Presentation Archive
2022
Considerations for Modernizing the Informed Consent Process
OHSRP Education Series
December 1, 2022/Nichelle Cobb and Christine Suver
PROTECT Electronic IRB (eIRB) Go-Live Town Hall
OHSRP Education Series
November 17, 2022/Jonathan Green, Nicole Grant and Tiffany Gommel
FDA Investigational Device Exemptions (IDE): Overview and Application to Research Involving MRI
OHSRP Education Series
October 6, 2022/William Pritchard, Alan Koretsky and Lauren Reoma
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
OHSRP Education Series
August 4, 2022/Julie Eiserman and Tiffany Gommel
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
OHSRP Education Series
June 2, 2022/Sue Tindall and Meredith Mullan
The Informed Consent Process-The Good, the Bad & the Ugly
OHSRP Education Series
May 5, 2022/Katherine W. Todman and Carol Squires
Investigational Devices: What you need to know and Sponsor and Investigator Responsibilities
OHSRP Education Series
April 7, 2022/Jonathan Green and Lisa Goldfeder
Determining Whether Your Project Might Require an Exemption or IRB Review
NCI CCR Clinical Research Forum
March 21, 2022/Julie M. Eiserman
Health Literacy Considerations for Clinical Trial Communication and Decision Making
OHSRP Education Series
March 3, 2022/Dr. Aisha Langford
Regulatory Considerations in Natural History Studies
OHSRP Education Series
February 03, 2022 / Jonathan Green
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 WilsonReaccreditation of the NIH Intramural Research Program Human Research Protection Program by AAHRPP
August 5, 2021 / Heather Bridge and Chris WitwerTwo 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
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
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)
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
Overview
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