111-114: Criteria for IRB Approval of Research and More

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 . Content by Charlotte Coley.

October

45 CFR 46.115: IRB Records

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. Content by Charlotte Coley.

November

45 CFR 46.116-117: General Requirements and Documentation of Consent

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. Content by Charlotte Coley.