NIH Protocol Navigation Training: Common Rule Issues with Tissues

The objectives of this talk are:• To describe the new provisions in the Final Rule that pertain to biospecimens and associated data;• To provide background on the multiple proposals to revise the Common Rule that were published in the ANPRM and the Notice of Proposed Rulemaking (NPRM), but which, ultimately, were withdrawn from the Final Rule, including suggestions to revise the definition of human subject and to render all research uses of human biological tissue human subject research;• To discuss the potential impact on policy and practice of the new provisions in the Final Rule that regulate the collection, storage, and future research uses of biospecimens and data; and• To review best practices for consent for donation of research tissue in light of the new provisions in the Final Rule. 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...
Source: Videocast - All Events - Category: General Medicine Tags: Upcoming Events Source Type: video