Session 6: Overview of Disclosure Requirements for Federally Funded Trials
Information Disclosure Administrator, Office of Research Protections
University of Pittsburgh, United States
Obligations to publicly disclose clinical trial information are rooted in law, ethics and organizational policy. Like many other major funders of clinical trials research, the United States federal government has numerous such policies in place. This session will primarily focus on policies requiring disclosure of registration information, summary results information and/or study documents, and which apply to trials funded in whole or in part by the US government. These include: 1) NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; 2) Revised Federal Policy for the Protection of Human Subjects (“Common Rule”); and 3) Other US Government Funding Agency Policies.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the main disclosure policies applied to clinical trials funded by the US Government
- Describe the who, what, when, and how of compliance with these policies
- Compare the consequences of unfamiliarity and noncompliance with these policies
Overview of Disclosure Requirements for Federally Funded Trials: Anthony Keyes, MBA, PMP
Program Administrator, Clinical Research Operations
Johns Hopkins University, United States
Overview of Disclosure Requirements for Federally Funded Trials: Diane Lehman Wilson, JD, MA
Regulatory Affairs Manager
University of Michigan Medical School Office of Regulatory Affairs, United States
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