Protecting Human Research Subject Doing it Right保护人类的研究主题.pptVIP

* * Kevin L. Nellis, MS, MT(ASCP) February 8, 2008 * Contact Information OHRP Web page: /ohrp Main Phone Number: 240-453-6900 Toll Free: 1-866-447-47771-866-HHS-HRPP Staff Phone Numbers: /ohrp/about/staff.html IRB Registration Assurance Staff: /ohrp/daqi-staff.html E-mail: ohrp@ Join Listserv: /ohrp/news/index.html * THANK YOU for protecting Human Subjects ! * * * * * * * * * * * * * * * * Kevin L. Nellis, MS, MT(ASCP) February 8, 2008 * * * * * * * * * * * * * * * Research Involving Humans! OHRP- Office For Human Subject Protections Freda E. Yoder, MA Division of Education Office for Human Research Protections (OHRP) Department of Health Human Services (HHS) NIH Regional Seminar on Program Funding and Grants Administration Philadelphia, PA – April 2010 Office for Human Research Protections Jerry Menikoff, MD, JD – Director, OHRP Melody Lin, PhD - Deputy Director Michael Carome, MD - Associate Director for Regulatory Affairs Ivor Pritchard, PhD – Senior Advisor to Director Division of Compliance Oversight Kristina Borror, PhD Director Division of Policy and Assurances Irene Stith-Coleman, PhD Director Division of Education and Development Elyse Summers, JD Director International Activities Melody Lin, PhD HHS - Office for Public Health Science Howard Koh, MD, MPH, Assistant Secretary For Health Outline HHS Regulations Applicability Protections Afforded by the Regulations Assurances IRB Review Informed Consent Reporting Requirements Compliance Oversight Procedures HHS Regulations Applicability The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979 Regulation for Protection of Human Subjects HHS regulations: Title 45 CFR part 46 Subpart A – basic HHS Policy - “The Common Rule” or Federal Policy - Basic IRB informed consent requir