A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Proposed Changes to DHHS Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Ambiguity for Investigators
Upcoming Courses
The DHHS, the United States’ agency that houses both OHRP and the FDA, recently released its announcement for proposed rule changes to the regulations that govern the conduct of human subject research in an effort to streamline, modernize, and increase their effectiveness. Human subject protection regulations have not always kept pace with the evolution of clinical research. As a result, the regulatory requirements to which those involved in clinical research are held accountable are unclear, inconsistent, and outdated. This web seminar will review DHHS’ proposed changes to 45 CFR 46 and 21 CFR 50 and 56 and the factors driving the transformation. Specifically, recent guidance documents and legislation will be linked to better understand how the conduct of clinical research can be utilized to enhance compliance.
- Discuss the identified need to ensure review of protocols is equivalent to degree of risk
- Review the proposed model for more efficient IRB review
- Assess how amendments to the consent document and process can enhance subject protection
- Examine how changes in risks have necessitated alterations in how and which information is protected
- Explore the impact of risk-based monitoring on human subject protection
- Professionals from Academia whose institutions or investigators hold INDs or IDEs or whose institutions support clinical research with Site Management Organizations (SMOs)/Academic Research Organizations (AROs)
- Clinical Quality Assurance Auditors and Compliance Professionals
- Clinical Research Associates
- Project Managers
- Institutional Review Board Staff and Members
- Regulatory Affairs Professionals
- Clinical Research Coordinators
- Sponsor-Investigators
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-010-L01-P. Released: 1/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
