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Protocol Navigation Training Program: Contemporary Challenges in Informed Consent (NIH Only)

Air date: Monday, May 21, 2018, 10:00:00 AM
Time displayed is Eastern Time, Washington DC Local
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Description: The NIH Intramural Research Program’s Protocol Navigation Training Program presents, “Contemporary Challenges in Informed Consent”

There are many new changes and, therefore, related new challenges to informed consent, which continues to be a mainstay of ethical clinical research. The informed consent process is becoming increasingly regulated and standardized, and new requirements have emerged relating to the revised Common Rule. However, with the new challenges have come advances in research methodologies and technologies, which could make informed consent more effective and impactful in the future.

In this presentation, Christine Grady, M.S.N., Ph.D., Chief of the Clinical Center Department of Bioethics, will provide an overview of informed consent. At the end of this session, participants should be able:

• To discuss some of the new informed consent requirements in the revised Common Rule;

• To recognize uncertainties and areas for learning and research associated with the informed consent process; and

• To identify challenges to informed consent that arise with advances in research methodologies and information technologies.

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

Previous seminars are available for viewing through GenomeTV, NHGRI’s YouTube channel, on the Protocol Navigation Training Program Seminar Series Playlist:

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:
Author: Christine Grady, MSN, PhD, NIH
Runtime: 1 hour