Protocol Navigation Training Program Seminar Series

The NIH Intramural Research Program’s Protocol Navigation Training Program presents “The OHSRP Education Series: Updates to NIH HRPP Policies for Reporting Events to the IRB Using the New Reportable Event Form” on Monday, May 20, 2019, 10:00 a.m. to 11:00 a.m. in Lipsett Auditorium.

This presentation will feature Jonathan Green, M.D., M.B.A., Director of the Office of Human Subjects Research Protections (OHSRP), and Peg Sanders, R.N., from the OHSRP office of Compliance and Training. This session will cover important changes coming to the reporting of research-related events within the NIH Intramural Research Program (IRP). In the coming months, OHSRP will roll out a new Reportable Event Form intended for use by clinical investigators to report unanticipated problems (UPs), major protocol deviations (PDs), non-compliance, and other reportable events to the NIH Institutional Review Boards (NIH IRBs). In addition, the way that the NIH IRBs will process and review event reports will be changing once existing IRBs are consolidated within the NIH Intramural IRB. The functions of two new entities within the OHSRP, the NIH Research Compliance Review Committee and the OHSRP office of Compliance and Training, will also be addressed.

At the end of this session, participants should: • Be informed of updates to the OHSRP policies describing research-related event reporting; • Be familiar with new terminology, investigator reporting requirements, and workflow processes for reporting research-related events using the new Reportable Event Form; • Be introduced to two new entities within the OHSRP: the NIH Research Compliance Review Committee and the OHSRP office of Compliance and Training; • Recognize and know how to fill out the new Reportable Event Form; and • Understand how to submit research-related event reports to the NIH IRBs using the new Reportable Event Form via iRIS (Integrated Research Information System), the NIH clinical protocol management and tracking system.

For more information about the OHSRP and the NIH Office of IRB Operations, please visit the following web sites: http://irbo.nih.gov/ https://ohsr.od.nih.gov/ (public site) https://ohsr.od.nih.gov/nih/index.php (NIH login required)

A list of recent seminars available on the Videocast archives web site is below:

3 April 2019: The OHSRP Education Series: Important Changes to Informed Consent 18 March 2019: The OHSRP Education Series: When IRB Approval Is Necessary and How to Complete the New Investigator Attestation for Tech Transfer Agreements 19 November 2018: The NHGRI Secondary Genomics Findings Service 15 October 2018: Moving Toward the NIH IRB 17 September 2018: The NIH Office of Clinical Research 21 May 2018: Contemporary Challenges in Informed Consent 16 April 2018: The NIH IRB Consolidation and iRIS Transition 19 March 2018: Common Rule Issues with Tissues 18 December 2017: Technology Transfer Agreements for Sharing Human Materials and Data: Policies and Procedures 20 November 2017: An Update on IRB Reorganization: A Panel Discussion 16 October 2017: Investigational Treatments and Emerging Medicines: A Regulatory Perspective 15 May 2017: News from the OHSRP: Informed Consent and Requests for Determination 24 April 2017: The NIH Office of Research Support and Compliance (ORSC) – an Update 20 March 2017: Panel Discussion: Improving Support for Clinical Research at the NIH 21 November 2016: The NIH Office of Research Support and Compliance (ORSC) – the First 100 Days 24 October 2016: Reliance Agreements and NIH Human Research Protections Program Requirements for Collaborative Research 19 September 2016: AAHRPP Re-Accreditation and New Updates to the NIH HRPP SOPs

Seminars that took place in 2012 through 2016 are available for viewing through GenomeTV, NHGRI’s YouTube channel, on the Protocol Navigation Training Program Seminar Series Playlist: https://www.youtube.com/playlist?list=PL1ay9ko4A8skercaqlHgd9E4-qP96StRc

NIH staff and contractors can subscribe to the NIH Protocol Navigation List-serv to receive informational emails about the Program and to connect with other community members interested in protocol navigation: https://list.nih.gov/cgi-bin/wa.exe?A0=protocol-navigation