The NIH Intramural Research Program’s Protocol Navigation Training Program presents, “The NIH Office of Clinical Research.”

The NIH Office of Clinical Research (OCR), located within the NIH Office of the Director, was established to facilitate clinical research and research training for the NIH Intramural Research Program (IRP) and external partners. The OCR promotes excellence in clinical research through the development of policies, procedures, and training with a goal of optimizing the IRP’s utilization of resources, and by facilitating partnerships between IRP researchers and extramural communities. The OCR also oversees the scientific review of all intramural clinical protocols.

In this presentation, John I. Gallin, M.D., Clinical Center Chief Scientific Officer and NIH Associate Director for Clinical Research, and Anne Zajicek, M.D., Pharm.D., Deputy Director of the OCR, will provide an overview of the OCR and describe some of the functions of their office. At the end of this session, participants should be able:

• To describe the training and outreach programs of the OCR;
• To understand the OCR’s oversight of the scientific review process for intramural clinical protocols; and
• To learn more about the OCR’s development of strategic partnerships with external and extramural communities.

A list of recent seminars available on the Videocast archives web site is below: 19 September 2016: AAHRPP Re-Accreditation and New Updates to the NIH HRPP SOPs 24 October 2016: Reliance Agreements and NIH Human Research Protections Program Requirements for Collaborative Research 21 November 2016: The NIH Office of Research Support and Compliance (ORSC) – the First 100 Days 20 March 2017: Panel Discussion: Improving Support for Clinical Research at the NIH 24 April 2017: The NIH Office of Research Support and Compliance (ORSC) – an Update 15 May 2017: News from the OHSRP: Informed Consent and Requests for Determination 16 October 2017: Investigational Treatments and Emerging Medicines: A Regulatory Perspective 20 November 2017: An Update on IRB Reorganization: A Panel Discussion 18 December 2017: Technology Transfer Agreements for Sharing Human Materials and Data: Policies and Procedures 19 March 2018: Common Rule Issues with Tissues 16 April 2018: The NIH IRB Consolidation and iRIS Transition 21 May 2018: Contemporary Challenges in Informed Consent

Previous seminars 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