Presentation Archive
2024
Key Ethical Issues in Pediatric Research
IRB Review of Research Involving AI
IVDs, LDTs, FDA and CLIA: Understanding the alphabet soup of laboratory assays
OHSRP Education Series
March 7, 2024/Dr. Jonathan Green, Dr. Joseph Chinquee, Dr. Keith T. Schmidt, and Victoria Lumelski
An overview of IRB expectations when non-English speaking persons enroll in research: The importance of ensuring comprehension
To pay or not to pay: Is that the question?
2023
The Single IRB Model at the NIH: Principles, Processes, and Pitfalls
Considerations for Informed Consent in Gene Therapy Trials
Emergency Preparedness for Investigators
OHSRP Education Series
September 7, 2023/Heather Bridge, Aaron Salter, Paula Barton-Mann, Arman Sabet-Kashani & Astrid Smith
More Ethics or More Compliance: What was Dr. Beecher Trying to Tell us?
Regulations and the Secrets of Big Data: Public, Private, or What?
Tips & Tricks for Avoiding Stips: How to Increase the Odds of Achieving Speedy IRB Approval
Protocol Navigator Work Group Meeting
May 11, 2023/Julie Eiserman
Ethics of Sharing Individual-level Data from Research with Human Subjects
A How to Guide: The Use of Social Media in Research
Preventing Unplanned Pregnancies in Clinical Research--Balancing Science, Safety, and Ethics
OHSRP Education Series
March 2, 2023/ Evan Myers, MD, MPH, Walter L. Thomas Distinguished Professor of Obstetrics and Gynecology at Duke University School of Medicine
Implementing the NIH Data Management and Sharing Policy within the NIH IRP
The What, When and Why of Investigator Financial Conflict of Interest Review
OHSRP Education Series
January 19, 2023/Tonia Smith Awoniyi, Heather Bridge and Jonathan Green
2022
Considerations for Modernizing the Informed Consent Process
PROTECT Electronic IRB (eIRB) Go-Live Town Hall
FDA Investigational Device Exemptions (IDE): Overview and Application to Research Involving MRI
NIH IRB Expectations for Return of Secondary Genomic Findings to Research Participants
Re-consent and Subject Notification: Expectations and Flexibilities for Complying with the Common Rule
Overview: NIH Multi-Site Protocol Processes
Protocol Navigator Meeting
July 14, 2022/Jeffrey Rollins and Shirley Rojas
(If login is required, use NIH username followed by nih.gov. For example, if John Doe’s NIH user name is doej, enter the following to logon: doej@nih.gov)
Electronic IRB (eIRB) System Demo and Change Considerations
The Informed Consent Process-The Good, the Bad & the Ugly
Investigational Devices: What you need to know and Sponsor and Investigator Responsibilities
Determining Whether Your Project Might Require an Exemption or IRB Review
Health Literacy Considerations for Clinical Trial Communication and Decision Making
Regulatory Considerations in Natural History Studies
OHSRP Town Hall
OHSRP Education Series
January 13, 2022 / Jonathan Green, Tiffany Gommel, Heather Bridge and Meredith Mullan
2021
Benefits in research: How should we think about and communicate them?
November 4, 2021 / Christine Grady, RN, PhD
Videocast
Reframing Lessons from the Syphilis Study Done at Tuskegee (1932-1972) to Address the COVID-19 Pandemic: From Vaccine Hesitancy to Vaccine Confidence
October 7, 2021 / Stephen B. Thomas, PhD
Using and Sharing Existing Specimens and Data for Secondary Research: Expectations for Consent and IRB Approval
NIDA Clinical Rounds
October 7, 2021 / Julie Eiserman
Ethical Conduct of Research with AI/AN Participants: Extending Protections through Respect for Tribal Sovereignty
September 2, 2021 / Sara Hull and Dave Wilson
Reaccreditation of the NIH Intramural Research Program Human Research Protection Program by AAHRPP
August 5, 2021 / Heather Bridge and Chris Witwer
OHSRP Town Hall
June 3, 2021 / Jonathan Green, Tiffany Gommel and Nicole Grant
Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing?
May 4, 2021 / Peg Sanders
Responsibilities of the Principal Investigator Part 2: Implementation of a Clinical Research Protocol
April 6, 2021 / Elizabeth Ness, RN, MS
Responsibilities of the Principal Investigator Part 1: What You Need to Know & Do Before Your Protocol Starts
March 2, 2021 / Nicole Grant
iRIS Multi-Site Enhancement: Overview and Implementation
February 2, 2021 / Anthony Marchi, Jeffrey Rollins and Shirley Rojas
Secondary Research: Fact, Fiction, Fears and Fantasies
January 19, 2021 / Jonathan Green
2020
The NIH Genomic Data Sharing Policy: Applicability to the Intramural Research Program
December 1, 2020 / Kathleen Calzone
Informed Consent Procedures in the Era of Covid-19: Beyond the Use of a Standard Written Consent Document
November 17, 2020 / Julie M. Eiserman
Transition to a new eIRB System: Where we are now, and where we are going
October 06, 2020 / Jonathan Green & Meredith Mullan
NIH HRPP Policies Related to Enrollment of Pregnant Women, Participants Lacking Capacity to Provide Informed Consent, and Prisoners: Current Status and Recent Updates
September 01, 2020 / Peg Sanders
What You Need to Know About Single IRB Review: Principles and Practice (Part 2)
August 04, 2020 / Jeffrey Rollins and Shirley Rojas
What You Need to Know About Single IRB Review: Principles and Practice (Part 1)
July 07, 2020 / Jeffrey Rollins and Shirley Rojas
Understanding the NIH IRB Review Processes to Improve Submissions
June 02, 2020 / Tiffany Gommel
Making iRIS Work for YOU
May 5, 2020 / Sue Tindall
Videocast (NIH only)
What information should be included in protocols submitted to the NIH IRP IRB? AKA: How to write a protocol 101
March 3, 2020 / Tiffany Gommel, Nicole Grant
Videocast (NIH only)
Research vs Practice: Separating church from state in NIH protocols
February 4, 2020 / Jonathan Green
Videocast (NIH only)
Informed Consent One Year after the 2018 Common Rule Revisions: Updated Information and Processes
January 14, 2020 / Nicole Grant, Peg Sanders
2019
Bench to Bedside to Market: FDA Regulation of Medical Devices (Part 1)
November 4, 2019 / William Pritchard
Videocast (both parts)
Bench to Bedside to Market: FDA Regulation of Medical Devices (Part 2)
November 4, 2019 / Jonathan Green
Videocast (both parts)
Research with Children-An Ethical and IRB Perspective
October 8, 2019 / Jonathan Green
OHSRP Town Hall - September 17, 2019
September 17, 2019 / Jonathan Green
Best Practices for the Approval and Conduct of Secondary Research, including Repositories
July 9, 2019 / Julie Eiserman & Jonathan Green
Exemptions from IRB Review and the Revised Common Rule: What Has Changed and What Has Stayed the Same?
June 13, 2019 / Julie Eiserman
NIH Intramural Research Program New Policies: Reporting Research Events and Non-compliance in Human Subjects Research
May 20, 2019 / Peg Sanders
Important Changes to Informed Consent: The Regs, the Policies, the Procedures and Forms, Oh My!
April 3, 2019 / Heather Bridge
When IRB Approval is Necessary and How to Complete the New Investigator Attestation for Tech Transfer Agreements
March 18, 2019 / Julie Eiserman
Changes to the NIH IRBs and Common Rule
/ Jonathan Green, Tiffany Gommel
Overview
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